Phase 3 N=103 Treatment

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

Spinal Cord Diseases · Spinal Cord Injuries · Neuralgia · Pain

Bottom Line

View on ClinicalTrials.gov: NCT01202227 ↗

Enrolled (actual)

103

Serious AEs

18.5%

Results posted

May 2013

Primary outcome: Primary: Number of Participants With Peripheral Edema — 5; 9; 2; 0 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: pregabalin (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Primary completion: Mar 2012

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	—

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).

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;

View full record on ClinicalTrials.gov →

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.