painful polyneuropathy of different origin
Conditions
Interventions
Trade Name: Cipralex
Product Name: Cipralex
Pharmaceutical Form: Tablet
INN or Proposed INN: escitalopram
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Pharma
Sponsors
Dept. of Neurology, Odense University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • 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
Exclusion criteria
Exclusion criteria: • 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Denmark
Outcome results
None listed