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

Viatris

Status and phase

Completed

Phase 3

Conditions

Spinal Cord Injuries

Spinal Cord Diseases

Pain

Neuralgia

Treatments

Drug: pregabalin

Study type

Interventional

Funder types

Industry

Identifiers

NCT01202227

A0081252

Details and patient eligibility

About

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).

Enrollment

104 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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;