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Acute Treatment Trial in Adult Subjects With Migraines

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ClinicalTrials.gov Identifier: NCT03872453
Recruitment Status : Not yet recruiting
First Posted : March 13, 2019
Last Update Posted : March 20, 2019
Sponsor:
Information provided by (Responsible Party):
Biohaven Pharmaceuticals, Inc.

Brief Summary:
This study will evaluate the safety and efficacy of three different intranasal dose levels of BHV-3500, relative to placebo, in the acute treatment of moderate to severe migraine.

Condition or disease Intervention/treatment Phase
Migraine Drug: BHV3500 10mg Drug: BHV3500 20mg Drug: BHV3500 5mg Drug: BHV3500 matching placebo Device: Intranasal Aptar Pharma Unit Dose System Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1600 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: BHV3500-201: Phase II: Double-Blind, Randomized, Placebo Controlled, Dose-Ranging Trial of BHV-3500 for the Acute Treatment of Migraine
Estimated Study Start Date : March 21, 2019
Estimated Primary Completion Date : November 20, 2019
Estimated Study Completion Date : November 20, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine

Arm Intervention/treatment
Active Comparator: Arm 1 - BHV-3500 5 mg
One dose of 5 mg
Drug: BHV3500 5mg
one dose

Device: Intranasal Aptar Pharma Unit Dose System
one dose intranasal device

Active Comparator: Arm 2 - BHV-3500 10mg
One dose of 10 mg
Drug: BHV3500 10mg
one dose

Device: Intranasal Aptar Pharma Unit Dose System
one dose intranasal device

Active Comparator: Arm 3 - BHV-3500 20mg
One dose of 20mg
Drug: BHV3500 20mg
one dose

Device: Intranasal Aptar Pharma Unit Dose System
one dose intranasal device

Placebo Comparator: Arm 4 - Matching BHV-3500 Placebo
One dose of placebo
Drug: BHV3500 matching placebo
one dose

Device: Intranasal Aptar Pharma Unit Dose System
one dose intranasal device




Primary Outcome Measures :
  1. To evaluate the efficacy of BHV-3500 compared with placebo in the acute treatment of migraine by using a likert scale to measure pain freedom and an 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. To evaluate BHV-3500 compared to placebo on pain relief: numeric rating scale [ Time Frame: 2 hours post-dose. ]
    Pain Relief as measured by a 4 point numeric rating scale (None, Mild, Moderate, Severe)

  2. To evaluate the effect of BHV-3500 relative to placebo on the patients ability function normally [ Time Frame: 2 hours post-dose, according to the Functional Disability scale. ]
    Subjects self-report "normal" on the functional disability scale

  3. To evaluate BHV-3500 compared to placebo on the probability of requiring rescue medication. [ Time Frame: Within 24 hours of initial treatment. ]
    Measures the percent difference in needing rescue medication on BHV3500 as compared to placebo.

  4. To evaluate BHV-3500 compared to placebo on freedom from photophobia. [ Time Frame: 2 hours post-dose. ]
    Freedom from photophobia will be measured in a multiple choice question.

  5. To evaluate BHV-3500 compared to placebo on freedom from phonophobia. [ Time Frame: 2 hours post-dose. ]
    Freedom from phonophobia will be measured in a multiple choice question.

  6. To evaluate BHV-3500 compared to placebo on pain relief: likert scale [ Time Frame: 60 minutes post-dose. ]
    Pain relief will be measured on a likert scale measuring pain relief after 60 minutes of dosing.

  7. To evaluate the effect of BHV-3500 relative to placebo on the patients ability function normally: Functional Disability scale [ Time Frame: 60 minutes post-dose according to the Functional Disability scale. ]
    The higher the score the worse the disability compared to placebo at 60 minutes.

  8. To evaluate BHV-3500 compared to placebo on pain relief: likert scale [ Time Frame: 30 minutes post-dose. ]
    Pain relief will be measured on a likert scale measuring pain relief after 30 minutes of dosing.

  9. To evaluate the effect of BHV-3500 relative to placebo on the patients ability function normally: Functional Disability scale [ Time Frame: 30 minutes post-dose according to the Functional Disability scale. ]
  10. To evaluate BHV-3500 compared to placebo on sustained pain relief: likert scale [ Time Frame: 2 to 24 hours post-dose. ]
    Pain relief will be measured on a likert scale measuring pain relief between 2-24 hours of dosing.

  11. To evaluate BHV-3500 compared to placebo on sustained pain freedom: 4 point numeric rating scale [ Time Frame: 2 to 24 hours post-dose. ]
    Sustained Pain Freedom as measured by a 4 point numeric rating scale (None, Mild, Moderate, Severe)

  12. To evaluate BHV-3500 compared to placebo on sustained pain relief: likert scale [ Time Frame: 2 to 48 hours post-dose. ]
    Pain relief will be measured on a likert scale measuring sustained pain relief between 2-48 hours of dosing.

  13. To evaluate BHV-3500 compared to placebo on sustained pain freedom: 4 point numeric rating scale [ Time Frame: 2 to 48 hours post-dose. ]
    Sustained Pain Freedom as measured by a 4 point numeric rating scale (None, Mild, Moderate, Severe)

  14. To evaluate BHV-3500 compared to placebo on freedom from nausea. [ Time Frame: 2 hours post-dose. ]
    Freedom from nausea will be measured in a multiple choice question.

  15. To evaluate BHV-3500 compared to placebo 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

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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:

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, Beta version [1] 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.

Exclusion Criteria:

Key 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. Subject has a current diagnosis of major depression, other pain syndromes, psychiatric conditions (e.g., schizophrenia), dementia, or significant neurological disorders (other than migraine) that, in the Investigator's opinion might interfere with study assessments.
  5. Subject 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.
  6. The subject has a history of current or evidence of any significant and/ or unstable medical conditions (e.g., 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 (AE) or interfere with assessments of safety or efficacy during the course of the trial.
  7. History of, treatment for, or evidence of, alcohol or drug abuse within the past 12 months or subjects who have met DSM-V criteria [15] for any significant substance use disorder within the past 12 months from the date of the screening visit.
  8. History of nasal surgery in the 6 months preceding the screening visit.
  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): NCT03872453


Contacts
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Contact: Robert Berman, MD 203-404-0410 clinicaltrials@biohavenpharma.com

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Sponsors and Collaborators
Biohaven Pharmaceuticals, Inc.

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Responsible Party: Biohaven Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT03872453     History of Changes
Other Study ID Numbers: BHV3500-201
First Posted: March 13, 2019    Key Record Dates
Last Update Posted: March 20, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No

Keywords provided by Biohaven Pharmaceuticals, Inc.:
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