Effect of F2695 on Functional Recovery After Ischemic Stroke

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01639014

Acronym

LIFE

Enrollment

532

Registered

2012-07-12

Start date

2012-07-31

Completion date

2015-02-28

Last updated

2015-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ischemic Stroke

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.

Interventions

DRUGF2695

75 mg OD in 2 capsules

DRUGplacebo

2 capsules

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame
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
Change from baseline to Week 12 of the mean NIHSS total and motor scores	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
Percentage of patients with a mRS score less than or equal to 2 at Week 12	baseline to week 12

Countries

Belgium, Czechia, France, Germany, Hungary, Italy, Portugal, Russia, Spain, Sweden, Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026