HEMITOX : Effect of Botulinum Toxin Injections on Motor and Functional Ability of Upper Limb in Adults at Earlier Phases of Spastic Hemiplegia After Stoke

This study is currently recruiting participants.

Verified by University Hospital, Clermont-Ferrand, July 2008

First Received: January 12, 2006 Last Updated: July 10, 2008 History of Changes

Sponsor:	University Hospital, Clermont-Ferrand
Collaborators:	J. Rebeyrol Hospital in Limoges Rennes University Hospital Center of Physical Medicine and Rehabilitation (Notre Dame de Lourdes Center in Rennes) Saint Jacques Hospital in Nantes Centre Hospitalier Universitaire de Saint Etienne Centre Régional de Département de médecine physique et réadaptation CHU-C3RF in Angers Centre Hospitalier Universitaire de Besancon
Information provided by:	University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier:	NCT00276185

Purpose

Botulinum toxin produced beneficial effects in spasticity in the hemiplegic upper limb. This study will test if botulinum toxin injections at earlier phases (<or = 3 months) in spasticity improve functional and motor tests compared with late injections (>or = 6 months).

Condition	Intervention	Phase
Hemiplegia	Drug: Time delay treatment of botulinum toxin	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Single Group Assignment, Efficacy Study
Official Title:	Effect of Botulinum Toxin Injections on Motor and Functional Ability of Upper Limb in Adults at Earlier Phases of Spastic Hemiplegia After Stoke

Resource links provided by NLM:

Drug Information available for: Clostridium botulinum toxin

U.S. FDA Resources

Further study details as provided by University Hospital, Clermont-Ferrand:

Primary Outcome Measures:

Deficiency, incapacity, handicap : Frenchay Arm test(post stroke arm function); Enjalbert test;
Box and blocks test
Enjalbert test
Modified Ashworth scale (upper limb)
Functional Independence Measure
Fugl-Meyer upper limb test
Clinical Global Impression (CGI)
36-Item Short Form (SF-36) quality of life

Secondary Outcome Measures:

Range of pain
Individual functional kinesitherapy

Estimated Enrollment:	180
Study Start Date:	December 2005
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Minimum age 18
Spastic hemiplegia after ischemic stoke (carotid occlusion) within the past 3 months.
Antispasticity medication stabilized for the last 30 days
Severe cognitive impairment such that patient is unable to provide scale assessment.
Significant spasticity impeding improvement by re-education for 2 months or less
Lack of muscular retraction defined by a minimal range of articular motion as :
- finger : complete extension and rolling up
- wrist : extension 40°/flexion : 45°
- elbow : extension - 10°/flexion : 120°
- shoulder : Enjalbert score 2 or more
Antagonist muscles (to spasticity) activity score 1 or more
Social Security benefits

Exclusion Criteria:

Ischemic stoke thought to be due to basilar or vertebral vessel occlusion
Known motor neuron or neuromuscular junction disease, disorders in which pain limits the ability to inject muscles (algodystrophy)
Absence of mobility in proximal part of upper limb that does not predict a functional gain
Minor stoke with non-disabling deficit or rapidly improving motor symptoms
other serious illness, e.g. severe hepatic, cardiac, or renal failure ; acute myocardial infarction ; or a complex disease that may confound treatment assessment
Treatment of spasticity by previous administration of botulinum toxin, if known
Known allergy to botulinum toxin
Currently participating in other research studies

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00276185

Contacts

Contact: Franck Durif

(33) 04 73 750 750

Locations

France, Auvergne
Clermont-Ferrand University Hospital	Recruiting
Clermont-Ferrand, Auvergne, France, 63000
Contact: Franck Durif (33) 04 73 750 750

Sponsors and Collaborators

University Hospital, Clermont-Ferrand

J. Rebeyrol Hospital in Limoges

Rennes University Hospital

Center of Physical Medicine and Rehabilitation (Notre Dame de Lourdes Center in Rennes)

Saint Jacques Hospital in Nantes

Centre Hospitalier Universitaire de Saint Etienne

Centre Régional de Département de médecine physique et réadaptation CHU-C3RF in Angers

Centre Hospitalier Universitaire de Besancon

Investigators

Principal Investigator:

Franck Durif

University Hospital, Clermont-Ferrand

More Information

Publications:

Wissel J, Muller J, Dressnandt J, Heinen F, Naumann M, Topka H, Poewe W. Management of spasticity associated pain with botulinum toxin A. J Pain Symptom Manage. 2000 Jul;20(1):44-9.

Responsible Party:	CHU Clermont-Ferrand ( Pr Franck DURIF )
Study ID Numbers:	CHU63-0003
Study First Received:	January 12, 2006
Last Updated:	July 10, 2008
ClinicalTrials.gov Identifier:	NCT00276185 History of Changes
Health Authority:	France: Ministry of Health

Keywords provided by University Hospital, Clermont-Ferrand:

spasticity ;
Botulinum toxin ;
Upper limb ;
motor function.
spastic hemiplegia after stoke

Additional relevant MeSH terms:

Paralysis
Signs and Symptoms
Hemiplegia
Botulinum Toxins
Anti-Dyskinesia Agents

Therapeutic Uses
Nervous System Diseases
Neurologic Manifestations
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010