Acute Treatment Trial in Adult Subjects With Migraines

Migraine Clinical Trial

Official title:

Phase II/III: Double-Blind, Randomized, Placebo-Controlled, Dose-Ranging Trial of BHV-3500 for the Acute Treatment of Migraine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03872453
• Other study ID #: BHV3500-201
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: March 25, 2019
• Est. completion date: November 11, 2019

Study information

• Verified date: September 2023
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to evaluate the safety and efficacy of three different intranasal dose levels of zavegepant (BHV-3500), relative to placebo, in the acute treatment of moderate to severe migraine.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2154
• Est. completion date: November 11, 2019
• Est. primary completion date: October 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Key Inclusion Criteria:

1. Participants have 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, 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. At least 2 consistent migraine headache attacks of moderate or severe intensity in each of the 3 months prior to the Screening Visit and throughout 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 throughout the Screening Period.

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

Exclusion Criteria:

Key Exclusion Criteria:

1. Participant with a history of basilar migraine or hemiplegic migraine.

2. Participant with a history of human immunodeficiency virus (HIV) disease.

3. Participant history with current evidence of uncontrolled, unstable or recently diagnosed cardiovascular disease, such as ischemic heart disease, coronary artery vasospasm, and cerebral ischemia. Participants with myocardial infarction, acute coronary syndrome, percutaneous coronary intervention, cardiac surgery, stroke or transient ischemic attack during the 6 months prior to screening.

4. 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).

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

6. Participant 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.

7. The participant has a history of current or evidence of any significant and/ or unstable medical conditions (for example, 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 or interfere with assessments of safety or efficacy during the course of the trial.

8. History of, treatment for, or evidence of, alcohol or drug abuse within the past 12 months or subjects who have met Diagnostic and Statistical Manual of Mental Disorders Fifth edition (DSM-V) criteria for any significant substance use disorder within the past 12 months from the date of the Screening Visit.

9. History of nasal surgery in the 6 months preceding the Screening Visit.

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

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

Drug:
• Zavegepant
A single dose of zavegepant
• Zavegepant matching placebo
A single dose of placebo matched to zavegepant

Device:
• Intranasal Aptar Pharma Unit Dose System
A single-dose intranasal device

Locations

Country	Name	City	State
United States	Albuquerque Clinical Trials, Inc.	Albuquerque	New Mexico
United States	Dent Neurosciences Research Center	Amherst	New York
United States	Michigan Head Pain & Neurological Institute	Ann Arbor	Michigan
United States	FutureSearch Trials of Neurology	Austin	Texas
United States	Northwest Clinical Research	Bellevue	Washington
United States	MedPharmics, LLC	Biloxi	Mississippi
United States	Boston Clinical Trials	Boston	Massachusetts
United States	Montefiore Medical Center: Headache Center	Bronx	New York
United States	Crescent City Headache and Neurology Center, LLC	Chalmette	Louisiana
United States	Clinical Trials of South Carolina	Charleston	South Carolina
United States	PMG Research of Charlotte, LLC	Charlotte	North Carolina
United States	Charlottesville Medical Research Center, LLC	Charlottesville	Virginia
United States	Center for Emotional Fitness	Cherry Hill	New Jersey
United States	Hometown Urgent Care and Research	Cincinnati	Ohio
United States	Hometown Urgent Care and Research	Columbus	Ohio
United States	CT Clinical Research	Cromwell	Connecticut
United States	Meridian Clinical Research	Dakota Dunes	South Dakota
United States	FutureSearch Trials of Dallas	Dallas	Texas
United States	Hometown Urgent Care and Research	Dayton	Ohio
United States	iResearch Atlanta, LLC	Decatur	Georgia
United States	Denver Neurological Research, LLC	Denver	Colorado
United States	Pharmacology Research Institute	Encino	California
United States	Ventavia Research Group	Fort Worth	Texas
United States	Headache Wellness Center	Greensboro	North Carolina
United States	PharmQuest	Greensboro	North Carolina
United States	MD Clinical	Hallandale Beach	Florida
United States	Texas Center for Drug Development, Inc.	Houston	Texas
United States	Clinical Neuroscience Solutions, Inc.	Jacksonville	Florida
United States	Center for Pharmaceutical Research, LLC	Kansas City	Missouri
United States	Clinical Investigation Specialists, Inc.	Kenosha	Wisconsin
United States	Alliance for Multispecialty Research/New Orleans Center for Clinical Research/Volunteer Research	Knoxville	Tennessee
United States	eStudySite	La Mesa	California
United States	Multi-Specialty Research Associates, Inc.	Lake City	Florida
United States	Red Star Research, LLC	Lake Jackson	Texas
United States	Synergy San Diego	Lemon Grove	California
United States	Baptist Health Center for Clinical Research	Little Rock	Arkansas
United States	Collaborative Neuroscience Network, LLC	Long Beach	California
United States	Pharmacology Research Institute	Los Alamitos	California
United States	Advanced Pharmaceutical Development Clinical Research	Magnolia	Texas
United States	Community Clinical Research Network	Marlborough	Massachusetts
United States	Clinical Neuroscience Solutions DBA CNS Healthcare	Memphis	Tennessee
United States	AGA Clinical Trials	Miami	Florida
United States	Qps Mra, Llc	Miami	Florida
United States	Clinical Research Institute, Inc.	Minneapolis	Minnesota
United States	Coastal Clinical Research, Inc.	Mobile	Alabama
United States	Coastal Carolina Research Center	Mount Pleasant	South Carolina
United States	Clinical Research Associates, Inc.	Nashville	Tennessee
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	Regeneris Medical	North Attleboro	Massachusetts
United States	Meritas Health Neurology	North Kansas City	Missouri
United States	Hightower Clinical	Oklahoma City	Oklahoma
United States	Clinical Neuroscience Solutions, Inc.	Orlando	Florida
United States	Ormond Medical Arts Pharmaceutical Research Center	Ormond Beach	Florida
United States	National Research Institute	Panorama City	California
United States	Elite Clinical Studies	Phoenix	Arizona
United States	Clinical Research Institute, Inc.	Plymouth	Minnesota
United States	Summit Research Network (Oregon) Inc.	Portland	Oregon
United States	Phoenix Medical Research	Prairie Village	Kansas
United States	PMG Research of Raleigh, LLC	Raleigh	North Carolina
United States	Rochester Clinical Research, Inc.	Rochester	New York
United States	Sundance Clinical Research, LLC	Saint Louis	Missouri
United States	StudyMetrix Research	Saint Peters	Missouri
United States	Oregon Center for Clinical Investigations, Inc. (OCCI, Inc.)	Salem	Oregon
United States	Wasatch Clinical Research, LLC	Salt Lake City	Utah
United States	Victorium Clinical Research	San Antonio	Texas
United States	Optimus Medical Group	San Francisco	California
United States	Neurological Research Institute	Santa Monica	California
United States	Meridian Clinical Research	Savannah	Georgia
United States	Clinvest Research LLC	Springfield	Missouri
United States	QPS Bio-Kinetic Clinical Applications, LLC	Springfield	Missouri
United States	Ki Health Partners, LLC, dba New England Institute for Clinical Research	Stamford	Connecticut
United States	Meridien Research	Tampa	Florida
United States	Dynamed Clinical Research	Tomball	Texas
United States	Tidewater Integrated Medical Research	Virginia Beach	Virginia
United States	Diablo Clinical Research, Inc.	Walnut Creek	California
United States	MedVadis Research Corporation	Watertown	Massachusetts
United States	Family Medicine Specialists/CIS	Wauconda	Illinois
United States	Premiere Research Institute	West Palm Beach	Florida
United States	Upstate Clinical Research Associates, LLC	Williamsville	New York
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 clinical outcome assessment (eCOA) handheld device. Pain freedom was defined as pain level of none post-dose.	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 eCOA handheld device. Symptom status (absent, present) was assessed post-dose using the eCOA handheld device separately for nausea, photophobia, and phonophobia. Freedom from MBS was defined as MBS reported at on-study migraine attack 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 eCOA handheld device. Pain relief was defined as pain level of none or mild.	2 hours post-dose
Secondary	Percentage of Participants Who Were Able to Function Normally at 2 Hours Post-dose	Functional disbaility level was assessed on a 4-point scale (normal function, mildly impaired, severely impaired, requires bedrest) using the eCOA handheld device. Normal function was defined as a functional disability level of normal post-dose in the subset of participants with functional disability (mildly impaired, severely impaired, requires bedrest) at on-study migraine attack onset.	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 eCOA handheld device) 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 (for example, metoclopramide or promethazine), or baclofen. The participant's use of rescue medication was recorded by the site on a case report form.	Through 24 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 eCOA handheld device. Freedom from photophobia was defined as photophobia absent post-dose in the subset of participants with photophobia present at on-study migraine attack onset.	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 eCOA handheld device. Freedom from phonophobia was defined as phonophobia absent post-dose in the subset of participants with phonophobia present at on-study migraine attack onset.	2 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 eCOA handheld device. Pain relief was defined as pain level of none or mild.	60 minutes post-dose
Secondary	Percentage of Participants Who Were Able to Function Normally at 60 Minutes Post-dose	Functional disbaility level was assessed on a 4-point scale (normal function, mildly impaired, severely impaired, requires bedrest) using the eCOA handheld device. Normal function was defined as a functional disability level of normal post-dose in the subset of participants with functional disability (mildly impaired, severely impaired, requires bedrest) at on-study migraine attack onset.	60 minutes post-dose
Secondary	Percentage of Participants With Pain Relief at 30 Minutes Post-dose	Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the eCOA handheld device. Pain relief was defined as pain level of none or mild.	30 minutes post-dose
Secondary	Percentage of Participants Who Were Able to Function Normally at 30 Minutes Post-dose	Functional disbaility level was assessed on a 4-point scale (normal function, mildly impaired, severely impaired, requires bedrest) using the eCOA handheld device. Normal function was defined as a functional disability level of normal post-dose in the subset of participants with functional disability (mildly impaired, severely impaired, requires bedrest) at on-study migraine attack onset.	30 minutes 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 eCOA handheld device. Sustained pain relief was defined as pain level of none or mild at 2 hours up to 24 hours post-dose.	From 2 hours up to 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 eCOA handheld device. Sustained pain freedom was defined as pain level of none at 2 hours up to 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 eCOA handheld device. Sustained pain relief was defined as pain level of none or mild at 2 hours up to 48 hours post-dose.	From 2 hours up to 48 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 eCOA handheld device. Sustained pain freedom was defined as pain level of none at 2 hours up to 48 hours post-dose.	From 2 hours up to 48 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 eCOA handheld device. Freedom from nausea was defined as nausea absent post-odse in the subset of participants with nausea present at on-study migraine attack onset.	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 eCOA handheld device. Pain relapse was defined as pain level of mild, moderate, or severe after 2 hours up to 48 hours post-dose in the subset of participants with pain level of none at 2 hours post-dose.	From 2 hours up to 48 hours post-dose

External Links

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