A PHASE III, MULTICENTRE, DOUBLE BLIND, PROSPECTIVE, RANDOMISED, CONTROLLED, MULTIPLE TREATMENT STUDY ASSESSING EFFICACY AND SAFETY OF DYSPORT USED IN THE TREATMENT OF UPPER LIMB SPASTICITY IN CHILDRE

IPSEN INNOVATIO0 sites210 target enrollmentOctober 28, 2015

Overview

No summary available.

Registry

who.int

Start Date

October 28, 2015

End Date

TBD

Last Updated

7 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

IPSEN INNOVATIO

•(1\) Signed informed consent obtained from the child’s parent(s)/guardian(s) and, if applicable, a signed assent from the child.
•(2\) Be from 2 to 17 years of age, inclusive.
•(3\) Body weight of 10 kg or more at the baseline visit.
•(4\) Have a diagnosis of CP, as defined by Rosenbaum.
•(5\) Have increased muscle tone/spasticity in at least one upper limb.
•(6\) Have a MAS score \=2 in the upper limb PTMG (elbow flexors or wrist flexors) of the study limb (the limb to be injected in the first treatment) at the baseline visit.
•(7\) Be classified as Gross Motor Function Classification System Level 1 to 4\.
•(8\) If undergoing therapy, such as physiotherapy, occupational therapy, or use of splints and/or orthoses, therapy must have been initiated at least 30 days prior to the baseline visit and agreed to continue the therapy throughout the study and at the minimum, up to Week 16 following the first treatment administration.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 210

•(1\) Fixed myocontracture in the PTMG (elbow flexors or wrist flexors) of the study limb defined as having an available range of motion angle of \<40°, regardless of the starting and finishing angles, measured at the Tardieu Scale (TS) slow (XV1\) speed at the baseline visit. (Available range for wrist flexors should be measured without holding the fingers and allowing free finger flexion).
•(2\) Subjects likely to be treated with BTX in the lower limb(s) and/or the non\-study upper limb before Treatment 2 of the study.
•(3\) Inadequate washout from previous BTX injection of any serotype for any condition:
•Within 6 months prior to the baseline visit in the study limb,
•Within 3 months prior to the baseline visit in any other part of the body.
•(4\) Subjects who require BTX treatment in a single muscle group in the study limb in Treatment 1\.
•(5\) Severe athetoid or dystonic movements in the study limb.
•(6\) Previous or planned surgery for spasticity in the PTMG(s) of the study limb.
•(7\) Previous injection of alcohol and/or phenol within 1 year prior to the baseline visit affecting the study limb wrist flexors and/or elbow flexors selected for injection in Treatment 1\.
•(8\) 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 treatment.