Dysport® Pediatric Lower Limb Spasticity Follow-on Study

Ipsen

Status and phase: Completed; Phase 3

Conditions: Cerebral Palsy; Children; Muscle Spasticity

Treatments: Biological: Botulinum toxin type A

Study type: Interventional

Funder types: Industry

Identifiers

NCT01251380

2010-019102-17 (EudraCT Number)

Y-55-52120-147

Details and patient eligibility

About

The purpose of this research study was to determine the long term safety and efficacy of repeated treatments with Dysport® used in the treatment of lower limb spasticity in children with dynamic equinus foot deformity due to cerebral palsy.

Enrollment: 216 patients

Sex: All

Ages: 2 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Subjects were eligible for participation in the study if they met the following criteria:

1. Completion of the double blind study (Study 141) up to the Week 12, Week 16, Week 22 or Week 28 follow up visit.
2. Without any major protocol deviations and/or any ongoing adverse events (AEs), either of which, in the opinion of the Investigator would pose an unacceptable risk to the subject were he/she to continue receiving treatment in this open label extension study.
3. Written informed consent obtained from the child's parent(s)/guardian(s) for this study, and assent from the child when and where applicable.

Exclusion criteria

Subjects were excluded from entering the study for the following reasons:

1. Major limitation in the passive range of motion at the ankle, as defined by maximum ankle dorsiflexion measured by the angle of arrest (XV1) at slow speed <80° (TS angle) in the most affected leg to be injected.
2. Unwillingness or inability to comply with the protocol.
3. Current need for surgery for spasticity of the gastrocnemius-soleus complex (GSC) and/or hamstring muscles (and/or tendons) in the most affected leg to be injected.
4. Treatment with any drug that interferes either directly or indirectly with neuromuscular function (e.g. aminoglycoside antibiotics) or neuroblocking agents used during surgery (e.g. curare) within the last 30 days prior to study medication or a planned treatment with such drugs.
5. Be pregnant and/or lactating.
6. Female subjects, not willing to use contraceptive measures throughout the course of the study if post pubertal and sexually active.
7. An infection at the injection site(s).
8. Planned treatment with any new investigational drug or device during the study period.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

216 participants in 1 patient group

Dysport

Experimental group

Description:

Dysport was injected into either one or both lower limbs in up to 4 cycles of treatment, a minimum of 12 weeks apart and up to a maximum of 40 weeks apart. Doses varied from 5 Units (U)/Kg to 20 U/kg for one leg, or from 10 U/Kg to 30 U/kg for two legs, with a maximum dose of no more than 30 U/Kg overall, or 1000 U, whichever was reached first.

Treatment:

Biological: Botulinum toxin type A