Efficacy of Folrex in the Superior Extremity Rehabilitation After Acute Stroke

Catalysis SL

Status and phase: Completed; Phase 3

Conditions: Stroke

Treatments: Drug: Folrex; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01016119

CAT-0915-CU

Details and patient eligibility

About

The purpose of the study is to evaluate whether Folrex, could improve the motor recovery of the upper extremity after stroke in comparison with placebo during 4 weeks of treatment.

Full description

Periodical measures of the motor recovery, of the upper extremity, by Fugl-Meyer score, it will be done at the beginning, at fifth day and at month. Each value will be compare to evaluate whether the groups of patient improve.

Enrollment: 40 estimated patients

Sex: All

Ages: 20 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with acute stroke < 24 hours.
• Patients with impairment up to 4 on NIHSS scale.
• Family support.
• Informed consent.

Exclusion criteria

• Presence of another disease not well controlled.
• Patient with dementia.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

In this group we will use Placebo cream, in the early rehabilitations in the upper extremity

Treatment:

Drug: Placebo

Folrex

Experimental group

Description:

In this group we will use Folrex cream, in the early rehabilitations in the upper extremity

Treatment:

Drug: Folrex