Trial in Adult Subjects With Acute Migraines

Migraine, With or Without Aura Clinical Trial

Official title:

BHV3000-303: Phase 3, Double-Blind, Randomized, Placebo Controlled, Safety and Efficacy Trial of BHV-3000 (Rimegepant) Orally Disintegrating Tablet (ODT) for the Acute Treatment of Migraine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03461757
• Other study ID #: BHV3000-303
• Status: Completed
• Phase: Phase 3
• Start date: February 27, 2018
• Est. completion date: October 15, 2018

Study information

• Verified date: December 2022
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the efficacy of BHV-3000 (rimegepant ODT) versus placebo in subjects with Acute Migraines.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1811
• Est. completion date: October 15, 2018
• Est. primary completion date: October 8, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Key Inclusion Criteria:

1. Subject has at least 1 year history of migraines (with or without aura), consistent with a diagnosis according to the International Classification of Headache Disorder, 3rd Edition, Beta version [1] including the following:

1. Migraine attacks present for more than 1 year with the age of onset prior to 50 years of age

2. Migraine attacks, on average, lasting about 4-72 hours if untreated

3. Not more than 8 attacks of moderate to severe intensity per month within the last 3 months

4. Consistent migraine headaches of at least 2 migraine headache attacks of moderate or severe intensity in each of the 3 months prior to the Screening Visit and maintains this requirement during the Screening period

5. Less than 15 days with headache (migraine or non-migraine) per month in each of the 3 months prior to the Screening Visit and maintains this requirement during the Screening Period.

6. Subjects on prophylactic migraine medication are permitted to remain on therapy provided they have been on a stable dose for at least 3 months prior to screening visit and the dose is not expected to change during the course of the study.

7. Subjects with contraindications for use of triptans may be included provided they meet all other study entry criteria.

Key Exclusion Criteria:

1. Subject with a history of HIV disease

2. Subject history with current evidence of uncontrolled, unstable or recently diagnosed cardiovascular disease, such as ischemic heart disease, coronary artery vasospasm, and cerebral ischemia. subjects with Myocardial Infarction (MI), Acute Coronary Syndrome (ACS), Percutaneous Coronary Intervention (PCI), cardiac surgery, stroke or transient ischemic attack (TIA) during the 6 months prior to screening

3. Uncontrolled hypertension (high blood pressure), or uncontrolled diabetes (however subjects can be included who have stable hypertension and/or diabetes for at least 3 months prior to being enrolled)

4. Subject has a current diagnosis of major depression, other pain syndromes, psychiatric conditions (e.g., schizophrenia), dementia, or significant neurological disorders (other than migraine) that, in the Investigator's opinion might interfere with study assessments.

5. Subject has a history of gastric, or small intestinal surgery (including Gastric Bypass, Gastric Banding, Gastric Sleeve, Gastric Balloon, etc.), or has disease that causes malabsorption

6. The subject has a history of current or evidence of any significant and/ or unstable medical conditions (e.g., history of congenital heart disease or arrhythmia, known suspected infection, hepatitis B or C, or cancer) that, in the investigator's opinion, would expose them to undue risk of a significant adverse event (AE) or interfere with assessments of safety or efficacy during the course of the trial.

7. History of, treatment for, or evidence of, alcohol or drug abuse within the past 12 months or subjects who have met DSM-V criteria for any significant substance use disorder within the past 12 months from the date of the screening visit.

8. Subjects are excluded if they have previously participated in any BHV-30000 (rimegepant) study within the last 2 years.

9. Participation in any other investigational clinical trial while participating in this clinical trial

Related Conditions & MeSH terms

• Migraine Disorders
• Migraine, With or Without Aura

Intervention

Drug:
• Rimegepant
75 mg ODT QD
• Placebo
Placebo ODT to match rimegepant dose QD

Locations

Country	Name	City	State
United States	Albuquerque Clinical Trials, Inc.	Albuquerque	New Mexico
United States	Synexus	Atlanta	Georgia
United States	Heartland Research Associates LLC	Augusta	Kansas
United States	Tekton Research, Inc	Austin	Texas
United States	Northwest Clinical Research Center	Bellevue	Washington
United States	Hassman Research Institute	Berlin	New Jersey
United States	Boston Clinical Trials	Boston	Massachusetts
United States	SPRI Clinical Trials, LLC	Brooklyn	New York
United States	Cresent City Headache and Neurology Center LLC	Chalmette	Louisiana
United States	Charlottesville Medical Research	Charlottesville	Virginia
United States	Radiant Research, Inc.	Columbus	Ohio
United States	Meridian Clinical Research	Dakota Dunes	South Dakota
United States	FutureSearch Trials of Dallas, LP	Dallas	Texas
United States	Hometown Urgent Care and Research	Dayton	Ohio
United States	Midwest Clinical Research Center	Dayton	Ohio
United States	Neurology Diagnostics, Inc.	Dayton	Ohio
United States	iResearch Atlanta, LLC	Decatur	Georgia
United States	Aventiv Research Inc	Dublin	Ohio
United States	Pharmacology Research Institute	Encino	California
United States	NECCR Primacare Research, LLC	Fall River	Massachusetts
United States	Ventavia Research Group, LLC	Fort Worth	Texas
United States	PharmQuest, LLC	Greensboro	North Carolina
United States	MD Clinical	Hallandale Beach	Florida
United States	AGA Clinical Trials	Hialeah	Florida
United States	Texas Center for Drug Development, Inc.	Houston	Texas
United States	CNS Research Science, Inc.	Jamaica	New York
United States	Center for Pharmaceutical Research	Kansas City	Missouri
United States	Clinical Investigation Specialists, Inc.	Kenosha	Wisconsin
United States	Volunteer Research Group	Knoxville	Tennessee
United States	eStudySite	La Mesa	California
United States	Multi-Specialty Research Associates, Inc.	Lake City	Florida
United States	Red Star Research	Lake Jackson	Texas
United States	Baptist Health Center for Clinical Research	Little Rock	Arkansas
United States	Woodland International Research Group, LLC	Little Rock	Arkansas
United States	Collaborative Neuroscience Network, LLC	Long Beach	California
United States	Pharmacology Research Institute	Los Alamitos	California
United States	Community Clinical Research Network/Milford Emergency Associates, Inc	Marlborough	Massachusetts
United States	Qps Mra, Llc	Miami	Florida
United States	Clinical Research Institute, Inc.	Minneapolis	Minnesota
United States	Coastal Clinical Research, LLC	Mobile	Alabama
United States	Coastal Carolina Research	Mount Pleasant	South Carolina
United States	Clinical Research Institute, Inc.	Nashville	Tennessee
United States	Nashville Neuroscience Group	Nashville	Tennessee
United States	Synergy San Diego	National City	California
United States	Yale University	New Haven	Connecticut
United States	DelRicht Research	New Orleans	Louisiana
United States	New Orleans Center for Clinical Research	New Orleans	Louisiana
United States	Pharmacology Research Institute	Newport Beach	California
United States	Meridian Clinical Research, LLC	Norfolk	Nebraska
United States	Clinical Neuroscience Solutions, Inc	Orlando	Florida
United States	Ormond Medical Arts Pharmaceutical Research	Ormond Beach	Florida
United States	Clinical Research of Philadelphia, LLC	Philadelphia	Pennsylvania
United States	Clinical Research Institute, Inc.	Plymouth	Minnesota
United States	Summit Research Network (Oregon) Inc.	Portland	Oregon
United States	PMG Research of Raleigh	Raleigh	North Carolina
United States	Rochester Clinical Research, Inc.	Rochester	New York
United States	Sundance Clinical Research	Saint Louis	Missouri
United States	StudyMetrix Research, LLC	Saint Peters	Missouri
United States	Optimus Medical Group	San Francisco	California
United States	Meridian Clinical Research, LLC	Savannah	Georgia
United States	Seattle Women's: Health, Research, Gynecology	Seattle	Washington
United States	Ki Health Partners LLC DBA New England Institute for Clinical Research	Stamford	Connecticut
United States	Clinical Research Consortium, An AMR Company	Tempe	Arizona
United States	DM Clinical Research	Tomball	Texas
United States	Radiant Research, Inc.	Tucson	Arizona
United States	Tidewater Integrated Medical Research	Virginia Beach	Virginia
United States	Diablo Clinical Research, Inc.	Walnut Creek	California
United States	Heartland Research Associates, LLC	Wichita	Kansas
United States	Wilmington Health, PLLC	Wilmington	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Freedom From Pain at 2 Hours Post-dose	Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the electronic diary (eDiary). Pain freedom was defined as pain level of none.	2 hours post-dose
Primary	Percentage of Participants With Freedom From Most Bothersome Symptom (MBS) at 2 Hours Post-dose	MBS was reported as nausea, photophobia, or phonophobia at migraine onset using the eDiary. Symptom status (absent, present) was assessed post-dose using the eDiary separately for nausea, photophobia, and phonophobia. Freedom from MBS was defined as MBS reported at onset that was absent post-dose.	2 hours post-dose
Secondary	Percentage of Participants With Pain Relief at 2 Hours Post-dose	Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the eDiary. Pain relief was defined as pain level of none or mild.	2 hours post-dose
Secondary	Percentage of Participants With Freedom From Functional Disability at 2 Hours Post-dose	Functional disability level was assessed in the eDiary on a 4-point scale: normal function, mild impairment, severe impairment, required bed rest. Freedom from functional disability was defined as normal function.	2 hours post-dose
Secondary	Percentage of Participants With Sustained Pain Relief From 2 to 24 Hours Post-dose	Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the eDiary. Sustained pain relief was defined as pain level of none or mild at 2 hours up to 24 hours post-dose with no rescue medication use through 24 hours post-dose.	From 2 hours up to 24 hours post-dose
Secondary	Percentage of Participants With Sustained Freedom From Most Bothersome Symptom (MBS) From 2 to 24 Hours Post-dose	MBS was reported as nausea, photophobia, or phonophobia at migraine onset using the eDiary. Symptom status (absent, present) was assessed post-dose using the eDiary separately for nausea, photophobia, and phonophobia. Sustained freedom was defined as MBS reported at onset that was absent at 2 hours up to 24 hours post-dose with no rescue medication use through 24 hours post-dose.	From 2 hours up to 24 hours post-dose
Secondary	Percentage of Participants With Rescue Medication Use Within 24 Hours Post-dose	Participants who did not experience relief of their migraine headache at the end of 2 hours after dosing with study medication (and after the 2-hour assessments had been completed on the eDiary) were permitted to use the following rescue medications: aspirin, ibuprofen, acetaminophen up to 1000 mg/day (this includes Excedrin Migraine), naproxen (or any other type of nonsteroidal anti-inflammatory drug), antiemetics (e.g., metoclopramide or promethazine), or baclofen. The participant's use of rescue medication was recorded by the participant in a paper diary.	24 hours post-dose
Secondary	Percentage of Participants With Sustained Freedom From Functional Disability From 2 to 24 Hours Post-dose	Functional disability level was assessed in the eDiary on a 4-point scale: normal function, mild impairment, severe impairment, required bed rest. Sustained freedom from functional disability was defined as normal function at 2 hours up to 24 hours post-dose with no rescue medication use through 24 hours post-dose.	From 2 hours up to 24 hours post-dose
Secondary	Percentage of Participants With Sustained Pain Relief From 2 to 48 Hours Post-dose	Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the eDiary. Sustained pain relief was defined as pain level of none or mild at 2 hours up to 48 hours post-dose with no rescue medication use through 48 hours post-dose.	From 2 hours up to 48 hours post-dose
Secondary	Percentage of Participants With Sustained Freedom From Most Bothersome Symptom (MBS) From 2 to 48 Hours Post-dose	MBS was reported as nausea, photophobia, or phonophobia at migraine onset using the eDiary. Symptom status (absent, present) was assessed post-dose using the eDiary separately for nausea, photophobia, and phonophobia. Sustained freedom was defined as MBS reported at onset that was absent at 2 hours up to 48 hours post-dose with no rescue medication use through 48 hours post-dose.	From 2 hours up to 48 hours post-dose
Secondary	Percentage of Participants With Sustained Freedom From Functional Disability From 2 to 48 Hours Post-dose	Functional disability level was assessed in the eDiary on a 4-point scale: normal function, mild impairment, severe impairment, required bed rest. Sustained freedom from functional disability was defined as normal function at 2 hours up to 48 hours post-dose with no rescue medication use through 48 hours post-dose.	From 2 hours up to 48 hours post-dose
Secondary	Percentage of Participants With Freedom From Photophobia at 2 Hours Post-dose	Photophobia (sensitivity to light) status was measured as absent or present in the eDiary. Freedom from photophobia was defined as photophobia absent.	2 hours post-dose
Secondary	Percentage of Participants With Freedom From Functional Disability at 90 Minutes Post-dose	Functional disability level was assessed in the eDiary on a 4-point scale: normal function, mild impairment, severe impairment, required bed rest. Freedom from functional disability was defined as normal function.	90 minutes post-dose
Secondary	Percentage of Participants With Pain Relief at 90 Minutes Post-dose	Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the eDiary. Pain relief was defined as pain level of none or mild.	90 minutes post-dose
Secondary	Percentage of Participants With Sustained Pain Freedom From 2 to 24 Hours Post-dose	Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the eDiary. Sustained pain freedom was defined as pain level of none at 2 hours up to 24 hours post-dose with no rescue medication use through 24 hours post-dose.	From 2 hours up to 24 hours post-dose
Secondary	Percentage of Participants With Freedom From Most Bothersome Symptom (MBS) at 90 Minutes Post-dose	MBS was reported as nausea, photophobia, or phonophobia at migraine onset using the eDiary. Symptom status (absent, present) was assessed post-dose using the eDiary separately for nausea, photophobia, and phonophobia. Freedom from MBS was defined as MBS reported at onset that was absent post-dose.	90 minutes post dose
Secondary	Percentage of Participants With Freedom From Pain at 90 Minutes Post-dose	Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the electronic diary (eDiary). Pain freedom was defined as pain level of none.	90 minutes post-dose
Secondary	Percentage of Participants With Freedom From Phonophobia at 2 Hours Post-dose	Phonophobia (sensitivity to sound) status was measured as absent or present in the eDiary. Freedom from phonophobia was defined as phonophobia absent.	2 hours post-dose
Secondary	Percentage of Participants With Sustained Pain Freedom From 2 to 48 Hours Post-dose	Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the eDiary. Sustained pain freedom was defined as pain level of none at 2 hours up to 48 hours post-dose with no rescue medication use through 48 hours post-dose.	From 2 hours up to 48 hours post-dose
Secondary	Percentage of Participants With Pain Relief at 60 Minutes Post-dose	Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the eDiary. Pain relief was defined as pain level of none or mild.	60 minutes post-dose
Secondary	Percentage of Participants With Freedom From Functional Disability at 60 Minutes Post-dose	Functional disability level was assessed in the eDiary on a 4-point scale: normal function, mild impairment, severe impairment, required bed rest. Freedom from functional disability was defined as normal function.	60 minutes post-dose
Secondary	Percentage of Participants With Freedom From Nausea at 2 Hours Post-dose	Nausea status was measured as absent or present in the eDiary. Freedom from nausea was defined as nausea absent.	2 hours post-dose
Secondary	Percentage of Participants With Pain Relapse From 2 to 48 Hours Post-dose	Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the eDiary. Pain relapse was defined as pain level of mild, moderate, or severe after 2 hours up to 48 hours post-dose for the participants who were pain-free at 2 hours post-dose.	From 2 hours up to 48 hours post-dose