Overview

Effect of F2695 on Functional Recovery After Ischemic Stroke

Status:
Completed
Trial end date:
2015-02-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of the study is to assess the efficacy of a new serotonin-norepinephrine reuptake inhibitor (SNRI) nin functional recovery after ischemic stroke.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Pierre Fabre Medicament
Criteria
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.