A Clinical Evaluation Of BW430C (Lamotrigine) In Bipolar I Disorder- Long-term Extension Of Study SCA104779 (NCT00550407) -

Condition(s) targeted: Bipolar Disorder

Intervention: BW430C (lamotrigine) (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: GlaxoSmithKline

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

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 (NCT00550407)), 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 (NCT00550407))

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Number of Participants With Any Serious Adverse Event (SAE) and Any Non Serious Adverse Event

Number of Participants With the Indicated Clinical Laboratory Test Values for Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH)

Number of Participants With Clinical Laboratory Test Values Out of the Normal Range and in the Normal Range for Total Bilirubin and Creatinine at Weeks 0, 6, 16, 28, 40, and 52/EW

Number of Participants With Clinical Laboratory Test Values Out of the Normal Range and in the Normal Range for Calcium, Cholesterol, Chloride, Potassium, Sodium, Triglycerides, and Urea/Blood Urea Nitrogen (BUN) at Weeks 0, 6, 16, 28, 40, and 52/EW

Number of Participants With Clinical Laboratory Test Values Out of the Normal Range and in the Normal Range for Platelet Count and White Blood Cell Count at Weeks 0, 6, 16, 28, 40, and 52/EW

Number of Participants With Clinical Laboratory Test Values Out of the Normal Range and in the Normal Range for Total Protein, Hemoglobin, and Hematocrit at Weeks 0, 6, 16, 28, 40, and 52/EW

Number of Participants With Clinical Laboratory Test Values Out of the Normal Range and in the Normal Range for Red Blood Cell Count at Weeks 0, 6, 16, 28, 40, and 52/EW

Number of Participants in the Indicated Category for Urine Glucose, Urine Protein, and Urine Urobilinogen at Baseline (Week 0) and Weeks 6, 16, 28, 40, and 52/EW

Mean Systolic Blood Pressure and Diastolic Blood Pressure of Participants at Baseline (Week 0) and Weeks 2, 4, 5, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52/EW

Mean Heart Rate of Participants at Week 0 (Baseline) and Weeks 2, 4, 5, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52/EW

Mean Weight of Participants at Baseline (Week 0) and Weeks 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52/EW

Mean Body Mass Index (BMI) of All Participants at Week 0 (Baseline) and Weeks 6, 8, 12, 16, 20, 24, 28, 32,36, 40, 44, 48, and 52/EW

Number of Participants With the Indicated Electrocardiogram (ECG) Findings at Weeks 0, 6, 28, and 52/EW

Secondary outcome:

Clinical Global Impressions of Severity (CGI-S) Total Score at Weeks 0, 2, 4, 5, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52/EW

Change From Baseline in the Clinical Global Impressions of Severity (CGI-S) Total Score at Weeks 2, 4, 5, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52/EW

Hamilton Rating Scale for Depression (HAM-D) Scale Total Score at Weeks 6, 16, 28, 40, and 52/EW

Change From Baseline in the Hamilton Rating Scale for Depression (HAM-D) Scale Total Score at Weeks 6, 16, 28, 40, and 52/EW

Young Mania Rating Scale (YMRS) Total Score at Weeks 6, 16, 28, 40, and 52/EW

Change From Baseline in the Young Mania Rating Scale (YMRS) Total Score at Weeks 6, 16, 28, 40, and 52/EW

Median Serum Lamotrigine 200 mg Concentration Among Participants With Concomitant Use of Inducer and Without Inhibitor (at the Timing of Blood Sample Collection)

Median Serum Lamotrigine 100 mg and 200 mg Concentration Among Participants With Concomitant Use of Inhibitor (at the Timing of Blood Sample Collection)

Median Serum Lamotrigine 25, 100, 125, 150, 200, 225, 300, and 400 mg Concentrations Among Participants Without Concomitant Use of Inhibitor and Inducer

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

GSK Investigational Site, Aichi 470-1141, Japan

GSK Investigational Site, Chiba 260-8677, Japan

GSK Investigational Site, Chiba 272-8516, Japan

GSK Investigational Site, Chiba 289-2511, Japan

GSK Investigational Site, Fukuoka 800-0217, Japan

GSK Investigational Site, Fukuoka 807-8555, Japan

GSK Investigational Site, Fukuoka 810-0004, Japan

GSK Investigational Site, Fukuoka 812-8582, Japan

GSK Investigational Site, Fukuoka 814-0180, Japan

GSK Investigational Site, Fukuoka 815-0041, Japan

GSK Investigational Site, Fukuoka 830-0011, Japan

GSK Investigational Site, Gunma 375-0017, Japan

GSK Investigational Site, Gunma 377-0055, Japan

GSK Investigational Site, Hiroshima 734-8551, Japan

GSK Investigational Site, Hiroshima 737-0023, Japan

GSK Investigational Site, Hokkaido 002-8029, Japan

GSK Investigational Site, Hokkaido 060-0042, Japan

GSK Investigational Site, Hokkaido 060-8648, Japan

GSK Investigational Site, Ibaraki 311-3193, Japan

GSK Investigational Site, Kanagawa 224-8503, Japan

GSK Investigational Site, Kanagawa 221-0835, Japan

GSK Investigational Site, Kanagawa 216-8511, Japan

GSK Investigational Site, Kanagawa 225-0011, Japan

GSK Investigational Site, Kanagawa 231-0023, Japan

GSK Investigational Site, Kanagawa 238-0042, Japan

GSK Investigational Site, Kumamoto 861-8002, Japan

GSK Investigational Site, Kyoto 616-8421, Japan

GSK Investigational Site, Mie 515-0044, Japan

GSK Investigational Site, Mie 510-8575, Japan

GSK Investigational Site, Nara 634-8522, Japan

GSK Investigational Site, Oita 879-7501, Japan

GSK Investigational Site, Oita 879-5593, Japan

GSK Investigational Site, Oita 874-0011, Japan

GSK Investigational Site, Okayama 700-8558, Japan

GSK Investigational Site, Osaka 569-1041, Japan

GSK Investigational Site, Osaka 590-0018, Japan

GSK Investigational Site, Osaka 583-0884, Japan

GSK Investigational Site, Saga 842-0192, Japan

GSK Investigational Site, Saitama 332-0012, Japan

GSK Investigational Site, Tokyo 154-0004, Japan

GSK Investigational Site, Tokyo 151-0053, Japan

GSK Investigational Site, Tokyo 152-0012, Japan

GSK Investigational Site, Tokyo 190-0023, Japan

GSK Investigational Site, Tokyo 166-0003, Japan

GSK Investigational Site, Tokyo 170-0002, Japan

GSK Investigational Site, Tokyo 113-8603, Japan

GSK Investigational Site, Tokyo 180-0005, Japan

GSK Investigational Site, Tokyo 183-0042, Japan

GSK Investigational Site, Tokyo 187-8551, Japan

GSK Investigational Site, Tokyo 173-0037, Japan

GSK Investigational Site, Tottori 682-0023, Japan

GSK Investigational Site, Yamagata 999-2221, Japan

Related publications:

Tsukasa Koyama, Teruhiko Higuchi, Shigeto Yamawaki, Shigenobu Kanba, Takeshi Terao and Atsuko Shinohara. Study SCA106052, a clinical evaluation of BW430C (lamotrigine) in bipolar I disorder - Long-term extension study -. Rinsho seishin igaku. 2011;40(7):981-995.

Starting date: May 2008
Last updated: April 23, 2015