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 Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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:

Intensity of muscle tone rated by the Modified Ashworth scale [ Time Frame: Change from baseline at week 4 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Physician's global assessment (PGA) of the treatment response. [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
Measurement of progress towards individual therapy [ Time Frame: Week 4 ] [ Designated as safety issue: No ]


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)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Children aged 2 to 17 years with cerebral palsy
Equinus foot position
Ambulatory
Intensity of muscle tone 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
Study First Received:	November 25, 2010
Last Updated:	May 26, 2015
Health Authority:	United States: Food and Drug Administration France: Agence Nationale de Sécurité du Médicament et des produits de santé Mexico: Ministry of Health Poland: Ministry of Health Turkey: Ministry of Health Chile: Ministry of Health

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 September 28, 2016