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Randomized Trial in Adult Subjects With Acute Migraines

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04571060
Recruitment Status : Completed
First Posted : September 30, 2020
Last Update Posted : October 27, 2021
Sponsor:
Information provided by (Responsible Party):
Biohaven Pharmaceuticals, Inc.

Tracking Information
First Submitted Date  ICMJE September 11, 2020
First Posted Date  ICMJE September 30, 2020
Last Update Posted Date October 27, 2021
Actual Study Start Date  ICMJE October 27, 2020
Actual Primary Completion Date October 10, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 25, 2020)
To evaluate the efficacy of BHV-3500 compared with placebo in the acute treatment of migraine by using a scale to measure pain freedom and a multiple choice question for most bothersome symptom. [ Time Frame: 2 hours post-dose ]
Freedom from Pain will be measured on a 4 point Likert scale (0=none, 1=mild, 2=moderate, 3=severe) and The MBS (nausea, phonophobia or photophobia) will measured using a binary scale (0=absent, 1=present).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 25, 2020)
  • BHV-3500 subjects compared to placebo subjects on pain relief: percentage of subjects with a pain intensity of none or mild. [ Time Frame: 2 hours post-dose ]
    Pain Relief as measured by a 4 point numeric rating scale (None, Mild, Moderate, Severe)
  • BHV-3500 subjects compared to placebo subjects on their ability to function normally, according to the Functional Disability scale. [ Time Frame: 2 hours post-dose ]
    Subjects self-report "normal" on the functional disability scale.
  • BHV-3500 subjects compared to placebo subjects on sustained pain relief. [ Time Frame: All time points from 2 to 24 hours post-dose ]
    Pain relief will be measured using the percentage of subjects with pain intensities of none or mild.
  • BHV-3500 subjects compared to placebo subjects on sustained pain relief. [ Time Frame: All time points from 2 to 48 hours post-dose ]
    Pain relief will be measured using the percentage of subjects with pain intensities of none or mild.
  • BHV-3500 subjects compared to placebo subjects on sustained pain freedom. [ Time Frame: All time points from 2 to 24 hours post-dose. ]
    Pain freedom will be measured using the percentage of subjects with pain intensities of none or mild.
  • BHV-3500 subjects compared to placebo subjects on sustained pain freedom. [ Time Frame: All the time points from 2 to 48 hours post-dose. ]
    Pain freedom will be measured using the percentage of subjects with pain intensities of none or mild.
  • BHV-3500 subjects compared to placebo subjects on freedom from phonophobia. [ Time Frame: 2 hours post-dose ]
    Freedom from phonophobia will be measured in a multiple choice question.
  • BHV-3500 subjects compared to placebo subjects on freedom from photophobia. [ Time Frame: 2 hours post-dose ]
    Freedom from photophobia will be measured in a multiple choice question with the subjects who reported photophobia present at the time of dosing.
  • BHV-3500 compared to placebo on sustained pain relief at 60 minutes after dosing. [ Time Frame: 60 minutes post-dose ]
    Pain relief will be measured using the percentage of subjects with a pain intensity of none or mild.
  • To evaluate the effect of BHV-3500 relative to placebo on the patients ability function normally at 60 minutes post-dose. [ Time Frame: 60 minutes post-dose, according to the Functional Disability scale. ]
    Subjects self-report "normal" on the functional disability scale.
  • To evaluate BHV-3500 compared to placebo on pain relief at 30 minutes post-dose. [ Time Frame: 30 minutes post-dose ]
    Pain relief will be measured 30 minutes of dosing.
  • To evaluate the effect of BHV-3500 relative to placebo on the patients ability function normally at 30 minutes post-dose. [ Time Frame: 30 minutes post-dose, according to the Functional Disability scale. ]
    Subjects self-report "normal" on the functional disability scale.
  • To evaluate BHV-3500 compared to placebo on pain relief at 15 minutes post-dose. [ Time Frame: 15 minutes post-dose ]
    Pain relief will be measured using the percentage of subjects with a pain intensity of none or mild.
  • To evaluate BHV-3500 compared to placebo on pain relief at 30 minutes post-dose [ Time Frame: 30 minutes post-dose ]
    Pain relief will be measured using the percentage of subjects with a pain intensity of none or mild.
  • BHV-3500 subjects compared to placebo subjects on rescue medication use within 24 hours post-dose. [ Time Frame: Within 24 hours post-dose ]
    Measures the percent difference in needing rescue medication on BHV3500 as compared to placebo.
  • BHV-3500 subjects compared to placebo subjects on freedom from nausea at 2 hours post-dose. [ Time Frame: 2 hours post-dose ]
    Nausea relief will be measured on a scale (0=absent, 1=present)
  • BHV-3500 subjects compared to placebo subjects for the incidence of pain relapse. [ Time Frame: 2 to 48 hours post-dose ]
    Pain relapse will be measured based on the lack of pain between 2-48 hours.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Randomized Trial in Adult Subjects With Acute Migraines
Official Title  ICMJE BHV3500-301: Phase 3: Double-Blind, Randomized, Placebo Controlled, Safety and Efficacy Trial of BHV-3500 (Zavegepant) Intranasal (IN) for the Acute Treatment of Migraine
Brief Summary The purpose of this study is to test the safety and efficacy of BHV-3500 versus placebo in the acute treatment of moderate or severe migraine.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Migraine
Intervention  ICMJE
  • Drug: Zavegepant (BHV3500)
    One dose of Zavegepant (BHV-3500)
  • Drug: Placebo
    One dose of matching placebo
Study Arms  ICMJE
  • Active Comparator: BHV-3500
    Zavegepant (BHV-3500)
    Intervention: Drug: Zavegepant (BHV3500)
  • Placebo Comparator: Placebo
    Matching placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 25, 2021)
1405
Original Estimated Enrollment  ICMJE
 (submitted: September 25, 2020)
1400
Actual Study Completion Date  ICMJE October 22, 2021
Actual Primary Completion Date October 10, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Subject 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. Subjects 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. Subjects with contraindications for use of triptans may be included provided they meet all other study entry criteria.
  2. Male and Female subjects ≥18 years of age.

Exclusion Criteria:

  1. Subject with a history of HIV disease
  2. Subject history with current evidence of uncontrolled, unstable or recently diagnosed cardiovascular disease, such as ischemic heart disease, coronary artery vasospasm, and cerebral ischemia. Subjects 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 subjects can be included who have stable hypertension and/or diabetes for at least 3 months prior to being enrolled).
  4. Subjects 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 subjects 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04571060
Other Study ID Numbers  ICMJE BHV3500-301
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Biohaven Pharmaceuticals, Inc.
Study Sponsor  ICMJE Biohaven Pharmaceuticals, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Biohaven Pharmaceuticals, Inc.
Verification Date October 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP