Safety and Efficacy in Adult Subjects With Acute Migraines

Migraine, With or Without Aura Clinical Trial

Official title:

BHV3000-302 : 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: NCT03237845
• Other study ID #: BHV3000-302
• Status: Completed
• Phase: Phase 3
• Start date: July 27, 2017
• Est. completion date: January 31, 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: 1499
• Est. completion date: January 31, 2018
• Est. primary completion date: January 25, 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 malabsorption.

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, hepatitisB 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 ofthe 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 thepast 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	Albuquerque Neuroscience, Inc.	Albuquerque	New Mexico
United States	PMG Research of McFrland Clinic	Ames	Iowa
United States	Radiant Research, Inc.	Anderson	South Carolina
United States	Radiant Research, Inc.	Atlanta	Georgia
United States	Heartland Research Associates, LLC	Augusta	Kansas
United States	Tekton Research	Austin	Texas
United States	Christie Clinic, LLC	Champaign	Illinois
United States	Radiant Research, Inc.	Cincinnati	Ohio
United States	Radiant Research, Inc.	Columbus	Ohio
United States	Midwest Clinical Research Center	Dayton	Ohio
United States	Neurology Diagnostics, Inc.	Dayton	Ohio
United States	Clinical Trials of the Rockies	Denver	Colorado
United States	Aventiv Research, Inc.	Dublin	Ohio
United States	NECCR Primacare Research, LLC	Fall River	Massachusetts
United States	Ventavia Research Group	Fort Worth	Texas
United States	Thunderbird Internal Medicine / Radiant Research, Inc.	Glendale	Arizona
United States	AGA Clinical Trials	Hialeah	Florida
United States	Clinical Neuroscience Solutions	Jacksonville	Florida
United States	Radiant Research, Inc.	Jamaica	New York
United States	eStudySite	La Mesa	California
United States	Red Star Research	Lake Jackson	Texas
United States	FMC Science	Lampasas	Texas
United States	Collaborative Neuroscience Network, LLC	Long Beach	California
United States	Pharmacology Research Institute	Los Alamitos	California
United States	PCP for Life	Magnolia	Texas
United States	Research Across America	Mesquite	Texas
United States	MedPharmics, LLC	Metairie	Louisiana
United States	Coastal Clinical Research	Mobile	Alabama
United States	Clinical Research Associates, Inc.	Nashville	Tennessee
United States	Pharmacology Research Institute	Newport Beach	California
United States	Heartland Research Associates, LLC	Newton	Kansas
United States	Pacific Research Partners LLC	Oakland	California
United States	Renstar Medical Research	Ocala	Florida
United States	Clinical Neuroscience Solutions, Inc.	Orlando	Florida
United States	National Research Institute	Panorama City	California
United States	Heartland Research Associates, LLC	Park City	Kansas
United States	Doctors of Internal Medicine, LTD / Radiant Research, Inc.	Plano	Texas
United States	Summit Research Network (Oregon), Inc.	Portland	Oregon
United States	PMG Research of Raleigh, Inc.	Raleigh	North Carolina
United States	Wake Research Associates, LLC	Raleigh	North Carolina
United States	Woodland Research Northwest, LLC	Rogers	Arkansas
United States	Oregon Center for Clinical Investigations, Inc	Salem	Oregon
United States	Savannah Neurology Specialists	Savannah	Georgia
United States	Fieve Clinical Research, Inc.	Scranton	Pennsylvania
United States	California Neuroscience Research Medical Group, Inc.	Sherman Oaks	California
United States	Meridien Research	Tampa	Florida
United States	DM Clinical Research	Tomball	Texas
United States	Heartland Research Associates, LLC	Wichita	Kansas
United States	Heartland Research Associates, LLC	Wichita	Kansas
United States	PMG Research of Wilmington, LLC	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
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