Dysport® Pediatric Lower Limb Spasticity Follow-on Study
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
2 other identifiers
interventional
216
6 countries
27
Brief Summary
The purpose of this research study was to determine the long term safety and efficacy of repeated treatments with Dysport® used in the treatment of lower limb spasticity in children with dynamic equinus foot deformity due to cerebral palsy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Oct 2011
Typical duration for phase_3
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 25, 2010
CompletedFirst Posted
Study publicly available on registry
December 1, 2010
CompletedStudy Start
First participant enrolled
October 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2015
CompletedResults Posted
Study results publicly available
June 1, 2017
CompletedSeptember 28, 2022
September 1, 2022
3.3 years
November 25, 2010
August 30, 2016
September 15, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Subjects With Treatment Emergent Adverse Events (TEAEs) Reported in the Double Blind (DB) + Open Label (OL) Period.
Adverse events (AEs) were monitored from the time of informed consent to the end of the study. All AEs were elicited by direct, non-leading questioning or by spontaneous reports.
From baseline (Day 1) until end of study (Week 40) of Cycle 1 and up to Week 28 of Cycles 2 to 4.
Secondary Outcomes (16)
Mean Change From Baseline (in the DB Study) in the MAS Score in the GSC Assessed at the Ankle Joint of the (Most) Affected Lower Limb
DB baseline; Weeks 4 and 12 of Treatment Cycles 1 to 3; Week 4 of Treatment Cycle 4
Mean Change From Baseline (Prior to the First Injection Cycle in the Hamstrings) in the MAS Score in the Knee Flexors Assessed at the Knee Joint of the (Most) Affected Lower Limb
Baseline and Weeks 4 and 12 of Treatment Cycles 1 to 3; Baseline and Week 4 of Treatment Cycle 4.
Mean Change From Baseline (Prior to the First Injection Cycle in Upper Limb Muscle Groups) in the Mean MAS Score for All Injected Upper Limb Muscle Groups From Treatment Cycle 2 Onwards
Baseline and Weeks 4 and 12 of Treatment Cycles 2 and 3.
Mean Physician's Global Assessment (PGA) Score
Weeks 4 and 12 of Treatment Cycles 1 to 3; Week 4 of Treatment Cycle 4.
Mean Goal Attainment Scale (GAS) Score
Weeks 4 and 12 of Treatment Cycles 1 to 3; Week 4 of Treatment Cycle 4
- +11 more secondary outcomes
Study Arms (1)
Dysport
EXPERIMENTALDysport was 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 varied from 5 Units (U)/Kg to 20 U/kg for one leg, or from 10 U/Kg to 30 U/kg for two legs, with a maximum dose of no more than 30 U/Kg overall, or 1000 U, whichever was reached first.
Interventions
Intramuscular (IM) injection on day 1 of each treatment cycle.
Eligibility Criteria
You may qualify if:
- Subjects were eligible for participation in the study if they met the following criteria:
- Completion of the double blind study (Study 141) up to the Week 12, Week 16, Week 22 or Week 28 follow up visit.
- Without any major protocol deviations and/or any ongoing adverse events (AEs), either of which, in the opinion of the Investigator would pose an unacceptable risk to the subject were he/she to continue receiving treatment in this open label extension study.
- Written informed consent obtained from the child's parent(s)/guardian(s) for this study, and assent from the child when and where applicable.
You may not qualify if:
- Subjects were excluded from entering the study for the following reasons:
- Major limitation in the passive range of motion at the ankle, as defined by maximum ankle dorsiflexion measured by the angle of arrest (XV1) at slow speed \<80° (TS angle) in the most affected leg to be injected.
- Unwillingness or inability to comply with the protocol.
- Current need for surgery for spasticity of the gastrocnemius-soleus complex (GSC) and/or hamstring muscles (and/or tendons) in the most affected leg to be injected.
- Treatment with any drug that interferes either directly or indirectly with neuromuscular function (e.g. aminoglycoside antibiotics) or neuroblocking agents used during surgery (e.g. curare) within the last 30 days prior to study medication or a planned treatment with such drugs.
- Be pregnant and/or lactating.
- Female subjects, not willing to use contraceptive measures throughout the course of the study if post pubertal and sexually active.
- An infection at the injection site(s).
- Planned treatment with any new investigational drug or device during the study period.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ipsenlead
Study Sites (27)
The Children's Hospital
Aurora, Colorado, 80045, United States
Rehabilitation Institute of Chicago
Chicago, Illinois, 60611, United States
Children's Hospital New Orleans
New Orleans, Louisiana, 70118, United States
Children's Hospital of Michigan
Detroit, Michigan, 48202, United States
Gillette Children's Speciality Healthcare
Saint Paul, Minnesota, 55101, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
Shriner's Hospital for Children
Portland, Oregon, 97210, United States
Texas Scottish Rite - Hospital for Children
Dallas, Texas, 75219, United States
Club De Leones Cruz Del Sur Rehabilitation Corporation Punta Arenas
Punta Arenas, Chile
Dr Roberto Del Rio Hospital
Santiago, Chile
Neurorehabilitation Laboratory, Pontifical Catholic University
Santiago, Chile
CHU Jean Minjoz
Besançon, France
Hospital San José Celaya
Celaya, Mexico
Centro de Rehabilitacion Infantil
Mexico City, Mexico
Centro de Rehabilitacion Integral de Queretaro (CRIQ)
Querétaro, Mexico
Non-public Healthcare Unit at the Association for Disabled People KROK PO KROKU
Gdansk, Poland
B i L- Specjalistyczne Centrum Medyczne
Lodz, Poland
Non-public Healthcare Unit - Grunwaldzka Clinic
Poznan, Poland
Non-public Healthcare Unit Mazovian Neurorehabilitatio
Wiązowna, Poland
Ghulane Military Medical Academy and School of Medicine
Ankara, Turkey (Türkiye)
Ibn-i-Sina Hospital
Ankara, Turkey (Türkiye)
Yildirim Beyazit Training and Research Hospital
Ankara, Turkey (Türkiye)
GATA Haydarpasa Training Hospital
Istanbul, Turkey (Türkiye)
Istanbul Fizik Tedavi Rehabilitasyon Egitim ve Arastirma Hastanesi
Istanbul, Turkey (Türkiye)
Istanbul University Medical School
Istanbul, Turkey (Türkiye)
Dokuz Eylül University Medical Faculty
Izmir, Turkey (Türkiye)
Kocaeli University Medical Faculty
İzmit, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Director, Neurology
- Organization
- Ipsen
Study Officials
- STUDY DIRECTOR
Ipsen Study Director
Ipsen
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 25, 2010
First Posted
December 1, 2010
Study Start
October 1, 2011
Primary Completion
January 1, 2015
Study Completion
January 1, 2015
Last Updated
September 28, 2022
Results First Posted
June 1, 2017
Record last verified: 2022-09
Data Sharing
- IPD Sharing
- Will share
- 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.
- Access Criteria
- Further details on Ipsen's sharing criteria, eligible studies and process for sharing are available here (https://vivli.org/members/ourmembers/).
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.