Randomized Efficacy Trial of Citicoline in Patients With Acute Ischemic Stroke "Citicoline 007"

Completed

Phase 3 Results

Trial Description

To evaluate the safety and effectiveness of 500mg citicoline compared to placebo in patients who are examined within 24 hours of stroke onset.

Interventions

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

Trial Design

Randomized, double-blind, efficacy trial involving 394 patients at 31 U.S. centers.

Patient Involvement

127 patients received placebo and 267 received citicoline (500 mg po daily) for 6 weeks.

Outcomes

Type Measure Time Frame Safety Issue
Primary Functional outcome by stratified Barthel Index at 12 weeks.
Secondary (1) Categorized Barthel Index at the other weeks, (2) percentage with full recovery (BI 95 or 100), (3) Modified Rankin scale (4) neurological, behavioral, and cognitive function by use of the NIHSS and Mini-Mental State Examination, (5) mortality, (6) full recovery defined as an NIHSS score of 1, (7) number of days from stroke to hospital discharge, (8) relative rate of improvement for the Barthel Index, Rankin scale, and NIHSS.

Sponsors

Interneuron Pharmaceuticals, Lexington, MA