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

A Phase 1b, Double-Blind, Crossover Study of BHV-7000 in Patients With Inherited Erythromelalgia (IEM) With NaV1.7 Gain of Function Mutations

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Familial Erythromelalgia
• Intervention / Treatment: Drug: BHV-7000; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 5
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06520
      • Site-001

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Matching placebo taken orally once daily
Experimental: BHV-7000	Drug: BHV-7000; Participants will take blinded investigational product (IP) orally once daily; Other Names: opakalim

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Biohaven Therapeutics Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: November 17, 2025
• First Submitted That Met QC Criteria: November 21, 2025
• First Posted (Actual): December 3, 2025

Study Record Updates

• Last Update Posted (Actual): April 8, 2026
• Last Update Submitted That Met QC Criteria: April 7, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Neuropathic Pain; Channelopathy; SCN9A; IEM; Erythomelalgia; Primary Erythomelalgia; NaV1.7; Red Neuralgia; Inherited Erythomelalgia
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Neuromuscular Diseases; Peripheral Nervous System Diseases; Peripheral Vascular Diseases; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neuralgia; Channelopathies; Erythromelalgia; Generalized Epilepsy With Febrile Seizures Plus, 7
• Other Study ID Numbers: BHV7000-119

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No