Safety and Efficacy Study of ELND005 as an Adjunctive Maintenance Treatment in Bipolar I Disorder

Bipolar 1 Disorder Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01674010
• Other study ID #: ELND005-BPD201
• Secondary ID: 2012-001935-30
• Status: Terminated
• Phase: Phase 2
• Start date: August 2012
• Est. completion date: June 2014

Study information

• Verified date: October 2019
• Source: OPKO Health, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 309
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Meets the DSM-IV-TR criteria for BPD I by the SCID, prior to the Screening Visit.

• 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:

• Woman of childbearing potential who is unwilling or unable to use an acceptable method of birth control or is using a prohibited contraceptive method.

• 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.

Related Conditions & MeSH terms

• Bipolar 1 Disorder
• Disease

Intervention

Drug:
• ELND005

• Lamotrigine

• Valproic acid

• Placebo

Locations

Country	Name	City	State
Bulgaria	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
Canada	Elan Investigational Site	Chatham	Ontario
Canada	Elan Investigational Site	Edmonton	Alberta
Canada	Elan Investigational Site	Halifax	Nova Scotia
Canada	Elan Investigational Site	Kelowna	British Columbia
Canada	Elan Investigational Site	Kingston	Ontario
Canada	Elan Investigational Site	London	Ontario
Canada	Elan Investigational Site	Toronto	Ontario
Canada	Elan Investigational Site	Toronto	Ontario
Czechia	Elan Investigational Site	Praha
Czechia	Elan Investigational Site	Praha
Czechia	Elan Investigational Site	Praha
Czechia	Elan Investigational Site	Praha
Czechia	Elan Investigational Site	Strakonice
France	Elan Investigational Site	Bully-Les-Mines
France	Elan Investigational Site	Dole
France	Elan Investigational Site	Elancourt
France	Elan Investigational Site	Nimes
France	Elan Investigational Site	Toulouse
France	Elan Investigational Site	Toulouse
Poland	Elan Investigational Site	Bydgoszcz
Poland	Elan Investigational Site	Gdansk
Poland	Elan Investigational Site	Lodz
Poland	Elan Investigational Site	Tuszyn
Romania	Elan Investigational Site	Brasov
Romania	Elan Investigational Site	Bucharest
Romania	Elan Investigational Site	Craiova
Romania	Elan Investigational Site	Sibiu
Spain	Elan Investigational Site	Barcelona
Spain	Elan Investigational Site	Oviedo	Asturias
Spain	Elan Investigational Site	Torrevieja	Alicante
Spain	Elan Investigational Site	Vitoria
Turkey	Elan Investigational Site	Ankara
Turkey	Elan Investigational Site	Diyarbakir
Turkey	Elan Investigational Site	Edirne
Turkey	Elan Investigational Site	Istanbul
United States	Elan Investigational Site	Atlanta	Georgia
United States	Elan Investigational Site	Beachwood	Ohio
United States	Elan Investigational Site	Bellevue	Washington
United States	Elan Investigational Site	Birmingham	Alabama
United States	Elan Investigational Site	Cerritos	California
United States	Elan Investigational Site	Charleston	South Carolina
United States	Elan Investigational Site	Cincinnati	Ohio
United States	Elan Investigational Site	Cleveland	Ohio
United States	Elan Investigational Site	Costa Mesa	California
United States	Elan Investigational Site	Creve Coeur	Missouri
United States	Elan Investigational Site	Escondido	California
United States	Elan Investigational Site	Fresh Meadows	New York
United States	Elan Investigational Site	Garden Grove	California
United States	Elan Investigational Site	Glendale	Arizona
United States	Elan Investigational Site	Houston	Texas
United States	Elan Investigational Site	Hurst	Texas
United States	Elan Investigational Site	Lincoln	Nebraska
United States	Elan Investigational Site	Little Rock	Arkansas
United States	Elan Investigational Site	Little Rock	Arkansas
United States	Elan Investigational Site	Marlton	New Jersey
United States	Elan Investigational Site	National City	California
United States	Elan Investigational Site	New York	New York
United States	Elan Investigational Site	North Miami	Florida
United States	Elan Investigational Site	Norwich	Connecticut
United States	Elan Investigational Site	Oakland Park	Florida
United States	Elan Investigational Site	Oceanside	California
United States	Elan Investigational Site	Oklahoma City	Oklahoma
United States	Elan Investigational Site	Palo Alto	California
United States	Elan Investigational Site	Philadelphia	Pennsylvania
United States	Elan Investigational Site	Phoenix	Arizona
United States	Elan Investigational Site	Raleigh	North Carolina
United States	Elan Investigational Site	Riverside	California
United States	Elan Investigational Site	Roswell	Georgia
United States	Elan Investigational Site	Saint Louis	Missouri
United States	Elan Investigational Site	Saint Louis	Missouri
United States	Elan Investigational Site	Salt Lake City	Utah
United States	Elan Investigational Site	San Antonio	Texas
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	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
OPKO Health, Inc.	Elan Pharmaceuticals

Countries where clinical trial is conducted

United States,  Bulgaria,  Canada,  Czechia,  France,  Poland,  Romania,  Spain,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment Emergent Adverse Events	The study was terminated early so no efficacy analysis was done, safety data are reported.	up to 48 weeks
Secondary	Proportion of Study Participants With Recurrence of Any Mood Episode		up to 48 weeks
Secondary	Time to Recurrence of a Depressive Episode		up to 48 weeks
Secondary	Time to Recurrence of a Manic/Hypomanic or a Mixed Episode		up to 48 weeks