Safety and Efficacy Study in Adult Subjects With Acute Migraines

Migraine, With or Without Aura Clinical Trial

Official title:

BHV3000-301: Phase 3: Double-Blind, Randomized, Placebo-Controlled, Safety and Efficacy Trial of BHV-3000 (Rimegepant) for the Acute Treatment of Migraine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03235479
• Other study ID #: BHV-3000-301
• Status: Completed
• Phase: Phase 3
• Start date: July 18, 2017
• Est. completion date: January 26, 2018

Study information

• Verified date: February 2023
• 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) versus placebo in subjects with Acute Migraines

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1485
• Est. completion date: January 26, 2018
• Est. primary completion date: January 21, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Key Inclusion Criteria:

1. Patient 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:

• Not more than 8 attacks of moderate or severe intensity per month within last 3 months
• 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

2. 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

3. Patients 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 study entry.

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

Key Exclusion Criteria:

1. Patient history of HIV disease

2. Patient history with current evidence of uncontrolled, unstable or recently diagnosed cardiovascular disease, such as ischemic heart disease, coronary artery vasospasm, and cerebral ischemia. Patients 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 patients can be included who have stable hypertension and/or diabetes for 3 months prior to being enrolled)

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

5. Patient has a history of gastric, or small intestinal surgery, or has a disease that causes mal-absorption

6. The patient has a history or current evidence of any significant and/or unstable medical conditions (eg, 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 patients who have met DSM-V criteria for any significant substance use disorder within the past 12 months from the date of the screening visit.

Related Conditions & MeSH terms

• Migraine Disorders
• Migraine, With or Without Aura

Intervention

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

Locations

Country	Name	City	State
United States	Michigan Head Pain & Neurological Institute	Ann Arbor	Michigan
United States	FutureSearch Trials of Neurology, LP	Austin	Texas
United States	Northwest Clinical Research Center	Bellevue	Washington
United States	Hassman Research Institute, LLC	Berlin	New Jersey
United States	Central Research Associates, Inc	Birmingham	Alabama
United States	Boston Clinical Trials, Inc	Boston	Massachusetts
United States	SPRI Clinical Trials, LLC	Brooklyn	New York
United States	CTI Clinical Research Center	Cincinnati	Ohio
United States	Meridian Clinical Research	Dakota Dunes	South Dakota
United States	FutureSearch Trials of Neurology, LP	Dallas	Texas
United States	Pharmacology Research Institute	Encino	California
United States	Regional Clinical Research, Inc.	Endwell	New York
United States	Neurological Physicians of Arizona/Radiant Research Inc	Gilbert	Arizona
United States	PharmQuest, LLC	Greensboro	North Carolina
United States	Qps Mra, Llc	Hollywood	Florida
United States	Texas Center for Drug Development	Houston	Texas
United States	The Center for Pharmaceutical Research	Kansas City	Missouri
United States	Multi-Specialty Research Associates, Inc	Lake City	Florida
United States	Clinical Research Consortium- Las Vegas	Las Vegas	Nevada
United States	Woodland International Research Group, LLC	Little Rock	Arkansas
United States	Central New York Clinical Research	Manlius	New York
United States	Milford Emergency Associates, Inc.	Marlborough	Massachusetts
United States	Advanced Pharma CR, LLC	Miami	Florida
United States	Qps Mra, Llc	Miami	Florida
United States	Clinical Research Institute	Minneapolis	Minnesota
United States	Clinical Research Institute, Inc	Minneapolis	Minnesota
United States	Coastal Carolina Research Center	Mount Pleasant	South Carolina
United States	New Orleans Center for Clinical Research	New Orleans	Louisiana
United States	Fieve Clinical Research	New York	New York
United States	Clinical Research Associates of Tidewater, Inc.	Norfolk	Virginia
United States	Meridian Clinical Research -Norfolk	Norfolk	Nebraska
United States	Meridian Clinical Research, LLC	Omaha	Nebraska
United States	Compass Research, LLC	Orlando	Florida
United States	Ormond Medical Arts Pharmaceutical Research	Ormond Beach	Florida
United States	Clinical Research of Philadelphia, LLC	Philadelphia	Pennsylvania
United States	Oregon Center for Clinical Investigations, Inc	Portland	Oregon
United States	Rochester Clinical Research, Inc	Rochester	New York
United States	Sundance Clinical Research, LLC	Saint Louis	Missouri
United States	J.Lewis Research Inc / Foothill Family Clinic South	Salt Lake City	Utah
United States	Optimus Medical Group	San Francisco	California
United States	California Medical Clinic for Headache	Santa Monica	California
United States	Meridian Clinical Research	Savannah	Georgia
United States	Seattle Women's:Health, Research & Gynecology	Seattle	Washington
United States	J.Lewis Research Inc. / Jordan River Family Med	South Jordan	Utah
United States	Clinical Research Consortium Arizona	Tempe	Arizona
United States	Radiant Research, Inc.	Tucson	Arizona
United States	Preferred Primary Care Physicians	Uniontown	Pennsylvania
United States	Tidewater Integrated Medical Research	Virginia Beach	Virginia
United States	Diablo Clinical Research, Inc	Walnut Creek	California
United States	Omega Medical Research	Warwick	Rhode Island

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 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 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 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 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 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 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 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 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 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 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 for the participants who were pain-free at 2 hours post-dose.	From 2 hours up to 48 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