Effect of F2695 on Functional Recovery After Ischemic Stroke

Phase 3

Completed

• Conditions: Ischemic Stroke
• Interventions: Drug: placebo; Drug: F2695

• Registration Number: NCT01639014
• Lead Sponsor: Pierre Fabre Medicament

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-07-10
• Study First Submitted QC: 2012-07-11
• Study First Posted: 2012-07-12
• Status Verified: 2014-03
• Primary Completion: 2015-02
• Study Completion: 2015-02
• Last Update Submitted: 2015-03-31
• Last Update Posted: 2015-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 532

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	placebo	-
F2695	F2695	-

Primary Outcome Measures

Name	Time	Method
Percentage of patients with a Modified Rankin Scale (mRS) less than or equal to 1 at Week 12	week 12

Secondary Outcome Measures

Name	Time	Method
Change from baseline to Week 12 of the mean NIHSS total and motor scores	baseline to week 12
Percentage of patients with NIHSS score less than or equal to 5 at Week 12	week 12
Percentage of patients with at least one moderate to severe depressive	Baseline to week 12
Percentage of patients with a mRS score less than or equal to 2 at Week 12	baseline to week 12
Safety and tolerability assessed by the investigator including SAEs, AEs, vital signs, ECG,physical examination and laboratory tests	baseline to week 12

Trial Locations

Locations (87)

Cliniques Universitaires Saint Luc; 🇧🇪 Brussels, Belgium

Universitair Ziekenhuis Gent; 🇧🇪 Ghent, Belgium

Universitaire Ziekenhuis Gasthuisberg; 🇧🇪 Leuven, Belgium

Clinique Saint-Joseph; 🇧🇪 Liege, Belgium

Regional Ziekenhuis Sint-Trudo; 🇧🇪 Sint-Truiden, Belgium

Sint-Andriesziekenhuis; 🇧🇪 Tielt, Belgium

Academisch Ziekenhuis Sint Augustinus; 🇧🇪 Wilrijk, Belgium

Fakultní nemocnice u sv. Anny v Brne; 🇨🇿 Brno, Czech Republic

Fakultní nemocnice Hradec Králové; 🇨🇿 Hradec Kralové, Czech Republic

Litomyšlská Nemocnice, a.s.; 🇨🇿 Litomyšl, Czech Republic

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