Long-term Safety Study of BHV-3500 (Zavegepant*) for the Acute Treatment of Migraine
Sponsor
Biohaven Pharmaceuticals, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT04408794
Collaborator
(none)
608
67
1
17.8
9.1
0.5
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 |
|---|---|---|
|
Phase 2/Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
608 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
:
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
- 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
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
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.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Biohaven Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT04408794
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:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Biohaven Pharmaceuticals, Inc.
Additional relevant MeSH terms: