Status:
COMPLETED
An Open-Label Long-Term Study Of Pregabalin For The Treatment Of Central Neuropathic Pain
Lead Sponsor:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Conditions:
Spinal Cord Diseases
Spinal Cord Injuries
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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;
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
104 Patients enrolled
Trial Details
Trial ID
NCT01202227
Start Date
September 1 2010
End Date
March 1 2012
Last Update
January 28 2021
Active Locations (26)
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1
Chubu Rosai Hospital
Nagoya, Aichi-ken, Japan
2
Kimura Clinic
Nagoya, Aichi-ken, Japan
3
Nagoya Kyoritsu Clinic
Nagoya, Aichi-ken, Japan
4
Senboku Kumiai General Hospital
Daisen, Akita, Japan