Repinotan in Patients With Acute Ischemic Stroke

Completed

Phase 2 Results

Trial Description

The purpose of this trial is to evaluate Repinotan HCl in patients with acute ischemic stroke. At study entry patients will be randomized to Repinotan HCl or placebo in a 1:1 ratio. The total treatment period wil be 72 hours.

Conditions

Interventions

  • Repinotan Drug
    Intervention Desc: Serotonin agonist (5HT1A receptor subtype)
  • Placebo Drug
    Intervention Desc: All patients receive 1.25 mg of placebo
    ARM 1: Kind: Experimental
    Label: Arm 2
  • Repinotan HCl (BAYX3702) Drug
    Intervention Desc: All patients receive 1.25 mg of repinotan
    ARM 1: Kind: Experimental
    Label: Arm 1

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Investigator)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Patient Involvement

Eligible patients will be randomized to receive either intravenous repinotan or placebo. Both drugs will be initially infused at a rate of 1.25 mg/day. Doses will be titrated down to the targeted blood level of 5 to 20 ug/L on the basis of a repinotan bedside test. Any patients who have received tPA must receive repinotan within one hour of tPA infusion. Patients will be followed-up at 24 hours, 1 month, and 3 months post-treatment.

Outcomes

Type Measure Time Frame Safety Issue
Primary Barthel Index (BI) at 3 months.
Secondary NIHSS, and modified Rankin Scale (MRS) scores.

Sponsors