Acute Treatment Trial in Adult Subjects With Migraines
Study Details
Study Description
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 |
---|---|---|
|
Phase 2/Phase 3 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Active Comparator: Arm 1 - BHV-3500 (zavegepant) 5 mg One dose of 5 mg |
Drug: BHV3500 (zavegepant) 5mg
one dose
Device: Intranasal Aptar Pharma Unit Dose System
one dose intranasal device
|
Active Comparator: Arm 2 - BHV-3500 (zavegepant) 10mg One dose of 10 mg |
Drug: BHV3500 (zavegepant) 10mg
one dose
Device: Intranasal Aptar Pharma Unit Dose System
one dose intranasal device
|
Active Comparator: Arm 3 - BHV-3500 (zavegepant) 20mg One dose of 20mg |
Drug: BHV3500 (zavegepant) 20mg
one dose
Device: Intranasal Aptar Pharma Unit Dose System
one dose intranasal device
|
Placebo Comparator: Arm 4 - Matching BHV-3500 (zavegepant) Placebo One dose of placebo |
Drug: BHV3500 (zavegepant) matching placebo
one dose
Device: Intranasal Aptar Pharma Unit Dose System
one dose intranasal device
|
Outcome Measures
Primary Outcome Measures
- 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. [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
- To evaluate BHV-3500 compared to placebo on pain relief: numeric rating scale [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 [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. [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. [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. [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 [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 [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 [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 [30 minutes post-dose according to the Functional Disability scale.]
- To evaluate BHV-3500 compared to placebo on sustained pain relief: likert scale [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 [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 [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 [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. [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. [2 to 48 hours post-dose.]
Pain relapse will be measured based on the lack of pain between 2-48 hours.
Eligibility Criteria
Criteria
Inclusion Criteria:
- 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:
-
Migraine attacks present for more than 1 year with the age of onset prior to 50 years of age
-
Migraine attacks, on average, lasting about 4-72 hours if untreated
-
Not more than 8 attacks of moderate to severe intensity per month within the last 3 months
-
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
-
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.
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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.
-
Subjects with contraindications for use of triptans may be included provided they meet all other study entry criteria.
Exclusion Criteria:
Key Exclusion Criteria:
-
Subject with a history of HIV disease
-
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.
-
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).
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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.
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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.
-
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.
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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.
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History of nasal surgery in the 6 months preceding the screening visit.
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Participation in any other investigational clinical trial while participating in this clinical trial.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Coastal Clinical Research, Inc. | Mobile | Alabama | United States | 36608 |
2 | Elite Clinical Studies | Phoenix | Arizona | United States | 85018 |
3 | Baptist Health Center for Clinical Research | Little Rock | Arkansas | United States | 72205 |
4 | Pharmacology Research Institute | Encino | California | United States | 91316 |
5 | eStudySite | La Mesa | California | United States | 91942 |
6 | Synergy San Diego | Lemon Grove | California | United States | 91945 |
7 | Collaborative Neuroscience Network, LLC | Long Beach | California | United States | 90806 |
8 | Pharmacology Research Institute | Los Alamitos | California | United States | 90720 |
9 | Pharmacology Research Institute | Newport Beach | California | United States | 92660 |
10 | National Research Institute | Panorama City | California | United States | 91402 |
11 | Optimus Medical Group | San Francisco | California | United States | 94102 |
12 | Neurological Research Institute | Santa Monica | California | United States | 90404 |
13 | Diablo Clinical Research, Inc. | Walnut Creek | California | United States | 94598 |
14 | Denver Neurological Research, LLC | Denver | Colorado | United States | 80210 |
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 | MD Clinical | Hallandale Beach | Florida | United States | 33009 |
18 | Clinical Neuroscience Solutions, Inc. | Jacksonville | Florida | United States | 32256 |
19 | Multi-Specialty Research Associates, Inc. | Lake City | Florida | United States | 32055 |
20 | AGA Clinical Trials | Miami | Florida | United States | 33012 |
21 | Qps Mra, Llc | Miami | Florida | United States | 33143 |
22 | Clinical Neuroscience Solutions, Inc. | Orlando | Florida | United States | 32801 |
23 | Ormond Medical Arts Pharmaceutical Research Center | Ormond Beach | Florida | United States | 32174 |
24 | Meridien Research | Tampa | Florida | United States | 33634 |
25 | Premiere Research Institute | West Palm Beach | Florida | United States | 33407 |
26 | iResearch Atlanta, LLC | Decatur | Georgia | United States | 30030 |
27 | Meridian Clinical Research | Savannah | Georgia | United States | 31405 |
28 | Family Medicine Specialists/CIS | Wauconda | Illinois | United States | 60084 |
29 | Phoenix Medical Research | Prairie Village | Kansas | United States | 66208 |
30 | Crescent City Headache and Neurology Center, LLC | Chalmette | Louisiana | United States | 70043 |
31 | New Orleans Center for Clinical Research | New Orleans | Louisiana | United States | 70119 |
32 | DelRicht Research | New Orleans | Louisiana | United States | 70124 |
33 | Boston Clinical Trials | Boston | Massachusetts | United States | 02131 |
34 | Community Clinical Research Network | Marlborough | Massachusetts | United States | 01752 |
35 | Regeneris Medical | North Attleboro | Massachusetts | United States | 02169 |
36 | MedVadis Research Corporation | Watertown | Massachusetts | United States | 02472 |
37 | Michigan Head Pain & Neurological Institute | Ann Arbor | Michigan | United States | 48104 |
38 | Clinical Research Institute, Inc. | Minneapolis | Minnesota | United States | 55402 |
39 | Clinical Research Institute, Inc. | Plymouth | Minnesota | United States | 55441 |
40 | MedPharmics, LLC | Biloxi | Mississippi | United States | 39531 |
41 | Center for Pharmaceutical Research, LLC | Kansas City | Missouri | United States | 64114 |
42 | Meritas Health Neurology | North Kansas City | Missouri | United States | 64116 |
43 | Sundance Clinical Research, LLC | Saint Louis | Missouri | United States | 63141 |
44 | StudyMetrix Research | Saint Peters | Missouri | United States | 63303 |
45 | QPS Bio-Kinetic Clinical Applications, LLC | Springfield | Missouri | United States | 65802 |
46 | Clinvest Research LLC | Springfield | Missouri | United States | 65810 |
47 | Center for Emotional Fitness | Cherry Hill | New Jersey | United States | 08002 |
48 | Albuquerque Clinical Trials, Inc. | Albuquerque | New Mexico | United States | 87102 |
49 | Dent Neurosciences Research Center | Amherst | New York | United States | 14226 |
50 | Montefiore Medical Center: Headache Center | Bronx | New York | United States | 10461 |
51 | Rochester Clinical Research, Inc. | Rochester | New York | United States | 14609 |
52 | Upstate Clinical Research Associates, LLC | Williamsville | New York | United States | 14221 |
53 | PMG Research of Charlotte, LLC | Charlotte | North Carolina | United States | 28209 |
54 | Headache Wellness Center | Greensboro | North Carolina | United States | 27405 |
55 | PharmQuest | Greensboro | North Carolina | United States | 27408 |
56 | PMG Research of Raleigh, LLC | Raleigh | North Carolina | United States | 27609 |
57 | Wilmington Health, PLLC | Wilmington | North Carolina | United States | 28401 |
58 | Hometown Urgent Care and Research | Cincinnati | Ohio | United States | 45215 |
59 | Hometown Urgent Care and Research | Columbus | Ohio | United States | 43214 |
60 | Hometown Urgent Care and Research | Dayton | Ohio | United States | 45424 |
61 | Hightower Clinical | Oklahoma City | Oklahoma | United States | 73134 |
62 | Summit Research Network (Oregon) Inc. | Portland | Oregon | United States | 97210 |
63 | Oregon Center for Clinical Investigations, Inc. (OCCI, Inc.) | Salem | Oregon | United States | 97301 |
64 | Clinical Trials of South Carolina | Charleston | South Carolina | United States | 29406 |
65 | Coastal Carolina Research Center | Mount Pleasant | South Carolina | United States | 29464 |
66 | Meridian Clinical Research | Dakota Dunes | South Dakota | United States | 57049 |
67 | Alliance for Multispecialty Research/New Orleans Center for Clinical Research/Volunteer Research | Knoxville | Tennessee | United States | 37920 |
68 | Clinical Neuroscience Solutions DBA CNS Healthcare | Memphis | Tennessee | United States | 38119 |
69 | Clinical Research Associates, Inc. | Nashville | Tennessee | United States | 37203 |
70 | FutureSearch Trials of Neurology | Austin | Texas | United States | 78731 |
71 | FutureSearch Trials of Dallas | Dallas | Texas | United States | 75231 |
72 | Ventavia Research Group | Fort Worth | Texas | United States | 76104 |
73 | Texas Center for Drug Development, Inc. | Houston | Texas | United States | 77081 |
74 | Red Star Research, LLC | Lake Jackson | Texas | United States | 77566 |
75 | Advanced Pharmaceutical Development Clinical Research | Magnolia | Texas | United States | 77355 |
76 | Victorium Clinical Research | San Antonio | Texas | United States | 78230 |
77 | Dynamed Clinical Research | Tomball | Texas | United States | 77375 |
78 | Wasatch Clinical Research, LLC | Salt Lake City | Utah | United States | 84107 |
79 | Charlottesville Medical Research Center, LLC | Charlottesville | Virginia | United States | 22911 |
80 | Tidewater Integrated Medical Research | Virginia Beach | Virginia | United States | 23454 |
81 | Northwest Clinical Research | Bellevue | Washington | United States | 98007 |
82 | Clinical Investigation Specialists, 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.- BHV3500-201