Last updated: 11/07/2018 04:57:38

A study to evaluate the effect of single doses of drug A (lamotrigine) and drug B (vofopitant) alone and in combination on resting motor threshold in healthy subjects

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GSK study ID
112676
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Clinicaltrials.gov ID
NCT00907985
EudraCT ID
2008-007451-28
EU CT Number
Not applicable
Trial status
Other
Other
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Double blind, double-dummy, randomised, placebo controlled study to evaluate the effect of single doses of drug A (lamotrigine) and drug B (vofopitant) alone and in combination on resting motor threshold in healthy subjects
Trial description: The purpose of this study is to investigate the effect of drug A on its own and when it is given in combination with drug B on markers of brain activity. The study will
1. Assess the effects of drug A and drug B on muscle movement after brain stimulation;
2. Examine how the body handles (absorbs, distributes, breaks down and gets rid of) drug A and drug B when given in combination;
3. Examine the safety of drug A and drug B when given together.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:

Effect of the study treatments on Resting Motor Thresholds (rMT)

Timeframe: Within 24 hours

Secondary outcomes:

The safety and tolerability of the combination of study treatments.

Timeframe: Within 24 hours

Interventions:
  • Drug: Placebo
  • Drug: Vofopitant
  • Drug: Lamotrigine
    • Enrollment:
    12
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Bipolar Disorder
    Product
    lamotrigine
    Collaborators
    GSK
    Study date(s)
    May 2009 to June 2010
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Male
    Age
    18 - 65 years
    Accepts healthy volunteers
    Yes
    • Healthy subject
    • Male aged 18-65
    • Positive drug/alcohol screen
    • Positive HIV antibody
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Healthy subject
    • Male aged 18-65
    • Greater than 50kg weight
    • BMI 19-29.9 kg/m2
    Exclusion criteria:
    • Positive drug/alcohol screen
    • Positive HIV antibody
    • History of drug dependence
    • History of neurological disease
    • Pacemaker
    • Smoker

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Goettingen, Niedersachsen, Germany, 37075
    Status
    Study Complete
    Contact us

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    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
    Other
    Actual primary completion date
    Not applicable
    Actual study completion date
    2010-10-06

    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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    Additional information
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