1. A Phase III prospective, multi-center, randomised, evaluator
The Nordic NeuroMuscular Junction Study A Phase III, prospective, multi-center, randomised, evaluator-blinded study An IPSEN AB sponsored study
Dept. of Dystonia, Bispebjerg Hospital, DK, Dept. of Neurology, Glostrup Hospital, DK, Dept. of Neurology, Roskilde Hospital, DK, Dept. of Neurology, Sydvestjysk Hospital, Esbjerg, DK, Dept. of Clinical Neurophysiology, Aalborg Hospital, DK, Neurocenter, Region Hospital Hammel, DK, Dept. of Neurology, Vejle Hospital, DK, Dept. of Rehabilitation, Central Hospital of Central Finland, FI, Invalidiliitto Käpylä Rehab center, FI, Dept. of Neurology, North Karelia Central Hospital, FI, Invalidiliiton Lapin kontouskekus, FI, Dept. of Neurology, Tampere University Hospital, FI, Dept. of Rehabilitation, Sykehuset Telemark HF, NO. Dept. of Neurology, Haukeland University Hospital, NO, Dept. of Medicine, Nyköpings Hospital, SE, Dept. of Rehabilitation Medicines, Sahlgrenska University Hospital, SE, Dept. of Hand Surgery, University Hospital Örebro, SE, NeuroUnit, Läkarhuset Odenplan, SE, Dept. of Rehabilitation Medicines, Danderyd Hospital, SE, Östersunds Rehabilitation Center, SE, NeuroUnit Utsikten, SE, Dept. of Rehabilitation Medicines, Mälarsjukhuset, SE, Dept. of Geriatric and Rehabilitation,Ystad Hospital, SE.
A Phase III prospective, multi-center, randomised, evaluator
blinded study to compare neuromuscular junction (NMJ) targeted technique for Dysport injections in upper limb spasticity post stroke or traumatic brain injury to the technique used in current clinical practice.
Introduction
 A study by Gracies et al (2009) showed that a NMJ targeted injection and a low-concentration dilution are superior to a NMJ non targeted injection of a high-concentration dilution, when injecting biceps brachii with BoNT-A in patients with spastic hemiparesis.
Mayer et al (2008) found that a NMJ targeted injection had similar impact on elbow flexor hypertonia when using a low-concentration dilution as multi-site distributed injections.
Injection techniques used in clinical practice for treatment of arm spasticity varies, however a common technique is to actively search for single NMJ zones by the use of electromyography (EMG) and inject where the EMG provides the strongest output. This implies a number of injection points per muscle.
Hypothesis
One high volume injection centrally located in the area/band of the NMJ zones will be as effective as the technique used today in current medical practice.
Primary Objective To compare Dysport treatment results after; - Clinical practice technique and 300U/mL dilution TO - Neuro muscular junction (NMJ) targeted technique and 100U/mL dilution Treatment efficacy in the elbow joint assessed by the Modified Ashworth Scale (MAS) 4 weeks post treatment. Change from baseline to week 4 for elbow flexors muscle tone. The clinical relevant change is considered to be -1 on the MAS scale
Study Design
Logistics
258 patients to be included
5-20 patients/clinic
25-30 clinics in the Nordic
Yearly investigator meetings
Presentation of results, Q4 2015
Publication, Q2-Q3 2016
NMJ targeted
injection points
Main Secondary Objectives
Elbow joint, assessed by MAS, Change from baseline to week 12
Wrist joint, assessed by MAS, Change from baseline to week 4 and 12
Elbow and wrist joints combined, assessed by MAS,
Change from baseline to week 4 and 12
Spasticity pain measured by VAS,
Mean change from baseline to week 4 and 12 of spasticity related pain
Injection pain measured by VAS,
Subject perceived injection site pain at day 1
Achievement of the primary goal measured by GAS,
At baseline, the investigator will interview the subject to identify the main problem area and establish an agreed primary goal related to elbow flexion to be followed up at week 4 or 12
Expected Recruitment
NORWAY
DENMARK
FINLAND
SWEDEN
Expected Outcome
- New scientific information
- Fewer injections for the patients
reduction of up to 16 injection points
- An easy to use injection technique
- Development of national BoNT-A injection guidelines