Normal skin sensitivity and experimentally-evoked hyperalgesia Signs and Symptoms Disturbances of skin sensation
Conditions
Interventions
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
Sponsors
University of Heidelberg (Germany)
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Germany
Outcome results
None listed