Effect of flupirtine on experimental hyperalgesia in humans

ISRCTN	ISRCTN64819760
DOI	https://doi.org/10.1186/ISRCTN64819760
Protocol serial number	FLUCAP/KAD 162
Sponsor	University of Heidelberg (Germany)
Funder	Dr. Kade Pharmazeutische Fabrik GmbH (Germany) (FLUCAP/KAD162)

Submission date: 16/09/2010
Registration date: 08/12/2010
Last edited: 08/12/2010

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Signs and Symptoms

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Rolf-Detlef Treede
Scientific

Department of Neurophysiology
Medical Faculty Mannheim of the University of Heidelberg
Centre for Biomedicine and Medical Technology Mannheim (CBTM)
Ludolf-Krehl-Str. 13 - 17
Mannheim
68167
Germany

Study information

Primary study design	Interventional
Study design	Single centre double blind randomised placebo controlled crossover group trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Effect of flupirtine on experimental hyperalgesia in humans: a double-blind, placebo-controlled crossover trial
Study objectives	Assessment of the effect of flupirtine versus placebo on acute pain (analgesia), secondary hyperalgesia, dynamic mechanical allodynia and wind up (pain summation) in healthy volunteers following intradermal capsaicin injection.
Ethics approval(s)	The Medical Ethics Commission II, Medical Faculty Mannheim of the University of Heidelberg (Med. Ethikkommission II Medizinische Fakultät Mannheim der Universität Heidelberg) approved on the 31st May 2010 (ref: 2010-010F-MA/monozentrisch) The trial will be conducted in accordance with the declaration of Helsinki, the German Medicines Act (AMG), and the guidelines of the International Conference on Harmonisation (ICH) for Good Clinical Practice (GCP).
Health condition(s) or problem(s) studied	Normal skin sensitivity and experimentally-evoked hyperalgesia
Intervention	The effect of 4 x 400 mg (= 1600 mg) flupirtine retard (Trancolong®) applied over 4 days will be compared to placebo in a two-way cross-over design (placebo-flupirtine). Sensory changes in normal skin will be determined by Quantitative Sensory Testing (QST) using non-nociceptive and low-intensity painful mechanical and thermal stimuli, which were applied in runs alternating between two skin sites on the forearms (a test site and a control site). In addition, the effect of flupirtine versus placebo on experimental mechanical hyperalgesia, which will be induced by intradermal capsaicin injection (100 µg), will be determined.
Intervention type	Drug
Phase	Phase I
Drug / device / biological / vaccine name(s)	Flupirtine (Trancolong®)
Primary outcome measure(s)	Hierarchical approach 1. Combined analgesia and anti-hyperalgesia to pinpricks: pain at conditioned skin site (test site) analysed 0.5 - 1.5 hours after capsaicin injection. If present, then: 1.1. Analgesia to pinpricks: pain to pinpricks in unconditioned skin (control site) normalised to pre-capsaicin 1.2. Anti-hyperalgesia: pain to pinpricks at the test site relative to control site (ratio) normalised to pre-capsaicin
Key secondary outcome measure(s)	1. Size reduction of area of secondary hyperalgesia 2. Size reduction of area of dynamic mechanical allodynia 3. Size reduction of the flare area (peripheral flupirtine effect) 4. Analgesia to measures of painful thermal and chemical stimuli in unconditioned skin after drug application (QST profile) 5. Wind-up to painful mechanical stimuli
Completion date	28/02/2011

Eligibility

Participant type(s)	Healthy volunteer
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	24
Key inclusion criteria	1. Healthy volunteers, age 18 - 65 years 2. Negative pregnancy test (on day of respective visit, female) 3. Written informed consent 4. Clinical laboratory values within the normal range
Key exclusion criteria	1. Any history of allergy or drug hypersensitivity 2. Any acute or chronic disease 3. Alcohol or drug abuse 4. Use of any medication within 1 day prior to study onset or, in case of any intake of medication during the last 6 weeks, the wash-out period prior to inclusion was at least less than 5 times the corresponding half-life of the medication taken (incl. dermatological applications; except contraceptives) 5. Dermatological, psychiatric or neurological disorder 6. Blood coagulation disorder 7. Chronic or severe liver disease (hep. encephalopathy, cholestase) 8. Myasthenia gravis 9. Acute or recently resolved tinnitus 10. Use of analgesics or CNS active drugs 11. Participation in any clinical study within 30 days prior to this study 12. Any relevant deviation in clinical or laboratory assessment 13. Known hypersensivity to flupirtine and its derivatives 14. Known hypersensitivity to histamine 15. Skin lesions at the test areas 16. Pregnant or nursing women
Date of first enrolment	01/09/2010
Date of final enrolment	28/02/2011

Locations

Countries of recruitment

Germany

Study participating centre

Department of Neurophysiology,

Mannheim
68167
Germany

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes