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Clinical Trials/NCT01639014
NCT01639014CompletedPhase 3

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

Pierre Fabre Medicament87 sites in 7 countries532 target enrollmentStarted: July 2012Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 3
Status
Completed
Enrollment
532
Locations
87
Primary Endpoint
Percentage of patients with a Modified Rankin Scale (mRS) less than or equal to 1 at Week 12
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

  • •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.

Arms & Interventions

F2695

Experimental

Intervention: F2695 (Drug)

placebo

Placebo Comparator

Intervention: placebo (Drug)

Outcomes

Primary Outcomes

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

Time Frame: week 12

Secondary Outcomes

  • 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)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (87)

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Similar Trials

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Phase 1
Trial is to assess the effect of 3-month treatment with F2695 on improving functionalrecovery after stroke. A study that will cover many study centres, and which will involve a random draw to decide whether placebo or active drug; neither the subject nor study doctor will know which of the two treatments are received.Functionnal impairment after acute ischemic strokeMedDRA version: 14.1Level: PTClassification code 10061256Term: Ischaemic strokeSystem Organ Class: 10029205 - Nervous system disorders
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Trial is to assess the effect of 3-month treatment with F2695 on improving functionalrecovery after stroke. A study that will cover many study centres, and which will involve a random draw to decide whether placebo or active drug; neither the subject nor study doctor will know which of the two treatments are received.Functionnal impairment after acute ischemic strokeMedDRA version: 17.0Level: PTClassification code 10061256Term: Ischaemic strokeSystem Organ Class: 10029205 - Nervous system disorders
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Trial is to assess the effect of 3-month treatment with F2695 on improving functionalrecovery after stroke. A study that will cover many study centres, and which will involve a random draw to decide whether placebo or active drug; neither the subject nor study doctor will know which of the two treatments are received.Functionnal impairment after acute ischemic strokeMedDRA version: 17.0Level: PTClassification code 10061256Term: Ischaemic strokeSystem Organ Class: 10029205 - Nervous system disorders
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Effect of 3-month treatment with F2695 (75mg OD) on improving functional recovery of patients with ischemic stroke. A Multicenter, Randomised, Double-blind, Parallel-group, Placebo-Controlled Study. LIFE-StudyI69.3Sequelae of cerebral infarction
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