Last updated: 11/04/2018 08:41:43
Measurement Of Serum Levels Of Two Antiepileptic Drugs During Conversion In Patients With Epilepsy
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A Multicenter, Open-Label Conversion of Valproate Monotherapy to Lamotrigine Monotherapy in Patients with Epilepsy
Trial description: This study includes patients 16 years of age or older with a confident diagnosis of epilepsy who are currently treated with an antiepileptic drug (AED) monotherapy but require a change in therapy due to inadequate seizure control and/or unacceptable side effects.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Not applicable
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Drug: lamotrigine
Enrollment:
72
Observational study model:
Not applicable
Primary completion date:
2003-29-01
Time perspective:
Not applicable
Clinical publications:
Sale M, Natarajan S, Biton V, Vuong A, Hammer A, Messenheimer J and Blum D. A dosing algorithm for converting from valproate monotherapy to lamotrigine monotherapy in patients with epilepsy. Epilepsy & Behavior, Volume 6, Issue 1, February 2005, Pages 63-70
Sale M, Natarajan S, Biton V, Vuong A, Hammer A, Messenheimer J and Blum D. A dosing algorithm for converting from valproate monotherapy to lamotrigine monotherapy in patients with epilepsy. Epilepsy & Behavior, Volume 6, Issue 1, February 2005, Pages 63-70
Medical condition
Epilepsy
Product
lamotrigine
Collaborators
Not applicable
Study date(s)
January 2002 to January 2003
Type
Interventional
Phase
4
Participation criteria
Sex
Female & Male
Age
16+ years
Accepts healthy volunteers
No
- 16 years old or older.
- Have confident diagnosis of epilepsy.
- A history of hypersensitivity to the drug being studied.
- Currently being treated with or has been treated in the past with the drug being studied.
Inclusion and exclusion criteria
Inclusion criteria:
- 16 years old or older.
- Have confident diagnosis of epilepsy.
- Have been on the medication valproate for at least 3 months and is currently on a stable daily dose.
- Male or female; females of child-bearing potential must have negative pregnancy test at screen and must agree to use an acceptable birth control method.
Exclusion criteria:
- A history of hypersensitivity to the drug being studied.
- Currently being treated with or has been treated in the past with the drug being studied.
- Undergoing polytherapy treatment with the medication valproate and one or more other antiepileptic drug(s).
- If undergoing treatment with vagal nerve stimulation, has had device implanted more than 30 days prior to enrollment.
- Has taken an investigational drug or the medication Felbatol within the previous 30 days.
- Is abusing alcohol and/or other substances.
Trial location(s)
No location data available.
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
Refer to study documents
Recruitment status
Completed
Actual primary completion date
2003-29-01
Actual study completion date
2003-30-01
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
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