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Dysport® Pediatric Lower Limb Spasticity Study

Primary Purpose

Cerebral Palsy, Muscle Spasticity, Children

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Botulinum toxin type A
Placebo
Sponsored by
Ipsen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy

Eligibility Criteria

2 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Children's Hospital
  • Rehabilitation Institute of Chicago
  • Children's Hospital New Orleans
  • Children's Hospital of Michigan
  • Gillette Children's Speciality Healthcare
  • Cincinnati Children's Hospital Medical Center
  • Shriner's Hospital for Children
  • Texas Scottish Rite - Hospital for Children
  • Club De Leones Cruz Del Sur Rehabilitation Corporation, Punta Arenas
  • Dr Roberto Del Rio Hospital
  • Neurorehabilitation Laboratory, Pontifical Catholic University
  • CHU Jean Minjoz
  • Hospital San José Celaya
  • Centro de Rehabilitacion Infantil
  • Centro de Rehabilitacion Integral de Queretaro (CRIQ)
  • Hospital Central Dr Ignacio Morones Prieto
  • Non-public Healthcare Unit at the Association for Disabled People KROK PO KROKU
  • B i L- Specjalistyczne Centrum Medyczne
  • Non-public Healthcare Unit - Grunwaldzka Clinic
  • Non-public Healthcare Unit Mazovian Neurorehabilitatio
  • Ghulane Military Medical Academy and School of Medicine
  • Ibn-i-Sina Hospital
  • Yildirim Beyazit Training and Research Hospital
  • GATA Haydarpasa Training Hospital
  • Istanbul Fizik Tedavi Rehabilitasyon Egitim ve Arastirma Hastanesi
  • Istanbul Fizik Tedavi Rehabilitasyon
  • Istanbul University Medical School
  • Dokuz Eylül University Medical Faculty
  • Kocaeli University Medical Faculty

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Dysport 10 U/Kg

Dysport 15 U/Kg

Placebo

Arm Description

10 U/Kg per lower limb. Either one or both lower limbs can be treated. Total volume injected, 2ml per leg.

15 U/Kg per lower limb. Either one or both lower limbs can be treated. Total volume injected, 2ml per leg.

Total volume to be injected per lower limb - 2ml. Either one or both lower limbs can be treated.

Outcomes

Primary Outcome Measures

Change in MAS Score in the Gastrocnemius-soleus Complex (GSC) at the Ankle Joint of the (Most) Affected Lower Limb
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.
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
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).

Full Information

First Posted
November 25, 2010
Last Updated
September 15, 2022
Sponsor
Ipsen
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1. Study Identification

Unique Protocol Identification Number
NCT01249417
Brief Title
Dysport® Pediatric Lower Limb Spasticity Study
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 Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ipsen

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy, Muscle Spasticity, Children

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
241 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dysport 10 U/Kg
Arm Type
Experimental
Arm Description
10 U/Kg per lower limb. Either one or both lower limbs can be treated. Total volume injected, 2ml per leg.
Arm Title
Dysport 15 U/Kg
Arm Type
Experimental
Arm Description
15 U/Kg per lower limb. Either one or both lower limbs can be treated. Total volume injected, 2ml per leg.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Total volume to be injected per lower limb - 2ml. Either one or both lower limbs can be treated.
Intervention Type
Biological
Intervention Name(s)
Botulinum toxin type A
Other Intervention Name(s)
AbobotulinumtoxinA (Dysport®)
Intervention Description
I.M. (in the muscle) injection on day 1 of a single treatment cycle.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
I.M. injection on day 1 of a single treatment cycle.
Primary Outcome Measure Information:
Title
Change in MAS Score in the Gastrocnemius-soleus Complex (GSC) at the Ankle Joint of the (Most) Affected Lower Limb
Description
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).
Time Frame
Change from baseline to Week 4
Secondary Outcome Measure Information:
Title
Physician's Global Assessment (PGA) of the Treatment Response.
Description
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).
Time Frame
Week 4
Title
Goal Attainment Scale (GAS) Score
Description
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).
Time Frame
Week 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ipsen Study Director
Organizational Affiliation
Ipsen
Official's Role
Study Director
Facility Information:
Facility Name
The Children's Hospital
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Rehabilitation Institute of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Children's Hospital New Orleans
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70118
Country
United States
Facility Name
Children's Hospital of Michigan
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Gillette Children's Speciality Healthcare
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55101
Country
United States
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Facility Name
Shriner's Hospital for Children
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Texas Scottish Rite - Hospital for Children
City
Dallas
State/Province
Texas
ZIP/Postal Code
75219
Country
United States
Facility Name
Club De Leones Cruz Del Sur Rehabilitation Corporation, Punta Arenas
City
Punta Arenas
Country
Chile
Facility Name
Dr Roberto Del Rio Hospital
City
Santiago
Country
Chile
Facility Name
Neurorehabilitation Laboratory, Pontifical Catholic University
City
Santiago
Country
Chile
Facility Name
CHU Jean Minjoz
City
Besancon
Country
France
Facility Name
Hospital San José Celaya
City
Celaya
Country
Mexico
Facility Name
Centro de Rehabilitacion Infantil
City
Mexico City
Country
Mexico
Facility Name
Centro de Rehabilitacion Integral de Queretaro (CRIQ)
City
Queretaro
Country
Mexico
Facility Name
Hospital Central Dr Ignacio Morones Prieto
City
San Luis Potosi
Country
Mexico
Facility Name
Non-public Healthcare Unit at the Association for Disabled People KROK PO KROKU
City
Gdansk
Country
Poland
Facility Name
B i L- Specjalistyczne Centrum Medyczne
City
Lodz
Country
Poland
Facility Name
Non-public Healthcare Unit - Grunwaldzka Clinic
City
Poznan
Country
Poland
Facility Name
Non-public Healthcare Unit Mazovian Neurorehabilitatio
City
Wiazowna
Country
Poland
Facility Name
Ghulane Military Medical Academy and School of Medicine
City
Ankara
Country
Turkey
Facility Name
Ibn-i-Sina Hospital
City
Ankara
Country
Turkey
Facility Name
Yildirim Beyazit Training and Research Hospital
City
Ankara
Country
Turkey
Facility Name
GATA Haydarpasa Training Hospital
City
Istanbul
Country
Turkey
Facility Name
Istanbul Fizik Tedavi Rehabilitasyon Egitim ve Arastirma Hastanesi
City
Istanbul
Country
Turkey
Facility Name
Istanbul Fizik Tedavi Rehabilitasyon
City
Istanbul
Country
Turkey
Facility Name
Istanbul University Medical School
City
Istanbul
Country
Turkey
Facility Name
Dokuz Eylül University Medical Faculty
City
Izmir
Country
Turkey
Facility Name
Kocaeli University Medical Faculty
City
Izmit
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized, and study documents will be redacted to protect the privacy of study participants. Any requests should be submitted to www.vivli.org for assessment by an independent scientific review board.
IPD Sharing Time Frame
Where applicable, data from eligible studies are available 6 months after the studied medicine and indication have been approved in the US and EU or after the primary manuscript describing the results has been accepted for publication, whichever is later.
IPD Sharing Access Criteria
Further details on Ipsen's sharing criteria, eligible studies and process for sharing are available here (https://vivli.org/members/ourmembers/).
IPD Sharing URL
https://vivli.org/members/ourmembers/

Learn more about this trial

Dysport® Pediatric Lower Limb Spasticity Study

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