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Study to Assess Impact of Dysport Injections Early After Stroke on Upper Limb Spasticity Progression (ONTIME Pilot)

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ClinicalTrials.gov Identifier: NCT02321436
Recruitment Status : Completed
First Posted : December 22, 2014
Results First Posted : June 26, 2017
Last Update Posted : September 3, 2019
Sponsor:
Information provided by (Responsible Party):
Ipsen

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.

Condition or disease Intervention/treatment Phase
Stroke Upper Limb Spasticity Biological: Botulinum toxin type A Drug: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : December 2014
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox

Arm Intervention/treatment
Active Comparator: Treatment group
Dysport® 500U intramuscular injection
Biological: Botulinum toxin type A
Subjects to receive Dysport® 500U administered intramuscularly in the targeted upper limb.
Other Name: AbobotulinumtoxinA (Dysport®)

Placebo Comparator: Placebo Group
Placebo intramuscular injection
Drug: Placebo
Placebo administered intramuscularly in the targeted upper limb.




Primary Outcome Measures :
  1. 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 ]

    The appearance of increased muscle tone was assessed using the MAS (scale ranges from 0 [no increase in muscle tone] to 4 [affected part rigid in flexion or extension]). For confirmation of reinjection criteria appearance, a subject had to have a MAS score in the primary targeted muscle group of ≥2 and at least 1 of the following 4 criteria confirming signs of symptomatic spasticity in the UL:

    1. A Numeric Pain Rating Scale (NPRS) pain score ≥ 4 (NPRS ranges from 0 [no pain] to 10 [severe pain])
    2. An impact on passive function measured by a score of ≥ 1 on the 4-point Likert scale (scale ranges from 0 [no impact] to 3 [severe impact])
    3. An impact on active function measured by a score of ≥ 1 on the 4-point Likert scale
    4. An involuntary movements score ≥1 on the 4-point Likert scale in relevant upper limb.

    Results are reported overall for subjects with both symptomatic and asymptomatic spasticity.



Secondary Outcome Measures :
  1. Mean Change in MAS of the Primary Targeted Muscle Group. [ Time Frame: From baseline up to Week 28 ]
    Increased muscle tone in the primary muscle group (selected by the investigator at the first visit, based on his/her clinical judgement and in agreement with the subject, in one of the following muscle groups: elbow flexors or pronators, wrist flexors, or finger flexors) was assessed using the MAS. Scale ranges from 0 (no increase in muscle tone) to 4 (affected part rigid in flexion or extension). Least Squares (LS) mean change from baseline to each subsequent visit (including the subject's last study visit) of the MAS score is reported.

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

    The Fugl-Meyer assessment is a validated tool for measuring motor functioning, balance, sensation, and joint functioning in the upper or lower limbs of subjects with post-stroke hemiplegia. The assessment scale is comprised of 155 items across 5 domains: motor functioning, sensory functioning, balance, joint range of motion and joint pain. For this study, only the UL motor part was assessed using the following criteria:

    A. Upper Extremity (from 0 to 36) B. Wrist (from 0 to 10) C. Hand (from 0 to 14) D. Coordination / Speed (from 0 to 6)

    Total motor function scores (A-D [from 0 to 66]) were calculated and LS mean changes from baseline up to (but not including) the visit when the reinjection criteria were met were reported.

    Higher values for change from baseline indicated a better outcome.


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

    Global assessment of changes was assessed by the investigator from Week 4 up to (but not including) the visit when the reinjection criteria were met. This endpoint was assessed by the investigator using a 5-point Likert scale to answer the following question: How does your patient feel compared to his/her condition at the first visit?

    • Much better
    • Better
    • No change
    • Worse
    • Much worse

    Results are reported overall for subjects with both symptomatic and asymptomatic spasticity.


  4. Number of Concomitant Non-drug Therapy Sessions. [ Time Frame: From baseline up to Week 28 ]
    The number of non-drug therapy sessions that the subject received for UL spasticity in combination with injections of either Dysport® or placebo - up to and including the subject's last study visit - were recorded in the Electronic Case Report Form (eCRF) as part of concomitant medications and therapies evaluation at all study visits (Prior and Concomitant Non-Drug Therapies eCRF page). All concomitant therapies in the indication of "Post Stroke UL Spasticity" were counted by subject from first administration of Dysport® or placebo to last study visit. Concomitant non-drug therapies were defined as received any time during study (on or after the day of the first injection of Dysport® or placebo) regardless of the start or stop date. For each subject, overlapping sessions were defined as one therapy session using the earliest start date as the start date and the latest start date as the stop date.

  5. Mean Duration of Concomitant Non-drug Therapy Sessions. [ Time Frame: From baseline up to Week 28 ]
    The duration of non-drug therapy sessions that the subject received for UL spasticity in combination with injections of either Dysport® or placebo - up to and including the subject's last study visit - were recorded in the Electronic Case Report Form (eCRF) as part of concomitant medications and therapies evaluation at all study visits (Prior and Concomitant Non-Drug Therapies eCRF page). Overall duration of concomitant therapies in the indication of "Post Stroke UL Spasticity" was computed for the period from first administration of Dysport® or placebo to last study visit. Concomitant non-drug therapies were defined as received any time during study (on or after the day of the first injection of Dysport® or placebo) regardless of the start or stop date. For each subject, overlapping sessions were defined as one therapy session using the earliest start date as the start date and the latest start date as the stop date.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02321436


Locations
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Malaysia
Neurology Laboratory -University Malaya Medical Centre
Kuala Lumpur, Malaysia, 59100
Philippines
Center for Neurodiagnostic and Therapeutic Services Metropolitan Medical Center
Manila, Philippines, 1003
Singapore
TTSH Rehabilitation Centre Ang Mo Kio Community Hospital
Singapore, Singapore, 569766
Thailand
Department of rehabilitation Medicine Faculty of medicine Siriraj Hospital, Madihol University Hospital
Bangkok, Thailand, 10700
Sponsors and Collaborators
Ipsen
Investigators
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Study Director: Ipsen Medical Director Ipsen
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT02321436    
Other Study ID Numbers: Y-79-52120-197
First Posted: December 22, 2014    Key Record Dates
Results First Posted: June 26, 2017
Last Update Posted: September 3, 2019
Last Verified: August 2019
Additional relevant MeSH terms:
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Muscle Spasticity
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Botulinum Toxins
Botulinum Toxins, Type A
abobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents