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

NCT00566020 | Completed Phase 3 Results

• 1 other identifier: SCA106052
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 52

Brief Summary

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.

Conditions

Bipolar Disorder

Keywords

Open-label extension; Tolerability; Lamotrigine; Safety; Bipolar I disorder

Outcome Measures

Primary Outcomes (13)

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

  An adverse event (AE) is any untoward medical occurrence in a participant, temporally associated with the use of medicinal product, which does not necessarily have a causal relationship with the treatment. An SAE is any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires inpatient hospitalization or causes its prolongation, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event. A complete list of all SAEs and AEs experienced in the study can be found in the SAE/AE section.

  From baseline (Week 0) until 2 weeks after the end of treatment (Week 54)

• 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)

  Participants in the study were evaluated for the following clinical laboratory parameters at the indicated time points: ALP, ALT, AST, GGT, and LDH. Participants were categorized as "High" for laboratory values above normal (reference) and as "Low" for laboratory values below normal ranges used by the central laboratory. Normal ranges: ALP, 104-338 International Units per liter (IU/L); ALT, 5-45 IU/L; AST, 10-40 IU/L; GGT, Male: 0-79 IU/L, Female: 0-48 IU/L; LDH 120-245 IU/L.

  Baseline (Week 0) and Weeks 6, 16, 28, 40, and 52/Early Withdrawal (EW)

• 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

  Participants in the study were evaluated for the following clinical laboratory parameters at the indicated time points: total bilirubin and creatinine. Participants were categorized as "High" for laboratory values above normal (reference) and as "Low" for laboratory values below normal ranges used by the central laboratory. Normal ranges: total bilirubin, 3.42-17.1 micromoles per liter (UMOL/L); creatinine, Male: 57.46-96.356 UMOL/L, Female: 40.664-72.488 UMOL/L.

  Baseline (Week 0) and Weeks 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

  Participants were evaluated for the following clinical laboratory parameters for blood chemistry at the indicated time points: electrolytes (calcium, chloride, potassium, sodium), cholesterol, triglycerides, and urea/BUN. Participants were categorized as "High" for laboratory values above normal (reference) and as "Low" for laboratory values below normal ranges used by the central laboratory. Normal ranges (micromoles per liter \[MMOL/L\]): calcium, 2.0459-2.495; chloride, 98-108; potassium, 3.5-5; sodium, 135-145; cholesterol, 3.879-5.66334; triglycerides, 0.565-1.6837; urea/BUN, 2.856-7.14.

  Baseline (Week 0) and Weeks 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

  Participants in the study were evaluated for the following clinical laboratory parameters of hematology at the indicated time points: platelet count and white blood cell count. Participants were categorized as "High" for laboratory values above normal (reference) and as "Low" for laboratory values below normal ranges used by the central laboratory. Normal ranges: platelet count, 140-379 GI (gibi; 10\^9) per liter (GI/L); white blood cell count, 3.5-9.7 GI/L.

  Baseline (Week 0) and Weeks 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

  Participants in the study were evaluated for total protein, hemoglobin, and hematocrit at the indicated time points. Participants were categorized as "High" for laboratory values above normal (reference) and as "Low" for laboratory values below normal ranges used by the central laboratory. Normal ranges: total protein, 65-82 grams per liter (G/L); hemoglobin, Male: 136-183 G/L, Female: 112-152 G/L; hematocrit (proportion of 1), Male: 0.404-0.519, Female: 0.343-0.452.

  Baseline (Week 0) and Weeks 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

  Red blood cell count was measured in participants at the indicated time points. Participants were categorized as "High" for laboratory values above normal (reference) and as "Low" for laboratory values below normal ranges used by the central laboratory. Normal ranges: red blood cell count, Male: 4.38-5.77 TI (tebi; 10\^12)/L, Female: 3.76-5.16 TI/L.

  Baseline (Week 0) and Weeks 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

  Urine glucose, urine protein, and urine urobilinogen were measured in participants at the indicated time points. In this dipstick (qualitative) test, the level of glucose, protein, and urobilinogen in urine samples was recorded as negative (NEG \[-\]), trace (TRA \[+/-\]), 1+, 2+, 3+, 4+, and 5+ (the plus sign increases with a higher level of glucose, protein, or urobilinogen in the urine: 1+=slightly positive, 2+=positive, 3+=high positive, 4+=very high positive, 5+=more positive than 4+).

  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

  Systolic and diastolic blood pressure was measured in participants at the indicated time points.

  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

  Heart rate was measured in participants at the indicated time points.

  Baseline (Week 0) 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

  The weight of participants was recorded at the indicated time points.

  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

  The BMI for participants was calculated at the indicated time points as body weight in kilograms divided by height in meters squared.

  Baseline (Week 0) and Weeks 0, 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

  ECGs were recorded in participants at the indicated time points. ECG findings, as determined by the physicians, were reported as normal, abnormal but not clinically significant (NCS), abnormal but clinically significant (CS), and no result. Specific definitions of ECG categorizations were not provided; physicians were expected to apply reasonable standards of clinical judgment.

  Weeks 0, 6, 28, and 52/EW

Secondary Outcomes (9)

• 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

  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

  Baseline (Week 0) and 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

  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

  Baseline (Week 0) and Weeks 6, 16, 28, 40, and 52/EW

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

  Weeks 6, 16, 28, 40, and 52/EW

Study Arms (1)

Lamotrigine

EXPERIMENTAL

study drug

Drug: BW430C (lamotrigine)

Interventions

BW430C (lamotrigine) DRUG

lamotrigine 50mg/day-400mg/day

Lamotrigine

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (52)

GSK Investigational Site

Aichi, 470-1141, Japan

Location

GSK Investigational Site

Chiba, 260-8677, Japan

Location

GSK Investigational Site

Chiba, 272-8516, Japan

Location

GSK Investigational Site

Chiba, 289-2511, Japan

Location

GSK Investigational Site

Fukuoka, 800-0217, Japan

Location

GSK Investigational Site

Fukuoka, 807-8555, Japan

Location

GSK Investigational Site

Fukuoka, 810-0004, Japan

Location

GSK Investigational Site

Fukuoka, 812-8582, Japan

Location

GSK Investigational Site

Fukuoka, 814-0180, Japan

Location

GSK Investigational Site

Fukuoka, 815-0041, Japan

Location

GSK Investigational Site

Fukuoka, 830-0011, Japan

Location

GSK Investigational Site

Gunma, 375-0017, Japan

Location

GSK Investigational Site

Gunma, 377-0055, Japan

Location

GSK Investigational Site

Hiroshima, 734-8551, Japan

Location

GSK Investigational Site

Hiroshima, 737-0023, Japan

Location

GSK Investigational Site

Hokkaido, 002-8029, Japan

Location

GSK Investigational Site

Hokkaido, 060-0042, Japan

Location

GSK Investigational Site

Hokkaido, 060-8648, Japan

Location

GSK Investigational Site

Ibaraki, 311-3193, Japan

Location

GSK Investigational Site

Kanagawa, 216-8511, Japan

Location

GSK Investigational Site

Kanagawa, 221-0835, Japan

Location

GSK Investigational Site

Kanagawa, 224-8503, Japan

Location

GSK Investigational Site

Kanagawa, 225-0011, Japan

Location

GSK Investigational Site

Kanagawa, 231-0023, Japan

Location

GSK Investigational Site

Kanagawa, 238-0042, Japan

Location

GSK Investigational Site

Kumamoto, 861-8002, Japan

Location

GSK Investigational Site

Kyoto, 616-8421, Japan

Location

GSK Investigational Site

Mie, 510-8575, Japan

Location

GSK Investigational Site

Mie, 515-0044, Japan

Location

GSK Investigational Site

Nara, 634-8522, Japan

Location

GSK Investigational Site

Okayama, 700-8558, Japan

Location

GSK Investigational Site

Osaka, 569-1041, Japan

Location

GSK Investigational Site

Osaka, 583-0884, Japan

Location

GSK Investigational Site

Osaka, 590-0018, Japan

Location

GSK Investigational Site

Ōita, 874-0011, Japan

Location

GSK Investigational Site

Ōita, 879-5593, Japan

Location

GSK Investigational Site

Ōita, 879-7501, Japan

Location

GSK Investigational Site

Saga, 842-0192, Japan

Location

GSK Investigational Site

Saitama, 332-0012, Japan

Location

GSK Investigational Site

Tokyo, 113-8603, Japan

Location

GSK Investigational Site

Tokyo, 151-0053, Japan

Location

GSK Investigational Site

Tokyo, 152-0012, Japan

Location

GSK Investigational Site

Tokyo, 154-0004, Japan

Location

GSK Investigational Site

Tokyo, 166-0003, Japan

Location

GSK Investigational Site

Tokyo, 170-0002, Japan

Location

GSK Investigational Site

Tokyo, 173-0037, Japan

Location

GSK Investigational Site

Tokyo, 180-0005, Japan

Location

GSK Investigational Site

Tokyo, 183-0042, Japan

Location

GSK Investigational Site

Tokyo, 187-8551, Japan

Location

GSK Investigational Site

Tokyo, 190-0023, Japan

Location

GSK Investigational Site

Tottori, 682-0023, Japan

Location

GSK Investigational Site

Yamagata, 999-2221, Japan

Location

Related Publications (1)

• 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.

  BACKGROUND

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Lamotrigine

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Triazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2007
• First Posted: November 30, 2007
• Study Start: May 1, 2008
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: April 4, 2017
• Results First Posted: July 27, 2011

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will share

Locations

JP (52)