Neuropathic pain patients with insufficient pain-relief of trial spinal cord stimulation.
Conditions
Interventions
Trade Name: Catapresan®
Product Name: Clonidine chloride
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Chlonidine chloride
Concentration unit: µg/ml microgram(s)/millilitre
Concentr
Sponsors
Karolinska Universitetssjukhuset
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients with neuropathic pain who have received a temporary electrode system for spinal cord stimulation, but experience pain reduction less than 50% or pain reduction not exeeding 45 minutes after completed spinal cord stimulation session. 2) Patients who previously have received a fully implanted system for spinal cord stimulation as a treatment for neuropathic pain, where pain-relief has diminished so that they now experience pain reduction less than 50% or pain reduction not exeeding 45 minutes after completed spinal cord stimulation session. 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: 1) Mental handicap or other disturbance of communication. 2) Ongoing infection. 3) CNS disease 4) Heart- or other vascular disease. 5) Medication that may interact with the test substances.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To explore if clonidine intrathecally can potentiate the effect of spinal cord stimulation in neuropathic pain conditions.;Secondary Objective: To compare a possible potentiating effect of intrathecal clonidine to that of intrathecal baclofen. To evaluate which patient types might have the best response to this kind of treatment.;Primary end point(s): Patient assessment of pain on VAS-scale (0-10) and duration of post-stimulatory pain relief. | — |
Countries
Sweden
Outcome results
None listed