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

Biohaven Pharmaceuticals, Inc. (Industry)
Overall Status
CT.gov ID

Study Details

Study Description

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
  • Drug: Vazegepant (BHV-3500)
Phase 2/Phase 3

Study Design

Study Type:
Actual Enrollment :
608 participants
Intervention Model:
Single Group Assignment
None (Open Label)
Primary Purpose:
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 :
Jun 29, 2020
Actual Primary Completion Date :
Dec 9, 2021
Actual Study Completion Date :
Dec 23, 2021

Arms and Interventions

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

Outcome Measures

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. [52 weeks]

Eligibility Criteria


Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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%

Contacts and Locations


Site City State Country Postal Code
1 Medical Affiliated Research Center Huntsville Alabama United States 35801
2 Coastal Clinical Research, LLC, An AMR Co. Mobile Alabama United States 36608
3 Tucson Neuroscience Research Tucson Arizona United States 85710
4 Baptist Health Center for Clinical Research Little Rock Arkansas United States 72205
5 Pharmacology Research Institute Encino California United States 91316
6 eStudySite La Mesa California United States 91942
7 Synergy San Diego Lemon Grove California United States 91945
8 Collaborative Neuroscience Network, LLC Long Beach California United States 90806
9 Pharmacology Research Institute Los Alamitos California United States 90720
10 Wr-Pri, Llc Newport Beach California United States 92660
11 Artemis Institute for Clinical Research San Diego California United States 92103
12 Artemis Institute for Clinical Research San Marcos California United States 92078
13 California Medical Clinic for Headache Santa Monica California United States 90404
14 California Neuroscience Research Medical Group, Inc. Sherman Oaks California United States 91403
15 CT Clinical Research Cromwell Connecticut United States 06416
16 Ki Health Partners, LLC dba New England Institute for Clinical Research Stamford Connecticut United States 06905
17 Clinical Neuroscience Solutions, Inc. Jacksonville Florida United States 32256
18 Multi-Specialty Research Associates, Inc. Lake City Florida United States 32055
19 Clinical Neuroscience Solutions, Inc. Orlando Florida United States 32801
20 Clinical Neuroscience Solutions, Inc. Orlando Florida United States 32819
21 Ormond Medical Arts Pharmaceutical Research Center Ormond Beach Florida United States 32174
22 Meridien Research Tampa Florida United States 33634
23 iResearch Atlanta, LLC Decatur Georgia United States 30030
24 Meridian Clinical Research, LLC Savannah Georgia United States 31406
25 Northwest Clinical Trials Inc. Boise Idaho United States 83704
26 Community Hospital of Anderson and Madison County Inc Anderson Indiana United States 46011
27 Fort Wayne Neurological Center Fort Wayne Indiana United States 46804
28 Collective Medical Research Prairie Village Kansas United States 66208
29 Crescent City Headache and Neurology Center Chalmette Louisiana United States 70043
30 Boston Clinical Trials Boston Massachusetts United States 02131
31 Community Clinical Research Network Marlborough Massachusetts United States 01752
32 Boston Neuro Research Center South Dartmouth Massachusetts United States 02747
33 Medvadis Research Corporation Waltham Massachusetts United States 02451
34 Michigan Headache and Neurological Institute Ann Arbor Michigan United States 48104
35 Clinical Research Institute, Inc. Minneapolis Minnesota United States 55402
36 Sundance Clinical Research, LLC Saint Louis Missouri United States 63141
37 StudyMetrix Research Saint Peters Missouri United States 63303
38 Clinvest Research LLC Springfield Missouri United States 65810
39 Dartmouth-Hitchcock Heater Road Lebanon New Hampshire United States 03766
40 Albuquerque Clinical Trials, Inc. Albuquerque New Mexico United States 87102
41 Montefiore Medical Center: Headache Center Bronx New York United States 10461
42 Regional Clinical Research Endwell New York United States 13760
43 Fieve Clinical Research, Inc New York New York United States 10017
44 Rochester Clinical Research, Inc. Rochester New York United States 14609
45 Headache Wellness Center Greensboro North Carolina United States 27405
46 PharmQuest LLC Greensboro North Carolina United States 27408
47 Wilmington Health, PLLC Wilmington North Carolina United States 28401
48 OK Clinical Research LLC Edmond Oklahoma United States 73034
49 Tekton Research, Inc. Yukon Oklahoma United States 73099
50 Summit Research Network Portland Oregon United States 97210
51 Clinical Research of Philadelphia, LLC Philadelphia Pennsylvania United States 19114
52 Preferred Primary Care Physicians, Inc. Pittsburgh Pennsylvania United States 15236
53 Preferred Primary Care Physicians, Inc. Union Pennsylvania United States 15401
54 Coastal Carolina Research Center Mount Pleasant South Carolina United States 29464
55 Volunteer Research Group Knoxville Tennessee United States 37920
56 Clinical Neuroscience Solutions, Inc. Memphis Tennessee United States 38119
57 FutureSearch Trials of Neurology Austin Texas United States 78731
58 FutureSearch Trials of Dallas, LP Dallas Texas United States 75231
59 Red Star Research LLC Lake Jackson Texas United States 77566
60 DM Clinical Research Tomball Texas United States 77375
61 Wasatch Clinical Research, LLC Salt Lake City Utah United States 84107
62 J. Lewis Research, Inc. / Jordan River Family Medicine South Jordan Utah United States 84095
63 Charlottesville Medical Research Center, LLC Charlottesville Virginia United States 22911
64 Tidewater Integrated Medical Research Virginia Beach Virginia United States 23454
65 Northwest Clinical Research Center Bellevue Washington United States 98007
66 Seattle Women's: Health, Research, Gynecology Seattle Washington United States 98105
67 Clinical Investigation Specialist, Inc. Kenosha Wisconsin United States 53144

Sponsors and Collaborators

  • Biohaven Pharmaceuticals, Inc.


None specified.

Study Documents (Full-Text)

None provided.

More Information


None provided.
Responsible Party:
Biohaven Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
Other Study ID Numbers:
  • BHV3500-202
First Posted:
May 29, 2020
Last Update Posted:
Feb 2, 2022
Last Verified:
Feb 1, 2022
Studies a U.S. FDA-regulated Drug Product:
Studies a U.S. FDA-regulated Device Product:
Keywords provided by Biohaven Pharmaceuticals, Inc.
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 2, 2022