A Safety Study of Galcanezumab in Participants With Migraine, With or Without Aura

• Sponsor: Eli Lilly and Company (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02614287
• Collaborator: (none)
• Enrollment: 270
• Locations: 27
• Arms: 2
• Actual Duration (Months): 32.5
• Patients Per Site: 10
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

The main purpose of this study is to evaluate the longer term safety of the study drug known as galcanezumab in participants with episodic or chronic migraine.

Condition or Disease	Intervention/Treatment	Phase
Migraine	Drug: Galcanezumab	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 270 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase 3, Long-Term, Open-Label Safety Study of LY2951742 in Patients With Migraine
• Actual Study Start Date: Nov 30, 2015
• Actual Primary Completion Date: May 12, 2017
• Actual Study Completion Date: Aug 14, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Galcanezumab 120 mg Galcanezumab 240mg given as loading dose at first dosing visit followed by 120 mg given by subcutaneous (SC) injection once a month for up to 11 months by auto injector or pre-filled syringe.	Drug: Galcanezumab; Administered SC; Other Names: LY2951742
Experimental: Galcanezumab 240 mg Galcanezumab 240 mg given by SC injection once a month for up to 12 months by auto injector or pre-filled syringe.	Drug: Galcanezumab; Administered SC; Other Names: LY2951742

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants Who Discontinued Due to Adverse Event [Baseline through Month 12]

   Adverse Event: Any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A summary of other non-serious AEs, and all SAE's, regardless of causality, is reported in the Adverse Events section.

Secondary Outcome Measures

1. Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of Galcanezumab [Baseline through Month 12]

   Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of Galcanezumab

2. Serum Concentrations of Galcanezumab [Month 12]

   Serum Concentrations of Galcanezumab.

3. Plasma Concentration of Calcitonin Gene-Related Peptide (CGRP) [Month 12]

   Plasma Concentration of Calcitonin Gene-Related Peptide (CGRP)

4. Percentage of Participants Developing Anti-Drug Antibodies to Galcanezumab [Month 1 through Month 12]

   A Treatment Emergent Anti-drug Antibody (TE ADA) evaluable participant is considered to be TE ADA+ if the participant has at least one post-baseline titer that is a 4-fold or greater increase in titer from baseline measurement. If baseline result is ADA Not Present, then the participant is TE ADA+ if there is at least one post-baseline result of ADA Present with titer >= 1: 20 (treatment-induced). There were 6 participants in the 120 mg arm who discontinued after receiving loading dose of 240mg, these participants were moved to 240mg arm for safety analysis.

5. Overall Mean Change From Baseline in the Number of Migraine Headache Days (MHD) [Baseline, Month 1 through Month 12]

   MHD: A calendar day on which a migraine headache or probable migraine headache occurred. Overall mean is derived from the average of months 1 to 12 from MMRM model. Least squares mean (LSMean) was calculated using mixed model repeated measures (MMRM) model with treatment, pooled investigative site, month, and treatment by month, baseline, and baseline by month as fixed effects.

6. Overall Mean Change From Baseline in the Number of Headache Days [Baseline, Month 1 through Month 12]

   Headache Day: A calendar day on which any type of headache occurred (including migraine, probable migraine, and non-migraine headache). Overall mean is derived from the average of months 1 to 12 from MMRM model. LSMean was calculated using MMRM model with treatment, pooled investigative site, month, and treatment by month, baseline, and baseline by month as fixed effects.

7. Percentage of Participants With Overall Reduction From Baseline ≥50% in Monthly Migraine Headache Days [Baseline, Month 1 through Month 12]

   Migraine Headache Day: A calendar day on which a migraine headache or probable migraine headache occurred. Overall percentage of participants with a given response rate were estimated from the generalized linear mixed models (GLIMMIX) model.

8. Overall Mean Change From Baseline in the Frequency of Medication Use for the Acute Treatment of Migraines or Headaches [Baseline, Month 1 through Month 12]

   Overall mean is derived from the average of months 1 to 12 from MMRM model. LSMean was calculated using MMRM model with treatment, pooled investigative site, month, and treatment by month, baseline, and baseline by month as fixed effects.

9. Overall Mean Patient Global Impression-Improvement (PGI-I) Score [Month 1 through Month 12]

   The Patient Global Impression of Improvement (PGI -I) scale is a participant-rated instrument that measures the participants own global impression of their symptom improvement. The participant was instructed as follows: "Mark the box that best describes your migraine headache condition since you started taking this medicine." Response options were on a 7-point scale in which a score of 1 indicates that the participant's condition is "very much better," a score of 4 indicates that the participant has experienced "no change," and a score of 7 indicates that the participant is "very much worse." Overall mean is derived from the average of months 1 to 12 from MMRM model. LSMean was calculated using MMRM model with treatment, pooled investigative site, month, and treatment by month, baseline PGI-S, and baseline PGI-S by month as fixed effects.

10. Overall Mean Change From Baseline on the Migraine Disability Assessment Test (MIDAS) Total Score [Baseline, Month 1 through Month 12]

    The MIDAS is a participant-rated scale which was designed to quantify headache-related disability over a 3-month period. This instrument consists of five items that reflect the number of days reported as missing or with reduced productivity at work or home, and the number of days of missed social events. Each item has a numeric response range from 0 to 90 days, if days are missed from work or home they are not counted as days with reduced productivity at work or home. The numeric responses are summed to produce a total score ranging from 0 to 270, in which a higher value is indicative of more disability. Overall mean is derived from the average of months 1 to 12 from MMRM model. LSMean was calculated using MMRM model with treatment, pooled investigative site, month, and treatment by month, baseline, and baseline by month.

11. Overall Mean Change From Baseline on the Migraine-Specific Quality of Life Questionnaire (MSQ) Version 2.1 [Baseline, Month 1 through Month 12]

    MSQv2.1 is a health status instrument,with a 4-week recall period, developed to address physical & emotional limitations of specific concern to individuals with migraine. Addressing the impact of migraine on work or daily activities, relationships with family & friends, leisure time, productivity, concentration, energy, tiredness & feelings.It consists of 14 items addressing 3 domains:(1)Role Function-Restrictive (items 1-7);(2)Role Function- Preventive (items 8-11);&(3)Emotional Function (items 12-14).Response options range from "none of the time" (value 1) to "all of the time" (value 6), & are reverse-recoded (value 6 to 1) before the domain scores are calculated. Total raw scores for each domain is the sum of the final item value for all of the items in that domain.After total raw score is computed for each domain & total score, they are transformed to a 0-100 scale with higher scores indicating a better health status & a positive change in scores reflecting functional improvement.

12. Percentage of Participants With Positive Responses on Patient Satisfaction With Medication Questionnaire-Modified (PSMQ-M) [Baseline through Month 12]

    The PSMQ-M is a self-rated scale which measures participants level of satisfaction with study medication.The scale has been modified for use in this study, assessing 3 items related to the clinical trial treatment over the past 4 weeks: satisfaction, preference, and side effects. Satisfaction responses range from "very unsatisfied" to "very satisfied" with the current treatment. Preference compares the current study medication to previous medications, with responses from "much rather prefer my previous medication" to "much rather prefer the medication administered to me during the study".

13. Number of Participant Visits With Positive Reponses by Device Type Subcutaneous Administration Assessment Questionnaire Q1, Q3-Q12 [Baseline through Month 12]

    The SQAAQ is a self-administered questionnaire that provides an assessment of ease of use and confidence with using a device to administer a subcutaneous injection of study drug. Participants will respond to questionnaire items using a 7-point Likert scale (from "Strongly Disagree" to "Strongly Agree") shortly after the injection. If a caregiver administers the injection, the participants should be prepared to provide the caregiver's ratings of the questions.strongly agree & agree are considered as positive responses.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Have a diagnosis of episodic or chronic migraine as defined by International Headache Society (IHS) International Classification of Headache Disorders (ICHD)-3 beta guidelines (1.1, 1.2 or 1.3) (ICHD-3 2013), with a history of migraine headaches of at least 1 year prior to screening, and migraine onset prior to age 50.

• Prior to baseline, a history of 4 or more migraine headache days per month on average for the past 3 months.

Exclusion Criteria:

• Are currently enrolled in or have participated within the last 30 days or within 5 half-lives (whichever is longer) in a clinical trial involving an investigational product.

• Current use or prior exposure to galcanezumab or another CGRP antibody.

• Known hypersensitivity to multiple drugs, monoclonal antibodies or other therapeutic proteins, or to galcanezumab.

• History of persistent daily headache, cluster headache or migraine subtypes including hemiplegic (sporadic or familial) migraine, ophthalmoplegic migraine, and migraine with brainstem aura (basilar-type migraine) defined by IHS ICHD-3 beta.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	California Medical Clinic for Headache	Santa Monica	California	United States	90404
2	Encompass Clinical Research	Spring Valley	California	United States	91978
3	New England Institute for Clinical Research	Stamford	Connecticut	United States	06905
4	Sunrise Clinical Research	Hollywood	Florida	United States	33021
5	Jacksonville Center for Clinical Research	Jacksonville	Florida	United States	32216
6	Mercy Health Research	Saint Louis	Missouri	United States	63141
7	Albuquerque Neurosciences	Albuquerque	New Mexico	United States	87109
8	PharmQuest	Greensboro	North Carolina	United States	27408
9	Wilmington Health Associates	Wilmington	North Carolina	United States	28401
10	Suburban Research Associates	Media	Pennsylvania	United States	19063
11	Clinpoint Trial, LLC	Waxahachie	Texas	United States	75165
12	Ericksen Research and Development	Clinton	Utah	United States	84015
13	Blue Ridge Research Center	Roanoke	Virginia	United States	24018
14	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Brugge		Belgium	8000
15	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Brussel		Belgium	1090
16	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Liege		Belgium	4000
17	For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.	Calgary		Canada	T3M 1M4
18	For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.	Sherbrooke		Canada	J1H1Z1
19	For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.	Toronto		Canada	M4S 1Y2
20	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Marseille		France	13385
21	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Nice		France	6000
22	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Paris		France	75010
23	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Saint Etienne		France	42055
24	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Budapest		Hungary	1083
25	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Esztergom		Hungary	2500
26	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Gyor		Hungary	9023
27	Ponce School of Medicine CAIMED Center	Ponce		Puerto Rico	00716

Sponsors and Collaborators

• Eli Lilly and Company

Investigators

• Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Study Documents (Full-Text)

• Study Protocol - Sep 23, 2015
• Statistical Analysis Plan - Nov 23, 2015

More Information

Publications

None provided.

• Responsible Party: Eli Lilly and Company
• ClinicalTrials.gov Identifier: NCT02614287
• Other Study ID Numbers: 15770; I5Q-MC-CGAJ; 2015-001884-38
• First Posted: Nov 25, 2015
• Last Update Posted: Jun 17, 2020
• Last Verified: Jun 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by Eli Lilly and Company: prevention; prophylaxis; headache
• Additional relevant MeSH terms: Migraine Disorders

Study Results

Participant Flow

Arm/Group Title	Galcanezumab 120 mg	Galcanezumab 240 mg
Arm/Group Description	Participants received a loading dose of 240 milligram (mg) galcanezumab at first dosing visit followed by120 mg galcanezumab once a month by subcutaneous injection during open label treatment phase. Participants did not receive any intervention during post treatment follow-up phase.	Participants received 240 mg of galcanezumab once a month by subcutaneous injection during open label treatment phase. Participants did not receive any intervention during post treatment follow-up phase.
Period Title: Open Label (OL) Treatment Phase
STARTED	135	135
Received at Least One Dose of Study Drug	135	135
COMPLETED	97	113
NOT COMPLETED	38	22
Period Title: Open Label (OL) Treatment Phase
STARTED	112	124
COMPLETED	103	119
NOT COMPLETED	9	5

Baseline Characteristics

Arm/Group Title	Galcanezumab 120 mg	Galcanezumab 240 mg	Total
Arm/Group Description	Participants received a loading dose of 240 mg galcanezumab at first dosing visit followed by 120 mg galcanezumab once a month by subcutaneous injection during open label treatment phase & participants did not receive any intervention during post treatment follow-up phase.	Participants received 240 mg galcanezumab once a month by subcutaneous injection during open label treatment phase & participants did not receive any intervention during post treatment follow-up phase.	Total of all reporting groups
Overall Participants	135	135	270
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	40.21 (11.68)	43.69 (10.99)	41.95 (11.45)
Sex: Female, Male (Count of Participants)
Female	110 81.5%	113 83.7%	223 82.6%
Male	25 18.5%	22 16.3%	47 17.4%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	12 8.9%	20 14.8%	32 11.9%
Not Hispanic or Latino	115 85.2%	108 80%	223 82.6%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	2 1.5%	0 0%	2 0.7%
Native Hawaiian or Other Pacific Islander	1 0.7%	0 0%	1 0.4%
Black or African American	6 4.4%	8 5.9%	14 5.2%
White	103 76.3%	108 80%	211 78.1%
More than one race	23 17%	19 14.1%	42 15.6%
Unknown or Not Reported	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants Who Discontinued Due to Adverse Event
Description	Adverse Event: Any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A summary of other non-serious AEs, and all SAE's, regardless of causality, is reported in the Adverse Events section.
Time Frame	Baseline through Month 12

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least one dose of study drug. There were 6 participants in the 120 mg group who discontinued after receiving loading dose of 240mg, these participants were moved to 240mg group for AE analysis.

Arm/Group Title	Galcanezumab 120 mg	Galcanezumab 240 mg
Arm/Group Description	Participants received a loading dose of 240 mg galcanezumab at first dosing visit followed by 120 mg galcanezumab once a month by subcutaneous injection 11 months.	Participants received 240 mg of galcanezumab once a month by subcutaneous injection for 12 months.
Measure Participants	129	141
Number [Percentage of Participants]	4.65 3.4%	4.96 3.7%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Galcanezumab 120 mg, Galcanezumab 240 mg
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	1
	Comments
	Method	Fisher Exact
	Comments

2. Secondary Outcome

Title	Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of Galcanezumab
Description	Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of Galcanezumab
Time Frame	Baseline through Month 12

Outcome Measure Data

Analysis Population Description

Zero participants analyzed. AUC data was not collected as AUC was not pre-specified in protocol.

Arm/Group Title	Galcanezumab 120 mg	Galcanezumab 240 mg
Arm/Group Description	Participants received a loading dose of 240 mg galcanezumab at first dosing visit followed by 120 mg galcanezumab once a month by subcutaneous injection for 11 months.	Participants received 240 mg of galcanezumab once a month by subcutaneous injection for 12 months.
Measure Participants	0	0

3. Secondary Outcome

Title	Serum Concentrations of Galcanezumab
Description	Serum Concentrations of Galcanezumab.
Time Frame	Month 12

Outcome Measure Data

Analysis Population Description

All randomized participants with measurable serum concentrations at month 12.

Arm/Group Title	Galcanezumab 120 mg	Galcanezumab 240 mg
Arm/Group Description	Participants received a loading dose of 240 mg galcanezumab at first dosing visit followed by 120 mg galcanezumab once a month by subcutaneous injection for 12 months.	Participants received 240 mg of galcanezumab once a month by subcutaneous injection for 12 months.
Measure Participants	61	78
Mean (Standard Deviation) [Nanogram per milliliter (ng/mL)]	16500 (8370)	31600 (15900)

4. Secondary Outcome

Title	Plasma Concentration of Calcitonin Gene-Related Peptide (CGRP)
Description	Plasma Concentration of Calcitonin Gene-Related Peptide (CGRP)
Time Frame	Month 12

Outcome Measure Data

Analysis Population Description

All randomized participants with measurable plasma concentration.

Arm/Group Title	Galcanezumab 120 mg	Galcanezumab 240 mg
Arm/Group Description	Participants received a loading dose of 240 mg galcanezumab at first dosing visit followed by 120 mg galcanezumab once a month by subcutaneous injection for 11 months.	Participants received 240 mg of galcanezumab once a month by subcutaneous injection for 12 months.
Measure Participants	87	103
Mean (Standard Deviation) [ng/mL]	2.74 (1.07)	3.85 (1.85)

5. Secondary Outcome

Title	Percentage of Participants Developing Anti-Drug Antibodies to Galcanezumab
Description	A Treatment Emergent Anti-drug Antibody (TE ADA) evaluable participant is considered to be TE ADA+ if the participant has at least one post-baseline titer that is a 4-fold or greater increase in titer from baseline measurement. If baseline result is ADA Not Present, then the participant is TE ADA+ if there is at least one post-baseline result of ADA Present with titer >= 1: 20 (treatment-induced). There were 6 participants in the 120 mg arm who discontinued after receiving loading dose of 240mg, these participants were moved to 240mg arm for safety analysis.
Time Frame	Month 1 through Month 12

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least one dose of study drug and had baseline and at least one post baseline evaluable data for TE ADA.

Arm/Group Title	Galcanezumab 120 mg	Galcanezumab 240 mg
Arm/Group Description	Participants received a loading dose of 240 mg galcanezumab at first dosing visit followed by 120 mg galcanezumab once a month by subcutaneous injection for 11 months.	Participants received 240 mg of galcanezumab once a month by subcutaneous injection for 12 months.
Measure Participants	129	137
Number [Percentage of Participants]	12.40 9.2%	7.30 5.4%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Galcanezumab 120 mg, Galcanezumab 240 mg
	Comments	TE ADA Positive (TE ADA+)
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.215
	Comments
	Method	Fisher Exact
	Comments

6. Secondary Outcome

Title	Overall Mean Change From Baseline in the Number of Migraine Headache Days (MHD)
Description	MHD: A calendar day on which a migraine headache or probable migraine headache occurred. Overall mean is derived from the average of months 1 to 12 from MMRM model. Least squares mean (LSMean) was calculated using mixed model repeated measures (MMRM) model with treatment, pooled investigative site, month, and treatment by month, baseline, and baseline by month as fixed effects.
Time Frame	Baseline, Month 1 through Month 12

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least one dose of study drug and had baseline & at least one post baseline value.

Arm/Group Title	Galcanezumab 120 mg	Galcanezumab 240 mg
Arm/Group Description	Participants received a loading dose of 240 mg galcanezumab at first dosing visit followed by 120 mg galcanezumab once a month by subcutaneous injection for 11 months.	Participants received 240 mg of galcanezumab once a month by subcutaneous injection for 12 months.
Measure Participants	132	135
Least Squares Mean (Standard Error) [Migraine Headache Days per Month]	-5.61 (0.34)	-6.47 (0.33)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Galcanezumab 120 mg, Galcanezumab 240 mg
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.60
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	LSMean Difference
	Estimated Value	-0.86
	Confidence Interval	(2-Sided) 95%; -1.76 to 0.04
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.46
	Estimation Comments

7. Secondary Outcome

Title	Overall Mean Change From Baseline in the Number of Headache Days
Description	Headache Day: A calendar day on which any type of headache occurred (including migraine, probable migraine, and non-migraine headache). Overall mean is derived from the average of months 1 to 12 from MMRM model. LSMean was calculated using MMRM model with treatment, pooled investigative site, month, and treatment by month, baseline, and baseline by month as fixed effects.
Time Frame	Baseline, Month 1 through Month 12

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least one dose of study drug and had baseline & at least one post baseline Value.

Arm/Group Title	Galcanezumab 120 mg	Galcanezumab 240 mg
Arm/Group Description	Participants received a loading dose of 240 mg galcanezumab at first dosing visit followed by 120 mg galcanezumab once a month by subcutaneous injection for 11 months.	Participants received 240 mg of galcanezumab once a month by subcutaneous injection for 12 months.
Measure Participants	132	135
Least Squares Mean (Standard Error) [Headache Days per Month]	-2.17 (0.30)	-2.09 (0.30)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Galcanezumab 120 mg, Galcanezumab 240 mg
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.835
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	LSMean Difference
	Estimated Value	0.09
	Confidence Interval	(2-Sided) 95%; -0.72 to 0.89
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.41
	Estimation Comments

8. Secondary Outcome

Title	Percentage of Participants With Overall Reduction From Baseline ≥50% in Monthly Migraine Headache Days
Description	Migraine Headache Day: A calendar day on which a migraine headache or probable migraine headache occurred. Overall percentage of participants with a given response rate were estimated from the generalized linear mixed models (GLIMMIX) model.
Time Frame	Baseline, Month 1 through Month 12

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least one dose of study drug and had baseline & at least one post baseline value.

Arm/Group Title	Galcanezumab 120 mg	Galcanezumab 240 mg
Arm/Group Description	Participants received a loading dose of 240 mg galcanezumab at first dosing visit followed by 120 mg galcanezumab once a month by subcutaneous injection for 11 months.	Participants received 240 mg of galcanezumab once a month by subcutaneous injection for 12 months.
Measure Participants	95	112
Number [percentage of Participants]	65.6 48.6%	73.7 54.6%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Galcanezumab 120 mg, Galcanezumab 240 mg
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.063
	Comments
	Method	CPLRM
	Comments	CPLRM: Categorical pseudo likelihood-based repeated measures model
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.467
	Confidence Interval	(2-Sided) 95%; 0.979 to 2.197
	Parameter Dispersion	Type: Value:
	Estimation Comments

9. Secondary Outcome

Title	Overall Mean Change From Baseline in the Frequency of Medication Use for the Acute Treatment of Migraines or Headaches
Description	Overall mean is derived from the average of months 1 to 12 from MMRM model. LSMean was calculated using MMRM model with treatment, pooled investigative site, month, and treatment by month, baseline, and baseline by month as fixed effects.
Time Frame	Baseline, Month 1 through Month 12

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least one dose of study drug and had baseline and at least one post baseline value.

Arm/Group Title	Galcanezumab 120 mg	Galcanezumab 240 mg
Arm/Group Description	Participants received a loading dose of 240 mg galcanezumab at first dosing visit followed by 120 mg galcanezumab once a month by subcutaneous injection for 11 months.	Participants received 240 mg of galcanezumab once a month by subcutaneous injection for 12 months.
Measure Participants	132	135
Least Squares Mean (Standard Error) [Medication Used Days per Month]	-5.09 (0.38)	-5.05 (0.37)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Galcanezumab 120 mg, Galcanezumab 240 mg
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.937
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	LSMean Difference
	Estimated Value	0.04
	Confidence Interval	(2-Sided) 95%; -0.96 to 1.04
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.51
	Estimation Comments

10. Secondary Outcome

Title	Overall Mean Patient Global Impression-Improvement (PGI-I) Score
Description	The Patient Global Impression of Improvement (PGI -I) scale is a participant-rated instrument that measures the participants own global impression of their symptom improvement. The participant was instructed as follows: "Mark the box that best describes your migraine headache condition since you started taking this medicine." Response options were on a 7-point scale in which a score of 1 indicates that the participant's condition is "very much better," a score of 4 indicates that the participant has experienced "no change," and a score of 7 indicates that the participant is "very much worse." Overall mean is derived from the average of months 1 to 12 from MMRM model. LSMean was calculated using MMRM model with treatment, pooled investigative site, month, and treatment by month, baseline PGI-S, and baseline PGI-S by month as fixed effects.
Time Frame	Month 1 through Month 12

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least one dose of study drug and had at least one post baseline value.

Arm/Group Title	Galcanezumab 120 mg	Galcanezumab 240 mg
Arm/Group Description	Participants received a loading dose of 240 mg galcanezumab at first dosing visit followed by 120 mg galcanezumab once a month by subcutaneous injection for 11 months.	Participants received 240 mg of galcanezumab once a month by subcutaneous injection for 12 months.
Measure Participants	130	135
Least Squares Mean (Standard Error) [units on a scale]	2.18 (0.08)	1.99 (0.08)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Galcanezumab 120 mg, Galcanezumab 240 mg
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.073
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	LSMean Difference
	Estimated Value	-0.19
	Confidence Interval	(2-Sided) 95%; -0.40 to 0.02
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.10
	Estimation Comments

11. Secondary Outcome

Title	Overall Mean Change From Baseline on the Migraine Disability Assessment Test (MIDAS) Total Score
Description	The MIDAS is a participant-rated scale which was designed to quantify headache-related disability over a 3-month period. This instrument consists of five items that reflect the number of days reported as missing or with reduced productivity at work or home, and the number of days of missed social events. Each item has a numeric response range from 0 to 90 days, if days are missed from work or home they are not counted as days with reduced productivity at work or home. The numeric responses are summed to produce a total score ranging from 0 to 270, in which a higher value is indicative of more disability. Overall mean is derived from the average of months 1 to 12 from MMRM model. LSMean was calculated using MMRM model with treatment, pooled investigative site, month, and treatment by month, baseline, and baseline by month.
Time Frame	Baseline, Month 1 through Month 12

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least one dose of study drug and had baseline and at least one post baseline value.

Arm/Group Title	Galcanezumab 120 mg	Galcanezumab 240 mg
Arm/Group Description	Participants received a loading dose of 240 mg of galcanezumab at first dosing visit followed by 120 mg galcanezumab once a month by subcutaneous injection for 11 months.	Participants received 240 mg of galcanezumab once a month by subcutaneous injection for 12 months.
Measure Participants	124	130
Least Squares Mean (Standard Error) [units on a scale]	-33.58 (2.11)	-32.67 (2.04)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Galcanezumab 120 mg, Galcanezumab 240 mg
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.747
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	LSMean Difference
	Estimated Value	0.91
	Confidence Interval	(2-Sided) 95%; -4.65 to 6.47
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 2.82
	Estimation Comments

12. Secondary Outcome

Title	Overall Mean Change From Baseline on the Migraine-Specific Quality of Life Questionnaire (MSQ) Version 2.1
Description	MSQv2.1 is a health status instrument,with a 4-week recall period, developed to address physical & emotional limitations of specific concern to individuals with migraine. Addressing the impact of migraine on work or daily activities, relationships with family & friends, leisure time, productivity, concentration, energy, tiredness & feelings.It consists of 14 items addressing 3 domains:(1)Role Function-Restrictive (items 1-7);(2)Role Function- Preventive (items 8-11);&(3)Emotional Function (items 12-14).Response options range from "none of the time" (value 1) to "all of the time" (value 6), & are reverse-recoded (value 6 to 1) before the domain scores are calculated. Total raw scores for each domain is the sum of the final item value for all of the items in that domain.After total raw score is computed for each domain & total score, they are transformed to a 0-100 scale with higher scores indicating a better health status & a positive change in scores reflecting functional improvement.
Time Frame	Baseline, Month 1 through Month 12

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least one dose of study drug and had baseline and at least one post baseline value. Overall mean is derived from the average of months 1 to 12.LSMean was calculated using MMRM model with treatment, pooled investigative site, month, and treatment by month, baseline, and baseline by month as fixed effects.

Arm/Group Title	Galcanezumab 120 mg	Galcanezumab 240 mg
Arm/Group Description	Participants received a loading dose of 240 mg of galcanezumab at first dosing visit followed by 120 mg galcanezumab once a month by subcutaneous injection for 11 months.	Participants received 240 mg of galcanezumab once a month by subcutaneous injection for 12 months.
Measure Participants	130	135
Total Score	28.27 (1.16)	30.25 (1.13)
Role Function-Restrictive Domain	31.55 (1.20)	33.40 (1.16)
Role Function-Preventive Domain	22.08 (1.11)	23.33 (1.08)
Emotional Function Domain	28.92 (1.35)	32.01 (1.31)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Galcanezumab 120 mg, Galcanezumab 240 mg
	Comments	Total Score
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.203
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	LSMean Difference
	Estimated Value	1.98
	Confidence Interval	(2-Sided) 95%; -1.07 to 5.03
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.55
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Galcanezumab 120 mg, Galcanezumab 240 mg
	Comments	Role Function-Restrictive Domain Score
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.247
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	LSMean Difference
	Estimated Value	1.85
	Confidence Interval	(2-Sided) 95%; -1.29 to 4.98
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.59
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Galcanezumab 120 mg, Galcanezumab 240 mg
	Comments	Role Function-Preventive Domain Score
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.399
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	LSMean Difference
	Estimated Value	1.26
	Confidence Interval	(2-Sided) 95%; -1.67 to 4.19
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.49
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Galcanezumab 120 mg, Galcanezumab 240 mg
	Comments	Emotional Function Domain Score
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.88
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	LSMean Difference
	Estimated Value	3.09
	Confidence Interval	(2-Sided) 95%; -0.46 to 6.64
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.80
	Estimation Comments

13. Secondary Outcome

Title	Percentage of Participants With Positive Responses on Patient Satisfaction With Medication Questionnaire-Modified (PSMQ-M)
Description	The PSMQ-M is a self-rated scale which measures participants level of satisfaction with study medication.The scale has been modified for use in this study, assessing 3 items related to the clinical trial treatment over the past 4 weeks: satisfaction, preference, and side effects. Satisfaction responses range from "very unsatisfied" to "very satisfied" with the current treatment. Preference compares the current study medication to previous medications, with responses from "much rather prefer my previous medication" to "much rather prefer the medication administered to me during the study".
Time Frame	Baseline through Month 12

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least one dose of study drug and had month 12 PSMQ-M measurement.

Arm/Group Title	Galcanezumab 120 mg	Galcanezumab 240 mg
Arm/Group Description	Participants received a loading dose of 240 mg galcanezumab at first dosing visit followed by 120 mg galcanezumab once a month by subcutaneous injection for 11 months.	Participants received 240 mg of galcanezumab once a month by subcutaneous injection for 12 months.
Measure Participants	90	112
Satisfaction: Very satisfied	57.78 42.8%	58.04 43%
Satisfaction: Somewhat satisfied	18.89 14%	15.18 11.2%
Preference: Much prefer study medication	66.67 49.4%	63.39 47%
Preference: Prefer study medication	22.22 16.5%	17.86 13.2%
Side effects: Much less side effects	66.67 49.4%	50.89 37.7%
Side effects: Less side effects	14.44 10.7%	30.36 22.5%

14. Secondary Outcome

Title	Number of Participant Visits With Positive Reponses by Device Type Subcutaneous Administration Assessment Questionnaire Q1, Q3-Q12
Description	The SQAAQ is a self-administered questionnaire that provides an assessment of ease of use and confidence with using a device to administer a subcutaneous injection of study drug. Participants will respond to questionnaire items using a 7-point Likert scale (from "Strongly Disagree" to "Strongly Agree") shortly after the injection. If a caregiver administers the injection, the participants should be prepared to provide the caregiver's ratings of the questions.strongly agree & agree are considered as positive responses.
Time Frame	Baseline through Month 12

Outcome Measure Data

Analysis Population Description

All randomized participants who switched from pre-filled syringe and received at least one dose of study drug by autoinjector.

Arm/Group Title	Galcanezumab 120 mg	Galcanezumab 240 mg
Arm/Group Description	Participants received a loading dose of 240 mg galcanezumab at first dosing visit followed by 120 mg galcanezumab once a month by subcutaneous injection for 11 months.	Participants received 240 mg of galcanezumab once a month by subcutaneous injection for 12 months.
Measure Participants	84	95
Measure Number of participant visits	899	1032
Pre-filled Syringe : Easy to learn how to use	611 452.6%	688 509.6%
Pre-filled Syringe : Easy to hold in hand	589 436.3%	660 488.9%
Pre-filled Syringe : Easy to inject my dose	580 429.6%	659 488.1%
Pre-filled Syringe : Easy to know dose is complete	615 455.6%	703 520.7%
Pre-filled Syringe: Easy to store device in fridge	536 397%	630 466.7%
Pre-filled Syringe : Easy to remove needle shield	610 451.9%	699 517.8%
Pre-filled Syringe : Easy to pickup	610 451.9%	693 513.3%
Pre-filled Syringe : overall, easy to use	600 444.4%	663 491.1%
Pre-filled Syringe:Dvc is stable against skin	590 437%	652 483%
Pre-filled Syringe:Confident in ability to use	580 429.6%	654 484.4%
Pre-filled Syringe : Confident my dose is complete	618 457.8%	708 524.4%
Autoinjector : Easy to learn how to use	250 185.2%	265 196.3%
Autoinjector : Easy to hold in hand	247 183%	267 197.8%
Autoinjector : Easy to inject my dose	245 181.5%	265 196.3%
Autoinjector : Easy to know dose is complete	241 178.5%	261 193.3%
Autoinjector : Easy store device in fridge	230 170.4%	256 189.6%
Autoinjector : Easy to remove needle shield	250 185.2%	268 198.5%
Autoinjector : Easy to pickup	251 185.9%	271 200.7%
Autoinjector : Overall, easy to use	251 185.9%	262 194.1%
Autoinjector : Dvc is stable against skin	244 180.7%	264 195.6%
Autoinjector : Confident in ability to use	247 183%	260 192.6%
Autoinjector : Confident my dose is complete	244 180.7%	263 194.8%

Adverse Events

Time Frame	Up to 421 days
Adverse Event Reporting Description	All randomized participants. There were 6 participants in the 120 mg open label arm who discontinued after receiving loading dose of 240mg, these participants were moved to 240mg arm for AE analysis. Per protocol, AE analysis was planned per treatment regimen received.
Arm/Group Title	Galcanezumab 120 mg - Open Label Phase		Galcanezumab 240 mg - Open Label Phase		Galcanezumab 120 mg - Post-treatment Phase		Galcanezumab 240 mg - Post-treatment Phase
Arm/Group Description	Participants received a loading dose of 240 mg galcanezumab at first dosing visit followed by 120 mg Galcanezumab once a month by subcutaneous injection for 11 months.		Participants received 240 mg of galcanezumab once a month by subcutaneous injection for 12 months.		Participants did not receive any intervention.		Participants did not receive any intervention.
All Cause Mortality
	Galcanezumab 120 mg - Open Label Phase		Galcanezumab 240 mg - Open Label Phase		Galcanezumab 120 mg - Post-treatment Phase		Galcanezumab 240 mg - Post-treatment Phase
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/129 (0%)		0/141 (0%)		0/112 (0%)		0/124 (0%)
Serious Adverse Events
	Galcanezumab 120 mg - Open Label Phase		Galcanezumab 240 mg - Open Label Phase		Galcanezumab 120 mg - Post-treatment Phase		Galcanezumab 240 mg - Post-treatment Phase
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/129 (2.3%)		7/141 (5%)		3/112 (2.7%)		2/124 (1.6%)
Gastrointestinal disorders
Diverticulum intestinal	0/129 (0%)	0	1/141 (0.7%)	1	0/112 (0%)	0	0/124 (0%)	0
General disorders
Non-cardiac chest pain	0/129 (0%)	0	1/141 (0.7%)	1	0/112 (0%)	0	0/124 (0%)	0
Hepatobiliary disorders
Cholecystitis	0/129 (0%)	0	1/141 (0.7%)	1	0/112 (0%)	0	0/124 (0%)	0
Infections and infestations
Endocarditis	0/129 (0%)	0	0/141 (0%)	0	1/112 (0.9%)	1	0/124 (0%)	0
Infective aneurysm	0/129 (0%)	0	0/141 (0%)	0	1/112 (0.9%)	1	0/124 (0%)	0
Pneumonia	0/129 (0%)	0	1/141 (0.7%)	1	0/112 (0%)	0	0/124 (0%)	0
Injury, poisoning and procedural complications
Subarachnoid haemorrhage	0/129 (0%)	0	0/141 (0%)	0	1/112 (0.9%)	1	0/124 (0%)	0
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion	0/129 (0%)	0	1/141 (0.7%)	1	0/112 (0%)	0	0/124 (0%)	0
Osteoarthritis	1/129 (0.8%)	1	0/141 (0%)	0	0/112 (0%)	0	0/124 (0%)	0
Pain in extremity	0/129 (0%)	0	1/141 (0.7%)	1	0/112 (0%)	0	0/124 (0%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant	0/129 (0%)	0	0/141 (0%)	0	1/112 (0.9%)	1	0/124 (0%)	0
Malignant melanoma	0/129 (0%)	0	0/141 (0%)	0	0/112 (0%)	0	1/124 (0.8%)	1
Nervous system disorders
Lumbar radiculopathy	1/129 (0.8%)	1	0/141 (0%)	0	0/112 (0%)	0	0/124 (0%)	0
Migraine	1/129 (0.8%)	1	0/141 (0%)	0	0/112 (0%)	0	0/124 (0%)	0
Pineal gland cyst	0/129 (0%)	0	0/141 (0%)	0	0/112 (0%)	0	1/124 (0.8%)	1
Reproductive system and breast disorders
Haemorrhagic ovarian cyst	0/104 (0%)	0	0/119 (0%)	0	1/91 (1.1%)	1	0/106 (0%)	0
Surgical and medical procedures
Uterine leiomyoma embolisation	0/104 (0%)	0	1/119 (0.8%)	1	0/91 (0%)	0	0/106 (0%)	0
Other (Not Including Serious) Adverse Events
	Galcanezumab 120 mg - Open Label Phase		Galcanezumab 240 mg - Open Label Phase		Galcanezumab 120 mg - Post-treatment Phase		Galcanezumab 240 mg - Post-treatment Phase
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	76/129 (58.9%)		83/141 (58.9%)		6/112 (5.4%)		8/124 (6.5%)
Gastrointestinal disorders
Nausea	10/129 (7.8%)	11	9/141 (6.4%)	15	1/112 (0.9%)	1	0/124 (0%)	0
General disorders
Injection site bruising	5/129 (3.9%)	5	8/141 (5.7%)	10	0/112 (0%)	0	0/124 (0%)	0
Injection site erythema	9/129 (7%)	20	9/141 (6.4%)	19	0/112 (0%)	0	0/124 (0%)	0
Injection site pain	22/129 (17.1%)	148	28/141 (19.9%)	272	0/112 (0%)	0	0/124 (0%)	0
Injection site reaction	15/129 (11.6%)	48	13/141 (9.2%)	32	0/112 (0%)	0	0/124 (0%)	0
Infections and infestations
Influenza	8/129 (6.2%)	9	8/141 (5.7%)	8	1/112 (0.9%)	1	1/124 (0.8%)	1
Sinusitis	14/129 (10.9%)	16	13/141 (9.2%)	17	0/112 (0%)	0	0/124 (0%)	0
Upper respiratory tract infection	9/129 (7%)	10	21/141 (14.9%)	23	0/112 (0%)	0	1/124 (0.8%)	2
Viral upper respiratory tract infection	21/129 (16.3%)	27	16/141 (11.3%)	19	0/112 (0%)	0	2/124 (1.6%)	2
Investigations
Weight increased	7/129 (5.4%)	7	4/141 (2.8%)	4	0/112 (0%)	0	0/124 (0%)	0
Musculoskeletal and connective tissue disorders
Arthralgia	8/129 (6.2%)	12	8/141 (5.7%)	10	1/112 (0.9%)	1	1/124 (0.8%)	1
Back pain	12/129 (9.3%)	15	15/141 (10.6%)	18	2/112 (1.8%)	2	3/124 (2.4%)	3
Myalgia	8/129 (6.2%)	9	3/141 (2.1%)	4	1/112 (0.9%)	1	0/124 (0%)	0
Nervous system disorders
Dizziness	5/129 (3.9%)	7	9/141 (6.4%)	11	0/112 (0%)	0	0/124 (0%)	0
Reproductive system and breast disorders
Prostatitis	0/25 (0%)	0	0/22 (0%)	0	0/21 (0%)	0	1/18 (5.6%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.