NCT00395694

Brief Summary

To evaluate safety information of BW430C when administered using the lower starting doses and slower dose escalations as recommended Global Data Sheet

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Aug 2006

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 7, 2006

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 2, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 3, 2006

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
25 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 26, 2009

Completed
3.5 years until next milestone

Results Posted

Study results publicly available

September 17, 2012

Completed
Last Updated

September 26, 2018

Status Verified

August 1, 2018

Enrollment Period

2.6 years

First QC Date

November 2, 2006

Results QC Date

August 16, 2012

Last Update Submit

August 30, 2018

Conditions

Epilepsy

Keywords

epilepsyIncidence of rashsafety evaluation for initial dosepatients with Valproic acid

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Any Rash Event (Including Stevens-Johnson Syndrome [SJS] and Any Other Serious Drug Eruption) During the Initial 8 Weeks of Study Treatment

    Any rash event (including SJS or any other serious drug eruption) includes: all event terms containing "rash"; drug eruption; SJS; toxic epidermal necrolysis; rash generalized; and events grouped into the "Skin and Subcutaneous Tissue Disorders" system organ class per the Medical Dictionary for Regulatory Activities (MedDRA), including the above-mentioned events that the GSK medical advisors judged to be included as any rash event. SJS, also called as erythema multiforme, is a skin disorder resulting from an allergic reaction or infection.

    8 weeks

Secondary Outcomes (11)

  • Number of Rash Events Experienced (Including SJS and Any Other Serious Drug Eruption) During the Initial 8 Weeks of Study Treatment

    8 weeks

  • Number of Participants With the Indicated Intensity of Rash (Including SJS and Any Other Serious Drug Eruption) During the Initial 8 Weeks of Study Treatment

    8 weeks

  • Number of Drug-related and Not Related Rash Events (Including SJS and Any Other Serious Drug Eruption) During the Initial 8 Weeks of Study Treatment

    8 weeks

  • Percentage of Participants With at Least a 50 Percent Reduction in Seizure Frequency for the Indicated Types of Seizures

    8 weeks

  • Percent Change in Seizure Frequency of the Indicated Types of Seizures

    Pre-treatment (Day 0) and Week 8 of the Maintenance Phase (Study Week 14)

  • +6 more secondary outcomes

Study Arms (1)

lamictal

EXPERIMENTAL
Drug: lamictal

Interventions

lamictalDRUG

anti-epileptic drug

lamictal

Eligibility Criteria

Age2 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Epilepsy with partial seizures
  • Tonic clonic seizures
  • Generalized seizures of Lennox-Gastaut
  • Subjects whose seizures are easily recognizable at least one seizure per month and counts for 8 consecutive weeks prior to the start of the study drug.
  • Concurrent AEDs: Subjects taking concurrent VPA.

You may not qualify if:

  • Previous participation in a study of Lamictal
  • Known hypersensitivity to any drugs
  • Pregnant women
  • nursing mothers
  • women who may be pregnant
  • women contemplating pregnancy during the study period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

GSK Investigational Site

Kumamoto, 860-8556, Japan

Location

GSK Investigational Site

Location

Related Publications (1)

  • Shunsuke Ohtahara, Tateki Fujiwara, Sunao Kaneko, Masafumi Iijima. Clinical Evaluation of Lamotrigine with the Current Recommended Dose in Overseas - Phase III study of lamotrigine in patients with epilepsy treated with valproate - . [J.New Rem. & Clin. Vol.57 No.9 2008]. 2008;57(J.New Rem. & Clin):1442-1453.

    BACKGROUND

MeSH Terms

Conditions

Epilepsy

Interventions

Lamotrigine

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

TriazinesHeterocyclic Compounds, 1-RingHeterocyclic 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 2, 2006

First Posted

November 3, 2006

Study Start

August 7, 2006

Primary Completion

March 1, 2009

Study Completion

March 26, 2009

Last Updated

September 26, 2018

Results First Posted

September 17, 2012

Record last verified: 2018-08

Locations

JP(1)