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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

This study has been terminated.
(Slow recruitment; trial unlikely to reach completion)
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00907985
First received: May 7, 2009
Last updated: March 31, 2011
Last verified: March 2011
  Purpose

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.

Condition Intervention Phase
Healthy Subjects
Healthy Volunteer
Bipolar Disorder
Drug: Placebo
Drug: Drug A (lamotrigine)
Drug: Drug B (vofopitant)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Effect of the study treatments on Resting Motor Thresholds (rMT) [ Time Frame: Within 24 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The safety and tolerability of the combination of study treatments. [ Time Frame: Within 24 hours ] [ Designated as safety issue: Yes ]

Enrollment: 12
Study Start Date: May 2009
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: Placebo
Placebo for both Drug A and Drug B
Experimental: Drug A (lamotrigine) Drug: Drug A (lamotrigine)
150mg/175mg
Experimental: Drug B (vofopitant) Drug: Drug B (vofopitant)
10mg

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00907985

Locations
Germany
GSK Investigational Site
Goettingen, Niedersachsen, Germany, 37075
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00907985     History of Changes
Other Study ID Numbers: 112676
Study First Received: May 7, 2009
Last Updated: March 31, 2011
Health Authority: Germany: Bundesinstitut für Arzneimittel und Medizinprodukte

Keywords provided by GlaxoSmithKline:
Healthy Volunteer
Resting motor threshold (rMT)
Transcranial magnetic stimulation (TMS)

Additional relevant MeSH terms:
Bipolar Disorder
Affective Disorders, Psychotic
Mental Disorders
Mood Disorders
Anticonvulsants
Lamotrigine
Vofopitant
Antiemetics
Autonomic Agents
Calcium Channel Blockers
Cardiovascular Agents
Central Nervous System Agents
Excitatory Amino Acid Agents
Excitatory Amino Acid Antagonists
Gastrointestinal Agents
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurokinin-1 Receptor Antagonists
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sodium Channel Blockers
Therapeutic Uses
Voltage-Gated Sodium Channel Blockers

ClinicalTrials.gov processed this record on November 25, 2014