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Efficacy of Folrex in the Superior Extremity Rehabilitation After Acute Stroke

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01016119
First Posted: November 18, 2009
Last Update Posted: March 8, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Catalysis SL
  Purpose
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.

Condition Intervention Phase
Stroke Drug: Folrex Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Folrex in the Superior Extremity Rehabilitation After Acute Stroke

Resource links provided by NLM:


Further study details as provided by Catalysis SL:

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). [ Time Frame: 4 weeks ]

Secondary Outcome Measures:
  • Barthel index [ Time Frame: 4 weeks ]
  • National Institutes of Health Stroke Scale (NIHSS) [ Time Frame: 4 weeks ]

Estimated Enrollment: 40
Study Start Date: October 2009
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
In this group we will use Placebo cream, in the early rehabilitations in the upper extremity
Drug: Placebo
Placebo cream, in the early rehabilitations in the upper extremity, before daily rehabilitation
Experimental: Folrex
In this group we will use Folrex cream, in the early rehabilitations in the upper extremity
Drug: Folrex
Folrex cream, in the early rehabilitations in the upper extremity, before daily rehabilitation

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01016119


Locations
Cuba
Salvador Allende Hospital
Havana City, Havana, Cuba
Sponsors and Collaborators
Catalysis SL
  More Information

Responsible Party: Jose Luis Giroud Benítez, MINSAP
ClinicalTrials.gov Identifier: NCT01016119     History of Changes
Other Study ID Numbers: CAT-0915-CU
First Submitted: September 28, 2009
First Posted: November 18, 2009
Last Update Posted: March 8, 2010
Last Verified: March 2010

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases