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

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 ]

Estimated Enrollment:	228
Study Start Date:	July 2011
Estimated Study Completion Date:	December 2014
Estimated Primary Completion Date:	July 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
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

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

Contacts

Contact: Ipsen Recruitment Enquiries

clinical.trials@ipsen.com

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Locations

United States, Colorado
The Children's Hospital	Recruiting
Aurora, Colorado, United States, 80045
United States, Illinois
Rehabilitation Institute of Chicago	Recruiting
Chicago, Illinois, United States, 60611
United States, Louisiana
Children's Hospital New Orleans	Recruiting
New Orleans, Louisiana, United States, 70118
United States, Michigan
Children's Hospital of Michigan	Recruiting
Detroit, Michigan, United States, 48202
United States, Minnesota
Gillette Children's Speciality Healthcare	Recruiting
Saint Paul, Minnesota, United States, 55101
United States, Ohio
Cincinnati Children's Hospital Medical Center	Recruiting
Cincinnati, Ohio, United States, 45229
United States, Oregon
Shriner's Hospital for Children	Recruiting
Portland, Oregon, United States, 97210
United States, Texas
Texas Scottish Rite - Hospital for Children	Recruiting
Dallas, Texas, United States, 75219
Cook Children's Medical Center	Withdrawn
Fort Worth, Texas, United States, 76104
United States, Utah
Primary Children's Medical Center	Not yet recruiting
Salt Lake City, Utah, United States, 84113
Chile
Club De Leones Cruz Del Sur Rehabilitation Corporation, Punta Arenas	Recruiting
Region de Magallanes y de la Antartica Chilena, Chile
Neurorehabilitation Laboratory, Pontifical Catholic University	Recruiting
Santiago, Chile
Dr Roberto Del Rio Hospital	Recruiting
Santiago, Chile
France
CHU Jean Minjoz	Recruiting
Besancon, France
Centre des Massues - Hopital de Jour	Withdrawn
Lyon, France
CHU Rangueil	Not yet recruiting
Toulouse, France
Mexico
Hospital San José Celaya	Recruiting
Celaya, Mexico
Centro de Rehabilitacion Infantil	Recruiting
Mexico City, Mexico
Centro de Rehabilitacion Integral de Queretaro (CRIQ)	Recruiting
Queretaro, Mexico
Hospital Central Dr Ignacio Morones Prieto	Terminated
San Luis Potosi, Mexico
Poland
Non-public Healthcare Unit at the Association for Disabled People KROK PO KROKU	Recruiting
Gdansk, Poland
B i L- Specjalistyczne Centrum Medyczne	Recruiting
Lodz, Poland
Prof. Antoni Gebala Children Hospital	Withdrawn
Lublin, Poland
Non-public Healthcare Unit - Grunwaldzka Clinic	Recruiting
Poznan, Poland
Non-public Healthcare Unit Mazovian Neurorehabilitatio	Recruiting
Wiazowna, Poland
Turkey
Yildirim Beyazit Training and Research Hospital	Recruiting
Ankara, Turkey
Ibn-i-Sina Hospital	Recruiting
Ankara, Turkey
Ghulane Military Medical Academy and School of Medicine	Recruiting
Ankara, Turkey
Istanbul Fizik Tedavi Rehabilitasyon	Recruiting
Istanbul, Turkey
Istanbul Fizik Tedavi Rehabilitasyon Egitim ve Arastirma Hastanesi	Recruiting
Istanbul, Turkey
GATA Haydarpasa Training Hospital	Recruiting
Istanbul, Turkey
Istanbul University Medical School	Recruiting
Istanbul, Turkey
Dokuz Eylül University Medical Faculty	Not yet recruiting
Izmir, Turkey
Ege University Medical Faculty	Not yet recruiting
Izmir, Turkey
Kocaeli University Medical Faculty	Recruiting
Izmit, Turkey

Sponsors and Collaborators

Ipsen

Investigators

Study Director:

Ipsen Study Director

Ipsen

More Information

No publications provided

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:	April 22, 2013
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
Botulinum Toxins, Type A
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013