NCT01016119

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at below P25 for phase_3 stroke

Timeline
Completed

Started Oct 2009

Shorter than P25 for phase_3 stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 28, 2009

Completed
3 days until next milestone

Study Start

First participant enrolled

October 1, 2009

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 18, 2009

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

March 8, 2010

Status Verified

March 1, 2010

Enrollment Period

5 months

First QC Date

September 28, 2009

Last Update Submit

March 4, 2010

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

  • 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).

    4 weeks

Secondary Outcomes (2)

  • Barthel index

    4 weeks

  • National Institutes of Health Stroke Scale (NIHSS)

    4 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Folrex

EXPERIMENTAL

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

Drug: Folrex

Interventions

FolrexDRUG

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

Folrex
PlaceboDRUG

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

Placebo

Eligibility Criteria

Age20 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Salvador Allende Hospital

Havana, La Habana, Cuba

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 28, 2009

First Posted

November 18, 2009

Study Start

October 1, 2009

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

March 8, 2010

Record last verified: 2010-03

Locations

CU(1)