Last updated: 11/07/2018 18:59:17
A Double-blind, Double-dummy, Parallel-group Comparison of Lamotrigine and Divalproex Sodium Initial Monotherapy in Patients with Epilepsy
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A Double-blind, Double-dummy, Parallel-group Comparison of Lamotrigine and Divalproex Sodium Initial Monotherapy in Patients with Epilepsy
Trial description: A Double-blind, Double-dummy, Parallel-group Comparison of Lamotrigine and Divalproex Sodium Initial Monotherapy in Patients with Epilepsy
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
Not applicable
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Abstract: Effects of lamotrigine vs valproate monotherapy on mood and weight gain: a randomised, double-blind clinical trial . V. Biton, A. Vuong A. Hammer J. Messenheimer 25th International Epilepsy Congress 10/12/2003 Lisbon; Portugal
Biton V, Levisohn P, Hoyler S, Vuong A, Hammer AE. Lamotrigine vs. valproate monotherapy associated weight change in adolescents with epilepsy: results from a post-hoc analysis of a randomized controlled trial. J Child Neurol 2003; Feb 18 (2):133-9.
Biton V, Mirza W, Montouris G, Vuong A, Hammer AE, Barrett PS. Weight change associated with valproate and lamotrigine initial monotherapy in patients with epilepsy. Neurology 2001; 56:172-177.
Edwards KR, Sackellares JC, Vuong A, Hammer AE, Barrett PS. Lamotrigine initial monotherapy improves depressive symptoms in epilepsy: A double-blind comparison with valproate. Epilepsy and Behavior 2001; 2: 28-36.
Sackellares, JC, Kwong, WJ, Vuong, A, Hammer, AE, Barrett, PS. Lamotrigine monotherapy improves health-related quality of life in epilepsy: A double-blind comparison with valproate. Epilepsy and Behavior 2001; 2: 28-36.
Medical condition
Epilepsy
Product
lamotrigine
Collaborators
Not applicable
Study date(s)
November 1996 to March 1999
Type
Not applicable
Phase
4
Participation criteria
Sex
Not applicable
Age
Not applicable
Accepts healthy volunteers
Not applicable
Inclusion and exclusion criteria
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Not applicable
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
1999-24-03
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Not applicable
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