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

PHASE4CompletedINTERVENTIONAL
Enrollment

220

Participants

Timeline

Start Date

August 31, 2006

Primary Completion Date

September 30, 2008

Study Completion Date

September 30, 2008

Conditions
Central Neuropathic Pain
Interventions
DRUG

Pregabalin

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.

DRUG

Placebo

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.

Trial Locations (33)

112

Pfizer Investigational Site, Taipei

407

Pfizer Investigational Site, Taichung

1000

Pfizer Investigational Site, Manila

1003

Pfizer Investigational Site, Manila

2010

Pfizer Investigational Site, Darlinghurst

2065

Pfizer Investigational Site, St Leonards

2250

Pfizer Investigational Site, East Gosford

2502

Pfizer Investigational Site, Warrawong

3011

Pfizer Investigational Site, Footscray

6000

Pfizer Investigational Site, Perth

10400

Pfizer Investigational Site, Ratchatewee

Pfizer Investigational Site, Bangkok

10430

Pfizer Investigational Site, Jakarta

11600

Pfizer Investigational Site, George Town

59100

Pfizer Investigational Site, Kuala Lumpur

60286

Pfizer Investigational Site, Surabaya

68100

Pfizer Investigational Site, Kuala Selangor

100083

Pfizer Investigational Site, Beijing

100730

Pfizer Investigational Site, Beijing

200003

Pfizer Investigational Site, Shanghai

200040

Pfizer Investigational Site, Shanghai

510180

Pfizer Investigational Site, Guangzhou

Unknown

Pfizer Investigational Site, Herston

Pfizer Investigational Site, New Territories

Pfizer Investigational Site, Karachi

Pfizer Investigational Site, Karachi

Pfizer Investigational Site, Gueishan Shiang

560 034

Pfizer Investigational Site, Bangalore

560 054

Pfizer Investigational Site, Bangalore

600 010

Pfizer Investigational Site, Chennai

226 014

Pfizer Investigational Site, Lucknow

110 002

Pfizer Investigational Site, New Delhi

138-736

Pfizer Investigational Site, Seoul

All Listed Sponsors
lead

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

INDUSTRY

NCT00313820 - Efficacy Of Pregabalin In Subjects With Post-Stroke Central Neuropathic Pain | Biotech Hunter | Biotech Hunter