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Long-term Safety Study of BHV-7000 in Participants With Major Depressive Disorder (MDD)

Sponsored by Biohaven Therapeutics Ltd.

About this trial

Last updated 8 months ago

Study ID

BHV7000-203

Status

Enrolling by invitation

Type

Interventional

Phase

Phase 2

Placebo

No

Accepting

18-75 Years
18 to 75 Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Started 10 months ago

What is this trial about?

The purpose of this study is to evaluate the long-term safety and tolerability of BHV-7000, in participants with Major Depressive Disorder (MDD).

What are the Participation Requirements?

Key Inclusion Criteria:

1. Eligible participants must have successfully completed the Treatment/Randomization
Phase of parent studies.

2. WOCBP must have a negative urine pregnancy test at Baseline Visit.

3. WOCBP must not be breastfeeding or lactating at Baseline Visit or at any point
during the study.

Key Exclusion Criteria:

1. Any medical condition, based on the judgement of the Investigator, that would
confound the ability to adequately assess safety and efficacy outcome measures.

2. Participant non-compliance with study procedures, study drug or visit attendance in
the parent study that the Investigator deems as clinically significant or
unacceptable risk potential for this study.

3. Investigator deems participant at imminent risk of danger to others.