- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00006191
Effect of Levetiracetam on Brain Excitability
Effects of Levetiracetam on Cortical Excitability in Humans
This study will examine the effect of the newly developed anti-epileptic drug, levetiracetam, on excitability of the cortex (surface layer) of the brain. Levetiracetam works differently from other anti-seizure drugs, but its mechanism is not well understood. This study may provide insight into a new protection mechanism against seizures as well as the effect of the drug on cortical excitability.
Healthy normal volunteers 18 years of age and older may be eligible for this study. Candidates will have a medical history taken and undergo physical and neurological examinations.
Participants will undergo two different procedures in four separate sessions. One procedure (cortical excitability) involves taking either levetiracetam or placebo (a look-alike inactive substance) and having transcranial magnetic stimulation (TMS). The other procedure (pinch-training related changes) involves taking levetiracetam or placebo, doing a motor exercise called pinch training, and having transcranial magnetic stimulation. For TMS, a very brief electrical current is passed through an insulated coil wire placed on the scalp. The magnetic pulse travels through the scalp and skull, causing small electrical currents in the cortex that may cause muscle, hand, or arm twitching or it may affect movements or reflexes. During the study, subjects may be asked to make movements, do simple tasks or tense muscles. Electrical activity of the muscles will be recorded using electrodes taped to the skin over the muscle. For the pinch training, the subject makes a brief, brisk pinch after each beat of a metronome every two seconds and then completely relaxes the hand until the next beat.
Subjects will be tested on four different days at least 72 hours apart. Each session will last about 3 to 4 hours.
Approximate schedule for cortical excitability testing:
TMS (study 1)
Take levetiracetam or placebo
TMS (study 2) < 60 minutes after drug or placebo
TMS (study 3) < 120 minutes after drug or placebo
Approximate schedule for pinch-training related changes:
Take levetiracetam or placebo
TMS and pinch power measurement < 60 minutes after drug or placebo
Pinch training for 30 minutes
TMS and pinch power measurement
Sample schedule:
Session 1 < LTC and cortical excitability testing
Session 2 < Placebo and cortical excitability testing
Session 3 < LTC and pinch-training related changes
Session 4 < Placebo and pinch-training related changes
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment
Contacts and Locations
Study Locations
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Maryland
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Bethesda, Maryland, United States, 20892
- National Institute of Neurological Disorders and Stroke (NINDS)
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
This study will be done on normal volunteers.
Subjects will be adults older than age 18.
No development of a serious medical condition.
Compliance with protocol evaluations or examinations.
Study Plan
How is the study designed?
Collaborators and Investigators
Publications and helpful links
General Publications
- Bialer M, Johannessen SI, Kupferberg HJ, Levy RH, Loiseau P, Perucca E. Progress report on new antiepileptic drugs: a summary of the fourth Eilat conference (EILAT IV). Epilepsy Res. 1999 Mar;34(1):1-41. doi: 10.1016/s0920-1211(98)00108-9.
- Wulfert E, Hanin I, Verloes R. Facilitation of calcium-dependent cholinergic function by ucb L059, a new "second generation" nootropic agent. Psychopharmacol Bull. 1989;25(3):498-502.
- Loscher W, Honack D. Profile of ucb L059, a novel anticonvulsant drug, in models of partial and generalized epilepsy in mice and rats. Eur J Pharmacol. 1993 Mar 2;232(2-3):147-58. doi: 10.1016/0014-2999(93)90768-d.
Study record dates
Study Major Dates
Study Start
Primary Completion
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 000207
- 00-N-0207
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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