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

Major Depressive Disorder Clinical Trial

Official title:

A Phase 2, Multicenter, Open-Label Extension Study to Assess the Long-Term Safety and Tolerability of BHV-7000 in Treatment of Major Depressive Disorder (MDD)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06423781
• Other study ID #: BHV7000-203
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: July 2024
• Est. completion date: November 2027

Study information

• Verified date: May 2024
• Source: Biohaven Pharmaceuticals, Inc.
• Contact: Chief Medical Officer
• Phone: 203-404-0410
• Email: clinicaltrials[@]biohavenpharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 480
• Est. completion date: November 2027
• Est. primary completion date: November 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Drug:
• BHV-7000
BHV-7000 75 mg taken once daily

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Biohaven Therapeutics Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Serious AEs (SAEs), AEs Leading to Study Drug Discontinuation, and AEs judged to be related to study medication	Safety and tolerability of BHV-7000 as assessed by frequency of unique subjects with SAEs; AEs leading to discontinuation; AEs judged to be related to study medication	Up to 52 weeks
Primary	Number of Participants With Clinically Significant Laboratory Abnormalities	To assess the safety and tolerability of BHV-7000. This objective will be measured by assessing the number of unique subjects with grade 3 and 4 laboratory abnormalities.	Up to 52 weeks