Safety and Efficacy Study of ELND005 as an Adjunctive Maintenance Treatment in Bipolar I Disorder
NCT ID: NCT01674010
Last Updated: 2019-10-21
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
309 participants
INTERVENTIONAL
2012-08-31
2014-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Lamotrigine or Valproic acid + ELND005
Lamotrigine or valproic acid plus ELND005 film coated tablets, 500mg BID for up to 48 weeks
ELND005
Lamotrigine
Valproic acid
Lamotrigine or Valproic acid + placebo
Lamotrigine or valproic acid plus matched placebo BID for up to 48 weeks
Lamotrigine
Valproic acid
Placebo
Interventions
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ELND005
Lamotrigine
Valproic acid
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Has a history in the last 3 years of ≥ 1 manic or mixed episodes of sufficient severity that required hospitalization and/or treatment with a mood stabilizer or antipsychotic, or confirmed by a family member or medical records to ensure the episode fulfills the DSM-IV-TR criteria.
* Has experienced a mood episode of any polarity within 4 months prior to the Screening Visit and responded to StOC therapy.
* Is euthymic at the Screening Visit (ie, score of ≤ 12 on the MADRS and a score of ≤ 12 on the Y-MRS).
* Is receiving maintenance treatment for his or her BPD I with either LTG or VPA; on stable doses for past 4 weeks and therapeutic drug levels (total VPA 50--125 µg/mL and LTG 10-50 µmol/L or as deemed appropriate by the investigator). Dose adjustments made for tolerability reasons will be acceptable.
A study patient must meet the following additional criteria to be eligible for randomization in the Double-blind Randomization Phase of this study:
\- Maintained in a stable euthymic state during Phase 1, defined as Y-MRS and MADRS scores of ≤ 12, with the following exceptions: a maximum of 2 nonconsecutive excursions will be allowed throughout Phase 1. Excursions are defined as Y-MRS or MADRS scores \>12 but ≤ 16.
Exclusion Criteria
* Is found to be actively suicidal on the C-SSRS (answer of "yes" to question 4 or 5 \[current or over the last 30 days\]) or a score of ≥4 on the MADRS item 10 at the Screening Visit.
* Has suboptimally treated thyroid disease as evidenced by thyroid-stimulating hormone (TSH) \>3 mIU/L at the Screening Visit.
* Has received electroconvulsive therapy (ECT) during the current episode or within 6 months prior to the Screening Visit.
* Has an estimated glomerular filtration rate \<40 mL/min/1.73 m2 according to the Modification of Diet in Renal Disease formula.
A study patient who meets ANY of the above and ANY of the criteria below will not be eligible for enrollment in the Double-blind Randomization Phase of this study:
* Has current signs or symptoms of psychosis.
* Has become actively suicidal as defined by C-SSRS answer of "yes" to question 4 or 5 (current or over the last 30 days) and/or has a score of ≥4 on MADRS item 10.
18 Years
65 Years
ALL
No
Sponsors
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Elan Pharmaceuticals
INDUSTRY
OPKO Health, Inc.
INDUSTRY
Responsible Party
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Locations
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Elan Investigational Site
Birmingham, Alabama, United States
Elan Investigational Site
Glendale, Arizona, United States
Elan Investigational Site
Phoenix, Arizona, United States
Elan Investigational Site
Little Rock, Arkansas, United States
Elan Investigational Site
Little Rock, Arkansas, United States
Elan Investigational Site
Cerritos, California, United States
Elan Investigational Site
Costa Mesa, California, United States
Elan Investigational Site
Escondido, California, United States
Elan Investigational Site
Garden Grove, California, United States
Elan Investigational Site
National City, California, United States
Elan Investigational Site
Oceanside, California, United States
Elan Investigational Site
Palo Alto, California, United States
Elan Investigational Site
Riverside, California, United States
Elan Investigational Site
San Diego, California, United States
Elan Investigational Site
Santa Ana, California, United States
Elan Investigational Site
Stanford, California, United States
Elan Investigational Site
Norwich, Connecticut, United States
Elan Investigational Site
North Miami, Florida, United States
Elan Investigational Site
Oakland Park, Florida, United States
Elan Investigational Site
Tampa, Florida, United States
Elan Investigational Site
Atlanta, Georgia, United States
Elan Investigational Site
Roswell, Georgia, United States
Elan Investigational Site
Creve Coeur, Missouri, United States
Elan Investigational Site
St Louis, Missouri, United States
Elan Investigational Site
St Louis, Missouri, United States
Elan Investigational Site
Lincoln, Nebraska, United States
Elan Investigational Site
Marlton, New Jersey, United States
Elan Investigational Site
Fresh Meadows, New York, United States
Elan Investigational Site
New York, New York, United States
Elan Investigational Site
Raleigh, North Carolina, United States
Elan Investigational Site
Beachwood, Ohio, United States
Elan Investigational Site
Cincinnati, Ohio, United States
Elan Investigational Site
Cleveland, Ohio, United States
Elan Investigational Site
Oklahoma City, Oklahoma, United States
Elan Investigational Site
Philadelphia, Pennsylvania, United States
Elan Investigational Site
Charleston, South Carolina, United States
Elan Investigational Site
Houston, Texas, United States
Elan Investigational Site
Hurst, Texas, United States
Elan Investigational Site
San Antonio, Texas, United States
Elan Investigational Site
Salt Lake City, Utah, United States
Elan Investigational Site
Bellevue, Washington, United States
Elan Investigational Site
Kardzhali, , Bulgaria
Elan Investigational Site
Pazardzhik, , Bulgaria
Elan Investigational Site
Sofia, , Bulgaria
Elan Investigational Site
Sofia, , Bulgaria
Elan Investigational Site
Varna, , Bulgaria
Elan Investigational Site
Vratsa, , Bulgaria
Elan Investigational Site
Edmonton, Alberta, Canada
Elan Investigational Site
Kelowna, British Columbia, Canada
Elan Investigational Site
Halifax, Nova Scotia, Canada
Elan Investigational Site
Chatham, Ontario, Canada
Elan Investigational Site
Kingston, Ontario, Canada
Elan Investigational Site
London, Ontario, Canada
Elan Investigational Site
Toronto, Ontario, Canada
Elan Investigational Site
Toronto, Ontario, Canada
Elan Investigational Site
Prague, , Czechia
Elan Investigational Site
Prague, , Czechia
Elan Investigational Site
Prague, , Czechia
Elan Investigational Site
Prague, , Czechia
Elan Investigational Site
Strakonice, , Czechia
Elan Investigational Site
Bully-les-Mines, , France
Elan Investigational Site
Dole, , France
Elan Investigational Site
Élancourt, , France
Elan Investigational Site
Nîmes, , France
Elan Investigational Site
Toulouse, , France
Elan Investigational Site
Toulouse, , France
Elan Investigational Site
Bydgoszcz, , Poland
Elan Investigational Site
Gdansk, , Poland
Elan Investigational Site
Lodz, , Poland
Elan Investigational Site
Tuszyn, , Poland
Elan Investigational Site
Brasov, , Romania
Elan Investigational Site
Bucharest, , Romania
Elan Investigational Site
Craiova, , Romania
Elan Investigational Site
Sibiu, , Romania
Elan Investigational Site
Torrevieja, Alicante, Spain
Elan Investigational Site
Oviedo, Principality of Asturias, Spain
Elan Investigational Site
Barcelona, , Spain
Elan Investigational Site
Vitoria-Gasteiz, , Spain
Elan Investigational Site
Ankara, , Turkey (Türkiye)
Elan Investigational Site
Diyarbakır, , Turkey (Türkiye)
Elan Investigational Site
Edirne, , Turkey (Türkiye)
Elan Investigational Site
Istanbul, , Turkey (Türkiye)
Countries
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Other Identifiers
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2012-001935-30
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ELND005-BPD201
Identifier Type: -
Identifier Source: org_study_id
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