Dysport® Pediatric Lower Limb Spasticity Study - Full Text View

Purpose

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	Intervention	Phase
Cerebral Palsy Muscle Spasticity Children	Drug: Botulinum type A toxin (Dysport®) Drug: Placebo	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (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

Resource links provided by NLM:

MedlinePlus related topics: Botox Cerebral Palsy Paralysis

Drug Information available for: OnabotulinumtoxinA

Genetic and Rare Diseases Information Center resources: Cerebral Palsy

U.S. FDA Resources

Further study details as provided by Ipsen:

Primary Outcome Measures:

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:

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).
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).


Enrollment:	241
Study Start Date:	July 2011
Study Completion Date:	June 2014
Primary Completion Date:	February 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

Eligibility


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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01249417

Show 29 Study Locations

Sponsors and Collaborators

Ipsen

Investigators


Study Director:	Ipsen Study Director	Ipsen

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 )
Study First Received:	November 25, 2010
Results First Received:	August 30, 2016
Last Updated:	December 8, 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 incobotulinumtoxinA 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

ClinicalTrials.gov processed this record on June 22, 2017