Pregabalin in patients with central neuropathic pain: a randomised, double-blind, placebo-controlled trial of a flexible-dose regime

Completed

Conditions: Central neuropathic pain
Signs and Symptoms
Other disorders of central nervous system

Registration Number: ISRCTN67414160

Lead Sponsor: Academic Medical Center (AMC) (Netherlands)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 40

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:
a. burning pain
b. paroxysmal episodes of shooting pain
c. pain on light touch
Additionally, patients had to score above 12 on the Leeds Assessment of Neuropathic Symptoms and Signs questionnaire (LANSS)

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 three days before receiving study medication

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary efficacy parameter is a pain intensity score recorded by patients (at baseline, and four weeks following treatment), using a Visual Analog Scale (VAS).

Secondary Outcome Measures

Name	Time	Method
Health status and Quality of Life (QOL) questionnaires (secondary outcomes) were completed before start of treatment and four weeks following start of treatment. <br><br>Health status and QOL measurements included the Pain Disability Index (PDI), the EuroQoL questionnaire (EQ-5D), and the Medical Outcomes Short-Form Health Survey questionnaire 36 (SF 36).