Familial ErythromelalgiaPhase 1NCT07262268
A Phase 1b Study of BHV-7000 in Participants With Inherited Erythromelalgia
A Phase 1 study testing BHV-7000 in people with Familial Erythromelalgia, run by Biohaven Therapeutics Ltd. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Familial Erythromelalgia
- What is being tested?
- BHV-7000
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2026to Nov 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- BHV-7000, Placebo
- Keywords
- Erythomelalgia, IEM, Primary Erythomelalgia, SCN9A, NaV1.7, Channelopathy, Red Neuralgia, Neuropathic Pain, Inherited Erythomelalgia
- Medical subject headings
- Erythromelalgia, Generalized Epilepsy With Febrile Seizures Plus, 7, Channelopathies, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BHV-7000Drug
Also called opakalim
Participants will take blinded investigational product (IP) orally once daily
PlaceboDrug
Matching placebo taken orally once daily
| Study group | Role | What they receive |
|---|---|---|
| BHV-7000 | Experimental | Not described Receives: Drug: BHV-7000 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Participants will be asked to record occurrence of pain attacks
Measured: 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
Measured: 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.
Measured: 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.
Measured: Up to 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2025
- Study start15 Jan 2026
- Primary completionNov 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Familial ErythromelalgiaStudies of the same condition, open and under way.
- More trials run by Biohaven Therapeutics Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biohaven Therapeutics Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07262268
- Sponsor's protocol ID
- BHV7000-119
- Status last verified
- Oct 2026
- First submitted
- 17 Nov 2025
- Last updated
- 29 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07262268
- Acronym / sponsor ID
- BHV7000-119
- Conditions
- Familial Erythromelalgia
- Keywords
- Erythomelalgia, IEM, Primary Erythomelalgia, SCN9A, NaV1.7, Channelopathy, Red Neuralgia, Neuropathic Pain
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- Biohaven Therapeutics Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Jan 2026 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 3 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BHV-7000 | Experimental | Drug: BHV-7000 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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 (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BHV-7000Also: opakalimParticipants will take blinded investigational product (IP) orally once daily | Drug | BHV-7000 |
| PlaceboMatching placebo taken orally once daily | Drug | Placebo |
Primary outcome
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
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BHV-7000 in people with Familial Erythromelalgia, run by Biohaven Therapeutics Ltd. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.