Dysport® Pediatric Lower Limb Spasticity Study
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| ClinicalTrials.gov Identifier: NCT01249417 |
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Recruitment Status :
Completed
First Posted : November 29, 2010
Results First Posted : February 3, 2017
Last Update Posted : November 5, 2020
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Sponsor:
Ipsen
Information provided by (Responsible Party):
Ipsen
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Brief Summary:
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 or disease | Intervention/treatment | Phase |
|---|---|---|
| Cerebral Palsy Muscle Spasticity Children | Biological: Botulinum toxin type A Drug: Placebo | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 241 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, 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 |
| Study Start Date : | July 2011 |
| Actual Primary Completion Date : | February 2014 |
| Actual Study Completion Date : | June 2014 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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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.
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Biological: Botulinum toxin type A
I.M. (in the muscle) injection on day 1 of a single treatment cycle.
Other Name: AbobotulinumtoxinA (Dysport®) |
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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.
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Biological: Botulinum toxin type A
I.M. (in the muscle) injection on day 1 of a single treatment cycle.
Other Name: AbobotulinumtoxinA (Dysport®) |
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Placebo Comparator: Placebo
Total volume to be injected per lower limb - 2ml. Either one or both lower limbs can be treated.
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Drug: Placebo
I.M. injection on day 1 of a single treatment cycle. |
Primary Outcome Measures :
- Change in MAS Score in the Gastrocnemius-soleus Complex (GSC) at the Ankle Joint of the (Most) Affected Lower Limb [ Time Frame: Change from baseline to Week 4 ]The MAS is a 6-point scale which measures the intensity of muscle tone by measuring the resistance of the muscle to passive lengthening or stretching. Investigator will grade muscle tone in the GSC from 0 (no increase in tone) to 4 (affected parts rigid in flexion or extension).
Secondary Outcome Measures :
- Physician's Global Assessment (PGA) of the Treatment Response. [ Time Frame: Week 4 ]PGA Scale of the Treatment Response: Global assessment of treatment response assessed by asking the Investigator the following question: "how would you rate the response to treatment in the subject's lower limb(s) since the last injection?" Answers will be made on a 9 point rating scale (-4: markedly worse, -3: much worse, -2: worse, -1: slightly worse, 0: no change, +1: slightly improved, +2: improved, +3: much improved, +4: markedly improved).
- Goal Attainment Scale (GAS) Score [ Time Frame: Week 4 ]GAS is a functional scale used to measure progress towards individual therapy goals. Individual goals defined for each subject by the physician, and the child's parents (caregiver) where applicable, prior to treatment. Post-baseline, the GAS for each goal rated using a defined scale (-2: Much less than expected outcome, -1: somewhat less than expected outcome, 0: expected outcome, 1: somewhat more than expected outcome, and 2: Much more than expected outcome).
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| Ages Eligible for Study: | 2 Years to 17 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Children aged 2 to 17 years with cerebral palsy
- Equinus foot position
- Ambulatory
- Intensity of muscle tone equal to or 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01249417
Locations
Show 29 study locations
Sponsors and Collaborators
Ipsen
Investigators
| Study Director: | Ipsen Study Director | Ipsen |
| Responsible Party: | Ipsen |
| ClinicalTrials.gov Identifier: | NCT01249417 |
| Other Study ID Numbers: |
Y-55-52120-141 2009-017709-12 ( EudraCT Number ) |
| First Posted: | November 29, 2010 Key Record Dates |
| Results First Posted: | February 3, 2017 |
| Last Update Posted: | November 5, 2020 |
| Last Verified: | November 2020 |
Additional relevant MeSH terms:
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Muscle Spasticity Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Nervous System Diseases Muscular Diseases Musculoskeletal Diseases Muscle Hypertonia Neuromuscular Manifestations Neurologic Manifestations |
Botulinum Toxins Botulinum Toxins, Type A abobotulinumtoxinA 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 |