NCT00276185

Brief Summary

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).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
180

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Dec 2005

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2005

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 12, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 13, 2006

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

January 19, 2011

Status Verified

January 1, 2011

Enrollment Period

3.1 years

First QC Date

January 12, 2006

Last Update Submit

January 18, 2011

Conditions

Hemiplegia

Keywords

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

Outcome Measures

Primary Outcomes (8)

  • 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 Outcomes (2)

  • Range of pain

  • Individual functional kinesitherapy

Interventions

Time delay treatment of botulinum toxinDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Minimum age 18
  • Spastic hemiplegia after ischemic stroke (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

You may not qualify if:

  • Ischemic stroke 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 stroke 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clermont-Ferrand University Hospital

Clermont-Ferrand, Auvergne, 63000, France

RECRUITING

Related Publications (1)

  • 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. doi: 10.1016/s0885-3924(00)00146-9.

    PMID: 10946168RESULT

MeSH Terms

Conditions

HemiplegiaMuscle Spasticity

Condition Hierarchy (Ancestors)

ParalysisNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsMuscular DiseasesMusculoskeletal DiseasesMuscle HypertoniaNeuromuscular Manifestations

Study Officials

  • Franck Durif

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Franck Durif

CONTACT

(33) 04 73 750 750

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 12, 2006

First Posted

January 13, 2006

Study Start

December 1, 2005

Primary Completion

January 1, 2009

Study Completion

December 1, 2009

Last Updated

January 19, 2011

Record last verified: 2011-01

Locations

FR(1)