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The trial is taking place at:
M

MCB Clinical Research Centers | Colorado Springs, CO

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

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Biohaven

Status and phase

Invitation-only
Phase 2

Conditions

Major Depressive Disorder

Treatments

Drug: BHV-7000

Study type

Interventional

Funder types

Industry

Identifiers

NCT06423781
BHV7000-203

Details and patient eligibility

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).

Enrollment

480 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

480 participants in 1 patient group

BHV-7000
Experimental group
Treatment:
Drug: BHV-7000

Trial contacts and locations

52

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Central trial contact

Chief Medical Officer

Data sourced from clinicaltrials.gov

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