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Enrolling by Invitation

NCT Number: NCT07262268

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

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.

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Key information

Conditions

Familial Erythromelalgia Cardiovascular Diseases Channelopathies Erythromelalgia Generalized Epilepsy With Febrile Seizures Plus, 7 Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Peripheral Vascular Diseases Signs and Symptoms Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Site-001

New Haven, Connecticut, 06520, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key 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.

Key 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

Treatment and study plan

BHV-7000

Drug

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

Other names: opakalim

Placebo

Drug

Matching placebo taken orally once daily

Primary outcomes

  1. 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

    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

Secondary outcomes

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

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

    Participants will be asked to record occurrence of pain attacks

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

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

    Participants will be asked to record the duration of their pain attacks

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

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

    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.

  4. 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

    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.

Sponsors and collaborators

Lead sponsor

Biohaven Therapeutics Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Dec 3, 2025
Registry last updated
Apr 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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