Study to Assess Impact of Dysport Injections Early After Stroke on Upper Limb Spasticity Progression

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02321436
• Date of registration: 17/12/2014
• Prospective Registration: No
• Primary sponsor: Ipsen
• Public title: Study to Assess Impact of Dysport Injections Early After Stroke on Upper Limb Spasticity Progression ONTIME Pilot
• Scientific 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.
• Date of first enrolment: December 2014
• Target sample size: 42
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02321436
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 4

Countries of recruitment

Malaysia, Philippines, Singapore, Thailand

Contacts

• Name: Ipsen Medical Director
• Affiliation: Ipsen

Key inclusion & exclusion 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)



Age minimum: 18 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Stroke

Upper Limb Spasticity

Intervention(s)

Drug: Placebo

Biological: Botulinum toxin type A

Primary Outcome(s)

Time Between the Initial Injection and the Appearance of Reinjection Criteria as Evaluated by the Modified Ashworth Scale (MAS) and Spasticity Symptoms [Time Frame: From Week 4 up to Week 28]

Secondary Outcome(s)

Mean Change in MAS of the Primary Targeted Muscle Group. [Time Frame: From baseline up to Week 28]

Mean Duration of Concomitant Non-drug Therapy Sessions. [Time Frame: From baseline up to Week 28]

Number of Concomitant Non-drug Therapy Sessions. [Time Frame: From baseline up to Week 28]

Mean Change in Fugl-Meyer Assessment for Evaluation of UL Motor Impairment. [Time Frame: From baseline up to Week 28]

Global Assessment of Changes at Last Visit [Time Frame: From Week 4 up to Week 28]

Secondary ID(s)

Y-79-52120-197

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 26/06/2017
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02321436