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Completed

NCT Number: NCT01639014

Effect of F2695 on Functional Recovery After Ischemic Stroke

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

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Key information

Conditions

Ischemic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Cliniques Universitaires Saint Luc, Brussels, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

F2695

Drug

75 mg OD in 2 capsules

Placebo

Drug

2 capsules

Primary outcomes

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

    Time frame: week 12

Secondary outcomes

  1. Percentage of patients with NIHSS score less than or equal to 5 at Week 12

    Time frame: week 12

  2. Percentage of patients with at least one moderate to severe depressive

    Time frame: Baseline to week 12

  3. Change from baseline to Week 12 of the mean NIHSS total and motor scores

    Time frame: baseline to week 12

  4. Safety and tolerability assessed by the investigator including SAEs, AEs, vital signs, ECG,physical examination and laboratory tests

    Time frame: baseline to week 12

  5. Percentage of patients with a mRS score less than or equal to 2 at Week 12

    Time frame: baseline to week 12

Sponsors and collaborators

Lead sponsor

Pierre Fabre Medicament

Industry

Registry information

Official study title

Effect of 3-month Treatment With F2695 (75mg OD) on Improving Functional Recovery of Patients With Ischemic Stroke. A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-Controlled Study

Acronym: LIFE

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Jul 12, 2012
Registry last updated
Apr 1, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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