NCT06443463
Long-term Safety and Tolerability of BHV-7000
Enrolling by Invitation
PHASE2Ages 18–75InterventionalTreatmentBiohaven Therapeutics Ltd.
~660 participants
Updated 2026-05-01 on ClinicalTrials.gov
What's tested:BHV-7000
At a glance
Recruiting sites
0 of 283 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Participants With Deaths, Serious AEs (SAEs), AEs Leading to Study Drug Discontinuation, and moderate or severe AEs
Measured over Up to 104 weeks
+1 more outcome measured
Conditions
Where it's being run
283 sites across 124 statesFlorida20
Spain13
Texas12
New York9
California8
Mexico7
Arizona6
Louisiana6
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
Subjects who completed the double-blind phase (DBP) of prior parent study, BHV7000-302 or BHV7000-303.
(FOCBP) Females of Child Bearing Potential must have a negative urine pregnancy test at the Baseline/Day 0 visit
Exclusion
Any condition, such as an ongoing AE with/without sequelae, or is poorly tolerating IP in the double-blind phase of the parent study, that would interfere with the subject's ability to comply with study instructions, place the subject at unacceptable risk, and/or confound the interpretation of safety or efficacy data from the study, as judged by the Investigator.
Any medical condition, based on the judgement of the Investigator, that would confound the ability to adequately assess safety and efficacy outcome measures
What this trial measures
- Number of Participants With Deaths, Serious AEs (SAEs), AEs Leading to Study Drug Discontinuation, and moderate or severe AEsUp to 104 weeks
To assess the safety and tolerability of BHV-7000. This objective will be measured by assessing the number of unique subjects with deaths, SAEs, AEs leading to discontinuation, and moderate and severe AEs.
- Number of Subjects with Clinically Significant Laboratory AbnormalitiesUp to 104 weeks
To assess the safety and tolerability of BHV-7000. This objective will be measured by assessing the number of unique subjects with grade 3 or 4 laboratory abnormalities.