Last updated: 06/09/2023 17:10:12
A Multicenter, Placebo-Controlled Parallel-Design, Phase III Evaluation of the Safety of Lamotrigine (LAMICTAL) as Add-On Therapy in Outpatients with Partial Seizures
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A Multicenter, Placebo-Controlled Parallel-Design, Phase III Evaluation of the Safety of Lamotrigine (LAMICTAL) as Add-On Therapy in Outpatients with Partial Seizures
Trial description: A Multicenter, Placebo-Controlled Parallel-Design, Phase III Evaluation of the Safety of Lamotrigine (LAMICTAL) as Add-On Therapy in Outpatients with Partial Seizures
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
Weekly Seizure Frequency – All Partial Seizures Types A, B, or C
Timeframe: Up to Week 27
Weekly Seizure Frequency – Simple or Complex Seizures (Types A or B)
Timeframe: Up to Week 27
Weekly Seizure Frequency - Secondarily Generalized Seizures (Type C)
Timeframe: Up to Week 27
Investigator’s Global Evaluation – Treatment Phase (Week 24)
Timeframe: Up to Week 24
Investigator’s Global Evaluation – Follow-up Phase (Week 27)
Timeframe: Up to Week 27
safety assessment via routine monitoring of adverse experiences in participants
Timeframe: Up to Week 27
Secondary outcomes:
Mean Steady-State Plasma Concentration (Css) of LTG Obtained at a Mean Time of 8.1hr (sd = 4.5hr) After Dosing
Timeframe: At 8 hours postdose
Mean Steady-State Plasma Concentration (Trough Css) of LTG Obtained at 8 to 16hr (mean = 12.1hr; sd = 2.4hr) After Dosing
Timeframe: At 16 hours postdose
Interventions:
Drug: Lamotrigine
Drug: Placebo
Enrollment:
446
Observational study model:
Not applicable
Primary completion date:
1990-13-09
Time perspective:
Not applicable
Clinical publications:
SC Schachter, IE Leppik, F Matsuo, JA Messenheimer, E Faught, EL Moore, ME Risner. Lamotrigine: a six-month, placebo-controlled, safety and tolerance study. J. Epilepsy 1995;8:201-209.
Medical condition
Partial Epilepsy
Product
lamotrigine
Collaborators
Not applicable
Study date(s)
July 1989 to September 1990
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
18 - 65 Years
Accepts healthy volunteers
No
Inclusion and exclusion criteria
Trial location(s)
No location data available.
Study documents
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
1990-13-09
Actual study completion date
1990-13-09
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
Additional information
Not applicable
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