A 17-Week Trial To Assess Pregabalin For The Treatment Of Nerve Pain Due To Spinal Cord Injury

Viatris

Status and phase: Completed; Phase 3

Conditions: Spinal Cord Injuries; Neuralgia

Treatments: Drug: placebo; Drug: pregabalin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00407745

A0081107

Details and patient eligibility

About

The purpose of this study is to evaluate if pregabalin relieves nerve pain associated with spinal cord injury compared to placebo (pill that contains no active medicine). This study will also evaluate the safety of pregabalin in this patient population.

Enrollment: 220 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects with nerve pain after Spinal cord injury (traumatic, diving, ischemic and after removal of benign tumors (except meningioma and fibromas)
• Pain has to be chronic(continuous for at least 3 months or intermittent for at least 6 months
• Pain score at least 4 in 4 of 7 days prior to receive treatment.

Exclusion criteria

• Pregabalin use in the last 60 days, prior intolerance to pregabalin
• Creatinine clearance <60 mL/min.
• White blood cell count <2500/mm3; neutrophil count <1500/mm3; platelet count <100 x 103/ mm3.
• Abuse of drugs or alcohol
• Unstable medial conditions
• Clinically significant abnormal electrocardiogram (ECG).
• Presence of severe pain associated with conditions other than spinal cord injury that could confound the assessment or self-evaluation of pain due to spinal cord injury.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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220 participants in 2 patient groups, including a placebo group

matched placebo

Placebo Comparator group

Treatment:

Drug: placebo

pregabalin

Experimental group

Description:

flexible dosing over 4 weeks followed by 12 weeks maintenance and one week taper period

Treatment:

Drug: pregabalin