central neuropathic pain
Conditions
Interventions
Pregabalin versus placebo.
Sponsors
Academic Medical Center, Amsterdam
Department of anesthesiology
Pain Relief Unit
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age 18 years or older; 2. Written informed consent; 3. Patients suffering from severe neuropathic pain caused by lesion or dysfunction in the central nervous system. Neuropathic pain was described by at least one of the following: burning pain, paroxysmal episodes of shooting pain, or pain on light touch. Additionally, patients had to score above 12 on the Leeds Assessment of Neuropathic Symptoms and Signs questionnaire (LANSS) (13).
Exclusion criteria
Exclusion criteria: 1. Pregnant; 2. Had a history of intolerance, hypersensitivity, or known allergy to pregabalin; 3. Had a known history of significant hepatic, renal, or psychiatric disorder; 4. Had a history of galactose-intolerance, lactase deficiency, or glucose-galactose malabsorption syndrome; 5. Subjects with a calculated creatinine clearance rate below 60 mL/m (estimated from serum creatinine using Cockroft-Gault equation) were specifically excluded. 6. No new analgesic therapies were to be initiated at any time during the trial. 7. Patients who had been exposed previously to gabapentin, regardless of dose and treatment duration, were permitted to enter the study. However, treatment with gabapentin was to be discontinued at least 3 days before receiving study medication.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy parameter is a pain intensity score recorded by patients (at baseline, and 4 weeks following treatment), using a visual analog scale (VAS). | — |
Secondary
| Measure | Time frame |
|---|---|
| Health status and quality of life (QOL) questionnaires (secondary outcomes) were completed before start of treatment and 4 weeks following start of treatment. Health status and QOL measurements included the Pain Disability Index (PDI), the EQ-5D, and the Medical Outcomes Short-form Health Survey questionnaire 36 (SF36). | — |
Contacts
Public ContactM.R. Kruis
Academic Medical Center (AMC), Pijncentrum, P.O. Box 22660
Outcome results
None listed