An Open-Label Long-Term Study Of Pregabalin For The Treatment Of Central Neuropathic Pai

Phase 3

• Conditions: Spinal Cord Diseases, Spinal Cord Injuries, Neuralgia, Pain

• Registration Number: JPRN-jRCT2080221298
• Lead Sponsor: Pfizer Japan Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-11-08
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Inclusion criteria for subjects to be shifted from Study A0081107
-Subjects who completed the 18-week study period in Study A0081107 conducted for chronic neuropathic pain after spinal cord injury;
-Subjects who completed assessments of all efficacy endpoints until the end of the treatment phase of the preceding Study A0081107 (V7);

Inclusion criteria for subjects to be new participatants in this study
-Subjects with central neuropatic pain after stroke or multiple sclerosis;
-At least 6 months have passed after the onset of central neuropathic pain;
-Pain VAS at least 40mm in Visit 1 and Visit 2;

Exclusion Criteria

-Creatinine clearance < 60 mL/min;
-Platelet count < 100 x 103/mm3 ; White blood cell (WBC) count < 2500/mm3; Neutrophil count < 1500/mm3;
-Subjects who are expected to require surgery during the trial;

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
-Adverse events <br>-Physical exams<br>-Weight, blood pressure, pulse rate, <br>-Edema assessments<br>-DVT assessments <br>-Ophthalmologic exams<br>-Neurological exams, <br>-12-lead ECG<br>-Clinical laboratory testing (hematology, blood chemistry, urinalysis)

Secondary Outcome Measures

Name	Time	Method
-The Short-Form McGill Pain Questionnaire <br>-The modified Brief Pain Inventory Interference Scale 10-items (mBPI-10) score<br>Self-assessment by subject