Methylphenidate in Early Poststroke Recovery

Completed

Phase 2 Results

Trial Description

To determine the efficacy and safety of methylphenidate in acute stroke rehabilitation.

Interventions

Trial Design

Prospective, randomized, double-blind, placebo-controlled study involving 21 patients at a single center.

Patient Involvement

Patients were consecutively admitted to a community-based rehabilitation unit where they received a three-week treatment of methylphenidate (or placebo) in conjunction with physical therapy. Methylphenidate was started at 5mg and increased gradually to 30mg and discontinued before discharge.

Outcomes

Type Measure Time Frame Safety Issue
Primary Mood measures included the Hamilton Depression Rating Scale (HAM-D) and Zung Self-Rating Depression Scale (ZDS). Cognitive status was evaluated using the Mini-Mental State Exam (MMSE). Motor functioning was assessed using the Fugl-Meyer Scale (FMS) and a modified version of the Functional Independence Measure (M-FIM). All measures were administered pretreatment and weekly thereafter.

Sponsors

CibaGeneva Pharmaceuticals and Ciba-Geigy Corporation