Dysport® Pediatric Lower Limb Spasticity Study

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Ipsen
ClinicalTrials.gov Identifier:
NCT01249417
First received: November 25, 2010
Last updated: February 26, 2014
Last verified: February 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
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
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

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: February 26, 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
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 August 27, 2014