Trials / Terminated
TerminatedNCT01674010
Safety and Efficacy Study of ELND005 as an Adjunctive Maintenance Treatment in Bipolar I Disorder
A Prospective, Randomized, Double-Blind, Placebo-Controlled, Phase 2 Safety and Efficacy Study of Oral ELND005 as an Adjunctive Maintenance Treatment in Patients With Bipolar I Disorder
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 309 (actual)
- Sponsor
- OPKO Health, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ELND005 | |
| DRUG | Lamotrigine | |
| DRUG | Valproic acid | |
| DRUG | Placebo |
Timeline
- Start date
- 2012-08-01
- Primary completion
- 2014-06-01
- Completion
- 2014-06-01
- First posted
- 2012-08-28
- Last updated
- 2019-10-21
- Results posted
- 2015-10-12
Locations
82 sites across 9 countries: United States, Bulgaria, Canada, Czechia, France, Poland, Romania, Spain, Turkey (Türkiye)
Source: ClinicalTrials.gov record NCT01674010. Inclusion in this directory is not an endorsement.