Enrolling by invitation NCT07262268
A Phase 1b Study of BHV-7000 in Participants With Inherited Erythromelalgia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: BHV-7000, Placebo.
- Who it may be relevant to
- Registry conditions: Familial Erythromelalgia. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase 1b, Double-Blind, Crossover Study of BHV-7000 in Patients With Inherited Erythromelalgia (IEM) With NaV1.7 Gain of Function Mutations
Overview
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.
Interventions
- Drug BHV-7000
Participants will take blinded investigational product (IP) orally once daily - Drug Placebo
Matching placebo taken orally once daily
Primary outcome measures
- Mean of the daily average maximum pain intensity scores collected every 2 hours. [Time frame: The last 3 weeks of each 4-week crossover treatment period]
Secondary outcome measures (4)
- The average weekly frequency of pain attacks on treatment vs. placebo [Time frame: The last 3 weeks of each 4-week crossover treatment period]
- The average duration of pain attacks on treatment vs. placebo [Time frame: The last 3 weeks of each 4-week crossover treatment period]
- The average peak severity of pain attacks on treatment vs. placebo [Time frame: 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. [Time frame: Up to 16 weeks]
Eligibility criteria
Inclusion criteria
- 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.
- Absence of concomitant mutation resulting in Kv7.2/7.3 gain of function.
- Ability and willingness to adhere to the study procedures and complete accurate pain diaries
- Stable background analgesic regimen for at least 30 days before screening and willingness to maintain the same analgesic regimen during the study period.
Exclusion criteria
- 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.
- Any medical condition, based on the judgement of the Investigator, that would confound the ability to adequately assess safety and efficacy outcome measures
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Site-001 — New Haven
Identifiers
NCT: NCT07262268 · BHV7000-119