Effect of the Kv7-channel Opener Flupirtine on the Excitability of Human Peripheral Myelinated Axons in Vivo

Pain Clinical Trial

Official title:

Evaluation of the Effect of the K+-Channel Opener Flupirtine on the Excitability of Human Peripheral Myelinated Axons in Vivo: a Randomised Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01450865
• Other study ID #: EudraCT 2007-007314-10
• Status: Completed
• Phase: Phase 1
• First received: October 10, 2011
• Last updated: January 12, 2015
• Start date: October 2009
• Est. completion date: August 2010

Study information

• Verified date: January 2015
• Source: Ludwig-Maximilians - University of Munich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesGermany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

Slow axonal Kv7 potassium channels are found along unmyelinated axons and at the nodes of Ranvier of myelinated axons in peripheral nerve. As such the pharmacological activation of Kv7 channels offers a potential means of reducing the excitability of peripheral axons. To determine whether this is the case for human peripheral myelinated axons, the effect of the Kv7 channel agonist flupirtine on the electrical excitability of A fibres was examined in both isolated segments of human sural nerve in vitro and in motor axons of the median nerve supplying abductor pollicus brevis in vivo. Axonal excitability was assessed in 21 human sural nerve fascicles in vitro and in 20 volunteers in vivo using threshold tracking in QTRAC (© Institute of Neurology, London, UK). Strength-duration time constant, rheobase current, relative refractory period (RRP), post spike superexcitability at 5 and 7 ms and threshold electrotonus over the 90 100 ms period were used as indices of electrical excitability. In addition, suppression of ectopic discharge in a model of upper limb ischaemia.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• voluntarily

• age > 18 years old

Exclusion Criteria:

• current use of medication (e.g. analgetics, antiepileptics, antidepressants, etc.)

• prevailing organic disease (e.g. diabetes, vascular or neurologic illness, etc.)

• previous physical trauma of the forearm (e.g. burning, surgery)

• primary organ failure

• pregnancy and lactation

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Axonal Change, Neuronal
• Pain

Intervention

Drug:
• flupirtine
Potassium channel opener (SNEPCO)

Locations

Country	Name	City	State
Germany	Multidisciplinary Pain Unit Department of Anaesthesiology University of Munich Pettenkoferstr. 8a	Munich	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
Ludwig-Maximilians - University of Munich

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Fleckenstein J, Sittl R, Averbeck B, Lang PM, Irnich D, Carr RW. Activation of axonal Kv7 channels in human peripheral nerve by flupirtine but not placebo - therapeutic potential for peripheral neuropathies: results of a randomised controlled trial. J Tra — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Axonal Excitability as assessed with QTrac	The primary outcome parameter of axonal excitability was the relative refractory period (RRP) as assessed with threshold tracking techniques. Strength-duration time constant, rheobase current, refractoriness determined at 2 and 2.5 ms, superexcitability at 7 ms and threshold electrotonus over the 90 100 ms period were used as secondary outcome measures.	Change of neuronal excitability from Baseline (before) to two hours after intervention	No
Secondary	Ectopic Discharge	Further secondary outcome measures were power content for the surface EMG and the ranked summed scores for the McGill pain questionnaire.	Change of neuronal excitability from Baseline (before) to two hours after intervention	No

External Links

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