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This study is designed to identify at least one dose of BHV-2100 that is safe and effective in reducing headache pain and other symptoms in the treatment of migraine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BHV-2100 75 mg | Experimental |
| |
| BHV-2100 150 mg | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BHV-2100 | Drug | BHV-2100 75mg |
| |
| BHV-2100 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Freedom From Pain at 2 Hours Post-dose | Pain levels are assessed on a 4-point scale (none, mild, moderate, severe) using the electronic diary (eDiary). Pain freedom is defined as pain level of none. Coprimary endpoints will be tested hierarachically by dose | 2 hours post-dose |
| Percentage of Participants With Freedom From Most Bothersome Symptom (MBS) at 2 Hours Post-dose | MBS is reported as nausea, photophobia, or phonophobia at migraine onset using the eDiary. Symptom status (absent, present) is assessed post-dose using the eDiary separately for nausea, photophobia, and phonophobia. Freedom from MBS is defined as MBS reported at onset that was absent post-dose. Coprimary endpoints will be tested hierarachically by dose | 2 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Pain Relief at 2 Hours Post-dose | Pain levels are assessed on a 4-point scale (none, mild, moderate, severe) using the eDiary. Pain relief is defined as pain level of none or mild. | 2 hours post-dose |
| Percentage of Participants With Return to Normal Function at 2 Hours Post-dose |
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Key Inclusion Criteria:
Participants with at least 1 year history of migraine (with or without aura) consistent with a diagnosis according to the International Classification of Headache Disorders, 3rd Edition,19 including the following:
Key Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MD First Research | Gilbert | Arizona | 85286 | United States | ||
| WR-PRI, LLC (Encino) |
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| Drug |
BHV-2100 150 mg |
|
| Placebo | Drug | matching placebo |
|
Return to normal function at 2 hours post-dose is assessed using the percentage of subjects with a functional disability level of normal at 2 hours post-dose in the subset of subjects with functional disability at the time of dosing. Functional disability level is measured on a 4-point numeric rating scale (0=normal, 1=mildly impaired, 2=severely impaired, 3=requires bedrest), and functional disability is defined as mildly impaired, severely impaired, or requires bedrest. |
| 2 hours post-dose |
| Percentage of Participants With Sustained Pain Relief From 2 to 24 Hours Post-dose | Pain levels are assessed on a 4-point scale (none, mild, moderate, severe) using the eDiary. Sustained pain relief is defined as pain level of none or mild at 2 hours up to 24 hours post-dose with no rescue medication use through 24 hours post-dose. | From 2 hours up to 24 hours post-dose |
| Percentage of Participants With Sustained Pain Relief From 2 to 48 Hours Post-dose | Pain levels are assessed on a 4-point scale (none, mild, moderate, severe) using the eDiary. Sustained pain relief is defined as pain level of none or mild at 2 hours up to 48 hours post-dose with no rescue medication use through 48 hours post-dose. | From 2 hours up to 48 hours post-dose |
| Percentage of Participants With Sustained Pain Freedom From 2 to 24 Hours Post-dose | Pain levels are assessed on a 4-point scale (none, mild, moderate, severe) using the eDiary. Sustained pain freedom is defined as pain level of none at 2 hours up to 24 hours post-dose with no rescue medication use through 24 hours post-dose. | From 2 hours up to 24 hours post-dose |
| Percentage of Participants With Sustained Pain Freedom From 2 to 48 Hours Post-dose | Pain levels are assessed on a 4-point scale (none, mild, moderate, severe) using the eDiary. Sustained pain freedom is defined as pain level of none at 2 hours up to 48 hours post-dose with no rescue medication use through 48 hours post-dose. | From 2 hours up to 48 hours post-dose |
| Percentage of Participants With Freedom From Phonophobia at 2 Hours Post-dose | Phonophobia (sensitivity to sound) status is measured as absent 2 hours postdose in the subset of subjects with phonophobia present at the time of dosing in the eDiary. Freedom from phonophobia is defined as phonophobia absent. | 2 hours post-dose |
| Percentage of Participants With Freedom From Photophobia at 2 Hours Post-dose | Photophobia (sensitivity to light) status is measured as absent 2 hours postdose in the subset of subjects with photophobia present at the time of dosing in the eDiary. Freedom from photophobia is defined as photophobia absent. | 2 hours post-dose |
| Percentage of Participants With Rescue Medication Use Within 24 Hours Post-dose | Participants who do not experience relief of their migraine headache at the end of 2 hours after dosing with study medication (and after the 2-hour assessments has been completed on the eDiary) are permitted to use the following rescue medications: aspirin, ibuprofen, acetaminophen up to 1000 mg/day (this includes Excedrin Migraine), naproxen (or any other type of nonsteroidal anti-inflammatory drug), antiemetics (e.g., metoclopramide or promethazine), or baclofen. The participant's use of rescue medication is recorded by the participant in a paper diary. | 24 hours post-dose |
| Percentage of Participants With Freedom From Nausea at 2 Hours Post-dose | Nausea status is measured as absent 2 hours postdose in the subset of subjects with nausea present at the time of dosing in the eDiary. Freedom from nausea is defined as nausea absent. | 2 hours post-dose |
| Percentage of Participants With Pain Relapse From 2 to 48 Hours Post-dose | Pain levels are assessed on a 4-point scale (none, mild, moderate, severe) using the eDiary. Pain relapse is defined as pain level of mild, moderate, or severe after 2 hours up to 48 hours for the participants who are pain-free at 2 hours post-dose. | From 2 hours up to 48 hours post-dose |
| Observed Plasma concentration in Patients After a Single Dose of BHV-2100 | At 2, 8, and 24 hours post-dose |
| Number of Participants with Deaths, Serious AEs (SAEs), and moderate or severe AEs | To assess the tolerability and safety of BHV-2100. This objective will be measured by assessing the number of unique subjects with deaths, SAEs, and moderate and severe AEs. | Up to 11 weeks |
| Number of Subjects with Clinically Significant Laboratory Abnormalities | To assess the tolerability and safety of BHV-2100. This objective will be measured by assessing the number of unique subjects with grade 3 and 4 laboratory abnormalities. | Up to 11 weeks |
| Encino |
| California |
| 91316 |
| United States |
| Cenexel CNS Los Alamitos | Los Alamitos | California | 90720 | United States |
| Clinical Research Institute | Los Angeles | California | 90048 | United States |
| WR-PRI, LLC (Newport Beach) | Newport Beach | California | 92660 | United States |
| Cenexel CIT IE | Riverside | California | 92506 | United States |
| Hasbani Neurology | New Haven | Connecticut | 06511 | United States |
| Ki Health Partners DBA/ New England Institute for Clinical Research | Stamford | Connecticut | 06905 | United States |
| Green Leaf Clinical Trials | Jacksonville | Florida | 32258 | United States |
| WR-MSRA (Multi-Specialty Research Associates) | Lake City | Florida | 32055 | United States |
| AppleMed Research Group | Miami | Florida | 33126 | United States |
| Ideal Research | Pembroke Pines | Florida | 33014 | United States |
| ForCare Clinical Research | Tampa | Florida | 33613 | United States |
| Premier Research Instiute | West Palm Beach | Florida | 33407 | United States |
| NeuroTrials Research, Inc. | Atlanta | Georgia | 30328 | United States |
| Velocity Clinical Research, Savannah | Savannah | Georgia | 31406 | United States |
| Chicago Headache Center & Research Center | Chicago | Illinois | 60657 | United States |
| Healthcare Research Network II, LLC | Flossmoor | Illinois | 60422 | United States |
| Velocity Clinical Research, Sioux City | Sioux City | Iowa | 51106 | United States |
| Integrated Clinical Trials Services | West Des Moines | Iowa | 50265 | United States |
| Collective Medical Research | Overland Park | Kansas | 66210 | United States |
| L-MARC Research Center | Louisville | Kentucky | 40213 | United States |
| Crescent City Headache & Neurology | Chalmette | Louisiana | 70043 | United States |
| DelRicht Research | New Orleans | Louisiana | 70115 | United States |
| Velocity Clinical Research, Rockville | Rockville | Maryland | 20854 | United States |
| Boston Clinical Trials | Boston | Massachusetts | 02131 | United States |
| Neurology Center of New England PC | Foxborough | Massachusetts | 02035 | United States |
| MedVadis Research Corp | Waltham | Massachusetts | 02451 | United States |
| Mass Institute of Clinical Research | Westborough | Massachusetts | 01581 | United States |
| Michigan Head Pain and Neurological Institute | Ann Arbor | Michigan | 48112 | United States |
| Quest Research Institute | Farmington Hills | Michigan | 47334 | United States |
| Clinical Research Institute | Minneapolis | Minnesota | 55402 | United States |
| StudyMedrix Research | City of Saint Peters | Missouri | 63303 | United States |
| Alliance for Multispecialty Research - Kansas City | Kansas City | Missouri | 64114 | United States |
| Clinvest Research | Springfield | Missouri | 65807 | United States |
| WR-CRNC (Wake Research) | Las Vegas | Nevada | 89118 | United States |
| ActivMed Practices & Research-Portsmouth/Pease | Portsmouth | New Hampshire | 03801 | United States |
| Albuquerque Clinical Trials | Albuquerque | New Mexico | 87102 | United States |
| Fieve Clinical Research, Inc. | New York | New York | 10017 | United States |
| Rochester Clinical Research | Rochester | New York | 14609 | United States |
| Velocity Clinical Research, Vestal | Vestal | New York | 13850 | United States |
| PharmQuest Life Sciences | Greensboro | North Carolina | 27408 | United States |
| Accellacare of Raleigh | Raleigh | North Carolina | 27609 | United States |
| Hometown Urgent Care and Research | Dayton | Ohio | 45424 | United States |
| OK Clinical Research, LLC | Edmond | Oklahoma | 73034 | United States |
| Preferred Primary Care Physicians | Uniontown | Pennsylvania | 15410 | United States |
| Velocity Clinical Research, Providence | East Greenwich | Rhode Island | 02818 | United States |
| Velocity Clinical Research, Columbia | Columbia | South Carolina | 29204 | United States |
| Coastal Carolina Research Center | North Charleston | South Carolina | 29405 | United States |
| KCA Neurology | Franklin | Tennessee | 37067 | United States |
| FutureSearch Trials of Neurology | Austin | Texas | 78732 | United States |
| Zenos Clinical Research | Dallas | Texas | 75230 | United States |
| DM Clinical Research - Belliare | Houston | Texas | 77081 | United States |
| Red Star Research, LLC | Lake Jackson | Texas | 77566 | United States |
| Epic Clinical Research | Lewisville | Texas | 75057 | United States |
| DM Clinical Research - Tomball | Tomball | Texas | 77375 | United States |
| Velocity Clinical Research, Salt Lake City | West Jordan | Utah | 84088 | United States |
| Charlottesville Medical Research | Charlottesville | Virginia | 22911 | United States |
| Northwest Clinical Research Center | Bellevue | Washington | 98007 | United States |
| Seattle Clinical Research Center | Seattle | Washington | 98104 | United States |
| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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