Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01674010 · ClinicalTrials.gov registry record · Phase 2
Safety and Efficacy Study of ELND005 as an Adjunctive Maintenance Treatment in Bipolar I Disorder
A Phase 2 study, sponsored by OPKO Health.
- Terminated
- Registry status
- Phase 2
- Development phase
- 309
- Enrollment target
NCT01674010: Clinical Trial Phase 2 study, sponsored by OPKO Health.
NCT01674010 is a Phase 2 study that was terminated before completion, run by OPKO Health. The registered enrollment target is 309 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (132% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01674010, a Phase 2 study, was terminated before completion, sponsored by OPKO Health.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 309 participants
- Enrollment target
Study Summary
The primary purpose of this study is to determine whether ELND005 is effective in the maintenance treatment of bipolar 1 disorder when added to other therapies.
Primary Outcome
The study was terminated early so no efficacy analysis was done, safety data are reported.
Interventions
- DRUG Placebo
- DRUG Lamotrigine
- DRUG ELND005
- DRUG Valproic acid
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 309 participants |
| Start Date | 2012-08 |
| Est. Completion | 2014-06 |
| Phase | Phase 2 |
Why NCT01674010 stopped before completion
NCT01674010 is an interventional study that assigns participants to a tested intervention. The registered 309 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (132% higher).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT01674010 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01674010 about?
NCT01674010 is a clinical study titled "Safety and Efficacy Study of ELND005 as an Adjunctive Maintenance Treatment in Bipolar I Disorder". The primary purpose of this study is to determine whether ELND005 is effective in the maintenance treatment of bipolar 1 disorder when added to other therapies.
What is the current status of trial NCT01674010?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 309 participants. The study started on 2012-08. Estimated completion is 2014-06.
What interventions are being tested in trial NCT01674010?
The interventions under investigation include: Placebo (DRUG), Lamotrigine (DRUG), ELND005 (DRUG), Valproic acid (DRUG).
Who is sponsoring clinical trial NCT01674010?
This trial is sponsored by OPKO Health, which has 32 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01674010's enrollment target sits among peer trials
309 163rd of 2000 higher than 1,838 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03011684 · 309 participants · Phase 3
Fertility Preservation Using Tamoxifen and Letrozole in Estrogen Sensitive Tumors Trial
- NCT06915233 · 309 participants · Phase 3
A Study of MACI in Patients Aged 17 to 65 Years With Symptomatic Chondral or Osteochondral Defects of the Ankle
- NCT03039439 · 310 participants
Molecular and Immunohistochemical Profiling of Tumors in Patients With Parathyroid Tumors
- NCT04178018 · 310 participants · NA
Transvaginal Ultrasound and Photoacoustic Imaging of Ovary
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia