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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

September 28, 2009
March 4, 2010
October 2009
March 2010   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01016119 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Barthel index [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
  • NIHSS [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Efficacy of Folrex in the Superior Extremity Rehabilitation After Acute Stroke
Efficacy of Folrex in the Superior Extremity Rehabilitation After Acute Stroke

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Stroke
  • Drug: Folrex
    Folrex cream, in the early rehabilitations in the upper extremity, before daily rehabilitation
  • Drug: Placebo
    Placebo cream, in the early rehabilitations in the upper extremity, before daily rehabilitation
  • Placebo Comparator: Placebo
    In this group we will use Placebo cream, in the early rehabilitations in the upper extremity
    Intervention: Drug: Placebo
  • Experimental: Folrex
    In this group we will use Folrex cream, in the early rehabilitations in the upper extremity
    Intervention: Drug: Folrex
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
March 2010
March 2010   (final data collection date for primary outcome measure)

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.
Both
20 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
Cuba
 
NCT01016119
CAT-0915-CU
Yes
Jose Luis Giroud Benítez, MINSAP
Catalysis SL
Not Provided
Not Provided
Catalysis SL
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP