Pilot Study to Compare Frovatriptan vs. Topiramate for Prevention of Migraine

• Sponsor: Clinvest (Other)
• Overall Status: Completed
• CT.gov ID: NCT00846495
• Collaborator: Endo Pharmaceuticals (Industry)
• Enrollment: 55
• Locations: 2
• Arms: 2
• Duration (Months): 17
• Patients Per Site: 27.5
• Patients Per Site Per Month: 1.6

Study Details

Study Description

Brief Summary

Subjects enrolled at 2 investigative sites will complete 3 visits. Following Visit 1, during a 1-month Baseline Period, subjects will treat with their usual medication and document any warning signs (Prodrome pre-headache) that a migraine will occur. Following randomization (like a flip of the coin) at Visit 2, subjects will treat daily with topiramate or during Prodrome with frovatriptan. Subjects complete a 2-month Treatment Period before exit at Visit 3.This study will compare the effectiveness of daily treatment vs. treatment during the pre-headache phase for prevention of migraine.

Condition or Disease	Intervention/Treatment	Phase
Migraine	Drug: topiramate; Drug: frovatriptan	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 55 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Prevention
• Official Title: A Randomized, Single-Blind Pilot Study to Compare the Efficacy and Cost-Effectiveness of Frovatriptan vs. Topiramate for the Prevention of Migraine
• Study Start Date: Aug 1, 2009
• Actual Primary Completion Date: Jan 1, 2011
• Actual Study Completion Date: Jan 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: topiramate Subjects randomized to Group A at Visit 2 were provided with topiramate, titrated over 4 weeks to a maximum dose of 100 mg daily. One dosage adjustment was allowed with a minimum dose of 50 mg daily.	Drug: topiramate; topiramate 25mg 1 tab in PM x 1 week topiramate 25mg 1 tab in AM / 1 tab in PM x 1 week topiramate 25mg 1 tab in AM / 2 tabs in PM x 1 week topiramate 25mg 2 tabs in AM / 2 tabs in PM x 5 weeks; Other Names: Topamax
Active Comparator: frovatriptan Subjects randomized to Group B at Visit 2 were provided with frovatriptan 5 mg to treat during prodrome at the point they were confident a disabling migraine would occur (before the onset of headache).	Drug: frovatriptan; frovatriptan 5mg tab during premonitory phase of migraine; Other Names: Frova

Outcome Measures

Primary Outcome Measures

1. Number of Migraine Attacks in Participants Using Frovatriptan in a Preemptive Treatment Paradigm vs. Daily Topiramate [Treatment Month 2]

   Compare number of migraine attacks reported by participants using frovatriptan in a preemptive treatment paradigm vs. daily topiramate during Treatment Period Month 2

2. Number of Headache Days Reported by Participants Using Frovatriptan in a Preemptive Treatment Paradigm vs. Daily Topiramate to Prevent Migraine [Treatment Month 2]

   Measure the change in number of headache days between participants using frovatriptan in a preemptive treatment paradigm vs. daily topiramate to prevent migraine

Secondary Outcome Measures

1. Number of Headache Days Each Month Following Initiation of Treatment With Study Medication [2 Months]

   Measure the change in number of headache days reported by participants during each treatment month following initiation of treatment with study medication

2. Participants With Greater Than 50% Reduction in Migraine Attacks and Headache Days Per Month Utilizing Each Treatment Paradigm [2 Months]

   Compare number of participants with greater than 50% reduction in migraine attacks and headache days from Baseline to Treatment Months 1 and 2

3. Quality of Life in Subjects Utilizing Each Treatment Paradigm [Randomization, End of Treatment Month 1, End of Treatment Month 2]

   Quality of Life is measured by the Migraine Specific Quality of Life Questionnaire (MSQ), which includes 3 dimensions: Role Function Restrictive (degree to which performance of daily activities is limited), Role Function Preventive (degree to which performance of daily activities is interrupted), and Emotional Function (frustration and helplessness due to migraine). Scores range from 0 to 100. For each dimension, a higher score indicates a better health status. Participants completed the MSQ at Randomization, and after Treatment Months 1 and 2.

4. Participant Satisfaction With Study Medications [Treatment Month 2]

   Participant satisfaction is measured by the Patient Perception of Migraine Questionnaire (PPMQ). Questions were categorized within 6 dimensions: Efficacy, Functionality, Ease of Use, Cost, Bothersomeness of Side Effects, and Total Score. Scores range from 0 to 100. Higher scores represent better satisfaction. Participants completed the PPMQ 24 hours following each first dose of frovatriptan.

5. Adverse Events Associated With Study Medications [Treatment Months 1 and 2]

   Includes Adverse Events at or above 5% frequency per group.

6. Cost of Frovatriptan vs. Topiramate as Preventive Treatment of Migraine [Treatment Months 1 and 2]

   Average cost of study medication taken by each subject. Measured in dollars.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

INCLUSION CRITERIA

1. Subject has at least a one-year history of migraine with or without aura meeting International Headache Society criteria (see Appendix)

2. Subject has a 3-month history of averaging 3-6 migraines per month

3. Subject reports premonitory symptoms and the ability to predict at least 50% of high impact headaches

4. Subjects must currently or have in the past successfully utilized a triptan as an acute treatment for migraine as determined by the investigator.

5. Male or female at least 18 years of age

6. Subject of childbearing potential agrees to use adequate contraception during the study. Adequate methods of contraception are to be determined by the investigator and should be consistent with contraceptive care administered in the regular clinical use of frovatriptan and topiramate.

7. Subject is aware of prodrome symptoms that may include physiological, psychological or cognitive changes. These may include, but are not limited to such symptoms as Pre-Menstrual Syndrome (PMS), change in mood, energy level, appetite, food craving, nausea, sense of hearing, sense of smell or swelling/fluid retention, excessive yawning, head pain, muscle pain/tenderness, irritability, confusion, extreme sleepiness, impaired speech or impaired memory. (The subject should be able to differentiate these symptoms from other similar symptoms that do not precede migraine). The symptoms should precede migraine by 4-24 hours signaling an impending migraine attack.

8. Subject is able to understand instructions for the study and complete the diary

9. Subject is willing to give informed consent to participate in the study

10. Any migraine prophylactic medication must have a stabilized dosage for one month

EXCLUSION CRITERIA

1. History of any medical condition that would confound the results of the study including but not limited to the following:

• Hepatic disease or significant hepatic dysfunction

• History of pancreatitis

• History of thrombocytopenia

• History of glaucoma

• History of osteoporosis or osteopenia

• Cardiovascular Disease - Coronary artery disease, Ischemic heart disease or Significant Arrhythmia

• History of active Cerebrovascular Disease

• Hypertension - Uncontrolled hypertension in a non-migrainous state (> 160 mmHg systolic or >95 mmHg. diastolic). Hypertension must be controlled effectively with medication for a period of 3 months.

• Basilar or Hemiplegic Migraine

• Significant peripheral vascular disease or Raynaud's Syndrome

• Significant Active Renal, Hepatic, Gastrointestinal, Endocrine or

• Neurological Disease

• History of depression, mood problems or suicidal thoughts or behavior that in the opinion of the Investigator would interfere with participation in the study.

1. History of ergotamine, "triptan", or analgesic abuse within past 3 months

2. History of current or recent drug or alcohol abuse that would interfere with participation in the study.

3. More than 15 headache days per month within past 3 months.

4. Women who are pregnant or breast feeding

5. Subjects with known hypersensitivity or intolerance to topiramate or any triptan-like medication

6. Subject is scheduled for surgical procedure to occur while enrolled in study.that in opinion of the Investigator would interfere with participation in the study.

7. Subject is on a ketogenic diet

8. Participation in another investigative drug study within the previous 30 days

9. Excluded medications: MAO Inhibitors, lithium, methylergonovine, methysergide, ergotamine-containing products, or topiramate daily for migraine prophylaxis.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Physician Associates LLC	Oviedo	Florida	United States	32765
2	Clinvest	Springfield	Missouri	United States	65807

Sponsors and Collaborators

• Clinvest
• Endo Pharmaceuticals

Investigators

• Principal Investigator: Roger K Cady, MD, Clinvest

Study Documents (Full-Text)

None provided.

More Information

Publications

• Luciani R, Carter D, Mannix L, Hemphill M, Diamond M, Cady R. Prevention of migraine during prodrome with naratriptan. Cephalalgia. 2000 Mar;20(2):122-6.

• Responsible Party: Clinvest, CEO, Cady, Roger, M.D.
• ClinicalTrials.gov Identifier: NCT00846495
• Other Study ID Numbers: Frova vs. Topiramate
• First Posted: Feb 18, 2009
• Last Update Posted: Jan 13, 2012
• Last Verified: Jan 1, 2012

• Keywords provided by Clinvest, CEO, Cady, Roger, M.D.: Migraine; Migraine prevention; Prodrome; Premonitory phase; Preemptive therapy
• Additional relevant MeSH terms: Migraine Disorders; Topiramate; Frovatriptan

Study Results

Participant Flow

Arm/Group Title	Topiramate	Frovatriptan
Arm/Group Description	Subjects randomized to Group A were provided with topiramate 25mg to titrate to a maximum dosage of 100mg during Month 1. One dose adjustment was allowed with 50mg/day the required minimum dosage. Group A subjects treated with daily topiramate during Months 2 and 3 and rescued any migraine headache that occurred with frovatriptan 2.5mg.	Subjects randomized to Group B were provided with frovatriptan 5mg to be utilized during prodrome at the point they were confident a disabling migraine would occur but before the onset of headache. Subjects were provided with frovatriptan 2.5mg for rescue of persistent or recurring headache between 4 and 24 hours following treatment during prodrome.
Period Title: Overall Study
STARTED	28	27
COMPLETED	20	24
NOT COMPLETED	8	3

Baseline Characteristics

Arm/Group Title	Topiramate	Frovatriptan	Total
Arm/Group Description	Subjects randomized to Group A were provided with topiramate 25mg to titrate to a maximum dosage of 100mg during Month 1. One dose adjustment was allowed with 50mg/day the required minimum dosage. Group A subjects treated with daily topiramate during Months 2 and 3 and rescued any migraine headache that occurred with frovatriptan 2.5mg.	Subjects randomized to Group B were provided with frovatriptan 5mg to be utilized during prodrome at the point they were confident a disabling migraine would occur but before the onset of headache. Subjects were provided with frovatriptan 2.5mg for rescue of persistent or recurring headache between 4 and 24 hours following treatment during prodrome.	Total of all reporting groups
Overall Participants	28	27	55
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	28 100%	27 100%	55 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	37.61 (10.3)	37.33 (9.46)	37.47 (9.82)
Sex: Female, Male (Count of Participants)
Female	22 78.6%	21 77.8%	43 78.2%
Male	6 21.4%	6 22.2%	12 21.8%
Region of Enrollment (participants) [Number]
United States	28 100%	27 100%	55 100%

Outcome Measures

1. Primary Outcome

Title	Number of Migraine Attacks in Participants Using Frovatriptan in a Preemptive Treatment Paradigm vs. Daily Topiramate
Description	Compare number of migraine attacks reported by participants using frovatriptan in a preemptive treatment paradigm vs. daily topiramate during Treatment Period Month 2
Time Frame	Treatment Month 2

Outcome Measure Data

Analysis Population Description

Number of Units Analyzed is equivalent to number of migraine attacks reported during 2nd Treatment Month.

Arm/Group Title	Topiramate	Frovatriptan
Arm/Group Description	Subjects randomized to Group A were provided with topiramate 25mg to titrate to a maximum dosage of 100mg during Month 1. One dose adjustment was allowed with 50mg/day the required minimum dosage. Group A subjects treated with daily topiramate during Months 2 and 3 and rescued any migraine headache that occurred with frovatriptan 2.5mg.	Subjects randomized to Group B were provided with frovatriptan 5mg to be utilized during prodrome at the point they were confident a disabling migraine would occur but before the onset of headache. Subjects were provided with frovatriptan 2.5mg for rescue of persistent or recurring headache between 4 and 24 hours following treatment during prodrome.
Measure Participants	20	24
Measure Migraine attacks	27	51
Mean (Standard Deviation) [Migraine attacks]	1.35 (1.31)	2.12 (1.75)

2. Primary Outcome

Title	Number of Headache Days Reported by Participants Using Frovatriptan in a Preemptive Treatment Paradigm vs. Daily Topiramate to Prevent Migraine
Description	Measure the change in number of headache days between participants using frovatriptan in a preemptive treatment paradigm vs. daily topiramate to prevent migraine
Time Frame	Treatment Month 2

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Topiramate	Frovatriptan
Arm/Group Description	Subjects randomized to Group A were provided with topiramate 25mg to titrate to a maximum dosage of 100mg during Month 1. One dose adjustment was allowed with 50mg/day the required minimum dosage. Group A subjects treated with daily topiramate during Months 2 and 3 and rescued any migraine headache that occurred with frovatriptan 2.5mg.	Subjects randomized to Group B were provided with frovatriptan 5mg to be utilized during prodrome at the point they were confident a disabling migraine would occur but before the onset of headache. Subjects were provided with frovatriptan 2.5mg for rescue of persistent or recurring headache between 4 and 24 hours following treatment during prodrome.
Measure Participants	20	24
Mean (Standard Deviation) [Headache Days]	4.75 (2.59)	2.79 (3.26)

3. Secondary Outcome

Title	Number of Headache Days Each Month Following Initiation of Treatment With Study Medication
Description	Measure the change in number of headache days reported by participants during each treatment month following initiation of treatment with study medication
Time Frame	2 Months

Outcome Measure Data

Analysis Population Description

Number of Units Analyzed is equivalent to number of headache days reported during Treatment Months 1 and 2.

Arm/Group Title	Topiramate	Frovatriptan
Arm/Group Description	Subjects randomized to Group A were provided with topiramate 25mg to titrate to a maximum dosage of 100mg during Month 1. One dose adjustment was allowed with 50mg/day the required minimum dosage. Group A subjects treated with daily topiramate during Months 2 and 3 and rescued any migraine headache that occurred with frovatriptan 2.5mg.	Subjects randomized to Group B were provided with frovatriptan 5mg to be utilized during prodrome at the point they were confident a disabling migraine would occur but before the onset of headache. Subjects were provided with frovatriptan 2.5mg for rescue of persistent or recurring headache between 4 and 24 hours following treatment during prodrome.
Measure Participants	20	24
Measure Headache Days	119	177
Treatment Month 1	4.20 (2.88)	3.96 (2.84)
Treatment Month 2	1.75 (1.86)	3.42 (2.98)

4. Secondary Outcome

Title	Participants With Greater Than 50% Reduction in Migraine Attacks and Headache Days Per Month Utilizing Each Treatment Paradigm
Description	Compare number of participants with greater than 50% reduction in migraine attacks and headache days from Baseline to Treatment Months 1 and 2
Time Frame	2 Months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Topiramate	Frovatriptan
Arm/Group Description	Subjects randomized to Group A were provided with topiramate 25mg to titrate to a maximum dosage of 100mg during Month 1. One dose adjustment was allowed with 50mg/day the required minimum dosage. Group A subjects treated with daily topiramate during Months 2 and 3 and rescued any migraine headache that occurred with frovatriptan 2.5mg.	Subjects randomized to Group B were provided with frovatriptan 5mg to be utilized during prodrome at the point they were confident a disabling migraine would occur but before the onset of headache. Subjects were provided with frovatriptan 2.5mg for rescue of persistent or recurring headache between 4 and 24 hours following treatment during prodrome.
Measure Participants	20	24
Migraine Attacks Treatment Month 1	11 39.3%	13 48.1%
Headache Days Treatment Month 1	7 25%	9 33.3%
Migraine Attacks Treatment Month 2	15 53.6%	15 55.6%
Headache Days Treatment Month 2	16 57.1%	13 48.1%

5. Secondary Outcome

Title	Quality of Life in Subjects Utilizing Each Treatment Paradigm
Description	Quality of Life is measured by the Migraine Specific Quality of Life Questionnaire (MSQ), which includes 3 dimensions: Role Function Restrictive (degree to which performance of daily activities is limited), Role Function Preventive (degree to which performance of daily activities is interrupted), and Emotional Function (frustration and helplessness due to migraine). Scores range from 0 to 100. For each dimension, a higher score indicates a better health status. Participants completed the MSQ at Randomization, and after Treatment Months 1 and 2.
Time Frame	Randomization, End of Treatment Month 1, End of Treatment Month 2

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Topiramate	Frovatriptan
Arm/Group Description	Subjects randomized to Group A were provided with topiramate 25mg to titrate to a maximum dosage of 100mg during Month 1. One dose adjustment was allowed with 50mg/day the required minimum dosage. Group A subjects treated with daily topiramate during Months 2 and 3 and rescued any migraine headache that occurred with frovatriptan 2.5mg.	Subjects randomized to Group B were provided with frovatriptan 5mg to be utilized during prodrome at the point they were confident a disabling migraine would occur but before the onset of headache. Subjects were provided with frovatriptan 2.5mg for rescue of persistent or recurring headache between 4 and 24 hours following treatment during prodrome.
Measure Participants	20	24
Role Function Restrictive - Baseline	56.00 (15.88)	59.88 (16.65)
Role Function Restrictive - Treatment Month 1	80.29 (19.33)	66.48 (18.75)
Role Function Restrictive - Treatment Month 2	86.64 (13.98)	71.84 (19.57)
Role Function Preventive - Baseline	77.75 (16.02)	77.50 (18.53)
Role Function Preventive - Treatment Month 1	85.25 (18.32)	79.25 (21.96)
Role Function Preventive - Treatment Month 2	93.95 (7.57)	84.96 (16.67)
Emotional Function - Baseline	60.67 (22.47)	64.71 (23.13)
Emotional Function - Treatment Month 1	80.00 (25.68)	73.18 (21.59)
Emotional Function - Treatment Month 2	91.46 (10.49)	75.10 (24.04)

6. Secondary Outcome

Title	Participant Satisfaction With Study Medications
Description	Participant satisfaction is measured by the Patient Perception of Migraine Questionnaire (PPMQ). Questions were categorized within 6 dimensions: Efficacy, Functionality, Ease of Use, Cost, Bothersomeness of Side Effects, and Total Score. Scores range from 0 to 100. Higher scores represent better satisfaction. Participants completed the PPMQ 24 hours following each first dose of frovatriptan.
Time Frame	Treatment Month 2

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Topiramate	Frovatriptan
Arm/Group Description	Subjects randomized to Group A were provided with topiramate 25mg to titrate to a maximum dosage of 100mg during Month 1. One dose adjustment was allowed with 50mg/day the required minimum dosage. Group A subjects treated with daily topiramate during Months 2 and 3 and rescued any migraine headache that occurred with frovatriptan 2.5mg.	Subjects randomized to Group B were provided with frovatriptan 5mg to be utilized during prodrome at the point they were confident a disabling migraine would occur but before the onset of headache. Subjects were provided with frovatriptan 2.5mg for rescue of persistent or recurring headache between 4 and 24 hours following treatment during prodrome.
Measure Participants	20	24
Efficacy	76.7857 (21.04)	75.1977 (30.21)
Functionality	77.8214 (22.68)	76.3648 (29.98)
Ease of Use	91.6607 (11.5639)	92.6989 (11.36)
Cost	81.2536 (19.85)	59.0886 (32.86)
Bothersomeness of Side Effects	95.1786 (6.08)	95.5398 (6.81)
Total Score	82.0925 (15.77)	81.1417 (21.76)

7. Secondary Outcome

Title	Adverse Events Associated With Study Medications
Description	Includes Adverse Events at or above 5% frequency per group.
Time Frame	Treatment Months 1 and 2

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Topiramate	Frovatriptan
Arm/Group Description	Subjects randomized to Group A were provided with topiramate 25mg to titrate to a maximum dosage of 100mg during Month 1. One dose adjustment was allowed with 50mg/day the required minimum dosage. Group A subjects treated with daily topiramate during Months 2 and 3 and rescued any migraine headache that occurred with frovatriptan 2.5mg.	Subjects randomized to Group B were provided with frovatriptan 5mg to be utilized during prodrome at the point they were confident a disabling migraine would occur but before the onset of headache. Subjects were provided with frovatriptan 2.5mg for rescue of persistent or recurring headache between 4 and 24 hours following treatment during prodrome.
Measure Participants	20	24
Measure Adverse Events	45	43
Number [Adverse Events]	26	11

8. Secondary Outcome

Title	Cost of Frovatriptan vs. Topiramate as Preventive Treatment of Migraine
Description	Average cost of study medication taken by each subject. Measured in dollars.
Time Frame	Treatment Months 1 and 2

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Topiramate	Frovatriptan
Arm/Group Description	Subjects randomized to Group A were provided with topiramate 25mg to titrate to a maximum dosage of 100mg during Month 1. One dose adjustment was allowed with 50mg/day the required minimum dosage. Group A subjects treated with daily topiramate during Months 2 and 3 and rescued any migraine headache that occurred with frovatriptan 2.5mg.	Subjects randomized to Group B were provided with frovatriptan 5mg to be utilized during prodrome at the point they were confident a disabling migraine would occur but before the onset of headache. Subjects were provided with frovatriptan 2.5mg for rescue of persistent or recurring headache between 4 and 24 hours following treatment during prodrome.
Measure Participants	20	24
Preventive Medication Taken	343.56 (50.4774)	101.41 (10.304)
Rescue Medication Taken	38.33 (10.45)	59.94 (9.54)
All Study Medication Taken	381.89 (51.8816)	161.35 (70.1844)

Adverse Events

Arm/Group Title	Topiramate		Frovatriptan
Arm/Group Description	Subjects randomized to Group A were provided with topiramate 25mg to titrate to a maximum dosage of 100mg during Month 1. One dose adjustment was allowed with 50mg/day the required minimum dosage. Group A subjects treated with daily topiramate during Months 2 and 3 and rescued any migraine headache that occurred with frovatriptan 2.5mg.		Subjects randomized to Group B were provided with frovatriptan 5mg to be utilized during prodrome at the point they were confident a disabling migraine would occur but before the onset of headache. Subjects were provided with frovatriptan 2.5mg for rescue of persistent or recurring headache between 4 and 24 hours following treatment during prodrome.
All Cause Mortality
	Topiramate		Frovatriptan
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Topiramate		Frovatriptan
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/28 (0%)		0/27 (0%)
Other (Not Including Serious) Adverse Events
	Topiramate		Frovatriptan
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	17/28 (60.7%)		5/27 (18.5%)
Gastrointestinal disorders
Diarrhea	0/28 (0%)	0	2/27 (7.4%)	3
Nausea	2/28 (7.1%)	2	2/27 (7.4%)	3
Stomach Flu	2/28 (7.1%)	2	0/27 (0%)	0
General disorders
Cold Symptoms	0/28 (0%)	0	2/27 (7.4%)	2
Concentration Problems	3/28 (10.7%)	3	0/27 (0%)	0
Dizziness	1/28 (3.6%)	1	2/27 (7.4%)	3
Irritability	2/28 (7.1%)	2	0/27 (0%)	0
Memory Problems	2/28 (7.1%)	2	0/27 (0%)	0
Taste Aversion	3/28 (10.7%)	3	0/27 (0%)	0
Nervous system disorders
Numbness in Extremities	2/28 (7.1%)	2	0/27 (0%)	0
Tingling in Extremities	3/28 (10.7%)	4	0/27 (0%)	0
Psychiatric disorders
Anxiety	3/28 (10.7%)	3	0/27 (0%)	0
Depression	2/28 (7.1%)	2	0/27 (0%)	0

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.