Efficacy Of Pregabalin In Subjects With Post-Stroke Central Neuropathic Pain

Completed

Phase 4 Results

Trial Description

Efficacy and Safety of flexibly dosed pregabalin compared to placebo among subjects with central post stroke pain (CPSP)

Conditions

Interventions

  • Placebo Drug
    Intervention Desc: Eligible subjects with post-stroke central pain will be randomized to receive double blinded treatment using pregabalin or matched placebo. The effects of pregabalin as compared to placebo on pain pain symptoms will be compared over the 13 week clinical trial. At baseline following pain ratings and clinical measures, subjects randomized to pregabalin receive instructions to take 75mg twice a day for 7days. The dosing of pregabalin or matching placebo will be titrated over the first 4 weeks (based on tolerability and pain scores). (Range 150-600mg) After the 4th week, the dose of medication will be maintained until week 12 (when tapering of medication begins) Ratings of Pain severity, review of pain/sleep diaries as well as medication tolerance occur bi-weekly throughout the study. Tapering off med occurs from week 12-13.
    ARM 1: Kind: Experimental
    Label: Placebo
    Description: The change in pain scores from baseline to endpoint will be compared among the two treatment groups- ie subjects receiving 12 weeks of pregabalin treatment vs subjects receiving 12 weeks of placebo treatment.
  • Pregabalin Drug
    Intervention Desc: Eligible subjects with post-stroke central pain will be randomized to receive double blinded treatment using pregabalin or matched placebo. The effects of pregabalin as compared to placebo on pain pain symptoms will be compared over the 13 week clinical trial. At baseline following pain ratings and clinical measures, subjects randomized to pregabalin receive instructions to take 75mg twice a day for 7days. The dosing of pregabalin or matching placebo will be titrated over the first 4 weeks (based on tolerability and pain scores). (Range 150-600mg) After the 4th week, the dose of medication will be maintained until week 12 (when tapering of medication begins) Ratings of Pain severity, review of pain/sleep diaries as well as medication tolerance occur bi-weekly throughout the study. Tapering off med occurs from week 12-13.
    ARM 1: Kind: Experimental
    Label: Pregabalin
    Description: The change from in pain scores from baseline to endpoint among stroke subjects receiving pregabalin will be compared to change in pain scores from baseline to endpoint among stroke subjects receiving matched placebo.

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Investigator)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Mean Pain Score at Endpoint as Measured by Daily Pain Rating Scale (DPRS) Up to Week 12 No
Secondary Pain Score as Measured by DPRS Week 1, Week 2, Week 3, Week 6, Week 9, and Week 12 No
Secondary Number of Subjects With at Least a 30% Reduction From Baseline in Mean Pain Score at Endpoint Baseline, Week 12 No
Secondary Number of Subjects With at Least a 50% Reduction From Baseline in Mean Pain Score at Endpoint Baseline, Week 12 No
Secondary Weekly Mean Sleep Interference Score From Daily Sleep Diary (Daily Sleep Interference Scale [DSIS]) Week 1, Week 2, Week 3, Week 6, Week 9, and Week 12 No
Secondary Short Form-McGill Pain Questionnaire (SF-MPQ Visual Analog Scale [VAS]) - Part B Only Week 12 No
Secondary Neuropathic Pain Symptom Inventory (NPSI) Week 12 No
Secondary Medical Outcome Study (MOS) Sleep Scale Week 12 No
Secondary Number of Subjects With Yes or No Response for Medical Outcome Study (MOS) Sleep Scale - Optimal Sleep Week 12 No
Secondary Hospital Anxiety and Depression Scale (HADS) - ITT Population Week 12 No
Secondary Euro Quality of Life (EQ-5D)- Health State Profile Utility Score Week 12 No
Secondary EQ-5D - VAS Week 12 No
Secondary Patient Global Impression of Change (PGIC) Week 12 No
Secondary Clinical Global Impression of Change (CGIC) Week 12 No
Secondary Quantitative Assessment of Neuropathic Pain (QANeP) - Sensory Threshold Baseline, Week 12 No
Secondary QANeP - Pain Rating Scales Baseline, Week 12 No

Sponsors