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

This study has been terminated.
(Business Decision)
Sponsor:
Collaborator:
Elan Pharmaceuticals
Information provided by (Responsible Party):
Transition Therapeutics Ireland Limited
ClinicalTrials.gov Identifier:
NCT01674010
First received: August 24, 2012
Last updated: October 15, 2015
Last verified: October 2015
Results First Received: September 14, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Bipolar 1 Disorder
Interventions: Drug: ELND005
Drug: Lamotrigine
Drug: Valproic acid
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Open Treatment Phase 1 ELND005 500 mg BID ELND005 500mg BID for 16 weeks
Phase 2 Placebo Double Blind Randomization (Phase 2)
Phase 2 ELND005 500 mg BID Randomization Phase 2 ELND005 500 mg BID

Participant Flow for 2 periods

Period 1:   Open Treatment Phase 1
    Open Treatment Phase 1 ELND005 500 mg BID     Phase 2 Placebo     Phase 2 ELND005 500 mg BID  
STARTED     309     0     0  
COMPLETED     129     0     0  
NOT COMPLETED     180     0     0  
Adverse Event                 10                 0                 0  
Death                 1                 0                 0  
Lost to Follow-up                 19                 0                 0  
Physician Decision                 9                 0                 0  
Protocol Violation                 7                 0                 0  
Sponsor Decision                 79                 0                 0  
Did not remain in a stable remission                 30                 0                 0  
Withdrawal by Subject                 25                 0                 0  

Period 2:   Randomization Phase 2
    Open Treatment Phase 1 ELND005 500 mg BID     Phase 2 Placebo     Phase 2 ELND005 500 mg BID  
STARTED     0     65     64  
COMPLETED     0     3     3  
NOT COMPLETED     0     62     61  
Adverse Event                 0                 1                 1  
Lost to Follow-up                 0                 1                 2  
Mood episode recurrence                 0                 8                 2  
Physician Decision                 0                 0                 2  
Pregnancy                 0                 1                 1  
Protocol Violation                 0                 1                 1  
Sponsor Decision                 0                 42                 45  
Withdrawal by Subject                 0                 8                 7  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
All Study Participants No text entered.

Baseline Measures
    All Study Participants  
Number of Participants  
[units: participants]
  309  
Age  
[units: years]
Mean (Standard Deviation)
 
Phase 1(n=309)     44.3  (11.09)  
Phase 2 Placebo (n=65)     44.5  (10.65)  
Phase 2 ELND005 500mg BID(n=64)     44.6  (10.61)  
Gender, Customized  
[units: participants]
 
Phase 1 Male     146  
Phase 1 Female     163  
Phase 2 Placebo Male     34  
Phase 2 Placebo Female     31  
Phase 2 ELND005 500 BID Male     32  
Phase 2 ELND005 500 BID Female     32  
Race/Ethnicity, Customized  
[units: participants]
 
Hispanic or Latino Phase 1     23  
Hispanic or Latino Phase 2 Placebo     4  
Hispanic or Latino Phase 2 ELND005 500 BID     6  
Not Hispanic or Latino Phase 1     284  
Not Hispanic or Latino Phase 2 Placebo     60  
Not Hispanic or Latino Phase 2 ELND005 500 BID     58  
Unknown Phase 1     2  
Unknown Phase 2 Placebo     1  
Unknown Phase 2 ELND005 500 BID     0  
Region of Enrollment  
[units: participants]
 
North America     210  
Europe     99  



  Outcome Measures
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1.  Primary:   Treatment Emergent Adverse Events   [ Time Frame: up to 48 weeks ]

2.  Secondary:   Proportion of Study Participants With Recurrence of Any Mood Episode   [ Time Frame: up to 48 weeks ]

3.  Secondary:   Time to Recurrence of a Depressive Episode   [ Time Frame: up to 48 weeks ]

4.  Secondary:   Time to Recurrence of a Manic/Hypomanic or a Mixed Episode   [ Time Frame: up to 48 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Aleksandra Pastrak,MD, PhD, VP of Clinical Development and Medical Officer
Organization: Transition Therapeutics Ireland Limited
phone: +1 416 263 1227
e-mail: apastrak@transitiontherapeutics.com



Responsible Party: Transition Therapeutics Ireland Limited
ClinicalTrials.gov Identifier: NCT01674010     History of Changes
Other Study ID Numbers: ELND005-BPD201
2012-001935-30 ( EudraCT Number )
Study First Received: August 24, 2012
Results First Received: September 14, 2015
Last Updated: October 15, 2015
Health Authority: United States: Food and Drug Administration