Clinical trial NCT02321436: Study to Assess Impact of Dysport Injections Early After Stroke on Upper Limb Spasticity Progression
Official title: Asian Multicentre, Double Blind, Randomised, Placebo Controlled Pilot Study, to Assess the Impact of Dysport® Intramuscular Injections When Administered Within the First 12 Weeks After Stroke on the Time to Spasticity Progression in Adult Subjects With Upper Limb (UL) Spasticity.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Stroke
Upper Limb Spasticity
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2014-12-22
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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)

Primary outcomes:
measure: Time Between the Initial Injection and the Appearance of Reinjection Criteria as Evaluated by the Modified Ashworth Scale (MAS) and Spasticity Symptoms
timeFrame: From Week 4 up to Week 28
Secondary outcomes:
measure: Mean Change in MAS of the Primary Targeted Muscle Group.
timeFrame: From baseline up to Week 28
measure: Mean Change in Fugl-Meyer Assessment for Evaluation of UL Motor Impairment.
timeFrame: From baseline up to Week 28
measure: Global Assessment of Changes at Last Visit
timeFrame: From Week 4 up to Week 28
measure: Number of Concomitant Non-drug Therapy Sessions.
timeFrame: From baseline up to Week 28
measure: Mean Duration of Concomitant Non-drug Therapy Sessions.
timeFrame: From baseline up to Week 28
Other outcomes:
Locations:
city: Kuala Lumpur
country: Malaysia
facility: Neurology Laboratory -University Malaya Medical Centre
city: Manila
country: Philippines
facility: Center for Neurodiagnostic and Therapeutic Services Metropolitan Medical Center
city: Singapore
country: Singapore
facility: TTSH Rehabilitation Centre Ang Mo Kio Community Hospital
city: Bangkok
country: Thailand
facility: Department of rehabilitation Medicine Faculty of medicine Siriraj Hospital, Madihol University Hospital
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References:
citation: Rosales RL, Balcaitiene J, Berard H, Maisonobe P, Goh KJ, Kumthornthip W, Mazlan M, Latif LA, Delos Santos MMD, Chotiyarnwong C, Tanvijit P, Nuez O, Kong KH. Early AbobotulinumtoxinA (Dysport(R)) in Post-Stroke Adult Upper Limb Spasticity: ONTIME Pilot Study. Toxins (Basel). 2018 Jun 21;10(7):253. doi: 10.3390/toxins10070253.