Phase 4
N=42
Study to Assess Impact of Dysport Injections Early After Stroke on Upper Limb Spasticity Progression
Stroke · Upper Limb Spasticity
Bottom Line
View on ClinicalTrials.gov: NCT02321436 ↗Enrolled (actual)
42
Serious AEs
7.1%
Results posted
Jun 2017
Primary outcome: Primary: Time Between the Initial Injection and the Appearance of Reinjection Criteria as Evaluated by the Modified Ashworth Scale (MAS) and Spasticity Symptoms — 156; 32 days — p=0.0176
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Botulinum toxin type A (Biological); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Ipsen
- Primary completion
- Mar 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time Between the Initial Injection and the Appearance of Reinjection Criteria as Evaluated by the Modified Ashworth Scale (MAS) and Spasticity Symptoms |
156; 32 | 0.0176 sig |
| SECONDARY Mean Change in MAS of the Primary Targeted Muscle Group. |
-1.27; -0.26; -1.29; -0.24; -1.29; -0.24 | 0.0005 sig |
| SECONDARY Mean Change in Fugl-Meyer Assessment for Evaluation of UL Motor Impairment. |
6.4; 5.6; 7.4; 8.3; 6.9; 9.2 | 0.8754 |
| SECONDARY Global Assessment of Changes at Last Visit |
9.1; 0; 81.8; 83.3; 4.5; 16.7 | 0.6128 |
| SECONDARY Number of Concomitant Non-drug Therapy Sessions. |
25; 14; 22; 14; 8; 5 | — |
| SECONDARY Mean Duration of Concomitant Non-drug Therapy Sessions. |
160.5; 126.1; 157.9; 126.1; 184.9; 154.6 | — |
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.
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT02321436). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.