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A Clinical Evaluation Of BW430C (Lamotrigine) In Bipolar I Disorder - Long-Term Extension Of Study SCA104779 -

This study is currently recruiting participants.
Verified by GlaxoSmithKline, October 2008

Sponsored by: GlaxoSmithKline
Information provided by: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00566020
  Purpose

This study is planned to assess the long-term safety of lamotrigine in Japanese patients with bipolar I disorder who will continue into the 52-week extension upon completion of a double-blind comparative study (Study No.: SCA104779), i.e. the patients who receive the addition of any additional treatment to intervene in a mood episode in the double-blind phase or the patients completing the double-blind phase.


Condition Intervention Phase
Bipolar Disorder
Drug: BW430C (lamotrigine)
Phase III

MedlinePlus related topics:   Bipolar Disorder   

ChemIDplus related topics:   Lamotrigine   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study
Official Title:   Study SCA106052, a Clinical Evaluation of BW430C (Lamotrigine) in Bipolar I Disorder - Long-Term Extension Study (Extension of Study SCA104779) -

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • - Adverse events at every visit - Abnormality of clinical laboratory test values at Week0, Week6, Week16, Week28, Week 40 and Week 52 - Vital signs at every visit - Electrocardiogram at Week0, Week6, Week28 and Week 52

Secondary Outcome Measures:
  • - CGI-S at every visit - HAM-D at Week0, Week6, Week16, Week28, Week 40 and Week 52 - YMRS at Week0, Week6, Week16, Week28, Week 40 and Week 52 - Serum lamotrigine concentrations at Week6, Week16, Week28, Week 40 and Week 52 [ Time Frame: Week 52 ]
  • Change from baseline of Clinical Global Impressions of Severity (CGI-S); Change from baseline of Hamilton Depression Rating Scale (HAM-D); Change from baseline of Young Mania Rating Scale (YMRS);

Estimated Enrollment:   63
Study Start Date:   September 2007
Estimated Study Completion Date:   December 2010
Estimated Primary Completion Date:   December 2010 (Final data collection date for primary outcome measure)

  Eligibility
Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • Of subjects participating in the preceding double-blind study, those who are judged by the investigator/sub-investigator to have well tolerated the double-blind treatment and to be eligible for the 52-week extension treatment
  • Sex: either sex. Female of child-bearing potential will be eligible for inclusion in this study. However they have to have a negative pregnancy test at the start of this study, agree to further pregnancy testing at the time points determined in study assessments and procedures and practice one of the following methods of contraception from the start of this study until the end of the follow-up examination:

Abstinence

Oral contraceptive, either combined or progestogen alone (except during the Dosage Adjustment Phase)

Injectable progestogen

Implants of levonorgestrel

Estrogenic vaginal ring (except during the Dosage Adjustment Phase)

Percutaneous contraceptive patches (except during the Dosage Adjustment Phase)

Intrauterine device (IUD) or intrauterine system (IUS) that meets the SOP effectiveness criteria as stated in the product label

Male partner sterilization (vasectomy with documentation of azoospermia) prior to the female subject's entry into the study, and this male is the sole partner for that subject

Double barrier method: condom or occlusive cap (diaphragm or cervical / vault caps) plus spermicidal agent (foam / gel / film / cream / suppository)

  • In/Out patient: Either
  • Informed consent: the subject capable of giving written informed consent

Exclusion Criteria:

  • Has a score of 3 or more on item of the HAM-D related to suicide or is at a high suicidal risk in the judgment of the investigator/sub-investigator
  • Has a history of severe rash or rash due to anti-epileptic drugs
  • Patients with severe hepatic/renal/cardiac/pulmonary disorder or hematopoietic disorder. The severity refers to Grade 3 according to "the Classification of the Severity of Adverse Experiences" (PAB/SD Notification No. 80, dated 29 June 1992)
  • Patients have less than 5 years of remission history from clinically significant malignancy (other than e.g. basal cell or squamous cell skin cancer, in-situ carcinoma of cervix or prostate CA in situ)
  • Patients with chronic hepatitis typeB and /or typeC which is positive of hepatitis B surface antigen (HBsAg)and/or hepatitis C antibody
  • Has an acute or chronic illness likely to impair drug absorption, distribution, metabolism or excretion or has any unstable physical symptoms likely to require hospitalisation during participation in the study
  • Female patients who are pregnant or lactating, who may be pregnant, or who plan for pregnancy during the study
  • Has a history or current diagnosis of epilepsy
  • Has received an investigational drug within 30 days of screening
  • Patients with a history of drug allergy to any ingredient of the test-drug
  • Patients whom the investigator or sub-investigator considers ineligible for the study
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00566020

Contacts
Contact: US GSK Clinical Trials Call Center     877-379-3718    

Show 63 study locations  Show 63 Study Locations

Sponsors and Collaborators
GlaxoSmithKline

Investigators
Study Director:     GSK Clinical Trials, MD     GlaxoSmithKline    
  More Information


Responsible Party:   GSK ( Study Director )
Study ID Numbers:   SCA106052
First Received:   November 28, 2007
Last Updated:   October 9, 2008
ClinicalTrials.gov Identifier:   NCT00566020
Health Authority:   Japan: Ministry of Health, Labor and Welfare

Keywords provided by GlaxoSmithKline:
Lamotrigine  
Bipolar I disorder  
Safety  
Tolerability  
Open-label extension  

Study placed in the following topic categories:
Affective Disorders, Psychotic
Mental Disorders
Bipolar Disorder
Lamotrigine
Mood Disorders
Psychotic Disorders

Additional relevant MeSH terms:
Membrane Transport Modulators
Pathologic Processes
Disease
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Calcium Channel Blockers
Cardiovascular Agents
Central Nervous System Agents
Anticonvulsants
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 15, 2008




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