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NCT01212458 Clinical Trial

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

Healthy Subjects Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01212458
Other study ID # Version 1.03
Secondary ID
Status Completed
Phase Phase 4
First received September 29, 2010
Last updated March 14, 2014
Start date October 2010
Est. completion date January 2013

Study information
Verified date March 2014
Source University of Zurich
Contact n/a
Is FDA regulated No
Health authority Switzerland: Swissmedic
Study type Observational

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 24
Est. completion date January 2013
Est. primary completion date January 2013
Accepts healthy volunteers No
Gender Male
Age group 18 Years to 65 Years
Eligibility 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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Switzerland University Hospital Zurich, Institut of Anaesthesiology Zurich ZH

Sponsors (1)
Lead Sponsor Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

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