Effects on Quality of Life Following Dysport Treatment in Post-stroke Spasticity of the Arm

Ipsen

Status and phase: Completed; Phase 4

Conditions: Cerebrovascular Accident; Muscle Spasticity

Treatments: Biological: Botulinum toxin type A; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00216411

A-9B-52120-097

Details and patient eligibility

About

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.

Enrollment: 96 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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96 participants in 2 patient groups, including a placebo group

Dysport

Experimental group

Treatment:

Biological: Botulinum toxin type A

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo