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Acute Treatment Trial in Adult Subjects With Migraines

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ClinicalTrials.gov Identifier: NCT03872453
Recruitment Status : Recruiting
First Posted : March 13, 2019
Last Update Posted : June 26, 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 Phase 3

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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
Actual Study Start Date : March 25, 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.



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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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United States, Alabama
Coastal Clinical Research, Inc. Recruiting
Mobile, Alabama, United States, 36608
Contact: Lauren Garner    251-414-1984 ext 122    lauren.garner@amrllc.com   
United States, Arkansas
Baptist Health Center for Clinical Research Recruiting
Little Rock, Arkansas, United States, 72205
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United States, California
Pharmacology Research Institute Recruiting
Encino, California, United States, 91316
Contact: Judy Morrissey    818-705-7451    jmorrissey@priresearch.com   
eStudySite Recruiting
La Mesa, California, United States, 91942
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Synergy San Diego Recruiting
Lemon Grove, California, United States, 91945
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Collaborative Neuroscience Network, LLC Recruiting
Long Beach, California, United States, 90806
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Pharmacology Research Institute Recruiting
Los Alamitos, California, United States, 90720
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Pharmacology Research Institute Recruiting
Newport Beach, California, United States, 92660
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National Research Institute Recruiting
Panorama City, California, United States, 91402
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Optimus Medical Group Recruiting
San Francisco, California, United States, 94102
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Neurological Research Institute Recruiting
Santa Monica, California, United States, 90404
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Walnut Creek, California, United States, 94598
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Denver Neurological Research, LLC Recruiting
Denver, Colorado, United States, 80210
Contact: Susie Mercer    720-588-2557    susie@denverneuroresearch.com   
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Ki Health Partners, LLC, dba New England Institute for Clinical Research Recruiting
Stamford, Connecticut, United States, 06905
Contact: Grace Valentin    203-914-1903    grace@neicr.com   
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MD Clinical Recruiting
Hallandale Beach, Florida, United States, 33009
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Jacksonville, Florida, United States, 32256
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Multi-Specialty Research Associates, Inc. Recruiting
Lake City, Florida, United States, 32055
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Miami, Florida, United States, 33143
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Clinical Neuroscience Solutions, Inc. Recruiting
Orlando, Florida, United States, 32801
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Ormond Medical Arts Pharmaceutical Research Center Recruiting
Ormond Beach, Florida, United States, 32174
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Tampa, Florida, United States, 33634
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West Palm Beach, Florida, United States, 33407
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Decatur, Georgia, United States, 30030
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Savannah, Georgia, United States, 31405
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Wauconda, Illinois, United States, 60084
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Prairie Village, Kansas, United States, 66208
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Crescent City Headache and Neurology Center, LLC Recruiting
Chalmette, Louisiana, United States, 70043
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New Orleans, Louisiana, United States, 70119
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New Orleans, Louisiana, United States, 70124
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Watertown, Massachusetts, United States, 02472
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Michigan Head Pain & Neurological Institute Recruiting
Ann Arbor, Michigan, United States, 48104
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Clinical Research Institute, Inc. Recruiting
Minneapolis, Minnesota, United States, 55402
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Plymouth, Minnesota, United States, 55441
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MedPharmics, LLC Recruiting
Biloxi, Mississippi, United States, 39531
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Center for Pharmaceutical Research, LLC Recruiting
Kansas City, Missouri, United States, 64114
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North Kansas City, Missouri, United States, 64116
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Saint Louis, Missouri, United States, 63141
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Springfield, Missouri, United States, 65802
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Springfield, Missouri, United States, 65810
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Cherry Hill, New Jersey, United States, 08002
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Albuquerque, New Mexico, United States, 87102
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Dent Neurosciences Research Center Recruiting
Amherst, New York, United States, 14226
Contact: Rebecca Hogan    716-558-5670    Rhogan@dentinstitute.com   
Montefiore Medical Center: Headache Center Recruiting
Bronx, New York, United States, 10461
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Rochester, New York, United States, 14609
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Williamsville, New York, United States, 14221
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PMG Research of Charlotte, LLC Recruiting
Charlotte, North Carolina, United States, 28209
Contact: Laura Butler    704-527-6672    lbutler@pmg-research.com   
Headache Wellness Center Recruiting
Greensboro, North Carolina, United States, 27405
Contact: Bridgette Smith    336-574-8000 ext 130    bsmith@headachewellnesscenter.com   
PharmQuest Recruiting
Greensboro, North Carolina, United States, 27408
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Raleigh, North Carolina, United States, 27609
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Wilmington, North Carolina, United States, 28401
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Cincinnati, Ohio, United States, 45215
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Columbus, Ohio, United States, 43214
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Dayton, Ohio, United States, 45424
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Oklahoma City, Oklahoma, United States, 73134
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Portland, Oregon, United States, 97210
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Salem, Oregon, United States, 97301
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Charleston, South Carolina, United States, 29406
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Mount Pleasant, South Carolina, United States, 29464
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Dakota Dunes, South Dakota, United States, 57049
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Knoxville, Tennessee, United States, 37920
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Clinical Neuroscience Solutions DBA CNS Healthcare Recruiting
Memphis, Tennessee, United States, 38119
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Nashville, Tennessee, United States, 37203
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Austin, Texas, United States, 78731
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Dallas, Texas, United States, 75231
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Fort Worth, Texas, United States, 76104
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Houston, Texas, United States, 77081
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Lake Jackson, Texas, United States, 77566
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Magnolia, Texas, United States, 77355
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Tomball, Texas, United States, 77375
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Wasatch Clinical Research, LLC Recruiting
Salt Lake City, Utah, United States, 84107
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Charlottesville Medical Research Center, LLC Recruiting
Charlottesville, Virginia, United States, 22911
Contact: James Clark    434-817-2442    Clarkmd@cvillemedresearch.com   
Tidewater Integrated Medical Research Recruiting
Virginia Beach, Virginia, United States, 23454
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Northwest Clinical Research Recruiting
Bellevue, Washington, United States, 98007
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Clinical Investigation Specialists, Inc. Recruiting
Kenosha, Wisconsin, United States, 53144
Contact: Vanessa Villanueva    262-925-1280 ext 202    vvillanueva@cisresearch.com   
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: June 26, 2019
Last Verified: June 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