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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.

Tracking Information
First Submitted Date  ICMJE March 6, 2019
First Posted Date  ICMJE March 13, 2019
Last Update Posted Date June 26, 2019
Actual Study Start Date  ICMJE March 25, 2019
Estimated Primary Completion Date November 20, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 12, 2019)
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03872453 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 12, 2019)
  • 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)
  • 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
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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. ]
  • 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.
  • 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)
  • 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.
  • 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)
  • 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.
  • 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.
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 Acute Treatment Trial in Adult Subjects With Migraines
Official Title  ICMJE BHV3500-201: Phase II: Double-Blind, Randomized, Placebo Controlled, Dose-Ranging Trial of BHV-3500 for the Acute Treatment of Migraine
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description:
Double-blind to Sponsor, Investigator and Subject
Primary Purpose: Treatment
Condition  ICMJE Migraine
Intervention  ICMJE
  • Drug: BHV3500 10mg
    one dose
  • Drug: BHV3500 20mg
    one dose
  • Drug: BHV3500 5mg
    one dose
  • Drug: BHV3500 matching placebo
    one dose
  • Device: Intranasal Aptar Pharma Unit Dose System
    one dose intranasal device
Study Arms  ICMJE
  • Active Comparator: Arm 1 - BHV-3500 5 mg
    One dose of 5 mg
    Interventions:
    • Drug: BHV3500 5mg
    • Device: Intranasal Aptar Pharma Unit Dose System
  • Active Comparator: Arm 2 - BHV-3500 10mg
    One dose of 10 mg
    Interventions:
    • Drug: BHV3500 10mg
    • Device: Intranasal Aptar Pharma Unit Dose System
  • Active Comparator: Arm 3 - BHV-3500 20mg
    One dose of 20mg
    Interventions:
    • Drug: BHV3500 20mg
    • Device: Intranasal Aptar Pharma Unit Dose System
  • Placebo Comparator: Arm 4 - Matching BHV-3500 Placebo
    One dose of placebo
    Interventions:
    • Drug: BHV3500 matching placebo
    • Device: Intranasal Aptar Pharma Unit Dose System
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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 12, 2019)
1600
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 20, 2019
Estimated Primary Completion Date November 20, 2019   (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, 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.
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: Robert Berman, MD 203-404-0410 clinicaltrials@biohavenpharma.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03872453
Other Study ID Numbers  ICMJE BHV3500-201
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: Yes
Device Product Not Approved or Cleared by U.S. FDA: 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 June 2019

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