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

Condition(s) targeted: Bipolar Disorder

Intervention: BW430C (lamotrigine) (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, MD, Study Director, Affiliation: GlaxoSmithKline

Overall contact:
US GSK Clinical Trials Call Center, Phone: 877-379-3718

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.

Official title: Study SCA106052, a Clinical Evaluation of BW430C (Lamotrigine) in Bipolar I Disorder - Long-term Extension Study (Extension of Study SCA104779) -

Study design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study

Primary outcome: - 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:

- 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

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);

Minimum age: 20 Years. Maximum age: N/A. Gender(s): Both.

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

US GSK Clinical Trials Call Center, Phone: 877-379-3718

GSK Investigational Site, Kanagawa 238-0042, Japan; Recruiting

GSK Investigational Site, Oita 879-7501, Japan; Recruiting

GSK Investigational Site, Chiba 260-8677, Japan; Active, not recruiting

GSK Investigational Site, Okayama 700-8558, Japan; Completed

GSK Investigational Site, Hiroshima 734-8551, Japan; Completed

GSK Investigational Site, Kyoto 616-8421, Japan; Recruiting

GSK Investigational Site, Kanagawa 225-0011, Japan; Recruiting

GSK Investigational Site, Yamagata 999-2221, Japan; Recruiting

GSK Investigational Site, Hiroshima 737-0023, Japan; Recruiting

GSK Investigational Site, Tokyo 180-0005, Japan; Recruiting

GSK Investigational Site, Kanagawa 231-0023, Japan; Recruiting

GSK Investigational Site, Oita 874-0011, Japan; Recruiting

GSK Investigational Site, Kanagawa 224-8503, Japan; Recruiting

GSK Investigational Site, Nara 634-8522, Japan; Recruiting

GSK Investigational Site, Tokyo 187-8551, Japan; Recruiting

GSK Investigational Site, Kumamoto 861-8002, Japan; Recruiting

GSK Investigational Site, Hokkaido 002-8029, Japan; Recruiting

GSK Investigational Site, Fukuoka 810-0004, Japan; Recruiting

GSK Investigational Site, Fukuoka 815-0041, Japan; Recruiting

GSK Investigational Site, Gunma 377-0055, Japan; Recruiting

GSK Investigational Site, Tokyo 170-0002, Japan; Recruiting

GSK Investigational Site, Gunma 375-0017, Japan; Recruiting

GSK Investigational Site, Osaka 569-1041, Japan; Recruiting

GSK Investigational Site, Hokkaido 060-0042, Japan; Recruiting

GSK Investigational Site, Tokyo 173-0037, Japan; Not yet recruiting

GSK Investigational Site, Saga 842-0192, Japan; Not yet recruiting

GSK Investigational Site, Mie 510-8575, Japan; Recruiting

GSK Investigational Site, Aichi 470-1141, Japan; Recruiting

GSK Investigational Site, Tokyo 151-0053, Japan; Recruiting

GSK Investigational Site, Fukuoka 807-8555, Japan; Recruiting

GSK Investigational Site, Chiba 289-2511, Japan; Recruiting

GSK Investigational Site, Fukuoka 812-8582, Japan; Recruiting

GSK Investigational Site, Tottori 682-0023, Japan; Recruiting

GSK Investigational Site, Tokyo 166-0003, Japan; Recruiting

GSK Investigational Site, Fukuoka 800-0217, Japan; Recruiting

GSK Investigational Site, Saitama 332-0012, Japan; Recruiting

GSK Investigational Site, Kanagawa 216-8511, Japan; Recruiting

GSK Investigational Site, Ibaraki 311-3117, Japan; Recruiting

GSK Investigational Site, Kanagawa 221-0835, Japan; Recruiting

GSK Investigational Site, Tokyo 152-0012, Japan; Recruiting

GSK Investigational Site, Chiba 272-8516, Japan; Recruiting

GSK Investigational Site, Tokyo 154-0004, Japan; Recruiting

GSK Investigational Site, Fukuoka 814-0180, Japan; Not yet recruiting

GSK Investigational Site, Tokyo 183-0042, Japan; Not yet recruiting

GSK Investigational Site, Osaka 590-0018, Japan; Not yet recruiting

GSK Investigational Site, Tokyo 190-0023, Japan; Not yet recruiting

GSK Investigational Site, Osaka 533-0005, Japan; Not yet recruiting

GSK Investigational Site, Mie 515-0044, Japan; Not yet recruiting

GSK Investigational Site, Tokyo 113-8602, Japan; Recruiting

GSK Investigational Site, Hokkaido 060-8648, Japan; Recruiting

GSK Investigational Site, Oita 879-5593, Japan; Recruiting

Starting date: May 2008
Ending date: December 2010
Last updated: October 8, 2009