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NCT06608641 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Endoxifen in Bipolar I Disorder Patients
A Phase 3 study of Bipolar 1 Disorder, sponsored by Jina Pharmaceuticals.
- Active
- Registry status
- Phase 3
- Development phase
- 490
- Enrollment target
- 12
- Study locations
NCT06608641: Active Phase 3 study of Bipolar 1 Disorder, sponsored by Jina Pharmaceuticals.
NCT06608641 is a Phase 3 study of Bipolar 1 Disorder that is active but no longer recruiting, run by Jina Pharmaceuticals. The registered enrollment target is 490 participants, above the 356-participant average among 3 other Bipolar 1 Disorder trials with a reported enrollment target (38% higher). The trial reports 12 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06608641, a Phase 3 study of Bipolar 1 Disorder, is active but no longer recruiting, sponsored by Jina Pharmaceuticals.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 490 participants
- Enrollment target
- 12
- Study locations
Study Summary
Bipolar disorder (BPD) is a chronic debilitating illness characterized by drastic swings in mood, energy and functional ability that affects the adult population. Endoxifen is an active metabolite of the marketed drug Tamoxifen and the present study aims to evaluate the efficacy and safety of 8 mg endoxifen in the Bipolar I disorder patient population compared to a placebo arm. Endoxifen will be compared to a placebo to demonstrate that the test product is active and to establish that the study is sufficiently sensitive to detect differences between the investigational products. Thus, Endoxifen will be compared to placebo to demonstrate that the test product is safe and active.
Primary Outcome
Primary efficacy endpoint will be the mean change from baseline to Day 21 in the total YMRS score. The point estimate and 95% confidence interval for the mean change from Day 0 (baseline) to Day 21 in total YMRS score for the difference between test and placebo control treatment will be computed and reported for mITT set. Superiority of test over placebo will be claimed if 95% confidence interval for mean change from Day 0 (baseline) to Day 21 in total YMRS score for the difference between test
Conditions Studied
Interventions
- DRUG Placebo Tablets
- DRUG Endoxifen enteric-coated tablet (8 mg)
Study Locations (12)
Florida
- Medical Research of Westchester, Inc. - Miami
- Sunshine Medical Research Studies Inc. - Miami
- Innovative Clinical Research, Inc. - Miami Lakes
- South Florida Research Phase I-IV, Inc. - Miami Springs
- Santos Research Center, CORP - Tampa
California
- Synexus - Cerritos
- NRC Research Institute - Los Angeles
- NRC Research Institute - Orange
Georgia
- Accelerated Clinical Trials, LLC - East Point
- Accelerated Clinical Trials, LLC - Norcross
- Accelerated Clinical Trials, LLC - Peachtree Corners
Mississippi
- Precise Research Centers - Flowood
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 490 participants |
| Start Date | 2024-03-19 |
| Est. Completion | 2025-12 |
| Phase | Phase 3 |
What the registry record for NCT06608641 still lists
NCT06608641 is an interventional study that assigns participants to a tested intervention. The registered 490 participants enrollment target is mid-sized for trials with a published cap, above the 356-participant average among 3 other Bipolar 1 Disorder trials with a reported enrollment target (38% higher).
The record links to 1 condition, with Bipolar 1 Disorder appearing as the primary indexed condition, and to 2 interventions - of which Placebo Tablets is the first listed.
NCT06608641 lists 12 locations in 4 states (Florida, California, Georgia).
Frequently Asked Questions
What is clinical trial NCT06608641 about?
NCT06608641 is a clinical study titled "Efficacy and Safety of Endoxifen in Bipolar I Disorder Patients". Bipolar disorder (BPD) is a chronic debilitating illness characterized by drastic swings in mood, energy and functional ability that affects the adult population. Endoxifen is an active metabolite of the marketed drug Tamoxifen and the present study aims to evaluate the efficacy and safety of 8 mg e...
What is the current status of trial NCT06608641?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 490 participants. The study started on 2024-03-19. Estimated completion is 2025-12.
What conditions does trial NCT06608641 study?
This clinical trial studies the following conditions: Bipolar 1 Disorder.
What interventions are being tested in trial NCT06608641?
The interventions under investigation include: Placebo Tablets (DRUG), Endoxifen enteric-coated tablet (8 mg) (DRUG).
Who is sponsoring clinical trial NCT06608641?
This trial is sponsored by Jina Pharmaceuticals, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06608641 being conducted?
This trial has 12 study locations across California, Florida, Georgia, Mississippi. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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