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Acute Treatment Trial in Adult Subjects With Migraines

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ClinicalTrials.gov Identifier: NCT03872453
Recruitment Status : Completed
First Posted : March 13, 2019
Results First Posted : October 13, 2022
Last Update Posted : September 25, 2023
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Migraine Drug: Zavegepant Drug: Zavegepant matching placebo Device: Intranasal Aptar Pharma Unit Dose System Phase 2 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2154 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: Double-blind to Sponsor, Investigator and Subject
Primary Purpose: Treatment
Official Title: Phase II/III: Double-Blind, Randomized, Placebo-Controlled, Dose-Ranging Trial of BHV-3500 for the Acute Treatment of Migraine
Actual Study Start Date : March 25, 2019
Actual Primary Completion Date : October 31, 2019
Actual Study Completion Date : November 11, 2019

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine
MedlinePlus related topics: Migraine

Arms and Interventions
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Arm Intervention/treatment
Experimental: Zavegepant 5 mg
Participants administered a single intranasal dose of zavegepant 5 mg on occurrence of migraine that reached moderate or severe intensity within 45 days after randomization. The dose was administered using Aptar Unidose System (UDS) liquid spray device.
 Drug: Zavegepant
A single dose of zavegepant
Other Name: BHV3500

Device: Intranasal Aptar Pharma Unit Dose System
A single-dose intranasal device
Experimental: Zavegepant 10 mg
Participants administered a single intranasal dose of zavegepant 10 mg on occurrence of migraine that reached moderate or severe intensity within 45 days after randomization. The dose was administered using Aptar UDS liquid spray device.
 Drug: Zavegepant
A single dose of zavegepant
Other Name: BHV3500

Device: Intranasal Aptar Pharma Unit Dose System
A single-dose intranasal device
Experimental: Zavegepant 20 mg
Participants administered a single intranasal dose of zavegepant 20 mg on occurrence of migraine that reached moderate or severe intensity within 45 days after randomization. The dose was administered using Aptar UDS liquid spray device.
 Drug: Zavegepant
A single dose of zavegepant
Other Name: BHV3500

Device: Intranasal Aptar Pharma Unit Dose System
A single-dose intranasal device
Placebo Comparator: Placebo
Participants administered a single intranasal dose of zavegepant-matching placebo on occurrence of migraine that reached moderate or severe intensity within 45 days after randomization. The dose was administered using Aptar UDS liquid spray device.
 Drug: Zavegepant matching placebo
A single dose of placebo matched to zavegepant

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


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants With Freedom From Pain at 2 Hours Post-dose [ Time Frame: 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. Percentage of Participants With Freedom From Most Bothersome Symptom (MBS) at 2 Hours Post-dose [ Time Frame: 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.


Secondary Outcome Measures :
  1. Percentage of Participants With Pain Relief at 2 Hours Post-dose [ Time Frame: 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. Percentage of Participants Who Were Able to Function Normally at 2 Hours Post-dose [ Time Frame: 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.

  3. Percentage of Participants With Rescue Medication Use Within 24 Hours Post-dose [ Time Frame: Through 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.

  4. Percentage of Participants With Freedom From Photophobia at 2 Hours Post-dose [ Time Frame: 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.

  5. Percentage of Participants With Freedom From Phonophobia at 2 Hours Post-dose [ Time Frame: 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.

  6. Percentage of Participants With Pain Relief at 60 Minutes Post-dose [ Time Frame: 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.

  7. Percentage of Participants Who Were Able to Function Normally at 60 Minutes Post-dose [ Time Frame: 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.

  8. Percentage of Participants With Pain Relief at 30 Minutes Post-dose [ Time Frame: 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.

  9. Percentage of Participants Who Were Able to Function Normally at 30 Minutes Post-dose [ Time Frame: 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.

  10. Percentage of Participants With Sustained Pain Relief From 2 to 24 Hours Post-dose [ Time Frame: From 2 hours up 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.

  11. Percentage of Participants With Sustained Pain Freedom From 2 to 24 Hours Post-dose [ Time Frame: From 2 hours up 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.

  12. Percentage of Participants With Sustained Pain Relief From 2 to 48 Hours Post-dose [ Time Frame: From 2 hours up 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.

  13. Percentage of Participants With Sustained Pain Freedom From 2 to 48 Hours Post-dose [ Time Frame: From 2 hours up 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.

  14. Percentage of Participants With Freedom From Nausea at 2 Hours Post-dose [ Time Frame: 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.

  15. Percentage of Participants With Pain Relapse From 2 to 48 Hours Post-dose [ Time Frame: From 2 hours up 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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03872453


Locations
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Sponsors and Collaborators
Pfizer
  Study Documents (Full-Text)

Documents provided by Pfizer:
Study Protocol  [PDF] August 8, 2019
Statistical Analysis Plan  [PDF] November 15, 2019

More Information
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Additional Information:

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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT03872453    
Other Study ID Numbers: BHV3500-201
First Posted: March 13, 2019    Key Record Dates
Results First Posted: October 13, 2022
Last Update Posted: September 25, 2023
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Pfizer:
Acute Migraine
phonophobia
photophobia
nausea
Additional relevant MeSH terms:
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Migraine Disorders
Headache Disorders, Primary
Headache Disorders
 Brain Diseases
Central Nervous System Diseases
Nervous System Diseases