Overview

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;