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
Terminated (halted prematurely)
Terminated (halted prematurely)
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
Observational study model:
Not applicable
Primary completion date:
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
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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
Terminated (halted prematurely)
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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