Effect of F2695 on Functional Recovery After Ischemic Stroke (LIFE)

Pierre Fabre

Status and phase: Completed; Phase 3

Conditions: Ischemic Stroke

Treatments: Drug: F2695; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01639014

F02695 LP 2 05

2012-001592-37 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 532 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female patient, 18 to 80 years of age
• Confirmed acute ischemic stroke within the past 2 - 10 days
• Unilateral motor deficit,
• National Institutes of Health stroke scale (NIHSS) motor score >= 5
• Modified Rankin Scale (mRS) of 4 or 5
• Able and willing to comply with the site rehabilitation program requirements

Exclusion criteria

• Aphasia
• Severe post-stroke condition
• Active depressive episode
• Intra-cerebral hemorrhage
• Use of anti-depressant drugs
• Cardiac rhythm disorder
• Uncontrolled arterial hypertension
• Other severe acute or chronic medical or psychiatric condition.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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532 participants in 2 patient groups, including a placebo group

F2695

Experimental group

Treatment:

Drug: F2695

placebo

Placebo Comparator group

Treatment:

Drug: placebo