Trial intelligence / Profile preview

Escitalopram for recovery after cortical ischemic stroke

NCT02865642Phase 2

Key facts

Status: Unknown
Start: Aug 2016
Primary completion: Sep 2020
Countries: 1
Sponsor: Insel Gruppe
Modality: Small Molecules

Drugs: escitalopram
Conditions: ischemic stroke

Overview

Phase 2, randomised, double-blind trial in ischemic stroke comparing Escitalopram with Placebo (2 arms). Primary endpoint: Effect of escitalopram on sensorimotor network at Month 9. Status: unknown.

Design

2 arms

Study design: RandomizedDouble-blind

Escitalopram
Escitalopram 5mg -> 20mg -> 10mg
Placebo
Placebo matching Escitalopram

Who it enrols

Adult patients with first-ever cortical ischemic stroke and clinically significant contralesional hand plegia or paresis. Exclusion criteria include severe aphasia or cognitive deficits, prior cerebrovascular events, significant stenosis, purely subcortical stroke, and use of interacting medications.

Endpoints

Primary

Effect of escitalopram on sensorimotor networkMonth 9

Secondary

Imaging patterns of rs-fMRIMonth 9
Imaging patterns of act-fMRIMonth 9
Jebsen-Taylor TestMonthly from baseline to Month 9
Mean cortical volume changesMonth 9
Serum concentration of escitalopramMonth 3
Genetic polymorphisms in genesMonth 3

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