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An Open-Label Extension Study Of Lamotrigine In Subjects With Bipolar Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00360126
Recruitment Status : Completed
First Posted : August 3, 2006
Results First Posted : March 30, 2017
Last Update Posted : March 30, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Tracking Information
First Submitted Date  ICMJE August 2, 2006
First Posted Date  ICMJE August 3, 2006
Results First Submitted Date  ICMJE February 13, 2017
Results First Posted Date  ICMJE March 30, 2017
Last Update Posted Date March 30, 2017
Study Start Date  ICMJE October 2005
Actual Primary Completion Date February 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 13, 2017)
Number of Participants With Serious Adverse Events (SAEs) [ Time Frame: Up to 54 weeks ]
An adverse event (AE) is defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An adverse event is therefore any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. An SAE is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect. Only SAEs were recorded and reported in this extension study.
Original Primary Outcome Measures  ICMJE
 (submitted: August 2, 2006)
Safety Safety will be evaluated on an ongoing basis during the scheduled visits, either in the clinic or by telephone
Change History Complete list of historical versions of study NCT00360126 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: August 2, 2006)
This study has no secondary outcome measures
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An Open-Label Extension Study Of Lamotrigine In Subjects With Bipolar Disorder
Official Title  ICMJE An Open-Label Extension Study to Assess the Safety of Lamotrigine in Subjects With Bipolar Disorder, Who Are in Remission Following a Manic/Hypomanic Index Episode or a Depressive Index Episode.
Brief Summary The precursor study (SCA101469) was an open-label, prospective multicentre study in adult subjects diagnosed with bipolar disorder consisting of 36 weeks treatment with lamotrigine. The current study is to provide 12 months post study access to open-label lamotrigine for participants of the SCA101469 study.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Bipolar Disorder
Intervention  ICMJE Drug: lamotrigine
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 13, 2017)
11
Original Enrollment  ICMJE
 (submitted: August 2, 2006)
15
Actual Study Completion Date  ICMJE February 2007
Actual Primary Completion Date February 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

A subject will be eligible for inclusion in this study only if all of the following criteria apply:

  • completed 32 weeks of open label treatment in study SCA101469 and, in the investigators opinion, has responded to lamotrigine therapy
  • male or female subject

A female is eligible to enter and participate in this study if she is of:

  1. non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is post-menopausal or sterilised) or,
  2. child-bearing potential, has a negative urine pregnancy test at screening, and agrees to one of the following contraceptive methods:

    • Complete abstinence from intercourse from 2 weeks prior to administration of the study drug, throughout the study, and for a time interval after completion of premature discontinuation from the study to account for elimination of the investigational drug (a minimum of 5 half-lives or longer if the pharmacodynamic profile of the investigational drug warrants a longer time period); or,
    • Sterilisation of male partner; or,
    • Implants of levonorgestrel; or,
    • Injectable progestogen; or,
    • Oral contraceptive (combined or progestogen only); or,
    • Any intrauterine device (IUD) with published data showing that the lowest expected failure rate is less than 1% per year (not all IUDs meet this criterion); or,
    • Any other methods with published data showing that the lowest expected failure rate for that method is less than 1% per year; or,
    • Barrier method only if used in combination with any of the above acceptable methods.

      • willing and able to give written informed consent to participate in the study.

Exclusion Criteria:

A subject will not be eligible for inclusion in this study if any of the following criteria apply:

  • subject experienced a 'mood episode' during participation in study SCA101469, or since completing participation in study SCA101469.
  • participation in a clinical drug trial other than SCA101469 within the past 30 days or previous participation in this clinical study
  • known hypersensitivity to lamotrigine
  • in the investigator's judgement, the subject poses a current serious suicidal or homicidal risk, or has made a suicide attempt within the past 6 months.
  • combination of carbamazepine and valproate
  • concurrent lamotrigine therapy, other than that commenced in study SCA101469
  • current or history of substance abuse
  • diagnosis of epilepsy
  • diagnosis or history of an obsessive-compulsive disorder, social phobia, or eating disorder
  • significant cardiac, renal, cerebrovascular, or hepatic condition; no significant abnormalities in the laboratory tests or ECG recording performed during study SCA101469.
  • unable to understand or implement instructions
  • unresolved drug related adverse event or serious adverse event occurring in study SCA101469
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00360126
Other Study ID Numbers  ICMJE SCA104753
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party GlaxoSmithKline
Study Sponsor  ICMJE GlaxoSmithKline
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: GSK Clinical Trials GlaxoSmithKline
PRS Account GlaxoSmithKline
Verification Date February 2017

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