Citicoline Stroke Study "Citicoline 001"

Completed

Phase 3 Results

Trial Description

To evaluate the effectiveness of citicoline in acute stroke.

Interventions

  • Citicoline (CerAxon®)Drug
    Other Names: CDP-choline
    Intervention Desc: Phosphatidylcholine precursor, membrane stabilizer (cytidyl diphosphocholine)

Trial Design

Randomized (3 doses of citicoline to 1 placebo), vehicle-controlled, double-blind trial involving 259 patients at 21 centers.

Patient Involvement

Patients were randomized to receive either placebo or citicoline tablets at doses of either 500 mg once a day, 500 mg bid, or 1000 mg bid.

Outcomes

Type Measure Time Frame Safety Issue
Primary Barthel Index at 12 weeks.
Secondary Percentage of patients with a favorable outcome (Barthel Index of 95 or 100 at 12 weeks), assessment of differences between each dose level and placebo on the Modified Rankin scale, neuropsychological test battery, NIHSS score <=1, number of days from stroke to hospital discharge.

Sponsors

Interneuron Pharmaceuticals, Lexington, MA