Effect of F2695 on Functional Recovery After Ischemic Stroke "LIFE"

Completed

Phase 3 Results N/A

Trial Description

The purpose of the study is to assess the efficacy of a new serotonin-norepinephrine reuptake inhibitor (SNRI) nin functional recovery after ischemic stroke.

Conditions

Interventions

  • Placebo Drug
    Intervention Desc: 2 capsules
    ARM 1: Kind: Experimental
    Label: placebo
  • F2695 Drug
    Intervention Desc: 75 mg OD in 2 capsules
    ARM 1: Kind: Experimental
    Label: F2695

Trial Design

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

Outcomes

Type Measure Time Frame Safety Issue
Primary Percentage of patients with a Modified Rankin Scale (mRS) less than or equal to 2 at Week 12 week 12 No
Secondary Percentage of patients with NIHSS score less than or equal to 5 at Week 12 week 12 No
Secondary Percentage of patients with at least one moderate to severe depressive Baseline to week 12 No
Secondary Change from baseline to Week 12 of the mean NIHSS total and motor scores baseline to week 12 No
Secondary Safety and tolerability assessed by the investigator including SAEs, AEs, vital signs, ECG,physical examination and laboratory tests baseline to week 12 No
Primary Percentage of patients with a Modified Rankin Scale (mRS) less than or equal to 1 at Week 12 week 12 No
Secondary Percentage of patients with a mRS score less than or equal to 2 at Week 12 baseline to week 12 No

Sponsors