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

An Open-Label Long-Term Study Of Pregabalin For The Treatment Of Central Neuropathic Pain (Post Spinal Cord Injury Pain, Post Stroke Pain, And Multiple Sclerosis Pain)

Status

Unknown

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080221298

Enrollment

100

Registered

2010-11-08

Start date

2010-11-08

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinal Cord Diseases, Spinal Cord Injuries, Neuralgia, Pain

Interventions

investigational material(s) Generic name etc : pregabalin INN of investigational material : pregabalin Therapeutic category code : 119 Other agents affecting central nervous system Dosage and Administ

Eligibility

Sex/Gender

All

Inclusion 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 participatants in this study -Subjects with central neuropatic 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

Exclusion criteria: -Creatinine clearance < 60 mL/min; -Platelet count < 100 x 103/mm3 ; White blood cell (WBC) count < 2500/mm3; Neutrophil count < 1500/mm3; -Subjects who are expected to require surgery during the trial;

Design outcomes

Primary

Measure	Time frame
-Adverse events -Physical exams -Weight, blood pressure, pulse rate, -Edema assessments -DVT assessments -Ophthalmologic exams -Neurological exams, -12-lead ECG -Clinical laboratory testing (hematology, blood chemistry, urinalysis)	—

Secondary

Measure	Time frame
-The Short-Form McGill Pain Questionnaire -The modified Brief Pain Inventory Interference Scale 10-items (mBPI-10) score Self-assessment by subject	—

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026