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

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

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Key information

Conditions

Healthy Subjects

Age range

18 year–65 year

Sex eligibility

Male

Study type

Observational

Primary location

University Hospital Zurich, Institut of Anaesthesiology

Zurich, Canton of Zurich, 8091, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rufinamid

Drug

Effect of oral rufinamide and oxcarbazepine on nerve excitability, hyperalgesia, allodynia and flare reaction compared to placebo.

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Important dates

Study start: 2010
Primary completion: 2013
Study completion: 2013
First posted: Sep 30, 2010
Registry last updated: Mar 17, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed