A Phase 1b Study of BHV-7000 in Participants With Inherited Erythromelalgia

NCT07262268 | Enrolling By Invitation Phase 1 FDA Drug

• 1 other identifier: BHV7000-119
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Familial Erythromelalgia

Keywords

Erythomelalgia; IEM; Primary Erythomelalgia; SCN9A; NaV1.7; Channelopathy; Red Neuralgia; Neuropathic Pain; Inherited Erythomelalgia

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• The average weekly frequency of pain attacks on treatment vs. placebo

  The last 3 weeks of each 4-week crossover treatment period

• The average duration of pain attacks on treatment vs. placebo

  The last 3 weeks of each 4-week crossover treatment period

• The average peak severity of pain attacks on treatment vs. placebo

  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.

  Up to 16 weeks

Study Arms (2)

BHV-7000

EXPERIMENTAL

Drug: BHV-7000

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

BHV-7000 DRUG

Participants will take blinded investigational product (IP) orally once daily

Also known as: opakalim

BHV-7000

Placebo DRUG

Matching placebo taken orally once daily

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Biohaven Therapeutics Ltd.: lead

Study Sites (1)

Site-001

New Haven, Connecticut, 06520, United States

Location

MeSH Terms

Conditions

Erythromelalgia; Generalized Epilepsy With Febrile Seizures Plus, 7; Channelopathies; Neuralgia

Condition Hierarchy (Ancestors)

Peripheral Vascular Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: December 3, 2025
• Study Start: January 15, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: April 8, 2026

Record last verified: 2026-04

Locations

US (1)