FREEDOM301: Phase 3 Study of MAP0004 in Adult Migraineurs

• Sponsor: Allergan (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00623636
• Collaborator: MAP Pharmaceuticals, Inc., a wholly owned subsidiary of Allergan (Industry)
• Enrollment: 902
• Location: 1
• Arms: 2
• Duration (Months): 30
• Patients Per Site Per Month: 30

Study Details

Study Description

Brief Summary

This is a randomized, double blind, placebo controlled, parallel group study of MAP0004 in adult migraineurs. Subjects will self administer study drug in the outpatient setting.

Condition or Disease	Intervention/Treatment	Phase
Migraine Disorders	Drug: MAP0004; Drug: Placebo	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 902 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Randomized, Double Blind, Placebo Controlled, Parallel Group, Phase 3 Study of MAP0004 in Adult Migraineurs for a Single Migraine Followed by Open Label Extension.
• Study Start Date: Jul 1, 2008
• Actual Primary Completion Date: Dec 1, 2010
• Actual Study Completion Date: Jan 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: MAP0004 MAP0004 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat qualifying migraines for up to an additional 52 weeks.	Drug: MAP0004; MAP0004 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat qualifying migraines for up to an additional 52 weeks. Placebo treated patients will receive MAP0004 1.0mg inhaled to treat qualifying migraines for up to 52 weeks only.
Other: Placebo Placebo 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat qualifying migraines for up to 52 weeks.	Drug: MAP0004; MAP0004 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat qualifying migraines for up to an additional 52 weeks. Placebo treated patients will receive MAP0004 1.0mg inhaled to treat qualifying migraines for up to 52 weeks only.; Drug: Placebo; Placebo 1.0mg inhaled to treat a qualifying migraine up to 8 weeks.

Outcome Measures

Primary Outcome Measures

1. Number of Subjects With Pain Relief at 2 Hours From Time of First Dose [2 hours from time of first dose]

   Pain relief at 2 hours was defined as change in rating from severe or moderate (score 3 or 2) to a rating of none or mild (score 0 or 1) at the 2-hour time point and no usage of rescue medications from the time of first dose to 2 hours. The 4-point scale from the International Headache Society was used: 0 = none; 1 = mild symptom, not interfering with normal daily activities; 2 = moderate symptom, causing some restriction to normal activities; 3 = severe, leading to inability to perform daily activities

2. Number of Subjects Photophobia Free at 2 Hours From Time of First Dose [2 hours from time of first dose]

   Photophobia free at 2 hours was defined as a rating of none (score 0) at the 2-hour time point and no usage of rescue medications from the time of first dose to 2 hours. The 4-point scale from the International Headache Society was used: 0 = none; 1 = mild symptom, not interfering with normal daily activities; 2 = moderate symptom, causing some restriction to normal activities; 3 = severe, leading to inability to perform daily activities

3. Number of Subjects Phonophobia Free at 2 Hours From Time of First Dose [2 hours from time of first dose]

   Phonophobia free at 2 hours was defined as a rating of none (score 0) at the 2-hour time point and no usage of rescue medications from the time of first dose to 2 hours. The 4-point scale from the International Headache Society was used: 0 = none; 1 = mild symptom, not interfering with normal daily activities; 2 = moderate symptom, causing some restriction to normal activities; 3 = severe, leading to inability to perform daily activities

4. Number of Subjects Nausea Free at 2 Hours From Time of First Dose [2 hours from time of first dose]

   Nausea free was defined as a rating of none (score 0) at the 2-hour time point and no usage of rescue medications from the time of first dose to 2 hours post-dose. The 4-point scale from the International Headache Society was used: 0 = none; 1 = mild symptom, not interfering with normal daily activities; 2 = moderate symptom, causing some restriction to normal activities; 3 = severe, leading to inability to perform daily activities

Secondary Outcome Measures

1. Number of Subjects With Sustained Pain Relief From 2 to 24 Hours [From 2 to 24 hours from time of first dose]

   Sustained Pain Relief was defined as a rating of none or mild (score 0 or 1) at the 2-hour time point that was maintained during the 2-24 hour post-dose period and no use of rescue medication from the time of first dose to 24 hours. The 4-point scale from the International Headache Society was used: 0 = none; 1 = mild symptom, not interfering with normal daily activities; 2 = moderate symptom, causing some restriction to normal activities; 3 = severe, leading to inability to perform daily activities

2. Number of Subjects Whose Time to Pain Relief Occurred Within 2 Hours [2 hours from the first dose]

   The number of subjects who reported pain relief (score of 0 or 1) at any time within the 2 hours following the time of first dose and who did not use rescue medication on or prior to this point. Subjects who did not reach pain relief by the end of the time period were not included. The 4-point scale from the International Headache Society was used: 0 = none; 1 = mild symptom, not interfering with normal daily activities; 2 = moderate symptom, causing some restriction to normal activities; 3 = severe, leading to inability to perform daily activities

3. Number of Subjects With Pain Relief at 4 Hours [4 hours from time of first dose]

   Pain Relief at 4 hours was defined as a change in rating from severe or moderate (score 3 or 2) to none or mild (score 0 or 1) at the 4-hour time point and no use of rescue medication from the time of first dose to 4 hours. The 4-point scale from the International Headache Society was used: 0 = none; 1 = mild symptom, not interfering with normal daily activities; 2 = moderate symptom, causing some restriction to normal activities; 3 = severe, leading to inability to perform daily activities

4. Number of Subjects With Pain Relief at 10 Minutes [2 hours from time of first dose]

   Pain Relief at 10 minutes was defined as a change in rating from severe or moderate (score 3 or 2) to none or mild (score 0 or 1) at the 10 minute time point and no use of rescue medication from the time of first dose to 2 hours. The 4-point scale from the International Headache Society was used: 0 = none; 1 = mild symptom, not interfering with normal daily activities; 2 = moderate symptom, causing some restriction to normal activities; 3 = severe, leading to inability to perform daily activities

Eligibility Criteria

Criteria

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

Major Inclusion Criteria:

• Male or female between 18 and 65 years of age.

• History of episodic, acute migraine (with or without aura) with onset prior to 50

Major Exclusion Criteria:

• Known allergy or sensitivity or contraindication to study drugs or their formulations

• History of chronic pulmonary disease, coronary artery disease (CAD), liver disease, kidney disease, seizures, stroke, or major psychiatric condition.

• Any condition that, in the opinion of the Investigator, would make the subject unsuitable for study participation

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Swedish Pain and Headache Clinic	Seattle	Washington	United States	98104

Sponsors and Collaborators

• Allergan
• MAP Pharmaceuticals, Inc., a wholly owned subsidiary of Allergan

Investigators

• Study Director: Medical Director, MAP Pharmaceuticals a Wholly Owned Subsidiary of Allergan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Allergan
• ClinicalTrials.gov Identifier: NCT00623636
• Other Study ID Numbers: MAP0004 CL P301
• First Posted: Feb 26, 2008
• Last Update Posted: Jan 9, 2014
• Last Verified: Dec 1, 2013

• Keywords provided by Allergan: Migraine
• Additional relevant MeSH terms: Migraine Disorders

Study Results

Participant Flow

Pre-assignment Detail	This study included a Double-blind period for 8 weeks followed by an open-label period that lasted an additional 52 weeks. All patients participating in the open-label period received MAP0004.

Arm/Group Title	Placebo	MAP0004
Arm/Group Description	Placebo 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat a qualifying migraine for up to an additional 52 weeks.	MAP0004 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat qualifying migraines for up to an additional 52 weeks.
Period Title: Double Blind
STARTED	452	450
COMPLETED	419	422
NOT COMPLETED	33	28
Period Title: Double Blind
STARTED	0	675
COMPLETED	0	263
NOT COMPLETED	0	412

Baseline Characteristics

Arm/Group Title	Placebo	MAP0004	Total
Arm/Group Description	Placebo 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat a qualifying migraine for up to an additional 52 weeks.	MAP0004 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat qualifying migraines for up to an additional 52 weeks.	Total of all reporting groups
Overall Participants	397	397	794
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	39.6 (11.67)	40.5 (11.30)	40.1 (11.49)
Sex: Female, Male (Count of Participants)
Female	362 91.2%	365 91.9%	727 91.6%
Male	35 8.8%	32 8.1%	67 8.4%

Outcome Measures

1. Primary Outcome

Title	Number of Subjects With Pain Relief at 2 Hours From Time of First Dose
Description	Pain relief at 2 hours was defined as change in rating from severe or moderate (score 3 or 2) to a rating of none or mild (score 0 or 1) at the 2-hour time point and no usage of rescue medications from the time of first dose to 2 hours. The 4-point scale from the International Headache Society was used: 0 = none; 1 = mild symptom, not interfering with normal daily activities; 2 = moderate symptom, causing some restriction to normal activities; 3 = severe, leading to inability to perform daily activities
Time Frame	2 hours from time of first dose

Outcome Measure Data

Analysis Population Description

mITT population was defined as all randomized subjects who reported a qualifying migraine and received at least one dose of study treatment, and had at least one post-treatment efficacy evaluation.

Arm/Group Title	Placebo	MAP0004
Arm/Group Description	Placebo 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat a qualifying migraine for up to an additional 52 weeks.	MAP0004 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat qualifying migraines for up to an additional 52 weeks.
Measure Participants	397	397
Number [participants]	136 34.3%	231 58.2%

2. Primary Outcome

Title	Number of Subjects Photophobia Free at 2 Hours From Time of First Dose
Description	Photophobia free at 2 hours was defined as a rating of none (score 0) at the 2-hour time point and no usage of rescue medications from the time of first dose to 2 hours. The 4-point scale from the International Headache Society was used: 0 = none; 1 = mild symptom, not interfering with normal daily activities; 2 = moderate symptom, causing some restriction to normal activities; 3 = severe, leading to inability to perform daily activities
Time Frame	2 hours from time of first dose

Outcome Measure Data

Analysis Population Description

mITT population was defined as all randomized subjects who reported a qualifying migraine and received at least one dose of study treatment, and had at least one post-treatment efficacy evaluation.

Arm/Group Title	Placebo	MAP0004
Arm/Group Description	Placebo 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat a qualifying migraine for up to an additional 52 weeks.	MAP0004 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat qualifying migraines for up to an additional 52 weeks.
Measure Participants	397	397
Number [participants]	107 27%	182 45.8%

3. Primary Outcome

Title	Number of Subjects Phonophobia Free at 2 Hours From Time of First Dose
Description	Phonophobia free at 2 hours was defined as a rating of none (score 0) at the 2-hour time point and no usage of rescue medications from the time of first dose to 2 hours. The 4-point scale from the International Headache Society was used: 0 = none; 1 = mild symptom, not interfering with normal daily activities; 2 = moderate symptom, causing some restriction to normal activities; 3 = severe, leading to inability to perform daily activities
Time Frame	2 hours from time of first dose

Outcome Measure Data

Analysis Population Description

mITT population was defined as all randomized subjects who reported a qualifying migraine and received at least one dose of study treatment, and had at least one post-treatment efficacy evaluation.

Arm/Group Title	Placebo	MAP0004
Arm/Group Description	Placebo 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat a qualifying migraine for up to an additional 52 weeks.	MAP0004 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat qualifying migraines for up to an additional 52 weeks.
Measure Participants	397	397
Number [participants]	133 33.5%	208 52.4%

4. Primary Outcome

Title	Number of Subjects Nausea Free at 2 Hours From Time of First Dose
Description	Nausea free was defined as a rating of none (score 0) at the 2-hour time point and no usage of rescue medications from the time of first dose to 2 hours post-dose. The 4-point scale from the International Headache Society was used: 0 = none; 1 = mild symptom, not interfering with normal daily activities; 2 = moderate symptom, causing some restriction to normal activities; 3 = severe, leading to inability to perform daily activities
Time Frame	2 hours from time of first dose

Outcome Measure Data

Analysis Population Description

mITT population was defined as all randomized subjects who reported a qualifying migraine and received at least one dose of study treatment, and had at least one post-treatment efficacy evaluation.

Arm/Group Title	Placebo	MAP0004
Arm/Group Description	Placebo 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat a qualifying migraine for up to an additional 52 weeks.	MAP0004 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat qualifying migraines for up to an additional 52 weeks.
Measure Participants	397	397
Number [participants]	234 58.9%	266 67%

5. Secondary Outcome

Title	Number of Subjects With Sustained Pain Relief From 2 to 24 Hours
Description	Sustained Pain Relief was defined as a rating of none or mild (score 0 or 1) at the 2-hour time point that was maintained during the 2-24 hour post-dose period and no use of rescue medication from the time of first dose to 24 hours. The 4-point scale from the International Headache Society was used: 0 = none; 1 = mild symptom, not interfering with normal daily activities; 2 = moderate symptom, causing some restriction to normal activities; 3 = severe, leading to inability to perform daily activities
Time Frame	From 2 to 24 hours from time of first dose

Outcome Measure Data

Analysis Population Description

mITT population was defined as all randomized subjects who reported a qualifying migraine and received at least one dose of study treatment, and had at least one post-treatment efficacy evaluation.

Arm/Group Title	Placebo	MAP0004
Arm/Group Description	Placebo 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat a qualifying migraine for up to an additional 52 weeks.	MAP0004 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat qualifying migraines for up to an additional 52 weeks.
Measure Participants	397	397
Number [participants]	76 19.1%	166 41.8%

6. Secondary Outcome

Title	Number of Subjects Whose Time to Pain Relief Occurred Within 2 Hours
Description	The number of subjects who reported pain relief (score of 0 or 1) at any time within the 2 hours following the time of first dose and who did not use rescue medication on or prior to this point. Subjects who did not reach pain relief by the end of the time period were not included. The 4-point scale from the International Headache Society was used: 0 = none; 1 = mild symptom, not interfering with normal daily activities; 2 = moderate symptom, causing some restriction to normal activities; 3 = severe, leading to inability to perform daily activities
Time Frame	2 hours from the first dose

Outcome Measure Data

Analysis Population Description

mITT population was defined as all randomized subjects who reported a qualifying migraine and received at least one dose of study treatment, and had at least one post-treatment efficacy evaluation.

Arm/Group Title	Placebo	MAP0004
Arm/Group Description	Placebo 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat a qualifying migraine for up to an additional 52 weeks.	MAP0004 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat qualifying migraines for up to an additional 52 weeks.
Measure Participants	397	397
Number [participants]	156 39.3%	244 61.5%

7. Secondary Outcome

Title	Number of Subjects With Pain Relief at 4 Hours
Description	Pain Relief at 4 hours was defined as a change in rating from severe or moderate (score 3 or 2) to none or mild (score 0 or 1) at the 4-hour time point and no use of rescue medication from the time of first dose to 4 hours. The 4-point scale from the International Headache Society was used: 0 = none; 1 = mild symptom, not interfering with normal daily activities; 2 = moderate symptom, causing some restriction to normal activities; 3 = severe, leading to inability to perform daily activities
Time Frame	4 hours from time of first dose

Outcome Measure Data

Analysis Population Description

mITT population was defined as all randomized subjects who reported a qualifying migraine and received at least one dose of study treatment, and had at least one post-treatment efficacy evaluation.

Arm/Group Title	Placebo	MAP0004
Arm/Group Description	Placebo 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat a qualifying migraine for up to an additional 52 weeks.	MAP0004 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat qualifying migraines for up to an additional 52 weeks.
Measure Participants	397	397
Number [participants]	145 36.5%	254 64%

8. Secondary Outcome

Title	Number of Subjects With Pain Relief at 10 Minutes
Description	Pain Relief at 10 minutes was defined as a change in rating from severe or moderate (score 3 or 2) to none or mild (score 0 or 1) at the 10 minute time point and no use of rescue medication from the time of first dose to 2 hours. The 4-point scale from the International Headache Society was used: 0 = none; 1 = mild symptom, not interfering with normal daily activities; 2 = moderate symptom, causing some restriction to normal activities; 3 = severe, leading to inability to perform daily activities
Time Frame	2 hours from time of first dose

Outcome Measure Data

Analysis Population Description

mITT population was defined as all randomized subjects who reported a qualifying migraine and received at least one dose of study treatment, and had at least one post-treatment efficacy evaluation.

Arm/Group Title	Placebo	MAP0004
Arm/Group Description	Placebo 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat a qualifying migraine for up to an additional 52 weeks.	MAP0004 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat qualifying migraines for up to an additional 52 weeks.
Measure Participants	397	397
Number [participants]	30 7.6%	37 9.3%

Adverse Events

Adverse Event Reporting Description	All subjects who received any dose of study treatment in the double-blind or open-label study period and had at least one post-dose safety evaluation were included in the adverse events analysis.
Arm/Group Title	Double-blind Placebo		Double-blind MAP0004		Open-label MAP0004
Arm/Group Description	Placebo 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat a qualifying migraine for up to an additional 52 weeks.		MAP0004 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat qualifying migraines for up to an additional 52 weeks.		MAP0004 1.0mg inhaled to treat a qualifying migraine for up to an additional 52 weeks.
All Cause Mortality
	Double-blind Placebo		Double-blind MAP0004		Open-label MAP0004
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Double-blind Placebo		Double-blind MAP0004		Open-label MAP0004
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/404 (0%)		0/410 (0%)		14/638 (2.2%)
Blood and lymphatic system disorders
Aplastic anemia	0/404 (0%)		0/410 (0%)		1/638 (0.2%)
Cardiac disorders
Acute myocardial infarction	0/404 (0%)		0/410 (0%)		1/638 (0.2%)
Gastrointestinal disorders
Inguinal hernia	0/404 (0%)		0/410 (0%)		1/638 (0.2%)
Rectal haemorrhage	0/404 (0%)		0/410 (0%)		1/638 (0.2%)
Umbilical hernia	0/404 (0%)		0/410 (0%)		1/638 (0.2%)
Infections and infestations
Gastroenteritis	0/404 (0%)		0/410 (0%)		1/638 (0.2%)
Appendicitis	0/404 (0%)		0/410 (0%)		1/638 (0.2%)
Septic shock	0/404 (0%)		0/410 (0%)		1/638 (0.2%)
Injury, poisoning and procedural complications
Decompression sickness	0/404 (0%)		0/410 (0%)		1/638 (0.2%)
Testicular injury	0/404 (0%)		0/410 (0%)		1/638 (0.2%)
Metabolism and nutrition disorders
Hypokalaemia	0/404 (0%)		0/410 (0%)		1/638 (0.2%)
Musculoskeletal and connective tissue disorders
Muscular weakness	0/404 (0%)		0/410 (0%)		1/638 (0.2%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer female	0/404 (0%)		0/410 (0%)		1/638 (0.2%)
Nervous system disorders
Encephalopathy	0/404 (0%)		0/410 (0%)		1/638 (0.2%)
Pregnancy, puerperium and perinatal conditions
Pregnancy	0/404 (0%)		0/410 (0%)		1/638 (0.2%)
Psychiatric disorders
Suicide attempt	0/404 (0%)		0/410 (0%)		2/638 (0.3%)
Renal and urinary disorders
Nephrolithiasis	0/404 (0%)		0/410 (0%)		1/638 (0.2%)
Reproductive system and breast disorders
Menorrhagia	0/404 (0%)		0/410 (0%)		1/638 (0.2%)
Uterine haemorrhage	0/404 (0%)		0/410 (0%)		1/638 (0.2%)
Respiratory, thoracic and mediastinal disorders
Pleural effusion	0/404 (0%)		0/410 (0%)		1/638 (0.2%)
Other (Not Including Serious) Adverse Events
	Double-blind Placebo		Double-blind MAP0004		Open-label MAP0004
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	60/404 (14.9%)		86/410 (21%)		454/638 (71.2%)
Gastrointestinal disorders
Nausea	7/404 (1.7%)		18/410 (4.4%)		78/638 (12.2%)
Vomiting	3/404 (0.7%)		8/410 (2%)		33/638 (5.2%)
Infections and infestations
Upper Respiratory Tract Infection	12/404 (3%)		11/410 (2.7%)		93/638 (14.6%)
Sinusitis	5/404 (1.2%)		3/410 (0.7%)		65/638 (10.2%)
Nasopharyngitis	15/404 (3.7%)		8/410 (2%)		67/638 (10.5%)
Influenza	0/404 (0%)		3/410 (0.7%)		35/638 (5.5%)
Respiratory, thoracic and mediastinal disorders
Cough	7/404 (1.7%)		10/410 (2.4%)		32/638 (5%)
Social circumstances
Pharmaceutical Product Compaint	11/404 (2.7%)		25/410 (6.1%)		51/638 (8%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.