Study to Evaluate Effects of DYSPORT® Injected in Lower and Upper Limb Combined With Guided Self-Rehabilitation Contract (GSC)

NCT02969356 | Completed Phase 4 Results FDA Drug

• 2 other identifiers: F-FR-52120-2282016-001989-29
• Study Type: interventional
• Target: 157
• Locations: 4 countries
• Sites: 19

Brief Summary

The purpose of this clinical study is to assess whether AbobotulinumtoxinA (Dysport®) injections in upper and lower limbs accompanied with a personal exercise plan called "Guided Self-rehabilitation Contract" (GSC) can improve voluntary movements in subjects with hemiparesis.

Conditions

Spastic Hemiparesis

Outcome Measures

Primary Outcomes (1)

• Percentage of Responder Participants at Week 6 After the Second Injection, According to Composite Active Range of Motion (AROM) in the Primary TT Limb

  Percentage of responder participants according to AROM was measured by goniometer in the primary TT limb, using zero as the theoretical position of minimal stretch for the muscle assessed. Participants were asked to perform the active movement as far as possible against that muscle and the angle was measured. A participant was considered a responder if he/she achieved at least the predefined improvement threshold - larger or equal to 35 degrees in UL or 5 degrees in LL - in the primary TT limb (based on the composite AROM individual change from baseline to Week 6 after the second injection).

  At Week 6, Cycle 2

Secondary Outcomes (14)

• Percentage of Responder Participants at Week 6 After the First Injection, According to Composite AROM in the Primary TT Limb

  At Week 6, Cycle 1

• Mean Change From Baseline in AROM Against 10 Prespecified Muscle Groups at Week 6 and Week 12 of Each Treatment Cycle, Reinjection Cycle Visit and Last Study Visit

  Week 6 and Week 12 of each treatment cycle, reinjection cycle visit and last study visit

• Mean Change From Baseline in Composite AROM Against Injected Muscle Groups (Any of the 10 Prespecified Muscles) at Week 6 and Week 12 of Each Treatment Cycle, Reinjection Cycle Visit and Last Study Visit

  Week 6 and Week 12 of each treatment cycle, reinjection cycle visit and last study visit

• Mean Change From Baseline in Full Composite AROM Against 5 UL or 5 LL Muscle Groups, Regardless of Whether the Muscle Groups Were Injected or Not at Week 6 and Week 12 of Each Treatment Cycle, Reinjection Cycle Visit and Last Study Visit

  Week 6 and Week 12 of each treatment cycle, reinjection cycle visit and last study visit

• Mean Change From Baseline in Modified Frenchay Scale (MFS) Overall Score Evaluated Locally and Centrally at Week 12 of Each Treatment Cycle and Last Study Visit

  Week 12 of each treatment cycle and last study visit

Study Arms (1)

Dysport

EXPERIMENTAL

Each subject will undergo two intramuscular injection (treatment) cycles, receiving AbobotulinumtoxinA (Dysport®) 1500 U on Day 1 of each cycle; the two dosing occasions will be separated by at least 12 weeks (maximum 20 weeks). Subjects will also receive daily GSC therapy. The main focus of GSC will be on the primary treatment target (TT) limb (as determined at the Baseline Visit) and then the other limb. All muscle groups requiring active training and/or stretching should be trained. Subjects will be be given a diary to record each day whether they have performed the GSC therapy.

Biological: Botulinum toxin type A; Other: GSC

Interventions

Botulinum toxin type A BIOLOGICAL

Dysport® administered in both upper and lower limbs (total dose of 1500 U per injection split between the 2 limbs).

Also known as: AbobotulinumtoxinA (Dysport®)

Dysport

GSC OTHER

The GSC is a motivational tool. The physiotherapist will teach each subject the stretching postures and exercises to perform on a daily basis throughout the study. These will be tailored to the individual subject's needs and will form the GSC therapy.

Dysport

Eligibility Criteria

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

You may qualify if:

• Subjects aged at least the national legal adult age.
• Subjects with hemiparesis due to acquired brain injury (ABI) presenting with muscle overactivity impeding motor function based on investigator's judgement including, but not limited to, at least one of the following requiring botulinum neurotoxin (BoNT) treatment: typical clenched fist; flexed wrist; flexed elbow; or plantar flexed foot pattern.
• At least 12 months since the ABI (i.e. stroke or traumatic brain injury (TBI)).
• Naïve or non-naïve to BoNT treatment; if non-naïve, at least 4 months after the last BoNT injection, of any serotype.
• Upper limb active function with an overall score between 2 and 7, as assessed by Modified Frenchay Scale (MFS), if the primary TT limb is the upper limb (UL).
• A 10-metre maximal WS barefoot between 0.2 and 1.4 m/s, if the primary TT limb is the lower limb (LL). Maximal WS barefoot will be performed without walking aids. However, a cane may be permitted if absolutely necessary (although this may prevent detection of treatment-induced improvements). In this case, the same aid will have to be used for all WS assessments during the study.
• Subjects must provide written informed consent to participate in the study prior to any study-related procedures.
• Female subjects of childbearing potential (not surgically sterile or 2 years postmenopausal) must use a medically accepted method of contraception and must agree to continue use of this method for the duration of the study until the last visit of the subjects and for at least 12 weeks post injection. Acceptable methods of contraception include total abstinence, male partner has had a vasectomy, double barrier method (e.g. male condom plus spermicide, or female diaphragm plus spermicide), intrauterine device, or hormonal contraceptive (oral, transdermal, implanted and injected).
• Subjects must be willing and able to comply with study restrictions and to remain at the clinic for the required duration during the study period and willing to return to the clinic for the follow-up evaluation as specified in the protocol

You may not qualify if:

• Inability to understand protocol procedures and requirements, which, in the opinion of the investigator, could negatively impact on protocol compliance, in particularly inability to exercise according to the GSC.
• Previous surgery on the affected muscles and ligaments, tendons, nerve trunks, or bones of the treated upper or lower limb.
• Previous treatment with phenol and/or alcohol in any of the treated limbs any time before the study.
• Any medical condition (including severe dysphagia or breathing difficulties) that may increase, in the opinion of the investigator, the likelihood of adverse events (AEs) related to BoNT A treatment.
• Current, planned or received within the last 4 weeks prior to study treatment, treatment with any drug that interferes either directly or indirectly with neuromuscular function (for example, aminoglycosides).
• Major neurological impairment other than spastic paresis (including major proprioceptive ataxia or apraxia on the paretic side) that could negatively impact on the functional performance of the subject.
• Known disease of the neuromuscular junction (such as Lambert-Eaton myasthenic syndrome or myasthenia gravis).
• Known sensitivity to BoNT-A or any excipient of Dysport.
• Infection at the injection site(s).
• Current pregnancy or lactation. A pregnancy test will be performed at the start of the study for all female subjects of childbearing potential (i.e. not surgically sterile or 2 years postmenopausal).
• Mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study and/or evidence of an uncooperative attitude.
• Abnormal baseline findings or any other medical condition(s) that, in the opinion of the investigator, might jeopardise the subject's safety.
• Subjects treated, or likely to be treated, with intrathecal baclofen during the course of the study or during the 4 weeks before study entry.
• Subjects who have participated in any therapeutic clinical study/received any investigational agent within 30 days of enrolment.

Sponsors & Collaborators

• Ipsen: lead

Study Sites (19)

Kansas Institute of Research, Kansas City Bone & Joint Clinic, Division of Signature Medical Group of KC

Kansas City, Kansas, 66211, United States

Location

University of Pittsburgh Medical Center, Physical Medicine and Rehabilitation

Pittsburgh, Pennsylvania, 15213, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Department of Neurology, Division of Movement Disorders, Vanderbilt University

Nashville, Tennessee, 37240-7915, United States

Location

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

UT Health Physical Medicine & Rehabilitation Department, TIRR Memorial Hermann

Houston, Texas, 77030, United States

Location

Fakultní nemocnice Královské Vinohrady, Neurologická klinika

Brno, 100 34, Czechia

Location

Neurology and Physiotherapy Outpatient Clinic

Brno, 615 00, Czechia

Location

Fakultní nemocnice Brno Neurologická klinika

Brno, 625 00, Czechia

Location

Neurology Department - Regional Hospital Pardubice

Pardubice, 532 03, Czechia

Location

Department of Neurology and Center of Clinical Neuroscience, Charles University in Prague, 1st Faculty of Medicine and General University Hospital in Prague

Prague, 120 00, Czechia

Location

Service de Médecine Physique et Réadaptation, Hôpital Albert-Chenevier

Créteil, Cedex, 94010, France

Location

Service de Médecine Physique et de Réadaptation, Bâtiment Tastet-Girard, Groupe Hospitalier Pellegrin

Bordeaux, 33000, France

Location

Service de Médecine Physique et Réadaptation, Hôpital Sébastopol - CHU de Reims

Reims, 51100, France

Location

Service de Médecine Physique et Réadaptation, CHU Saint Etienne - Hôpital Bellevue

Saint-Etienne, 42055, France

Location

Federal Siberian Scientific Clinical Center

Krasnoyarsk, 660049, Russia

Location

Medical Rehabilitation Center

Moscow, 125367, Russia

Location

Saint-Petersburg Bekhterev Psychoneurological Research Institute

Saint Petersburg, 192019, Russia

Location

Samara Regional Clinical Hospital n.a. V.D.Seredavin

Samara, 443035, Russia

Location

Related Publications (1)

• Gracies JM, Francisco GE, Jech R, Khatkova S, Rios CD, Maisonobe P; ENGAGE Study Group. Guided Self-rehabilitation Contracts Combined With AbobotulinumtoxinA in Adults With Spastic Paresis. J Neurol Phys Ther. 2021 Jul 1;45(3):203-213. doi: 10.1097/NPT.0000000000000359.

  PMID: 34039905 DERIVED

Related Links

• Lay language results summary

MeSH Terms

Conditions

Hemiplegia

Interventions

Botulinum Toxins, Type A; abobotulinumtoxinA

Condition Hierarchy (Ancestors)

Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

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 Director
• Organization: Ipsen

clinical.trials@ipsen.com

see email

Study Officials

• Ipsen Medical Director

  Ipsen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2016
• First Posted: November 21, 2016
• Study Start: December 18, 2016
• Primary Completion: April 26, 2018
• Study Completion: July 1, 2018
• Last Updated: February 19, 2025
• Results First Posted: June 4, 2019

Record last verified: 2025-02

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

FR (4); RU (4); US (6); CZ (5)