Dysport® Pediatric Lower Limb Spasticity Follow-on Study

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Ipsen
ClinicalTrials.gov Identifier:
NCT01251380
First received: November 25, 2010
Last updated: April 29, 2014
Last verified: April 2014
  Purpose

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
Children
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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Intensity of muscle tone rated by the Modified Ashworth scale [ Time Frame: Every 4 weeks ] [ Designated as safety issue: No ]
  • Physician's global assessment (PGA) of the treatment response [ Time Frame: Every 4 weeks ] [ Designated as safety issue: No ]
  • Measurement of progress towards individual therapy [ Time Frame: Every 4 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 221
Study Start Date: October 2011
Estimated Study Completion Date: June 2015
Estimated 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, which ever is reached first.
Drug: Botulinum type A toxin (Dysport®)
IM (in the muscle) injection on day 1 of each treatment cycle.

  Eligibility

Ages Eligible for Study:   2 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT01251380

  Show 28 Study Locations
Sponsors and Collaborators
Ipsen
Investigators
Study Director: Ipsen Study Director Ipsen
  More Information

No publications provided

Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT01251380     History of Changes
Other Study ID Numbers: Y-55-52120-147
Study First Received: November 25, 2010
Last Updated: April 29, 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 July 29, 2014