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

Primary Purpose

Bipolar Disorder

Status

Completed

Phase

Phase 3

Locations

Japan

Study Type

Interventional

Intervention

BW430C (lamotrigine)

About this trial

This is an interventional treatment trial for Bipolar Disorder focused on measuring Open-label extension, Tolerability, Lamotrigine, Safety, Bipolar I disorder

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Lamotrigine

Arm Description

study drug

Outcomes

Primary Outcome Measures

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.

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.

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.

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.

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.

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.

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.

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+).

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.

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.

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.

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.

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.

Secondary Outcome Measures

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

The CGI-S is a standardized assessment tool that uses a 7-point scale to assess a participant's severity of illness. The total score ranges from 0 to 7: 0=not assessed, 1=normal, 2=borderline ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severly ill, 7=extremely ill. Higher scores reflect a higher severity of current illness states. The number of participants with an assessment varied depending on the number of assessments completed at each visit (indicated time points).

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

The CGI-S is a standardized assessment tool that uses a 7-point scale to assess a participant's severity of illness. The total score ranges from 0 to 7: 0=not assessed, 1=normal, 2=borderline ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severly ill, 7=extremely ill. Higher scores reflect a higher severity of current illness states. Change from baseline was calculated as the values at Weeks 2, 4, 5, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 (or EW) minus the baseline value (Week 0).

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

The HAMD-17 is a 17-item questionnaire that detects change and measures illness severity. Individual items were rated on a scale of 0-4 and 0-2, with the total HAMD-17 score ranging from 0 (not ill) to 52 (severely ill). Change from baseline was calculated as the values at Week 6, 16, 28, 40, and 52 (or EW) minus the baseline value (Week 0).

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

The YMRS is an 11-item, multiple-choice diagnostic questionnaire used to measure the severity of disease in participants. Individual items (1=elevated mood, 2=increased motor activity, 3=sexual interest, 4=sleep, 5=irritability, 6=speech, 7=language thought disorder, 8=content, 9=disruptive aggressive behaviour, 10=appearance, 11=insight) were rated on a scale of 0-4 and 0-8. For all items, 0 is the "best" rating and 4 or 8 is the "worst" rating. YMRS total score was computed as the sum of the scores for the 11 items on the scale. The possible total scores range from 0 (best) to 60 (worst).

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

The YMRS is an 11-item, multiple-choice diagnostic questionnaire used to measure the severity of disease in participants. Individual items (1=elevated mood, 2=increased motor activity, 3=sexual interest, 4=sleep, 5=irritability, 6=speech, 7=language thought disorder, 8=content, 9=disruptive aggressive behaviour, 10=appearance, 11=insight) were rated on a scale of 0-4 and 0-8. YMRS total score (range of 0-60) was computed as sum of the scores for the 11 items on the scale. Change from baseline was calculated as the values at Week 6, 16, 28, 40, and 52 (or EW) minus the baseline value (Week 0).

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

Pharmacokinetic (PK) samples were collected at Weeks 6, 16, 28, 40, 52/EW, and the plasma lamotrigine concentrations were measured. Participants were required to visit the study site without taking the investigational product on the morning of the PK blood sampling. Inhibitors are defined as drugs that inhibit lamotrigine glucuronidation (i.e., valproate). Inducers are defined as drugs that induce lamotrigine glucuronidation (e.g., carbamazepine). The median value presented is the median of all samples collected at Weeks 6, 16, 28, 40, and 52/EW.

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

PK samples were collected at Weeks 6, 16, 28, 40, 52/EW, and the plasma lamotrigine concentrations were measured. Participants were required to visit the study site without taking the investigational product on the morning of the PK blood sampling. Inhibitors are defined as drugs that inhibit lamotrigine glucuronidation (i.e., valproate). The median value presented is the median of all samples collected at Weeks 6, 16, 28, 40, and 52/EW.

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

PK samples were collected at Weeks 6, 16, 28, 40, 52/EW, and the plasma lamotrigine concentrations were measured. Participants were required to visit the study site without taking the investigational product on the morning of the PK blood sampling. Inhibitors are defined as drugs that inhibit lamotrigine glucuronidation (i.e., valproate). Inducers are defined as drugs that induce lamotrigine glucuronidation (e.g., carbamazepine). The median value presented is the median of all samples collected at Weeks 6, 16, 28, 40, and 52/EW.

Full Information

NCT ID

NCT00566020

First Posted

November 28, 2007

Last Updated

March 7, 2017

Sponsor

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT00566020

Brief Title

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

Official Title

Study SCA106052, a Clinical Evaluation of BW430C (Lamotrigine) in Bipolar I Disorder- Long-term Extension Study (Extension of Study SCA104779 (NCT00550407))

Study Type

Interventional

2. Study Status

Record Verification Date

March 2017

Overall Recruitment Status

Completed

Study Start Date

May 2008 (undefined)

Primary Completion Date

October 2010 (Actual)

Study Completion Date

October 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

GlaxoSmithKline

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bipolar Disorder

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

92 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Lamotrigine

Arm Type

Experimental

Arm Description

study drug

Intervention Type

Drug

Intervention Name(s)

BW430C (lamotrigine)

Intervention Description

lamotrigine 50mg/day-400mg/day

Primary Outcome Measure Information:

Title

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

Description

Time Frame

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

Title

Description

Time Frame

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

Title

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

Description

Time Frame

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

Title

Description

Time Frame

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

Title

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

Description

Time Frame

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

Title

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

Description

Time Frame

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

Title

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

Description

Time Frame

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

Title

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

Description

Time Frame

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

Title

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

Description

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

Time Frame

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

Title

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

Description

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

Time Frame

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

Title

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

Description

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

Time Frame

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

Title

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

Description

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

Time Frame

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

Title

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

Description

Time Frame

Weeks 0, 6, 28, and 52/EW

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

Weeks 0, 2, 4, 5, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52/EW

Title

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

Description

The CGI-S is a standardized assessment tool that uses a 7-point scale to assess a participant's severity of illness. The total score ranges from 0 to 7: 0=not assessed, 1=normal, 2=borderline ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severly ill, 7=extremely ill. Higher scores reflect a higher severity of current illness states. Change from baseline was calculated as the values at Weeks 2, 4, 5, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 (or EW) minus the baseline value (Week 0).

Time Frame

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

Title

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

Description

Time Frame

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

Title

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

Description

Time Frame

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

Title

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

Description

Time Frame

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

Title

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

Description

The YMRS is an 11-item, multiple-choice diagnostic questionnaire used to measure the severity of disease in participants. Individual items (1=elevated mood, 2=increased motor activity, 3=sexual interest, 4=sleep, 5=irritability, 6=speech, 7=language thought disorder, 8=content, 9=disruptive aggressive behaviour, 10=appearance, 11=insight) were rated on a scale of 0-4 and 0-8. YMRS total score (range of 0-60) was computed as sum of the scores for the 11 items on the scale. Change from baseline was calculated as the values at Week 6, 16, 28, 40, and 52 (or EW) minus the baseline value (Week 0).

Time Frame

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

Title

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

Description

Time Frame

from Week 6 to Week 52/EW

Title

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

Description

Time Frame

from Week 6 to Week 52/EW

Title

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

Description

PK samples were collected at Weeks 6, 16, 28, 40, 52/EW, and the plasma lamotrigine concentrations were measured. Participants were required to visit the study site without taking the investigational product on the morning of the PK blood sampling. Inhibitors are defined as drugs that inhibit lamotrigine glucuronidation (i.e., valproate). Inducers are defined as drugs that induce lamotrigine glucuronidation (e.g., carbamazepine). The median value presented is the median of all samples collected at Weeks 6, 16, 28, 40, and 52/EW.

Time Frame

from Week 6 to Week 52/EW

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

GSK Clinical Trials

Organizational Affiliation

GlaxoSmithKline

Official's Role

Study Director

Facility Information:

Facility Name

GSK Investigational Site

City

Aichi

ZIP/Postal Code

470-1141

Country

Japan

Facility Name

GSK Investigational Site

City

Chiba

ZIP/Postal Code

260-8677

Country

Japan

Facility Name

GSK Investigational Site

City

Chiba

ZIP/Postal Code

272-8516

Country

Japan

Facility Name

GSK Investigational Site

City

Chiba

ZIP/Postal Code

289-2511

Country

Japan

Facility Name

GSK Investigational Site

City

Fukuoka

ZIP/Postal Code

800-0217

Country

Japan

Facility Name

GSK Investigational Site

City

Fukuoka

ZIP/Postal Code

807-8555

Country

Japan

Facility Name

GSK Investigational Site

City

Fukuoka

ZIP/Postal Code

810-0004

Country

Japan

Facility Name

GSK Investigational Site

City

Fukuoka

ZIP/Postal Code

812-8582

Country

Japan

Facility Name

GSK Investigational Site

City

Fukuoka

ZIP/Postal Code

814-0180

Country

Japan

Facility Name

GSK Investigational Site

City

Fukuoka

ZIP/Postal Code

815-0041

Country

Japan

Facility Name

GSK Investigational Site

City

Fukuoka

ZIP/Postal Code

830-0011

Country

Japan

Facility Name

GSK Investigational Site

City

Gunma

ZIP/Postal Code

375-0017

Country

Japan

Facility Name

GSK Investigational Site

City

Gunma

ZIP/Postal Code

377-0055

Country

Japan

Facility Name

GSK Investigational Site

City

Hiroshima

ZIP/Postal Code

734-8551

Country

Japan

Facility Name

GSK Investigational Site

City

Hiroshima

ZIP/Postal Code

737-0023

Country

Japan

Facility Name

GSK Investigational Site

City

Hokkaido

ZIP/Postal Code

002-8029

Country

Japan

Facility Name

GSK Investigational Site

City

Hokkaido

ZIP/Postal Code

060-0042

Country

Japan

Facility Name

GSK Investigational Site

City

Hokkaido

ZIP/Postal Code

060-8648

Country

Japan

Facility Name

GSK Investigational Site

City

Ibaraki

ZIP/Postal Code

311-3193

Country

Japan

Facility Name

GSK Investigational Site

City

Kanagawa

ZIP/Postal Code

216-8511

Country

Japan

Facility Name

GSK Investigational Site

City

Kanagawa

ZIP/Postal Code

221-0835

Country

Japan

Facility Name

GSK Investigational Site

City

Kanagawa

ZIP/Postal Code

224-8503

Country

Japan

Facility Name

GSK Investigational Site

City

Kanagawa

ZIP/Postal Code

225-0011

Country

Japan

Facility Name

GSK Investigational Site

City

Kanagawa

ZIP/Postal Code

231-0023

Country

Japan

Facility Name

GSK Investigational Site

City

Kanagawa

ZIP/Postal Code

238-0042

Country

Japan

Facility Name

GSK Investigational Site

City

Kumamoto

ZIP/Postal Code

861-8002

Country

Japan

Facility Name

GSK Investigational Site

City

Kyoto

ZIP/Postal Code

616-8421

Country

Japan

Facility Name

GSK Investigational Site

City

Mie

ZIP/Postal Code

510-8575

Country

Japan

Facility Name

GSK Investigational Site

City

Mie

ZIP/Postal Code

515-0044

Country

Japan

Facility Name

GSK Investigational Site

City

Nara

ZIP/Postal Code

634-8522

Country

Japan

Facility Name

GSK Investigational Site

City

Oita

ZIP/Postal Code

874-0011

Country

Japan

Facility Name

GSK Investigational Site

City

Oita

ZIP/Postal Code

879-5593

Country

Japan

Facility Name

GSK Investigational Site

City

Oita

ZIP/Postal Code

879-7501

Country

Japan

Facility Name

GSK Investigational Site

City

Okayama

ZIP/Postal Code

700-8558

Country

Japan

Facility Name

GSK Investigational Site

City

Osaka

ZIP/Postal Code

569-1041

Country

Japan

Facility Name

GSK Investigational Site

City

Osaka

ZIP/Postal Code

583-0884

Country

Japan

Facility Name

GSK Investigational Site

City

Osaka

ZIP/Postal Code

590-0018

Country

Japan

Facility Name

GSK Investigational Site

City

Saga

ZIP/Postal Code

842-0192

Country

Japan

Facility Name

GSK Investigational Site

City

Saitama

ZIP/Postal Code

332-0012

Country

Japan

Facility Name

GSK Investigational Site

City

Tokyo

ZIP/Postal Code

113-8603

Country

Japan

Facility Name

GSK Investigational Site

City

Tokyo

ZIP/Postal Code

151-0053

Country

Japan

Facility Name

GSK Investigational Site

City

Tokyo

ZIP/Postal Code

152-0012

Country

Japan

Facility Name

GSK Investigational Site

City

Tokyo

ZIP/Postal Code

154-0004

Country

Japan

Facility Name

GSK Investigational Site

City

Tokyo

ZIP/Postal Code

166-0003

Country

Japan

Facility Name

GSK Investigational Site

City

Tokyo

ZIP/Postal Code

170-0002

Country

Japan

Facility Name

GSK Investigational Site

City

Tokyo

ZIP/Postal Code

173-0037

Country

Japan

Facility Name

GSK Investigational Site

City

Tokyo

ZIP/Postal Code

180-0005

Country

Japan

Facility Name

GSK Investigational Site

City

Tokyo

ZIP/Postal Code

183-0042

Country

Japan

Facility Name

GSK Investigational Site

City

Tokyo

ZIP/Postal Code

187-8551

Country

Japan

Facility Name

GSK Investigational Site

City

Tokyo

ZIP/Postal Code

190-0023

Country

Japan

Facility Name

GSK Investigational Site

City

Tottori

ZIP/Postal Code

682-0023

Country

Japan

Facility Name

GSK Investigational Site

City

Yamagata

ZIP/Postal Code

999-2221

Country

Japan

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Citations:

Citation

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.

Results Reference

background

Links:

URL

https://www.clinicalstudydatarequest.com

Description

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

Available IPD and Supporting Information:

Available IPD/Information Type

Individual Participant Data Set

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

SCA106052

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Annotated Case Report Form

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

SCA106052

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Statistical Analysis Plan

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

SCA106052

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Dataset Specification

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

SCA106052

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Learn more about this trial

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

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

Bipolar Disorder

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial