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Effect of Oral Rufinamide and Oxcarbazepine on Nerve Excitability, Hyperalgesia, Allodynia and Flare Reaction Compared to Placebo. A Monocenter, Randomized, Double-blind, Cross-over Study

This study is currently recruiting participants.
Verified August 2011 by University of Zurich
Sponsor:
Information provided by:
University of Zurich
ClinicalTrials.gov Identifier:
NCT01212458
First received: September 29, 2010
Last updated: August 5, 2011
Last verified: August 2011
History of Changes
  Purpose

Untersuchungen über die Wirkmechanismen von Antiepileptika haben gezeigt, dass durch eine Blockierung von spannungsabhängigen Natrium-Kanälen im Nervensystem die Schmerzübertragung moduliert werden kann. Verschiedene Antiepileptika werden in der chronischen Schmerztherapie schon lange angewendet (z.B. Oxcarbazepinum, Trileptal ® bei Trigeminusneuralgie oder diabetischer Polyneuropathie).

In unserer Untersuchung wollen wir zwei in der Schweiz zugelassene Antiepileptika bezüglich ihrer Wirkung auf das Schmerzempfinden untersuchen. Eines dieser Medikamente, Trileptal® (Wirkstoff: Oxcarbazepinum), wird schon häufig bei chronischen Schmerzzuständen eingesetzt. Das zweite Medikament, Inovelon® (Wirkstoff: Rufinamid) ist seit mehr als einem Jahr in der Schweiz zugelassen und wird klinisch vor allem in der Behandlung von besonderen Epilepsieformen im Kindesalter eingesetzt. Wir erwarten, dass auch nach Gabe von Inovelon® die Schmerzleitung in den Nervenzellen verändert und die lokalen Schmerzreaktionen in der Haut vermindert werden.

  • Trial with medicinal product

Condition Intervention Phase
Healthy Subjects
 Drug: Rufinamid
 Phase 4

Study Type: Observational
Study Design: Time Perspective: Prospective

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Zurich:

Estimated Enrollment: 24
Study Start Date: October 2010
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Rufinamid
    Effect of oral rufinamide and oxcarbazepine on nerve excitability, hyperalgesia, allodynia and flare reaction compared to placebo.
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

healthy volunteers

Criteria

Inclusion criteria: Male

  • Age: 18-65 years
  • Weight: 50 - 100 kg
  • Height: 155 - 195 cm
  • Signed and dated informed consent

Exclusion criteria:

  • Contraindications to the class of drugs under study
  • Intellectually or mental impaired subjects
  • Known hypersensitivity to class of drugs or the investigational product
  • Drug abuse
  • Known peripheral neuropathies
  • Diabetes mellitus
  • Chronic alcohol consumption
  • Congestive heart disease
  • Participants of other studies during study period and 30 days prior to study begin
  • Smoker
  • Abnormal electrocardiogram
  • Any regular concomitant medication
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01212458

Contacts
Contact: 01 Studienregister MasterAdmins +41 (0)44 255 11 11

Locations
Switzerland
Recruiting
Zurich, Switzerland
Sponsors and Collaborators
University of Zurich
Investigators
Study Director: 01 Studienregister MasterAdmins UniversitaetsSpital Zuerich
  More Information

No publications provided

Responsible Party: Maurer Konrad, Dr., University Hospital Zurich, IFA Institut f. Anästhesiologie
ClinicalTrials.gov Identifier: NCT01212458     History of Changes
Other Study ID Numbers: Version 1.03
Study First Received: September 29, 2010
Last Updated: August 5, 2011
Health Authority: Switzerland: Swissmedic

Keywords provided by University of Zurich:
gesunde Probanden

Additional relevant MeSH terms:
Oxcarbazepine
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013