Dysport® Pediatric Lower Limb Spasticity Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ipsen
ClinicalTrials.gov Identifier:
NCT01249417
First received: November 25, 2010
Last updated: September 30, 2014
Last verified: September 2014
  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:


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
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

  Hide Study Locations
Locations
United States, Colorado
The Children's Hospital
Aurora, Colorado, United States, 80045
United States, Illinois
Rehabilitation Institute of Chicago
Chicago, Illinois, United States, 60611
United States, Louisiana
Children's Hospital New Orleans
New Orleans, Louisiana, United States, 70118
United States, Michigan
Children's Hospital of Michigan
Detroit, Michigan, United States, 48202
United States, Minnesota
Gillette Children's Speciality Healthcare
Saint Paul, Minnesota, United States, 55101
United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
United States, Oregon
Shriner's Hospital for Children
Portland, Oregon, United States, 97210
United States, Texas
Texas Scottish Rite - Hospital for Children
Dallas, Texas, United States, 75219
Chile
Club De Leones Cruz Del Sur Rehabilitation Corporation, Punta Arenas
Region de Magallanes y de la Antartica Chilena, Chile
Dr Roberto Del Rio Hospital
Santiago, Chile
Neurorehabilitation Laboratory, Pontifical Catholic University
Santiago, Chile
France
CHU Jean Minjoz
Besancon, France
Mexico
Hospital San José Celaya
Celaya, Mexico
Centro de Rehabilitacion Infantil
Mexico City, Mexico
Centro de Rehabilitacion Integral de Queretaro (CRIQ)
Queretaro, Mexico
Hospital Central Dr Ignacio Morones Prieto
San Luis Potosi, Mexico
Poland
Non-public Healthcare Unit at the Association for Disabled People KROK PO KROKU
Gdansk, Poland
B i L- Specjalistyczne Centrum Medyczne
Lodz, Poland
Non-public Healthcare Unit - Grunwaldzka Clinic
Poznan, Poland
Non-public Healthcare Unit Mazovian Neurorehabilitatio
Wiazowna, Poland
Turkey
Ibn-i-Sina Hospital
Ankara, Turkey
Ghulane Military Medical Academy and School of Medicine
Ankara, Turkey
Yildirim Beyazit Training and Research Hospital
Ankara, Turkey
Istanbul Fizik Tedavi Rehabilitasyon Egitim ve Arastirma Hastanesi
Istanbul, Turkey
Istanbul University Medical School
Istanbul, Turkey
Istanbul Fizik Tedavi Rehabilitasyon
Istanbul, Turkey
GATA Haydarpasa Training Hospital
Istanbul, Turkey
Dokuz Eylül University Medical Faculty
Izmir, Turkey
Kocaeli University Medical Faculty
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: September 30, 2014
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
Muscle Hypertonia
Muscular Diseases
Musculoskeletal Diseases
Nervous System Diseases
Neurologic Manifestations
Neuromuscular Manifestations
Signs and Symptoms
Botulinum Toxins, Type A
Neuromuscular Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 23, 2014