Dysport® Pediatric Lower Limb Spasticity Study

Cerebral Palsy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01249417
• Other study ID #: Y-55-52120-141
• Secondary ID: 2009-017709-12
• Status: Completed
• Phase: Phase 3
• Start date: July 2011
• Est. completion date: June 2014

Study information

• Verified date: September 2022
• Source: Ipsen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 241
• Est. completion date: June 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy
• Children
• Muscle Spasticity

Intervention

Biological:
• Botulinum toxin type A
I.M. (in the muscle) injection on day 1 of a single treatment cycle.

Drug:
• Placebo
I.M. injection on day 1 of a single treatment cycle.

Locations

Country	Name	City	State
Chile	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
France	CHU Jean Minjoz	Besancon
Mexico	Hospital San José Celaya	Celaya
Mexico	Centro de Rehabilitacion Infantil	Mexico City
Mexico	Centro de Rehabilitacion Integral de Queretaro (CRIQ)	Queretaro
Mexico	Hospital Central Dr Ignacio Morones Prieto	San Luis Potosi
Poland	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	Wiazowna
Turkey	Ghulane Military Medical Academy and School of Medicine	Ankara
Turkey	Ibn-i-Sina Hospital	Ankara
Turkey	Yildirim Beyazit Training and Research Hospital	Ankara
Turkey	GATA Haydarpasa Training Hospital	Istanbul
Turkey	Istanbul Fizik Tedavi Rehabilitasyon	Istanbul
Turkey	Istanbul Fizik Tedavi Rehabilitasyon Egitim ve Arastirma Hastanesi	Istanbul
Turkey	Istanbul University Medical School	Istanbul
Turkey	Dokuz Eylül University Medical Faculty	Izmir
Turkey	Kocaeli University Medical Faculty	Izmit
United States	The Children's Hospital	Aurora	Colorado
United States	Rehabilitation Institute of Chicago	Chicago	Illinois
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio
United States	Texas Scottish Rite - Hospital for Children	Dallas	Texas
United States	Children's Hospital of Michigan	Detroit	Michigan
United States	Children's Hospital New Orleans	New Orleans	Louisiana
United States	Shriner's Hospital for Children	Portland	Oregon
United States	Gillette Children's Speciality Healthcare	Saint Paul	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Ipsen

Countries where clinical trial is conducted

United States,  Chile,  France,  Mexico,  Poland,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Change from baseline to Week 4
Secondary	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).	Week 4
Secondary	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).	Week 4