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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00360126




Registration number
NCT00360126
Ethics application status
Date submitted
2/08/2006
Date registered
3/08/2006
Date last updated
30/03/2017

Titles & IDs
Public title
An Open-Label Extension Study Of Lamotrigine In Subjects With Bipolar Disorder
Scientific title
An Open-Label Extension Study to Assess the Safety of Lamotrigine in Subjects With Bipolar Disorder, Who Are in Remission Following a Manic/Hypomanic Index Episode or a Depressive Index Episode.
Secondary ID [1] 0 0
SCA104753
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bipolar Disorder 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Other mental health disorders
Mental Health 0 0 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - lamotrigine

Treatment: Drugs: lamotrigine
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Serious Adverse Events (SAEs)
Timepoint [1] 0 0
Up to 54 weeks

Eligibility
Key inclusion criteria
A subject will be eligible for inclusion in this study only if all of the following
criteria apply:

- completed 32 weeks of open label treatment in study SCA101469 and, in the
investigators opinion, has responded to lamotrigine therapy

- male or female subject

A female is eligible to enter and participate in this study if she is of:

1. non-childbearing potential (i.e., physiologically incapable of becoming pregnant,
including any female who is post-menopausal or sterilised) or,

2. child-bearing potential, has a negative urine pregnancy test at screening, and agrees
to one of the following contraceptive methods:

- Complete abstinence from intercourse from 2 weeks prior to administration of the
study drug, throughout the study, and for a time interval after completion of
premature discontinuation from the study to account for elimination of the
investigational drug (a minimum of 5 half-lives or longer if the pharmacodynamic
profile of the investigational drug warrants a longer time period); or,

- Sterilisation of male partner; or,

- Implants of levonorgestrel; or,

- Injectable progestogen; or,

- Oral contraceptive (combined or progestogen only); or,

- Any intrauterine device (IUD) with published data showing that the lowest
expected failure rate is less than 1% per year (not all IUDs meet this
criterion); or,

- Any other methods with published data showing that the lowest expected failure
rate for that method is less than 1% per year; or,

- Barrier method only if used in combination with any of the above acceptable
methods.

- willing and able to give written informed consent to participate in the
study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
A subject will not be eligible for inclusion in this study if any of the following criteria
apply:

- subject experienced a 'mood episode' during participation in study SCA101469, or since
completing participation in study SCA101469.

- participation in a clinical drug trial other than SCA101469 within the past 30 days or
previous participation in this clinical study

- known hypersensitivity to lamotrigine

- in the investigator's judgement, the subject poses a current serious suicidal or
homicidal risk, or has made a suicide attempt within the past 6 months.

- combination of carbamazepine and valproate

- concurrent lamotrigine therapy, other than that commenced in study SCA101469

- current or history of substance abuse

- diagnosis of epilepsy

- diagnosis or history of an obsessive-compulsive disorder, social phobia, or eating
disorder

- significant cardiac, renal, cerebrovascular, or hepatic condition; no significant
abnormalities in the laboratory tests or ECG recording performed during study
SCA101469.

- unable to understand or implement instructions

- unresolved drug related adverse event or serious adverse event occurring in study
SCA101469

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2007
Sample size
Target
Accrual to date
Final
11
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 0 0
GSK Investigational Site - Greenwich
Recruitment hospital [2] 0 0
GSK Investigational Site - Everton Park
Recruitment hospital [3] 0 0
GSK Investigational Site - New Farm
Recruitment postcode(s) [1] 0 0
2065 - Greenwich
Recruitment postcode(s) [2] 0 0
4053 - Everton Park
Recruitment postcode(s) [3] 0 0
4005 - New Farm

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The precursor study (SCA101469) was an open-label, prospective multicentre study in adult
subjects diagnosed with bipolar disorder consisting of 36 weeks treatment with lamotrigine.
The current study is to provide 12 months post study access to open-label lamotrigine for
participants of the SCA101469 study.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00360126
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00360126