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

• Status: Completed
• Trial end date: 2012-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess the safety of the long-term use of pregabalin at doses up to 600 mg/day in patients with central neuropathic pain (post spinal cord injury pain, post stroke pain, and multiple sclerosis pain).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer; Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• Treatments: Pregabalin

Criteria

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 participants in this study

• Subjects with central neuropathic 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 × 103/mm3 ; White blood cell (WBC) count < 2500 / mm3; Neutrophil count < 1500/ mm3;

• Subjects who are expected to require surgery during the trial;