TerminatedNCT01674010
Safety and Efficacy Study of ELND005 as an Adjunctive Maintenance Treatment in Bipolarity type I
This study evaluates the safety and effectiveness of ELND005 for people with bipolarity.
Medication studyAges 18–65Multiple countries
Understand this study
What is this study about?
This study evaluates the safety and effectiveness of ELND005 for people with bipolarity.
Who could participate?
This study is for people with type I bipolarity. Listed age limits: 18 years to 65 years. Other eligibility criteria apply.
- Listed locations
- Birmingham and 81 more locationsSee all locations and recruitment
- Study phase
- Phase 2Usually explores whether the intervention may work, while continuing to monitor safety.
What to know before participating
A point to clarify
This summary does not cover all risks or eligibility requirements. What risks or changes to my care would apply to me?
Things to check before joining
Study start dateAugust 2012
- Recruitment status
- Terminated
- Enrollment listed in the registry
- 309
- Sponsor
- OPKO Health, Inc.
- Sponsor type
- Other organization
- Study type
- Drug
- Intervention type
- Medication / drug
- Study phase
- Phase 2Usually explores whether the intervention may work, while continuing to monitor safety.
- Locations
- United States, France, Canada, ...
- Age range
- From 18 Years to 65 Years
- Official registry ID
- NCT01674010
- Official title
Show the full official title
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
Recruitment & locations
TerminatedBirmingham, United States · Glendale, United States · Phoenix, United States
73 more locations
- Little Rock, United States
- Cerritos, United States
- Costa Mesa, United States
- Escondido, United States
- Garden Grove, United States
- National City, United States
- Oceanside, United States
- Palo Alto, United States
- Riverside, United States
- San Diego, United States
- Santa Ana, United States
- Stanford, United States
- Norwich, United States
- North Miami, United States
- Oakland Park, United States
- Tampa, United States
- Atlanta, United States
- Roswell, United States
- Creve Coeur, United States
- St Louis, United States
- Lincoln, United States
- Marlton, United States
- Fresh Meadows, United States
- New York, United States
- Raleigh, United States
- Beachwood, United States
- Cincinnati, United States
- Cleveland, United States
- Oklahoma City, United States
- Philadelphia, United States
- Charleston, United States
- Houston, United States
- Hurst, United States
- San Antonio, United States
- Salt Lake City, United States
- Bellevue, United States
- Kardzhali, Bulgaria
- Pazardzhik, Bulgaria
- Sofia, Bulgaria
- Varna, Bulgaria
- Vratsa, Bulgaria
- Edmonton, Canada
- Kelowna, Canada
- Halifax, Canada
- Chatham, Canada
- Kingston, Canada
- London, Canada
- Toronto, Canada
- Prague, Czechia
- Strakonice, Czechia
- Bully-les-Mines, France
- Dole, France
- Élancourt, France
- Nîmes, France
- Toulouse, France
- Bydgoszcz, Poland
- Gdansk, Poland
- Lodz, Poland
- Tuszyn, Poland
- Brasov, Romania
- Bucharest, Romania
- Craiova, Romania
- Sibiu, Romania
- Torrevieja, Spain
- Oviedo, Spain
- Barcelona, Spain
- Vitoria-Gasteiz, Spain
- Ankara, Türkiye
- Diyarbakır, Türkiye
- Edirne, Türkiye
- Istanbul, Türkiye
- Czechia
- Türkiye
A listed location does not confirm current availability.
Questions about this study
What is this study about?
This study evaluates the safety and effectiveness of ELND005 for people with bipolarity.
Who is behind this study?
The study sponsor is OPKO Health, Inc.
Does this study involve medication?
Yes. The study involves medication, including ELND005, lamotrigine, Valproic acid and Placebo.
Who can participate?
This study is for people with type I bipolarity. Listed age limits: 18 years to 65 years. Other eligibility criteria apply.
Is this study still recruiting?
The registry lists this study as terminated.
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