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Effects of Lacosamide on Human Motor Cortex Excitability: a Transcranial Magnetic Stimulation Study

NCT ID: NCT01382017

Last Updated: 2012-08-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2012-08-31

Brief Summary

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This study has been designed to explore dose-depended effects of lacosamide (LCM) on motor cortex excitability with TMS in a randomized, double-blind, placebo-controlled crossover trial in young healthy human subjects, and to compare the pattern of excitability changes induced by LCM with those of carbamazepine (CBZ). LCM selectively enhances slow inactivation of voltage-gated sodium channel, and, in contrast to CBZ, does not affect steady-state fast inactivation (Errington et al., 2006). The enhancement of slow inactivation of sodium channels by LCM is a novel manner to modulate sodium channels and leads to normalization of activation thresholds and a reduced pathophysiological hyper-responsiveness, thereby effectively controlling neuronal hyperexcitability without affecting physiological activity (Beyreuther et al., 2007). Therefore, it is thought that LCM, compared to CBZ, will be better tolerated in clinical settings while being as or even more effective in controlling seizure activity. On the basis of the results from nonhuman studies, it is hypothesized that the TMS profile of LCM will be distinguishable from that of CBZ. CBZ, like other 'classical' sodium channel blockers such as phenytoin, predominantly demonstrated elevated TMS motor thresholds indicating reduced neuronal membrane excitability, without developing significant changes of synaptic intracortical inhibition and facilitation (Ziemann et al., 1996; Chen et al., 1997; Lee et al., 2005). Because of its novel mode of action it can only be speculated which TMS parameters LCM might affect. For example, more than exclusively affecting neuronal membrane excitability, LCM could possibly also affect inhibitory mechanisms such as short- and long-latency intracortical inhibition (Valls-Sole et al., 1992; Kujirai et al., 1993). This would in line with other well-tolerated modern antiepileptic drugs (Ziemann et al., 1996; Reis et al., 2002; Lang et al., 2006).

Detailed Description

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Conditions

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Healthy Male Volunteers

Keywords

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lacosamide carbamazepine placebo transcranial magnetic stimulation TMS motor cortex sodium channel inhibition threshold

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo

Placebo arm

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Lasosamide 200

Lacosamide 200 mg

Group Type EXPERIMENTAL

Lacosamide

Intervention Type DRUG

Lacosamide 200 or 400 mg

Lacosamide 400

Lacosamide 400 mg

Group Type EXPERIMENTAL

Lacosamide

Intervention Type DRUG

Lacosamide 200 or 400 mg

Carbamazepine 600

Carbamazepine 600 mg

Group Type ACTIVE_COMPARATOR

Carbamazepine

Intervention Type DRUG

Carbamazepine 600 mg

Interventions

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Lacosamide

Lacosamide 200 or 400 mg

Intervention Type DRUG

Placebo

Placebo

Intervention Type DRUG

Carbamazepine

Carbamazepine 600 mg

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* healthy
* male
* right-handed
* aged 18-45 years

Exclusion Criteria

* cardiac pacemaker
* metal implants in the head
* intake of any medication
* previous neurologic, psychiatric, or chronic internal diseases
* pregnancy or breastfeeding; drug, nicotine, or alcohol abuse
* known or expected intolerance to soy beans, peanuts, LCM or CBZ; abnormal ECG with prolonged PQ-interval
* participation in another clinical trial within the previous 8 weeks
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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UCB Pharma

INDUSTRY

Sponsor Role collaborator

University of Kiel

OTHER

Sponsor Role lead

Responsible Party

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Nicolas Lang

PD Dr. med.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nicolas Lang, PD Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Christian-Albrechts University Kiel, Germany

Locations

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Departmenr of Neurology, UKSH Campus Kiel

Kiel, , Germany

Site Status

Countries

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Germany

Related Links

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http://www.uksh.de/neurologie-kiel

Department of Neurology, University of Kiel, Germany

Other Identifiers

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LCM-TMS-2010

Identifier Type: -

Identifier Source: org_study_id