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Long-term Safety Study of BHV-3500 (Zavegepant*) for the Acute Treatment of Migraine

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: NCT04408794
Recruitment Status : Recruiting
First Posted : May 29, 2020
Last Update Posted : August 5, 2020
Sponsor:
Information provided by (Responsible Party):
Biohaven Pharmaceuticals, Inc.

Brief Summary:

The purpose of this study is to evaluate the long-term safety of BHV-3500/vazegepant intranasal in the acute treatment of migraine.

* BHV-3500, formerly "vazegepant", is now referred to as "zavegepant" (za ve' je pant). The World Health Organization (WHO) International Nonproprietary Names (INN) Expert Committee revised the name to "zavegepant" which was accepted by the United States Adopted Names (USAN ) Council for use in the U.S. and is pending formal adoption by the INN for international use.


Condition or disease Intervention/treatment Phase
Acute Migraine Drug: Vazegepant (BHV-3500) Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2/3 Open-label, Long-Term, Safety Trial of BHV3500 (Zavegepant*) Intranasal (IN) for the Acute Treatment of Migraine
Actual Study Start Date : June 29, 2020
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : January 2022

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine
MedlinePlus related topics: Migraine

Arm Intervention/treatment
Experimental: Vazegepant (BHV-3500)
10 mg intranasal (IN) up to 8 times per month, up to 1 year
Drug: Vazegepant (BHV-3500)
10 mg intranasal (IN) up to 8 times per month, up to 1 year




Primary Outcome Measures :
  1. To assess the safety and tolerability of vazegepant (BHV-3500) by measuring the frequency and intensity of AEs that occur in at least 5% of treated subjects, frequencies of SAEs, AEs leading to study drug discontinuation and clinically significant labs. [ Time Frame: 52 weeks ]


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.


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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:

  • 2-8 moderate to severe migraines/month within the last 3 months
  • Migraine attacks present for more than 1 year with age of onset of migraines prior to 50 years of age
  • Migraine attacks, on average, lasting about 4-72 hours if untreated
  • Less than 15 days with headaches (migraine or non-migraine) per month in each of the 3 months prior to the screening visit
  • Ability to distinguish migraine attacks from tension/cluster headaches
  • Subjects with contraindications for use of triptans may be included provided they meet all other study entry criteria

Exclusion Criteria:

  • History of HIV disease
  • History of basilar or hemiplegic migraine
  • Current diagnosis of major depressive disorder requiring treatment with atypical antipsychotics, schizophrenia, bipolar disorder, or borderline personality disorder
  • History of nasal surgery in the 6 months preceding the screening visit
  • History of gallstones or cholecystectomy
  • History of gastric, or small intestinal surgery (including Gastric Bypass, Gastric Banding, Gastric Sleeve, Gastric Balloon, etc.), or other disease or condition (e.g. chronic pancreatitis, ulcerative colitis, etc.) that causes malabsorption.
  • BMI ≥ 33
  • HbA1c ≥6.5%

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): NCT04408794


Contacts
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Contact: Elyse Stock, MD 203-404-0410 clinicaltrials@biohavenpharma.com

Locations
Show Show 67 study locations
Sponsors and Collaborators
Biohaven Pharmaceuticals, Inc.
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Responsible Party: Biohaven Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT04408794    
Other Study ID Numbers: BHV3500-202
First Posted: May 29, 2020    Key Record Dates
Last Update Posted: August 5, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Biohaven Pharmaceuticals, Inc.:
migraine, headache, Biohaven, intranasal
Additional relevant MeSH terms:
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Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases