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

Condition(s) targeted: Central Nervous System Disorders; Cerebrovascular Accident; Pain; Central Neuropathic Pain

Intervention: Pregabalin (Drug); Placebo (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Overall contact:
Pfizer CT.gov Call Center, Phone: 1-800-718-1021

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

Official title: A 13-Week, Randomized, Multi-Center, Double-Blind, Placebo-Controlled, Parallel-Group Study To Evaluate The Efficacy, Safety And Tolerability Of Pregabalin (150-600 Mg/Day) Using A Flexible Dosing Schedule In The Treatment Of Subjects With Central Post-Stroke Pain (CPSP)

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety/Efficacy Study

Primary outcome: Weekly Mean Pain Score Change at Endpoint (week 12) compared to Baseline

Secondary outcome:

Medical Outcome Study (MOS) Sleep Scale (4 month recall by subject of sleep patterns). Baseline, Week 12

Hospital Anxiety and Depression Scale (HADS) Subject completes questionnaire assessing depressive and anxiety symptoms (Baseline, Week 12)

Clinical Global Impression of Change (CGIC) Endpoint (Week 12, prior to taper of study med)

Short Form-McGill Pain Questionnaire, [SF-MPQ (VAS)] - Part B only. (Assess at Baseline and Week 12)

Patient Global Impression of Change (PGIC) Week 12

Screening, Baseline, Weeks 1, 2, 3, 6, 9, 12 assess medication tolerance, inquire adverse events, vital signs, physical and neurological examinations, clinical laboratory tests and electrocardiogram.

EuroQOL (EQ-5D) Health State Profile and Visual Analogue Scale (VAS). Baseline and Week 12

Mean Weekly pain score (from Daily Pain Diary) Baseline, Weeks 1, 2, 3, 6, 9, 12

Quantitative Assessment of Neuropathic Pain (QANeP) Assessed at Baseline, Week 1 and Week 12

Neuropathic Pain Symptom Inventory (NPSI-symptoms of NeP; Bouhasira et al. in Pain, 2004) Assessed at Baseline, Week 1 and Week 12

Mean of Weekly Ratings for "DailySleep Interference Score" (DSIS) Baseline, Weeks 1, 2, 3, 6, 9, 12

Proportion of subjects with at least a 30% and 50% reduction in mean pain score at endpoint as compared with baseline. Baseline, Week 12

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Positive history of clinical stroke at least 4 months prior to randomization CPSP--3

months prior to screening

Exclusion Criteria:

- History of dementia or any other severe cognitive impairment

- Diabetic Peripheral Neuropathy (DPN)

Pfizer CT.gov Call Center, Phone: 1-800-718-1021

Pfizer Investigational Site, Shang Hai 200040, China; Completed

Pfizer Investigational Site, Shang Hai 200003, China; Completed

Pfizer Investigational Site, Beijing 100730, China; Completed

Pfizer Investigational Site, Beijing 100083, China; Completed

Pfizer Investigational Site, Guang Zhou 510180, China; Completed

Pfizer Investigational Site, New Territories, Hong Kong; Active, not recruiting

Pfizer Investigational Site, Lucknow 226 014, India; Completed

Pfizer Investigational Site, Bangalore 560 054, India; Completed

Pfizer Investigational Site, Chennai 600 010, India; Completed

Pfizer Investigational Site, New Delhi 110 002, India; Completed

Pfizer Investigational Site, Bangalore 560 034, India; Recruiting

Pfizer Investigational Site, Surabaya 60286, Indonesia; Recruiting

Pfizer Investigational Site, Jakarta 10430, Indonesia; Completed

Pfizer Investigational Site, Seoul 138-736, Korea, Republic of; Recruiting

Pfizer Investigational Site, Selangor 68100, Malaysia; Active, not recruiting

Pfizer Investigational Site, Kuala Lumpur 59100, Malaysia; Active, not recruiting

Pfizer Investigational Site, Penang 11600, Malaysia; Active, not recruiting

Pfizer Investigational Site, Karachi, Pakistan; Recruiting

Pfizer Investigational Site, Manila 1003, Philippines; Completed

Pfizer Investigational Site, Manila 1000, Philippines; Completed

Pfizer Investigational Site, Taipei 112, Taiwan; Completed

Pfizer Investigational Site, Taichung 407, Taiwan; Completed

Pfizer Investigational Site, Bangkok 10400, Thailand; Recruiting

Pfizer Investigational Site, Ratchatewee, Bangkok 10400, Thailand; Recruiting

Pfizer Investigational Site, Patumwan, Bangkok 10330, Thailand; Not yet recruiting

Pfizer Investigational Site, Warrawong, New South Wales 2502, Australia; Active, not recruiting

Pfizer Investigational Site, St Leonards, New South Wales 2065, Australia; Completed

Pfizer Investigational Site, Darlinghurst, New South Wales 2010, Australia; Completed

Pfizer Investigational Site, East Gosford, New South Wales 2250, Australia; Active, not recruiting

Pfizer Investigational Site, Herston, Queensland, Australia; Completed

Pfizer Investigational Site, Karachi, Sindh, Pakistan; Recruiting

Pfizer Investigational Site, Gueishan Shiang, Taoyuan Hsien, Taiwan; Completed

Pfizer Investigational Site, Footscray, Victoria 3011, Australia; Completed

Pfizer Investigational Site, Perth, Western Australia 6000, Australia; Active, not recruiting

To obtain contact information for a study center near you, click here.

Starting date: August 2006
Ending date: August 2008
Last updated: August 5, 2008