NCT00216411

Brief Summary

The main purpose of this study is to assess the effect on Quality of Life of two cycles of Dysport treatment on post-stroke spasticity of the upper limb. The effect of treatment on spasticity and function will also be measured.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
96

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Nov 2004

Geographic Reach
1 country

6 active sites

Status
completed

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

November 1, 2004

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2006

Completed
Last Updated

July 29, 2019

Status Verified

July 1, 2019

Enrollment Period

1.7 years

First QC Date

September 13, 2005

Last Update Submit

July 25, 2019

Conditions

Cerebrovascular AccidentMuscle Spasticity

Outcome Measures

Primary Outcomes (1)

  • Change in quality of life measured using the Assessment of Quality of Life questionnaire (12 question version).

Secondary Outcomes (7)

  • Change in muscle spasticity assessed on Modified Ashworth Scale (MAS)

  • Change in the Modified Motor Assessment Scale

  • Change in patient disability and carer burden rating scale total score

  • Achievement of the patient identified functional outcome measures (Goal Attainment Scaling)

  • Change in the degree of pain

  • +2 more secondary outcomes

Study Arms (2)

Dysport

EXPERIMENTAL
Biological: Botulinum toxin type A

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

Botulinum toxin type ABIOLOGICAL
Also known as: AbobotulinumtoxinA (Dysport®)
Dysport
PlaceboDRUG
Placebo

Eligibility Criteria

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

You may qualify if:

  • The patient has suffered a stroke, as defined by the World Health Organisation (WHO) criteria, at least 6 months previously.
  • The patient has a hemiparetic arm and meets minimum score requirements on the Modified Ashworth Scale.
  • The patient has the cognitive and communication ability to participate in the study.

You may not qualify if:

  • Patients who have received botulinum toxin treatment within the past 120 days.
  • Contraindication to botulinum toxin treatment.
  • Patients who are receiving oral anti-spasticity medication and who have had a change in dosage of this medication in the month prior to study entry.
  • Patients who have previously been treated with phenol for their upper limb spasticity.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

St Josephs Hospital

Auburn, New South Wales, 2144, Australia

Location

Royal Prince Alfred Hospital

Camperdown, New South Wales, 2050, Australia

Location

Prince of Wales Hospital

Randwick, New South Wales, 2031, Australia

Location

Box Hill Hospital

Box Hill, Victoria, 3128, Australia

Location

Caulfield General Medical Centre

Caulfield, Victoria, 3162, Australia

Location

Austin Health

Heidelberg, Victoria, 3084, Australia

Location

Related Publications (1)

  • Turner-Stokes L, Baguley IJ, De Graaff S, Katrak P, Davies L, McCrory P, Hughes A. Goal attainment scaling in the evaluation of treatment of upper limb spasticity with botulinum toxin: a secondary analysis from a double-blind placebo-controlled randomized clinical trial. J Rehabil Med. 2010 Jan;42(1):81-9. doi: 10.2340/16501977-0474.

    PMID: 20111849DERIVED

MeSH Terms

Conditions

StrokeMuscle Spasticity

Interventions

Botulinum Toxins, Type AabobotulinumtoxinA

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesMuscular DiseasesMusculoskeletal DiseasesMuscle HypertoniaNeuromuscular ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Botulinum ToxinsMetalloendopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesMetalloproteasesBacterial ProteinsProteinsAmino Acids, Peptides, and ProteinsBacterial ToxinsToxins, BiologicalBiological Factors

Study Officials

  • Ipsen Medical Director

    Ipsen

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 22, 2005

Study Start

November 1, 2004

Primary Completion

July 20, 2006

Study Completion

July 20, 2006

Last Updated

July 29, 2019

Record last verified: 2019-07

Locations

AU(6)