At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 92 enrolled
Drug / intervention
BW430C (lamotrigine)drug
Likely dose
BW430C (lamotrigine) 50mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Study SCA106052, a Clinical Evaluation of BW430C (Lamotrigine) in Bipolar I Disorder- Long-term Extension Study (Extension of Study SCA104779 (NCT00550407))
In Brief
A Phase 3 clinical trial evaluating BW430C (lamotrigine) for Bipolar Disorder. Completed, enrolled 92 participants across 52 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBipolar Disorder
CountriesJapan
Collaborators--
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 2007
Enrollment StartMay 2008
Primary CompletionOct 2010
TodayJul 2026
First PostedNov 30, 2007
Enrollment StartMay 1, 2008
Primary CompletionOct 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 18.6 years ago
Interventions
BW430C (lamotrigine)drug
lamotrigine 50mg/day-400mg/day