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

NCT02321436 | Completed Phase 4 Results

• 1 other identifier: Y-79-52120-197
• Study Type: interventional
• Target: 42
• Locations: 4 countries
• Sites: 4

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.

Conditions

Stroke; Upper Limb Spasticity

Outcome Measures

Primary Outcomes (1)

• Time Between the Initial Injection and the Appearance of Reinjection Criteria as Evaluated by the Modified Ashworth Scale (MAS) and Spasticity Symptoms

  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.

  From Week 4 up to Week 28

Secondary Outcomes (5)

• Mean Change in MAS of the Primary Targeted Muscle Group.

  From baseline up to Week 28

• Mean Change in Fugl-Meyer Assessment for Evaluation of UL Motor Impairment.

  From baseline up to Week 28

• Global Assessment of Changes at Last Visit

  From Week 4 up to Week 28

• Number of Concomitant Non-drug Therapy Sessions.

  From baseline up to Week 28

• Mean Duration of Concomitant Non-drug Therapy Sessions.

  From baseline up to Week 28

Study Arms (2)

Treatment group

ACTIVE COMPARATOR

Dysport® 500U intramuscular injection

Biological: Botulinum toxin type A

Placebo Group

PLACEBO COMPARATOR

Placebo intramuscular injection

Drug: Placebo

Interventions

Botulinum toxin type A BIOLOGICAL

Subjects to receive Dysport® 500U administered intramuscularly in the targeted upper limb.

Also known as: AbobotulinumtoxinA (Dysport®)

Treatment group

Placebo DRUG

Placebo administered intramuscularly in the targeted upper limb.

Placebo Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Ipsen: lead

Study Sites (4)

Neurology Laboratory -University Malaya Medical Centre

Kuala Lumpur, 59100, Malaysia

Location

Center for Neurodiagnostic and Therapeutic Services Metropolitan Medical Center

Manila, 1003, Philippines

Location

TTSH Rehabilitation Centre Ang Mo Kio Community Hospital

Singapore, 569766, Singapore

Location

Department of rehabilitation Medicine Faculty of medicine Siriraj Hospital, Madihol University Hospital

Bangkok, 10700, Thailand

Location

Related Publications (1)

• 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.

  PMID: 29933562 DERIVED

MeSH Terms

Conditions

Stroke

Interventions

Botulinum Toxins, Type A; abobotulinumtoxinA

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Results Point of Contact

• Title: Medical Affairs Director, Neurology
• Organization: Ipsen

clinical.trials@ipsen.com

Study Officials

• Ipsen Medical Director

  Ipsen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2014
• First Posted: December 22, 2014
• Study Start: December 1, 2014
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: September 28, 2022
• Results First Posted: June 26, 2017

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will share
• Time Frame: Where applicable, data from eligible studies are available 6 months after the studied medicine and indication have been approved in the US and EU or after the primary manuscript describing the results has been accepted for publication, whichever is later.
• Access Criteria: Further details on Ipsen's sharing criteria, eligible studies and process for sharing are available here (https://vivli.org/members/ourmembers/).

Locations

PH (1); SG (1); MY (1); TH (1)