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Trial record 56 of 83 for:    CARBAMAZEPINE AND Cytochrome P-450 CYP3A Inducers

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

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ClinicalTrials.gov Identifier: NCT01382017
Recruitment Status : Completed
First Posted : June 27, 2011
Last Update Posted : August 29, 2012
Sponsor:
Collaborator:
UCB Pharma
Information provided by (Responsible Party):
Nicolas Lang, University of Kiel

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Healthy Male Volunteers Drug: Lacosamide Drug: Placebo Drug: Carbamazepine Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Study Start Date : June 2011
Actual Primary Completion Date : August 2012
Actual Study Completion Date : August 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo arm
Drug: Placebo
Placebo

Experimental: Lasosamide 200
Lacosamide 200 mg
Drug: Lacosamide
Lacosamide 200 or 400 mg

Experimental: Lacosamide 400
Lacosamide 400 mg
Drug: Lacosamide
Lacosamide 200 or 400 mg

Active Comparator: Carbamazepine 600
Carbamazepine 600 mg
Drug: Carbamazepine
Carbamazepine 600 mg




Primary Outcome Measures :
  1. TMS measures of cortical excitability [ Time Frame: within 24h after intake of study medication ]
    Transcranial magnetic stimulation (TMS) measurements included resting motor thresholds (RMT) and active motor thresholds (AMT), the intensity to evoke MEP of ∼1mV peak-to-peak amplitude (SI1mV), short-interval intracortical inhibition/intracortical facilitation (SICI/ICF), long-interval intracortical inhibition (LICI), short-interval intracortical facilitation (SICF), recruitment curves, MEP under tonic activation (aMEP), and cortical silent period (CSP), and MEP changes in response to short trains of repetitive TMS.



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01382017


Locations
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Germany
Departmenr of Neurology, UKSH Campus Kiel
Kiel, Germany, 24105
Sponsors and Collaborators
University of Kiel
UCB Pharma
Investigators
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Principal Investigator: Nicolas Lang, PD Dr. med. Christian-Albrechts University Kiel, Germany

Additional Information:
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Responsible Party: Nicolas Lang, PD Dr. med., University of Kiel
ClinicalTrials.gov Identifier: NCT01382017     History of Changes
Other Study ID Numbers: LCM-TMS-2010
First Posted: June 27, 2011    Key Record Dates
Last Update Posted: August 29, 2012
Last Verified: August 2012
Keywords provided by Nicolas Lang, University of Kiel:
lacosamide
carbamazepine
placebo
transcranial magnetic stimulation
TMS
motor cortex
sodium channel
inhibition
threshold
Additional relevant MeSH terms:
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Carbamazepine
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers
Lacosamide
Anticonvulsants
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents