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Efficacy of Folrex in the Superior Extremity Rehabilitation After Acute Stroke

Primary Purpose

Stroke

Status

Completed

Phase

Phase 3

Locations

Cuba

Study Type

Interventional

Intervention

Folrex

Placebo

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

20 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Salvador Allende Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Folrex

Arm Description

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

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

Outcomes

Primary Outcome Measures

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 (4 weeks).

Secondary Outcome Measures

Barthel index

National Institutes of Health Stroke Scale (NIHSS)

Full Information

NCT ID

NCT01016119

First Posted

September 28, 2009

Last Updated

March 4, 2010

Sponsor

Catalysis SL

1. Study Identification

Unique Protocol Identification Number

NCT01016119

Brief Title

Efficacy of Folrex in the Superior Extremity Rehabilitation After Acute Stroke

Official Title

Efficacy of Folrex in the Superior Extremity Rehabilitation After Acute Stroke

Study Type

Interventional

2. Study Status

Record Verification Date

March 2010

Overall Recruitment Status

Completed

Study Start Date

October 2009 (undefined)

Primary Completion Date

March 2010 (Actual)

Study Completion Date

March 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Catalysis SL

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stroke

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Arm Title

Folrex

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Folrex

Intervention Description

Folrex cream, in the early rehabilitations in the upper extremity, before daily rehabilitation

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo cream, in the early rehabilitations in the upper extremity, before daily rehabilitation

Primary Outcome Measure Information:

Title

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 (4 weeks).

Time Frame

4 weeks

Secondary Outcome Measure Information:

Title

Barthel index

Time Frame

4 weeks

Title

National Institutes of Health Stroke Scale (NIHSS)

Time Frame

4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Facility Information:

Facility Name

Salvador Allende Hospital

City

Havana City

State/Province

Havana

Country

Cuba

12. IPD Sharing Statement

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Efficacy of Folrex in the Superior Extremity Rehabilitation After Acute Stroke

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