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

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GSK study ID
P42-16
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Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

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
    Primary completion date:
    1990-13-09
    Observational study model:
    Not applicable
    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)

    This study does not involve prospective enrollment of participants.

    Study documents

    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    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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