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Completed

NCT Number: NCT03872453

Acute Treatment Trial in Adult Subjects With Migraines

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.

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Key information

Conditions

Migraine Brain Diseases Central Nervous System Diseases Ear Diseases Eye Diseases Headache Disorders Headache Disorders, Primary Hearing Disorders Hyperacusis Migraine Disorders Nausea Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Photophobia Sensation Disorders Signs and Symptoms Signs and Symptoms, Digestive Vision Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Coastal Clinical Research, Inc., Mobile, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Key Inclusion Criteria:

  • 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:
  • Migraine attacks present for more than 1 year with the age of onset prior to 50 years of age.
  • Migraine attacks, on average, lasting about 4-72 hours if untreated.
  • Not more than 8 attacks of moderate to severe intensity per month within the last 3 months.
  • 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.
  • 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.
  • 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.
  • Participants with contraindications for use of triptans may be included provided they meet all other study entry criteria.

Exclusion criteria

Key Exclusion Criteria:

  • Participant with a history of basilar migraine or hemiplegic migraine.
  • Participant with a history of human immunodeficiency virus (HIV) disease.
  • 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.
  • 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).
  • 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.
  • 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.
  • 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.
  • 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.
  • History of nasal surgery in the 6 months preceding the Screening Visit.
  • Participation in any other investigational clinical trial while participating in this clinical trial.

Treatment and study plan

Zavegepant

Drug

A single dose of zavegepant

Other names: BHV3500

Zavegepant matching placebo

Drug

A single dose of placebo matched to zavegepant

Intranasal Aptar Pharma Unit Dose System

Device

A single-dose intranasal device

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Mar 13, 2019
Registry last updated
Sep 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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