Randomized Trial in Adult Participants With Acute Migraines

Migraine Clinical Trial

Official title:

Double-Blind, Randomized, Placebo-controlled, Safety and Efficacy Trial of BHV-3500 (Zavegepant) Intranasal for the Acute Treatment of Migraine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04571060
• Other study ID #: BHV3500-301
• Secondary ID: C5301001
• Status: Completed
• Phase: Phase 3
• Start date: October 27, 2020
• Est. completion date: October 22, 2021

Study information

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

Clinical Trial Summary

The purpose of this study is to test the safety and efficacy of BHV-3500 (zavegepant) versus placebo in the acute treatment of moderate or severe migraine.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1978
• Est. completion date: October 22, 2021
• Est. primary completion date: October 10, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Participant 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, 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 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. 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.

2. Male and Female participants =18 years of age.

Exclusion Criteria:

1. Participant with a history of HIV disease

2. 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 (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 participants can be included who have stable hypertension and/or diabetes for at least 3 months prior to being enrolled).

4. Participants with major depressive episode within the last 12 months, major depressive disorder or any anxiety disorder requiring more than 1 medication for each disorder.

5. History of, treatment for, or evidence of, alcohol or drug abuse within the past 12 months or participants who have met DSM-V criteria for any significant substance use disorder within the past 12 months.

6. History of nasal surgery in the 6 months.

7. Evidence at screening of significant nasal conditions that may affect the administration or absorption of the nasal product (e.g. severe septum deviation, nasal deformity or blockage, inflammation, perforation, mucosal erosion or ulceration, polyposis, nasal trauma)

8. Participation in any other investigational clinical trial while participating in this clinical trial. Participation in a COVID-19 mRNA vaccine study (vaccine must be authorized under FDA emergency use authorization or approval) who are at least 30 days post last dose of the vaccine are permitted to be screened for this study.

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

Drug:
• Zavegepant
One dose of zavegepant
• Placebo
One dose of matching placebo

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 Headache and Neurological Institute	Ann Arbor	Michigan
United States	Donald J. Garcia, Jr, MD, PA	Austin	Texas
United States	FutureSearch Trials of Neurology	Austin	Texas
United States	Northwest Clinical Research Center	Bellevue	Washington
United States	Neurology Offices of South Florida	Boca Raton	Florida
United States	Northwest Clinical Trials Inc.	Boise	Idaho
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	Chalmette	Louisiana
United States	MD First Research	Chandler	Arizona
United States	Charlottesville Medical Research Center, LLC	Charlottesville	Virginia
United States	Center for Emotional Fitness	Cherry Hill	New Jersey
United States	Cedar Crosse Research Center	Chicago	Illinois
United States	Hometown Urgent Care & Research/ Wellnow	Cincinnati	Ohio
United States	Axiom Research, LLC	Colton	California
United States	Hometown Urgent Care and Research	Columbus	Ohio
United States	CT Clinical Research	Cromwell	Connecticut
United States	FutureSearch Trials of Dallas, LP	Dallas	Texas
United States	Hometown Urgent Care and Research	Dayton	Ohio
United States	iResearch Atlanta, LLC	Decatur	Georgia
United States	OK Clinical Research LLC	Edmond	Oklahoma
United States	Pharmacology Research Institute	Encino	California
United States	Regional Clinical Research	Endwell	New York
United States	Healthcare Research Network II, LLC	Flossmoor	Illinois
United States	Fort Wayne Neurological Center	Fort Wayne	Indiana
United States	Headache Wellness Center	Greensboro	North Carolina
United States	PharmQuest LLC	Greensboro	North Carolina
United States	Healthcare Research Network	Hazelwood	Missouri
United States	Medical Affiliated Research Center	Huntsville	Alabama
United States	Clinical Neuroscience Solutions, Inc.	Jacksonville	Florida
United States	Clinical Investigation Specialist, 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 LLC	Lake Jackson	Texas
United States	Meridien Research	Lake Mary	Florida
United States	MD First Research	Lancaster	South Carolina
United States	Excel Clinical Research	Las Vegas	Nevada
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	Clinical Research Institute	Los Angeles	California
United States	L-MARC Research Center	Louisville	Kentucky
United States	Central New York Clinical Research	Manlius	New York
United States	Community Clinical Research Network	Marlborough	Massachusetts
United States	Clinical Neuroscience Solutions, Inc.	Memphis	Tennessee
United States	AppleMed Research Group, LLC	Miami	Florida
United States	The Neurology Research Group	Miami	Florida
United States	Clinical Research Institute, Inc.	Minneapolis	Minnesota
United States	Coastal Clinical Research, LLC, An AMR Co.	Mobile	Alabama
United States	Coastal Carolina Research Center	Mount Pleasant	South Carolina
United States	The Orthopedic Foundation	New Albany	Ohio
United States	DelRicht Research	New Orleans	Louisiana
United States	Fieve Clinical Research, Inc	New York	New York
United States	Wr-Pri, Llc	Newport Beach	California
United States	Health Research of Hampton Roads, Inc.	Newport News	Virginia
United States	Clinical Neuroscience Solutions, Inc.	Orlando	Florida
United States	Clinical Neuroscience Solutions, Inc.	Orlando	Florida
United States	Complete Health Research	Ormond Beach	Florida
United States	Ideal Clinical Research	Pembroke Pines	Florida
United States	Clinical Research of Philadelphia, LLC	Philadelphia	Pennsylvania
United States	Preferred Primary Care Physicians, Inc.	Pittsburgh	Pennsylvania
United States	Clinical Research Center of Florida	Pompano Beach	Florida
United States	Summit Research Network	Portland	Oregon
United States	Collective Medical Research	Prairie Village	Kansas
United States	PMG of Raleigh, LLC	Raleigh	North Carolina
United States	Artemis Institute for Clinical Research	Riverside	California
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	Alpine Medical Group	Salt Lake City	Utah
United States	Clinical Trials of Texas, Inc. (CTT)	San Antonio	Texas
United States	Artemis Institute for Clinical Research	San Diego	California
United States	Meridian Clinical Research, LLC	Savannah	Georgia
United States	Seattle Women's: Health, Research, Gynecology	Seattle	Washington
United States	California Neuroscience Research Medical Group, Inc.	Sherman Oaks	California
United States	Boston Neuro Research Center	South Dartmouth	Massachusetts
United States	J. Lewis Research, Inc. / Jordan River Family Medicine	South Jordan	Utah
United States	Clin-Med Research & Development, LLC	South Miami	Florida
United States	Clinvest Research LLC	Springfield	Missouri
United States	Ki Health Partners, LLC dba New England Institute for Clinical Research	Stamford	Connecticut
United States	ForCare Clinical Research	Tampa	Florida
United States	JSV Clinical Research Study, Inc.	Tampa	Florida
United States	DM Clinical Research	Tomball	Texas
United States	Tucson Neuroscience Research	Tucson	Arizona
United States	Preferred Primary Care Physicians, Inc.	Union	Pennsylvania
United States	Tidewater Integrated Medical Research	Virginia Beach	Virginia
United States	Medvadis Research Corporation	Waltham	Massachusetts
United States	Alliance for Multispecialty Research, LLC	Wichita	Kansas
United States	Wilmington Health, PLLC	Wilmington	North Carolina
United States	Tekton Research, Inc.	Yukon	Oklahoma

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 immediately before dosing 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 disability 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 Sustained Pain Relief From 2 Hours to 24 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 to 24 hours post-dose
Secondary	Percentage of Participants With Sustained Pain Relief From 2 Hours to 48 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 to 48 hours post-dose
Secondary	Percentage of Participants With Sustained Pain Freedom From 2 Hours to 24 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 to 24 hours post-dose
Secondary	Percentage of Participants With Sustained Pain Freedom From 2 Hours to 48 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 to 48 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 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 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 disability 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) present 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 disability 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 Pain Relief at 15 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.	15 minutes post-dose
Secondary	Percentage of Participants Who Were Able to Function Normally at 15 Minutes Post-dose	Functional disability 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.	15 minutes 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 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-dose 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 to 48 hours post-dose