Ignite Creation Date:
2025-12-24 @ 5:39 PM
Ignite Modification Date:
2026-01-04 @ 4:16 PM
Study NCT ID:
NCT07262268
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-03
First Post:
2025-11-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase 1b Study of BHV-7000 in Participants With Inherited Erythromelalgia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004916', 'term': 'Erythromelalgia'}, {'id': 'C567827', 'term': 'Generalized Epilepsy With Febrile Seizures Plus, 7'}, {'id': 'D053447', 'term': 'Channelopathies'}, {'id': 'D009437', 'term': 'Neuralgia'}], 'ancestors': [{'id': 'D016491', 'term': 'Peripheral Vascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 5}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-21', 'studyFirstSubmitDate': '2025-11-17', 'studyFirstSubmitQcDate': '2025-11-21', 'lastUpdatePostDateStruct': {'date': '2025-12-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean of the daily average maximum pain intensity scores collected every 2 hours.', 'timeFrame': 'The last 3 weeks of each 4-week crossover treatment period', 'description': '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'}], 'secondaryOutcomes': [{'measure': 'The average weekly frequency of pain attacks on treatment vs. placebo', 'timeFrame': 'The last 3 weeks of each 4-week crossover treatment period', 'description': 'Participants will be asked to record occurrence of pain attacks'}, {'measure': 'The average duration of pain attacks on treatment vs. placebo', 'timeFrame': 'The last 3 weeks of each 4-week crossover treatment period', 'description': 'Participants will be asked to record the duration of their pain attacks'}, {'measure': 'The average peak severity of pain attacks on treatment vs. placebo', 'timeFrame': 'The last 3 weeks of each 4-week crossover treatment period', 'description': '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.'}, {'measure': '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.', 'timeFrame': 'Up to 16 weeks', 'description': '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.'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Erythomelalgia', 'IEM', 'Primary Erythomelalgia', 'SCN9A', 'NaV1.7', 'Channelopathy', 'Red Neuralgia', 'Neuropathic Pain', 'Inherited Erythomelalgia'], 'conditions': ['Familial Erythromelalgia']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n1. 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.\n2. Absence of concomitant mutation resulting in Kv7.2/7.3 gain of function.\n3. Ability and willingness to adhere to the study procedures and complete accurate pain diaries\n4. Stable background analgesic regimen for at least 30 days before screening and willingness to maintain the same analgesic regimen during the study period.\n\nKey Exclusion Criteria:\n\n1. 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.\n2. Any medical condition, based on the judgement of the Investigator, that would confound the ability to adequately assess safety and efficacy outcome measures'}, 'identificationModule': {'nctId': 'NCT07262268', 'briefTitle': 'A Phase 1b Study of BHV-7000 in Participants With Inherited Erythromelalgia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Biohaven Pharmaceuticals, Inc.'}, 'officialTitle': 'A Phase 1b, Double-Blind, Crossover Study of BHV-7000 in Patients With Inherited Erythromelalgia (IEM) With NaV1.7 Gain of Function Mutations', 'orgStudyIdInfo': {'id': 'BHV7000-119'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BHV-7000', 'interventionNames': ['Drug: BHV-7000']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'BHV-7000', 'type': 'DRUG', 'otherNames': ['opakalim'], 'description': 'Participants will take blinded investigational product (IP) orally once daily', 'armGroupLabels': ['BHV-7000']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Matching placebo taken orally once daily', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Chief Medical Officer', 'role': 'CONTACT', 'email': 'clinicaltrials@biohavenpharma.com', 'phone': '203-404-0410'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biohaven Therapeutics Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}