Dysport® Adult Lower Limb Spasticity Follow-on Study

Ipsen

Status and phase: Completed; Phase 3

Conditions: Spasticity Post-Traumatic Brain Injury; Post-stroke Spasticity

Treatments: Biological: Botulinum toxin type A

Study type: Interventional

Funder types: Industry

Identifiers

NCT01251367

2009-017723-26 (EudraCT Number)

Y-55-52120-142

Details and patient eligibility

About

The purpose of this research study is to assess the long term safety of Dysport® in hemiparetic subjects with lower limb spasticity due to stroke or traumatic brain injury over repeated treatment cycles.

Enrollment: 352 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Completion of Dysport® Adult Lower Limb Spasticity Double Blind study Y-55-52120-140 (NCT01249404)

Exclusion criteria

• Fixed contractures in lower limb

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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352 participants in 1 patient group

Dysport®

Experimental group

Description:

Dysport® is injected into lower limbs across 4 cycles of treatment, a minimum of 12 weeks between 2 injections. Doses vary from 1000 U to 1500 U.

Treatment:

Biological: Botulinum toxin type A