Dysport® Adult Lower Limb Spasticity Study

Ipsen

Status and phase: Completed; Phase 3

Conditions: Leg Spasticity

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01249404

Y-55-52120-140

2009-015868-34 (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 lower limb spasticity due to stroke or traumatic brain injury.

Enrollment: 388 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects aged 18 to 80 years of age
• Post stroke or brain injury
• Intensity of muscle tone greater than or equal to 2, as measured on the Modified Ashworth Scale
• Ambulatory patients

Exclusion criteria

• Fixed contractures
• Physiotherapy initiated less than 4 weeks before entry
• Previous surgery or previous treatment with phenol and/or alcohol in lower 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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388 participants in 3 patient groups, including a placebo group

Dysport® 1000 U, IM

Experimental group

Description:

1000 U, I.M. (in the muscle), on day 1 (single treatment cycle)

Treatment:

Biological: Botulinum toxin type A

Dysport® 1500 U, IM

Experimental group

Description:

1500 U, I.M., on day 1 (single treatment cycle)

Treatment:

Biological: Botulinum toxin type A

Placebo

Placebo Comparator group

Description:

I.M., on day 1 (single treatment cycle)

Treatment:

Drug: Placebo