Phase 1b Study of BHV-7000 for Inherited Erythromelalgia
This study is testing a medication called BHV-7000 to see if it can help reduce chronic pain in people with inherited erythromelalgia (IEM). IEM is a condition that causes burning pain, often in the hands and feet. Participants will take either BHV-7000 or a matching placebo (an inactive substance) by mouth once a day. The main goal is to see how much the average maximum pain intensity changes over the last three weeks of each treatment period. To join, you must be between 18 and 75 years old, have a diagnosis of inherited erythromelalgia with a specific genetic change (gain of function NaV1.7 mutation), and not have another specific genetic change (Kv7.2/7.3 gain of function). The study plans to enroll 5 participants, but its current status is unclear.
- Study design
- This is an interventional study where participants will take either BHV-7000 or a placebo, both blinded (meaning neither you nor your doctor will know which you are taking). It is a Phase 1b study and plans to enroll 5 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary outcome is measured during the last three weeks of each 4-week crossover treatment period, but overall follow-up duration is not specified.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Phase 1b Study of BHV-7000 in Participants With Inherited Erythromelalgia
At a glance
Conditions
NCT07262268
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Site-001
New Haven, Connecticutno site contact published
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
What this trial measures
- 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