Dysport® Adult Upper Limb Spasticity

Ipsen

Status and phase: Completed; Phase 3

Conditions: Nervous System Disorders

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01313299

Y-52-52120-145

2010-019069-28 (EudraCT Number)

Details and patient eligibility

About

The purpose of this research study is to assess the efficacy of Dysport compared to placebo in improving muscle tone in hemiparetic subjects with upper limb spasticity due to stroke or traumatic brain injury.

Enrollment: 243 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients - post stroke or brain injury
• Modified Ashworth Scale ≥ 2
• Ambulatory patients

Exclusion criteria

• Previous treatment with botulinum toxin of any type within 4 months prior to study entry for any condition
• Physiotherapy initiated less than 4 weeks before inclusion
• Previous surgery, alcohol, phenol in upper limb
• Neurological/neuromuscular disorders which may interfere with protocol evaluations

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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243 participants in 3 patient groups, including a placebo group

Dysport 500 U

Experimental group

Treatment:

Biological: Botulinum toxin type A

Biological: Botulinum toxin type A

Dysport 1000 U

Experimental group

Treatment:

Biological: Botulinum toxin type A

Biological: Botulinum toxin type A

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo