A Study to Compare the Safety and Efficacy of Dysport® and Botox® in Adults With Upper Limb Spasticity.

Last updated: March 31, 2025
Sponsor: Ipsen
Overall Status: Active - Not Recruiting

Phase

4

Condition

Limb Spasticity

Treatment

OnaBoNT-A

AboBoNT-A

Clinical Study ID

NCT04936542
CLIN-52120-452
2021-000161-32
  • Ages 18-80
  • All Genders

Study Summary

This study is aiming to demonstrate the non-inferiority of AbobotulinumtoxinA (aboBoNT-A) versus OnabotulinumtoxinA (onaBoNT-A) as the primary safety endpoint, and the superiority of aboBoNT-A over onaBoNT-A with respect to duration of response as the key secondary efficacy endpoint when used at optimal doses according to approved prescribing information of each product.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participant must be 18 to 80 years of age inclusive, at the time of signing theinformed consent

  • 2a. [US/France] Participants with stable Upper Limb Spasticity (ULS) for at least 3months, in whom treatment of only one upper limb is necessary for the duration ofthe study;

  • 2b. [Canada] Participants with stable post-stroke ULS for at least 3 months, in whomtreatment of only one upper limb is necessary for the duration of the study

  • Participants who are either naïve to Botulinum toxin type A (BoNT-A) for ULS or whohave been previously treated with BoNT-A for ULS;

  • Participants with MAS score of at least 2 at two muscle groups (one of these twomuscles groups should be the PTMG) and at least 1 in the remaining muscle group.

  • Participants with DAS score of at least 2 on the Principal Target of Treatment (PTT) (one of four functional domains: dressing, hygiene, limb position and pain);

  • Participants who require BoNT-A injection in all of the following muscles: flexorcarpi radialis, flexor carpi ulnaris, flexor digitorum profundus, flexor digitorumsuperficialis and biceps brachii;

  • Participants for whom injection of a total dose of 900 Units aboBoNT-A or 360 UnitsonaBoNT-A is considered by the investigator to be clinically appropriate;

  • Participants who have been stable for at least 3 months prior to study entry interms of oral antispasticity, anticoagulant and/or anticholinergic medication iftreated are considered by the investigator likely to remain stable for the durationof the study;

Exclusion

Exclusion Criteria:

  • Major limitations in the passive range of motion in the paretic upper limb;

  • Major neurological impairment (other than limb paresis) that could negatively affectfunctional performance;

  • Participants clinically requiring injection into any upper limb muscles other thanthe five muscles of one arm listed in Section 5.1, or requiring injection into botharms or any lower limb within the timeframe of the study;

  • Hypersensitivity to any BoNT product or excipients;

  • Hypersensitivity to cow's milk protein (casein);

  • Infection at the proposed injection site(s);

  • Known peripheral motor neuropathic diseases, amyotrophic lateral sclerosis orneuromuscular junction disorders (e.g. myasthenia gravis or Lambert-Eaton syndrome);

  • Any medical condition (including dysphagia or breathing difficulties/compromisedrespiratory function) that in the opinion of the investigator, might jeopardize theparticipant's safety;

  • Women who are pregnant or lactating

  • Participants treated with BoNT of any type for any indication (e.g. bladderinjection, headache or cosmetic) within the previous 12 weeks or planned/likely tobe treated during the course of the study;

  • Prior history of non-responsiveness to BoNT treatment;

  • Previous surgery, or administration of alcohol or phenol in the study limb 6 monthsor earlier from study enrolment or planned/likely to be treated during the course ofthe study;

  • Participants treated with intrathecal baclofen (except if treatment has reached astable dose for >4 weeks and is likely to remain stable throughout the study),aminoglycosides or other agents interfering with neuromuscular transmission (e.g.curare-like agents) within the 4 weeks prior to study enrolment or planned/likely tobe treated during the course of the study

  • BoNT naïve participants with a history of facial neurogenic disorder (facialparalysis, polyradiculoneuropathy) (only for France).

  • Participants receiving concomitant medication treatment with the following PT/OTinterventions on the study limb: new splinting/orthotics/casting, serial casting,shockwave therapy, dry needling and needle tenotomies. However, PT/OT interventionsnot intended to reduce study limb spasticity (e.g. functional training exercises) orwith a transient (<1 day) reduction of study limb spasticity (e.g. stretching,weight bearing) are allowed.

Study Design

Total Participants: 464
Treatment Group(s): 2
Primary Treatment: OnaBoNT-A
Phase: 4
Study Start date:
June 23, 2021
Estimated Completion Date:
October 31, 2025

Connect with a study center

  • Lawson Health Research Institute

    London, Ontario N6C 5J1
    Canada

    Site Not Available

  • Glenrose Rehabilitation Hospital

    Edmonton, T5G 0B7
    Canada

    Site Not Available

  • CDHA

    Halifax,
    Canada

    Site Not Available

  • Moncton Hospital

    Moncton, E1C 6Z8
    Canada

    Site Not Available

  • Genge Partners

    Montréal, H3A 2B4
    Canada

    Site Not Available

  • McGill University Health Center

    Montréal, H3A 2B4
    Canada

    Site Not Available

  • Royal Columbian Hospital

    New Westminster,
    Canada

    Site Not Available

  • Hotel Dieu Shaver Health And Rehabilitation Centre

    Saint Catharines,
    Canada

    Site Not Available

  • West Park Healthcare Centre

    Toronto,
    Canada

    Site Not Available

  • Victoria General Hospital

    Victoria, V9A 3P2
    Canada

    Site Not Available

  • Victoria Medical Rehab Consultants

    Victoria, V9A 3P2
    Canada

    Site Not Available

  • Centre Les Capucins

    Angers, 49100
    France

    Site Not Available

  • Hôpital Pellegrin CHU Bordeaux

    Bordeaux, 33000
    France

    Site Not Available

  • Hopital Albert Chennevier (CHU Henri Mondor)

    Créteil, 94000
    France

    Site Not Available

  • Hopital Sud

    Echirolles, 38434
    France

    Site Not Available

  • Hôpital d'Instruction des Armées Laveran

    Marseille, 13384
    France

    Site Not Available

  • Hôpital Saint-Jacques (CHU Nantes)

    Nantes, 44000
    France

    Site Not Available

  • Hopital Archet (CHU de Nice)

    Nice, 06202
    France

    Site Not Available

  • Hopital Fernand Widal

    Paris, 75010
    France

    Site Not Available

  • Hôpital Sainte-Marie Paris - Groupe VYV

    Paris,
    France

    Site Not Available

  • Centre Mutualiste de Rééducation et de Réadaptation Fonction

    Ploemeur,
    France

    Site Not Available

  • Hôpital Jean Bernard (CHU Poitiers)

    Poitiers, 86000
    France

    Site Not Available

  • Hôpital Pontchaillou (CHU Rennes)

    Rennes, 35033
    France

    Site Not Available

  • Pole Saint Helier

    Rennes, 35043
    France

    Site Not Available

  • Centre de Perharidy

    Roscoff, 29680
    France

    Site Not Available

  • Centre Hospitalier de Saint Amand Montrond

    Saint-Amand-Montrond, 18200
    France

    Site Not Available

  • Centre Hospitalier de Saint-Amand-les-Eaux

    Saint-Amand-Montrond, 18200
    France

    Site Not Available

  • Centre Hospitalier de Saint-Amand-les-Eaux

    Saint-Amand-les-Eaux, 59230
    France

    Site Not Available

  • Hopital Henry Gabrielle (HCL)

    Saint-Genis-Laval, 69230
    France

    Site Not Available

  • Hopitaux Universitaires De Strasbourg

    Strasbourg, 67091
    France

    Site Not Available

  • Hopital de Rangueil

    Toulouse, 31059
    France

    Site Not Available

  • University of Puerto Rico

    Santurce, 00912
    Puerto Rico

    Site Not Available

  • University of Alabama

    Birmingham, Alabama 25233
    United States

    Site Not Available

  • HonorHealth Scottsdale Osborn Medical Center

    Scottsdale, Arizona 85251
    United States

    Site Not Available

  • Movement Disorders Center of Arizona

    Scottsdale, Arizona 85258
    United States

    Site Not Available

  • The University of Arizona

    Tucson, Arizona 85724
    United States

    Site Not Available

  • Rancho Los Amigos National Rehabilitation Center (RLANRC) - Neurology

    Downey, California 90242
    United States

    Site Not Available

  • Parkinson's & Movement Disorders Institute

    Fountain Valley, California 92708
    United States

    Site Not Available

  • Neuro-Pain Medical Center

    Fresno, California 93710
    United States

    Site Not Available

  • Loma Linda University Health Care

    Loma Linda, California 92350
    United States

    Site Not Available

  • Southland Neurologic Institute

    Long Beach, California 90808
    United States

    Site Not Available

  • University of California Los Angeles

    Los Angeles, California 90095
    United States

    Site Not Available

  • Hasbani And Hasbani Medical Group

    New Haven, Connecticut 06511
    United States

    Site Not Available

  • Ki Health Partners LLC D/B/A New England Institute for Clinical Research

    Stamford, Connecticut 06905
    United States

    Site Not Available

  • First Choice Neurology

    Boca Raton, Florida 33428
    United States

    Site Not Available

  • Parkinson's Disease Treatment Center of S.W. Florida

    Port Charlotte, Florida 33980
    United States

    Site Not Available

  • Suncoast Neuroscience Associates, Inc

    Saint Petersburg, Florida 33713
    United States

    Site Not Available

  • James A Haley Veterans Hospital

    Tampa, Florida 33612
    United States

    Site Not Available

  • University of South Florida Health-Morsani Center for Advanced Healthcare

    Tampa, Florida 33612
    United States

    Site Not Available

  • Emory University of School of Medicine

    Atlanta, Georgia 30322
    United States

    Site Not Available

  • Hawaii Pacific Neuroscience

    Honolulu, Hawaii 96817
    United States

    Site Not Available

  • Shirley Ryan Ability Lab

    Chicago, Illinois 60611-3167
    United States

    Site Not Available

  • Fort Wayne Neurological Center

    Fort Wayne, Indiana 46804
    United States

    Site Not Available

  • McFarland Clinic PC

    Ames, Iowa 500101
    United States

    Site Not Available

  • Kansas City Bone and Joint Clinic, P.A. (KCBJ) - Overland Pa

    Leawood, Kansas 66211-1358
    United States

    Site Not Available

  • Kansas City Bone and Joint Clinic, P.A. (KCBJ) - Overland Pa

    Overland Park, Kansas 66211-1358
    United States

    Site Not Available

  • University of Louisville

    Louisville, Kentucky 40202
    United States

    Site Not Available

  • Culicchia Neurological Clinic

    New Orleans, Louisiana 70115
    United States

    Site Not Available

  • LSU Healthcare network

    New Orleans, Louisiana 70112
    United States

    Site Not Available

  • University Medical Center New Orleans

    New Orleans, Louisiana 70112
    United States

    Site Not Available

  • UMass Memorial Medical Center - University Campus

    Worcester, Massachusetts 01655
    United States

    Site Not Available

  • Quest Research Institute

    Bingham Farms, Michigan 48025
    United States

    Site Not Available

  • William Beaumont Hospital

    Dearborn, Michigan 48124
    United States

    Site Not Available

  • Ascension Genesys Hospital

    Grand Blanc, Michigan 48439
    United States

    Site Not Available

  • Medical Rehabilitation Group, PC

    Grand Blanc, Michigan 48439
    United States

    Site Not Available

  • Mary Free Bed Rehabilitation Hospital

    Grand Rapids, Michigan 49503
    United States

    Site Not Available

  • Beaumont Hospital, Grosse Pointe

    Grosse Pointe, Michigan 48230
    United States

    Site Not Available

  • Michigan Center of Medical Research

    Grosse Pointe, Michigan 48334
    United States

    Site Not Available

  • Wayne Neurology PLC

    Plymouth, Michigan 48170
    United States

    Site Not Available

  • Rusk Rehabilitation Center

    Columbia, Missouri 65203-3248
    United States

    Site Not Available

  • Wr-Crcn, Llc

    Las Vegas, Nevada 89106
    United States

    Site Not Available

  • Cooper University Health Care

    Cherry Hill, New Jersey 08003
    United States

    Site Not Available

  • Montefiore Medical Center

    Bronx, New York 10467
    United States

    Site Not Available

  • North Suffolk Neurology

    Commack, New York 11725
    United States

    Site Not Available

  • Mount Sinai Medical Center

    New York, New York 10029
    United States

    Site Not Available

  • NY Neurology Institute

    New York, New York 10003
    United States

    Site Not Available

  • New York University

    New York, New York 10016
    United States

    Site Not Available

  • Weill Cornell Medicine Clinical and Translational Science Center

    New York, New York 10065
    United States

    Site Not Available

  • North Suffolk Neurology

    Port Jefferson, New York 11725
    United States

    Site Not Available

  • Mayo Clinic

    Rochester, New York 55905
    United States

    Site Not Available

  • Sunnyview Rehabilitation Hospital

    Schenectady, New York 12308
    United States

    Site Not Available

  • Stony Brook University Medical Center

    Stony Brook, New York 11794
    United States

    Site Not Available

  • Cleveland Clinic - Neurological Institute

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • MossRehab - Einstein Medical Center

    Elkins Park, Pennsylvania 20010
    United States

    Site Not Available

  • Penn State Health Physical Medicine and Rehabilitation - Neurology

    Hershey, Pennsylvania 17033
    United States

    Site Not Available

  • Rehabilitation Associates of the Main Line

    Paoli, Pennsylvania 19301
    United States

    Site Not Available

  • Temple University Hospital

    Philadelphia, Pennsylvania 19140
    United States

    Site Not Available

  • University of Pittsburgh Medical Center (UPMC)

    Pittsburgh, Pennsylvania 15213
    United States

    Site Not Available

  • Albert D. Janerich M.D. and Associates

    Plains, Pennsylvania 18705
    United States

    Site Not Available

  • Aether Medicine

    Wayne, Pennsylvania 19087
    United States

    Site Not Available

  • Siskin Hospital for Rehabilitation - Neurology

    Chattanooga, Tennessee 37403
    United States

    Site Not Available

  • The Vanderbilt Clinic

    Nashville, Tennessee 37232
    United States

    Site Not Available

  • University of Texas Southwestern

    Dallas, Texas 75390
    United States

    Site Not Available

  • North Texas Institute of Neurology & Headache

    Frisco, Texas 75034
    United States

    Site Not Available

  • TIRR Memorial Hermann Research Center

    Houston, Texas 77030
    United States

    Site Not Available

  • UT Health San Antonio

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Texas Institute for Neurological Disorders

    Sherman, Texas 75093
    United States

    Site Not Available

  • University of Utah School of Medicine

    Salt Lake City, Utah 84132
    United States

    Site Not Available

  • Carilion Clinic Institute of Orthopaedics and Neurosciences

    Roanoke, Virginia 24016
    United States

    Site Not Available

  • Virginia Tech - Carilion School of Medicine

    Roanoke, Virginia 24016
    United States

    Site Not Available

  • MedStar National Rehabilitation Network

    Columbia, Washington 20010
    United States

    Site Not Available

  • MedStar National Rehabilitation Network

    Northwest, Washington 20010
    United States

    Site Not Available

  • Swedish Neuroscience Institute

    Seattle, Washington 98122
    United States

    Site Not Available

  • Medical College of Wisconsin - Froedtert Hospital

    Milwaukee, Wisconsin 53226
    United States

    Site Not Available

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