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Efficacy of Folrex in the Superior Extremity Rehabilitation After Acute Stroke

This study has been completed.
Sponsor:
Information provided by:
Catalysis SL
ClinicalTrials.gov Identifier:
NCT01016119
First received: September 28, 2009
Last updated: March 4, 2010
Last verified: March 2010
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Folrex in the Superior Extremity Rehabilitation After Acute Stroke

Resource links provided by NLM:

MedlinePlus related topics: Rehabilitation
U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Barthel index [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
  • National Institutes of Health Stroke Scale (NIHSS) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   20 Years to 90 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01016119

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

No publications provided

Responsible Party: Jose Luis Giroud Benítez, MINSAP
ClinicalTrials.gov Identifier: NCT01016119     History of Changes
Other Study ID Numbers: CAT-0915-CU
Study First Received: September 28, 2009
Last Updated: March 4, 2010
Health Authority: Cuba: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 19, 2013