Efficacy Of Pregabalin In Subjects With Post-Stroke Central Neuropathic Pain

Viatris

Status and phase: Completed; Phase 4

Conditions: Central Neuropathic Pain

Treatments: Drug: Pregabalin; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00313820

A0081063

Details and patient eligibility

About

Efficacy and Safety of flexibly dosed pregabalin compared to placebo among subjects with central post stroke pain (CPSP)

Enrollment: 220 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Positive history of clinical stroke at least 4 months prior to randomization CPSP--3 months prior to screening

Exclusion criteria

• History of dementia or any other severe cognitive impairment
• Diabetic Peripheral Neuropathy (DPN)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

220 participants in 2 patient groups, including a placebo group

Pregabalin

Active Comparator group

Description:

The change from in pain scores from baseline to endpoint among stroke subjects receiving pregabalin will be compared to change in pain scores from baseline to endpoint among stroke subjects receiving matched placebo.

Treatment:

Drug: Pregabalin

Placebo

Placebo Comparator group

Description:

The change in pain scores from baseline to endpoint will be compared among the two treatment groups- ie subjects receiving 12 weeks of pregabalin treatment vs subjects receiving 12 weeks of placebo treatment.

Treatment:

Drug: Placebo