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The purpose of this study is to test the potential benefits of BHV-7000 in reducing chronic pain in participants with IEM with a previously demonstrated gain of function mutation in the SCN9A gene.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BHV-7000 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BHV-7000 | Drug | Participants will take blinded investigational product (IP) orally once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean of the daily average maximum pain intensity scores collected every 2 hours. | Participants will be asked to record peak (worst) pain experienced in the previous 2 hours using an 11-point Likert scale (0-10) where 0=no pain and 10=worst possible pain | The last 3 weeks of each 4-week crossover treatment period |
| Measure | Description | Time Frame |
|---|---|---|
| The average weekly frequency of pain attacks on treatment vs. placebo | Participants will be asked to record occurrence of pain attacks | The last 3 weeks of each 4-week crossover treatment period |
| The average duration of pain attacks on treatment vs. placebo |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site-001 | New Haven | Connecticut | 06520 | United States |
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| ID | Term |
|---|---|
| D004916 | Erythromelalgia |
| C567827 | Generalized Epilepsy With Febrile Seizures Plus, 7 |
| D053447 | Channelopathies |
| D009437 | Neuralgia |
| ID | Term |
|---|---|
| D016491 | Peripheral Vascular Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| Placebo | Drug | Matching placebo taken orally once daily |
|
Participants will be asked to record the duration of their pain attacks |
| The last 3 weeks of each 4-week crossover treatment period |
| The average peak severity of pain attacks on treatment vs. placebo | Participants will be asked to record the maximum severity of their pain attacks using an 11-point Likert scale (0-10) where 0=no pain and 10=worst possible pain. | The last 3 weeks of each 4-week crossover treatment period |
| Safety and tolerability by reporting the frequency of unique participants with SAEs, severe AEs, AEs leading to discontinuation, deaths, and Grade 3-4 (CTCAE/DAIDS) laboratory abnormalities. | Measured by assessing the number of unique participants who experience treatment-emergent serious adverse events, adverse events leading to discontinuation, or moderate and severe adverse events. | Up to 16 weeks |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |