Phase 3
Completed N=103
An Open-Label Long-Term Study Of Pregabalin For The Treatment Of Central Neuropathic Pain
Spinal Cord Diseases · Spinal Cord Injuries · Neuralgia · Postoperative Pain
Source: ClinicalTrials.gov NCT01202227 ↗
Enrolled (actual)
103
Serious AEs
18.5%
Results posted
May 2013
Primary outcomePrimary: Number of Participants With Peripheral Edema — 5; 9; 2; 0 Participants
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Peripheral Edema |
5; 9; 2; 0; 8; 8 | — |
| PRIMARY Number of Participants With Facial/Periorbital Edema |
0; 0; 0; 0; 1; 0 | — |
| PRIMARY Number of Participants With Generalized or Abdominal Edema |
0; 0; 0; 0; 1; 0 | — |
| PRIMARY Number of Participants With Localized Pain Related to Deep Vein Thrombosis (DVT) |
2; 3; 1; 5; 1; 0 | — |
| PRIMARY Number of Participants With Localized Tenderness Related to Deep Vein Thrombosis (DVT) |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants With Swelling Related to Deep Vein Thrombosis (DVT) |
4; 2; 0; 3; 2; 0 | — |
| PRIMARY Number of Participants With Pitting Edema Related to Deep Vein Thrombosis (DVT) |
6; 1; 0; 5; 2; 0 | — |
| PRIMARY Number of Participants With Collateral Superficial Veins (Non-varicose) Related to Deep Vein Thrombosis (DVT) |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants With Skin Redness Related to Deep Vein Thrombosis (DVT) |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants With Visual Field Deteriorated |
0; 0 | — |
| PRIMARY Number of Participants With Deterioration in Neurological Examination Findings |
0; 0; 0; 2; 1; 0 | — |
| PRIMARY Number of Participants With Suicidal Ideation According to Sheehan Suicidality Tracking Scale (Sheehan-STS) |
3; 2; 1; 0; 0; 2 | — |
| SECONDARY Change From Baseline in Short-Form McGill Pain Questionnaire (SF-MPQ) at Each Time Point: Total Scores |
-4.2; -5.2; -5.3; -5.7; -6.1; -5.1 | — |
| SECONDARY Change From Baseline in Short-Form McGill Pain Questionnaire (SF-MPQ) at Each Time Point: Sensory Scores |
-3.1; -3.9; -3.9; -4.2; -4.5; -3.8 | — |
| SECONDARY Change From Baseline in Short-Form McGill Pain Questionnaire (SF-MPQ) at Each Time Point: Affective Scores |
-1.1; -1.3; -1.3; -1.5; -1.6; -1.3 | — |
| SECONDARY Change From Baseline in the Modified Brief Pain Inventory (10 Item) (mBPI-10)Total Scores at Last Evaluation Score |
-1.4 | — |
Eligibility 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;
Data sourced from ClinicalTrials.gov (NCT01202227). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.