Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04571060
Recruitment Status : Recruiting
First Posted : September 30, 2020
Last Update Posted : February 4, 2021
Sponsor:
Information provided by (Responsible Party):
Biohaven Pharmaceuticals, Inc.

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.

Condition or disease Intervention/treatment Phase
Migraine Drug: Zavegepant (BHV3500) Drug: Placebo Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : October 27, 2020
Estimated Primary Completion Date : March 1, 2021
Estimated Study Completion Date : March 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine
MedlinePlus related topics: Migraine

Arm Intervention/treatment
Active Comparator: BHV-3500
Zavegepant (BHV-3500)
Drug: Zavegepant (BHV3500)
One dose of Zavegepant (BHV-3500)

Placebo Comparator: Placebo
Matching placebo
Drug: Placebo
One dose of matching placebo




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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)

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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)

  17. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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. Subject has a history of gastric, or small intestinal surgery (including Gastric Bypass, Gastric Banding, Gastric Sleeve, Gastric Balloon, etc.), or has other disease or condition that causes malabsorption.
  6. 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.
  7. History of nasal surgery in the 6 months.
  8. 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)
  9. Participation in any other investigational clinical trial while participating in this clinical trial.

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): NCT04571060


Contacts
Layout table for location contacts
Contact: Elyse Stock 203-404-0410 clinicaltrials@biohavenpharma.com

Locations
Show Show 79 study locations
Sponsors and Collaborators
Biohaven Pharmaceuticals, Inc.
Layout table for additonal information
Responsible Party: Biohaven Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT04571060    
Other Study ID Numbers: BHV3500-301
First Posted: September 30, 2020    Key Record Dates
Last Update Posted: February 4, 2021
Last Verified: February 2021

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Biohaven Pharmaceuticals, Inc.:
Acute Migraine
Phonophobia
Photophobia
Nausea
Additional relevant MeSH terms:
Layout table for MeSH terms
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases