Escitalopram til behandling af smerter ved polyneuropatiEn dobbeltblind, randomiseret, placebokontrolleret undersøgelse(Escitalopram as a treatment for painful polyneuropathy: A double-blind, randomised, placebo-controlled trial.)
- Conditions
- painful polyneuropathy of different origin
- Registration Number
- EUCTR2004-001010-13-DK
- Lead Sponsor
- Dept. of Neurology, Odense University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 50
•age over 20 and under 80 years
•characteristic symptoms of polyneuropathy within at least 6 months
•diagnosis confirmed by physical examination, neurophysiologic exam. and/or quantitative sensory testing
•median total pain score at baseline week >=4 on a 10 point numerical rating scale
•pain at least 4 of 7 days
•fertile women are using anticonception
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
•other cause to pain than polyneuropathy
•former allergic reactions on escitalopram
•known adverse events on escitalopram
•pregnancy or nursing
•critical disease (terminal cancer, cardial incompensation or critical renal or lung disease)
•treatment with monoaminooxidase inhibitors between the trial or 2 weeks before or after
•treatment with other antidepressants, antiepilectic agents or opioids
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: to evaluate, if escitalopram (Cipralex) provides pain relief in patients with painful polyneuropathy;Secondary Objective: to evaluate, if escitalopram has an effect on total pain and different subtypes of pain, on quantitative sensory testing, on pain related sleep disturbances and on quality of life. ;Primary end point(s): Pain relief during last treatment period
- Secondary Outcome Measures
Name Time Method