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Dysport® Pediatric Lower Limb Spasticity Follow-on Study

This study has been completed.
Information provided by (Responsible Party):
Ipsen Identifier:
First received: November 25, 2010
Last updated: May 26, 2015
Last verified: May 2015
The purpose of this research study is to determine whether repeat treatments with Dysport® are safe and effective in the treatment of increased stiffness of the calf muscles and whether Dysport® can lessen the pain caused by spasticity and improve the child's wellbeing.

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

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase III, Prospective, Multicentre, Open Label, Extension Study Assessing the Long Term Safety and Efficacy of Repeated Treatment With 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:
  • Safety through collection of Adverse Events [ Time Frame: Every 4 weeks ]

Secondary Outcome Measures:
  • Intensity of muscle tone rated by the Modified Ashworth scale [ Time Frame: Every 4 weeks ]
  • Physician's global assessment (PGA) of the treatment response [ Time Frame: Every 4 weeks ]
  • Measurement of progress towards individual therapy [ Time Frame: Every 4 weeks ]

Enrollment: 216
Study Start Date: October 2011
Study Completion Date: January 2015
Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dysport
Dysport is injected into either one or both lower limbs in up to 4 cycles of treatment, a minimum of 12 weeks apart and up to a maximum of 40 weeks apart. Doses vary from 5 U/Kg per leg, up to 15 U/Kg per leg, with a maximum dose of no more than 30 U/Kg overall, or 1000 U, whichever is reached first.
Drug: Botulinum type A toxin (Dysport®)
IM (in the muscle) injection on day 1 of each treatment cycle.


Ages Eligible for Study:   2 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Completion of Dysport® Pediatric Lower Limb Spasticity Double Blind Study, Y-55-52120-141 (NCT01249417)

Exclusion Criteria:

  • Fixed contracture
  • Current need for surgery of the muscles of any affected limb
  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 identifier: NCT01251380

  Show 27 Study Locations
Sponsors and Collaborators
Study Director: Ipsen Study Director Ipsen
  More Information

Responsible Party: Ipsen Identifier: NCT01251380     History of Changes
Other Study ID Numbers: Y-55-52120-147
Study First Received: November 25, 2010
Last Updated: May 26, 2015

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
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 processed this record on May 23, 2017