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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/NCT00043875




Registration number
NCT00043875
Ethics application status
Date submitted
14/08/2002
Date registered
15/08/2002
Date last updated
15/09/2016

Titles & IDs
Public title
Pediatric Epilepsy Trial in Subjects 1-24 Months
Scientific title
A Double-Blind, Placebo-Controlled, Add-On Clinical Trial of the Safety, Pharmacokinetics and Efficacy of Lamictal in Pediatric Age Subjects (1-24 Months)
Secondary ID [1] 0 0
LAM20006
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Epilepsy 0 0
Condition category
Condition code
Neurological 0 0 0 0
Epilepsy

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
The efficacy of LAMICTAL add-on therapy will be measured by the proportion of subjects who meet escape criteria during the Double-Blind Phase.
Timepoint [1] 0 0
36 Months
Secondary outcome [1] 0 0
Time to escape patterns in Double-Blind phase. Reduction in partial seizure frequency at end of Open-Label Phase. Investigators' global evaluation of subjects' status at end of Open-Label and Double-Blind Phases; Standard pharmacokinetics; Adverse Events
Timepoint [1] 0 0
36 Months

Eligibility
Key inclusion criteria
INCLUSION CRITERIA:

- Have a confident diagnosis of epilepsy

- Must be experiencing 4 or more reliably detectable partial seizures per month while
receiving at least 1 anti-epileptic drug (AED)

- Must weigh at least 7 lbs if currently receiving enzyme inducing antiepileptic drugs
(EIADs) OR weigh at least 15 lbs if currently receiving non-enzyme inducing
antiepileptic drugs (non-EIADs)

- Have no underlying chronic metabolism problems

- Have normal lab results

- Have a normal electrocardiogram (ECG)

EXCLUSION CRITERIA:

- Have a diagnosis of severe, progressive myoclonus.

- Have seizures not related to epilepsy.

- Have previously demonstrated sensitivity or allergic reaction to the study drug or its
related compounds.

- Have progressive or unstable condition of the nervous system.

- Used experimental medication within 30 of enrollment into the study.

- Have any significant, chronic heart, kidney, liver or stomach/intestinal (GI)
condition.

- Current use of the medication felbamate.

- Current use of adrenocorticotrophic hormone (ACTH).

- Following a ketogenic diet.

- Receiving vagal nerve stimulation (VNS).
Minimum age
1 Month
Maximum age
24 Months
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
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
1/05/2000
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2003
Sample size
Target
Accrual to date
Final
177
Recruitment in Australia
Recruitment state(s)
QLD,VIC,WA
Recruitment hospital [1] 0 0
GSK Investigational Site - South Brisbane
Recruitment hospital [2] 0 0
GSK Investigational Site - Parkville, Melbourne
Recruitment hospital [3] 0 0
GSK Investigational Site - West Heidleberg, Melbourne
Recruitment hospital [4] 0 0
GSK Investigational Site - Perth
Recruitment postcode(s) [1] 0 0
4101 - South Brisbane
Recruitment postcode(s) [2] 0 0
3050 - Parkville, Melbourne
Recruitment postcode(s) [3] 0 0
- West Heidleberg, Melbourne
Recruitment postcode(s) [4] 0 0
- Perth
Recruitment outside Australia
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United States of America
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Arizona
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Arkansas
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California
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Colorado
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District of Columbia
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Florida
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Georgia
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Kentucky
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Minnesota
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Missouri
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New Jersey
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New York
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North Carolina
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Ohio
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Oregon
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Pennsylvania
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Tennessee
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Texas
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United States of America
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Virginia
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Estonia
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Tallinn
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Estonia
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Tartu
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France
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Reims Cedex
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Hungary
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Budapest
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Hungary
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Debrecen
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Hungary
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Miskolc
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Hungary
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Szeged
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Italy
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Campania
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Italy
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Emilia-Romagna
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Italy
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Lombardia
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Italy
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Sicilia
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Italy
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Veneto
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Latvia
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Riga
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Lebanon
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Beirut
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Lithuania
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Kaunas
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Netherlands
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Groningen
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Netherlands
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Rotterdam
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Netherlands
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Utrecht
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Portugal
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Coimbra
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Portugal
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Lisboa
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Portugal
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Porto
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Slovakia
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Banska Bystrica
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Slovakia
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Bratislava
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Slovakia
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Presov
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Spain
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Las Palmas De Gran Canaria
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Turkey
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Ankara

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

Ethics approval
Ethics application status

Summary
Brief summary
This study is being conducted to evaluate the effectiveness and safety of LAMICTAL added to
the current therapy of pediatric patients age 1-24 months old with partial seizures. The
medication used in this study has been approved by FDA for the adjunctive treatment of
partial seizures in patients 2 years and older.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00043875
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/NCT00043875