BHV-7000: Participants will take blinded investigational product (IP) orally once daily
Placebo: Matching placebo taken orally once daily
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Key Inclusion Criteria:
1. Adult men and women between 18 to 75 years of age, inclusive, at time of consent with a diagnosis of inherited erythromelalgia with a previously characterized gain of function NaV1.7 mutation resulting in chronic pain.
2. Absence of concomitant mutation resulting in Kv7.2/7.3 gain of function.
3. Ability and willingness to adhere to the study procedures and complete accurate pain diaries
4. Stable background analgesic regimen for at least 30 days before screening and willingness to maintain the same analgesic regimen during the study period.
Key Exclusion Criteria:
1. Any clinically significant laboratory abnormalities or clinically significant abnormalities on screening physical examination, vital signs, or ECG that, in the judgment of the principal investigator, indicates a medical problem that would preclude study participation.
2. Any medical condition, based on the judgement of the Investigator, that would confound the ability to adequately assess safety and efficacy outcome measures
Primary outcome measure(s)
Mean of the daily average maximum pain intensity scores collected every 2 hours. — The last 3 weeks of each 4-week crossover treatment period 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
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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