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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Elan Pharmaceuticals
Information provided by (Responsible Party):
Elan Pharmaceuticals ( Elan Pharma International Limited )
ClinicalTrials.gov Identifier:
NCT01674010
First received: August 24, 2012
Last updated: April 8, 2014
Last verified: April 2014

August 24, 2012
April 8, 2014
August 2012
August 2014   (final data collection date for primary outcome measure)
Time to recurrence of any mood episode [ Time Frame: up to 48 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01674010 on ClinicalTrials.gov Archive Site
  • Proportion of study participants with recurrence of any mood episode [ Time Frame: up to 48 weeks ] [ Designated as safety issue: No ]
  • Time to recurrence of a depressive episode [ Time Frame: up to 48 weeks ] [ Designated as safety issue: No ]
  • Time to recurrence of a manic/hypomanic or a mixed episode [ Time Frame: up to 48 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Bipolar 1 Disorder
  • Drug: ELND005
    Other Name: Scyllo-inositol
  • Drug: Lamotrigine
  • Drug: Valproic acid
  • Drug: Placebo
  • Experimental: Lamotrigine or Valproic acid + ELND005
    Lamotrigine or valproic acid plus ELND005 film coated tablets, 500mg BID for up to 48 weeks
    Interventions:
    • Drug: ELND005
    • Drug: Lamotrigine
    • Drug: Valproic acid
  • Placebo Comparator: Lamotrigine or Valproic acid + placebo
    Lamotrigine or valproic acid plus matched placebo BID for up to 48 weeks
    Interventions:
    • Drug: Lamotrigine
    • Drug: Valproic acid
    • Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
400
Not Provided
August 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Bulgaria,   Canada,   Czech Republic,   France,   Poland,   Romania,   Spain,   Turkey
 
NCT01674010
ELND005-BPD201, 2012-001935-30
Yes
Elan Pharmaceuticals ( Elan Pharma International Limited )
Elan Pharma International Limited
Elan Pharmaceuticals
Not Provided
Elan Pharmaceuticals
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP