Dysport® Pediatric Lower Limb Spasticity Study

Study Description

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Brief Summary:

The purpose of this research study is to determine whether Dysport® is effective in the treatment of increased stiffness of the calf muscles and to evaluate the safety of this treatment in children with Cerebral Palsy. In addition this study will also check whether Dysport® can lessen the pain caused by spasticity and improve the child's wellbeing.

Condition or disease	Intervention/treatment	Phase
Cerebral Palsy; Muscle Spasticity; Children	Drug: Botulinum type A toxin (Dysport®); Drug: Placebo	Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	241 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	A Phase III, Multicentre, Double Blind, Prospective, Randomised, Placebo Controlled Study Assessing the Efficacy and Safety of DYSPORT® Used in the Treatment of Lower Limb Spasticity in Children With Dynamic Equinus Foot Deformity Due to Cerebral Palsy
Study Start Date :	July 2011
Actual Primary Completion Date :	February 2014
Actual Study Completion Date :	June 2014

Arms and Interventions

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Arm	Intervention/treatment
Experimental: Dysport 10 U/Kg; 10 U/Kg per lower limb. Either one or both lower limbs can be treated. Total volume injected, 2ml per leg.	Drug: Botulinum type A toxin (Dysport®); I.M. (in the muscle) injection on day 1 of a single treatment cycle.
Experimental: Dysport 15 U/Kg; 15 U/Kg per lower limb. Either one or both lower limbs can be treated. Total volume injected, 2ml per leg.	Drug: Botulinum type A toxin (Dysport®); I.M. (in the muscle) injection on day 1 of a single treatment cycle.
Placebo Comparator: Placebo; Total volume to be injected per lower limb - 2ml. Either one or both lower limbs can be treated.	Drug: Placebo; I.M. injection on day 1 of a single treatment cycle.

Outcome Measures

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Primary Outcome Measures :

1. Change in MAS Score in the Gastrocnemius-soleus Complex (GSC) at the Ankle Joint of the (Most) Affected Lower Limb [ Time Frame: Change from baseline to Week 4 ]
   The MAS is a 6-point scale which measures the intensity of muscle tone by measuring the resistance of the muscle to passive lengthening or stretching. Investigator will grade muscle tone in the GSC from 0 (no increase in tone) to 4 (affected parts rigid in flexion or extension).

Secondary Outcome Measures :

1. Physician's Global Assessment (PGA) of the Treatment Response. [ Time Frame: Week 4 ]
   PGA Scale of the Treatment Response: Global assessment of treatment response assessed by asking the Investigator the following question: "how would you rate the response to treatment in the subject's lower limb(s) since the last injection?" Answers will be made on a 9 point rating scale (-4: markedly worse, -3: much worse, -2: worse, -1: slightly worse, 0: no change, +1: slightly improved, +2: improved, +3: much improved, +4: markedly improved).
2. Goal Attainment Scale (GAS) Score [ Time Frame: Week 4 ]
   GAS is a functional scale used to measure progress towards individual therapy goals. Individual goals defined for each subject by the physician, and the child's parents (caregiver) where applicable, prior to treatment. Post-baseline, the GAS for each goal rated using a defined scale (-2: Much less than expected outcome, -1: somewhat less than expected outcome, 0: expected outcome, 1: somewhat more than expected outcome, and 2: Much more than expected outcome).

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	2 Years to 17 Years (Child)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• Children aged 2 to 17 years with cerebral palsy
• Equinus foot position
• Ambulatory
• Intensity of muscle tone equal to or greater than 2 in affected lower limb, as measured on the Modified Ashworth Scale

Exclusion Criteria:

• Fixed contracture
• Previous phenol, alcohol injection or surgical intervention
• Other neurological / neuromuscular disorder
• Severe athetoid or dystonic movements

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

  Show 29 Study Locations

Sponsors and Collaborators

Ipsen

Investigators

Study Director:	Ipsen Study Director	Ipsen

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Ipsen
ClinicalTrials.gov Identifier:	NCT01249417 History of Changes
Other Study ID Numbers:	Y-55-52120-141; 2009-017709-12 ( EudraCT Number )
First Posted:	November 29, 2010
Results First Posted:	February 3, 2017
Last Update Posted:	February 3, 2017
Last Verified:	December 2016

Additional relevant MeSH terms:

Cerebral Palsy; Muscle Spasticity; Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms	abobotulinumtoxinA; Botulinum Toxins, Type A; onabotulinumtoxinA; Acetylcholine Release Inhibitors; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Cholinergic Agents; Neurotransmitter Agents; Physiological Effects of Drugs; Neuromuscular Agents; Peripheral Nervous System Agents