Study to Assess Impact of Dysport Injections Early After Stroke on Upper Limb Spasticity Progression (NCT02321436) | Clinical Trial Compass
CompletedPhase 4
Study to Assess Impact of Dysport Injections Early After Stroke on Upper Limb Spasticity Progression
Malaysia, Philippines, Singapore42 participantsStarted 2014-12
Plain-language summary
The purpose of this study is to investigate if early administration (i.e. within 12 weeks after stroke) of Dysport® 500 U injections may delay the appearance or the progression of upper limb symptomatic spasticity.
Who can participate
Age range18 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 2 to 12 weeks after first ever stroke according to the World Health Organisation criteria (previous transient ischaemic attack or clinically silent infarct on computerised tomography (CT)/magnetic resonance imaging (MRI) are not counted as previous stroke)
* Stroke confirmed by CT/MRI scan and classified as ischaemic/haemorrhagic stroke
* Presence of spasticity:
* either symptomatic, based on symptomatic spasticity criteria (i.e. at least one of the following items: impacted passive/active function, involuntary movements, or pain ≥4 on a numeric pain rating scale \[NPRS\]), in addition to increased muscle tone \[Modified Ashworth Scale, MAS ≥2\])
* or only increased muscle tone (MAS≥2)
Exclusion Criteria:
* Neuromuscular junction (NMJ) diseases, or any other neurological disorders (including prior local joint, tendon, and intrinsic muscle disorders) that could potentially interfere with assessment of spasticity in the primary targeted muscle group selected by the Investigator and in agreement with the subject
* Currently receiving drugs affecting NMJ transmission e.g. aminoglycosides, aminoquinolines, cyclosporine, D penicillamine
* Previous surgery of the affected muscles/ ligaments/tendons
* Severe comorbidities (e.g. congestive heart failure, myocardial infarction, multiple organ failure, hepatic renal failures, severe infections)
What they're measuring
1
Time Between the Initial Injection and the Appearance of Reinjection Criteria as Evaluated by the Modified Ashworth Scale (MAS) and Spasticity Symptoms