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

NCT00313820 | Completed Phase 4 Results

• 1 other identifier: A0081063
• Study Type: interventional
• Target: 220
• Locations: 11 countries
• Sites: 33

Brief Summary

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

Conditions

Central Neuropathic Pain

Keywords

Post-stroke pain, pregabalin

Outcome Measures

Primary Outcomes (1)

• Mean Pain Score at Endpoint as Measured by Daily Pain Rating Scale (DPRS)

  Mean pain score obtained from last 7 available DPRS scores up to and including day of Week 12 visit or early termination (ET) equivalent. DPRS: subject rated 11-point numeric scale ranging from 0 (no pain) to 10 (worst possible pain) during past 24-hour period. Higher score indicates greater level of pain. Self-assessment performed daily on awakening prior to taking study medication.

  Up to Week 12

Secondary Outcomes (15)

• Pain Score as Measured by DPRS

  Week 1, Week 2, Week 3, Week 6, Week 9, and Week 12

• Number of Subjects With at Least a 30% Reduction From Baseline in Mean Pain Score at Endpoint

  Baseline, Week 12

• Number of Subjects With at Least a 50% Reduction From Baseline in Mean Pain Score at Endpoint

  Baseline, Week 12

• 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

• Short Form-McGill Pain Questionnaire (SF-MPQ Visual Analog Scale [VAS]) - Part B Only

  Week 12

Study Arms (2)

Pregabalin

ACTIVE COMPARATOR

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.

Drug: Pregabalin

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

Pregabalin DRUG

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.

Pregabalin

Placebo DRUG

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.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• History of dementia or any other severe cognitive impairment
• Diabetic Peripheral Neuropathy (DPN)

Sponsors & Collaborators

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

Study Sites (33)

Pfizer Investigational Site

Darlinghurst, New South Wales, 2010, Australia

Location

Pfizer Investigational Site

East Gosford, New South Wales, 2250, Australia

Location

Pfizer Investigational Site

St Leonards, New South Wales, 2065, Australia

Location

Pfizer Investigational Site

Warrawong, New South Wales, 2502, Australia

Location

Pfizer Investigational Site

Herston, Queensland, Australia

Location

Pfizer Investigational Site

Footscray, Victoria, 3011, Australia

Location

Pfizer Investigational Site

Perth, Western Australia, 6000, Australia

Location

Pfizer Investigational Site

Beijing, 100083, China

Location

Pfizer Investigational Site

Beijing, 100730, China

Location

Pfizer Investigational Site

Guangzhou, 510180, China

Location

Pfizer Investigational Site

Shanghai, 200003, China

Location

Pfizer Investigational Site

Shanghai, 200040, China

Location

Pfizer Investigational Site

New Territories, Hong Kong

Location

Pfizer Investigational Site

Bangalore, 560 034, India

Location

Pfizer Investigational Site

Bangalore, 560 054, India

Location

Pfizer Investigational Site

Chennai, 600 010, India

Location

Pfizer Investigational Site

Lucknow, 226 014, India

Location

Pfizer Investigational Site

New Delhi, 110 002, India

Location

Pfizer Investigational Site

Jakarta, 10430, Indonesia

Location

Pfizer Investigational Site

Surabaya, 60286, Indonesia

Location

Pfizer Investigational Site

George Town, 11600, Malaysia

Location

Pfizer Investigational Site

Kuala Lumpur, 59100, Malaysia

Location

Pfizer Investigational Site

Kuala Selangor, 68100, Malaysia

Location

Pfizer Investigational Site

Karachi, Sindh, Pakistan

Location

Pfizer Investigational Site

Karachi, Pakistan

Location

Pfizer Investigational Site

Manila, 1000, Philippines

Location

Pfizer Investigational Site

Manila, 1003, Philippines

Location

Pfizer Investigational Site

Seoul, 138-736, South Korea

Location

Pfizer Investigational Site

Gueishan Shiang, Taoyuan Hsien, Taiwan

Location

Pfizer Investigational Site

Taichung, 407, Taiwan

Location

Pfizer Investigational Site

Taipei, 112, Taiwan

Location

Pfizer Investigational Site

Ratchatewee, Bangkok, 10400, Thailand

Location

Pfizer Investigational Site

Bangkok, 10400, Thailand

Location

Related Links

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

MeSH Terms

Interventions

Pregabalin

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.govCallCenter@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2006
• First Posted: April 12, 2006
• Study Start: August 1, 2006
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: February 9, 2021
• Results First Posted: October 9, 2009

Record last verified: 2009-10

Locations

AU (7); CN (5); PA (2); TW (3); IN (5); MY (3); PH (2); TH (2); KR (1); ID (2); HK (1)