Phase
Condition
Limb Spasticity
Treatment
OnaBoNT-A
AboBoNT-A
Clinical Study ID
Ages 18-80 All Genders
Study Summary
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
Connect with a study center
Lawson Health Research Institute
London, Ontario N6C 5J1
CanadaSite Not Available
Glenrose Rehabilitation Hospital
Edmonton, T5G 0B7
CanadaSite Not Available
CDHA
Halifax,
CanadaSite Not Available
Moncton Hospital
Moncton, E1C 6Z8
CanadaSite Not Available
Genge Partners
Montréal, H3A 2B4
CanadaSite Not Available
McGill University Health Center
Montréal, H3A 2B4
CanadaSite Not Available
Royal Columbian Hospital
New Westminster,
CanadaSite Not Available
Hotel Dieu Shaver Health And Rehabilitation Centre
Saint Catharines,
CanadaSite Not Available
West Park Healthcare Centre
Toronto,
CanadaSite Not Available
Victoria General Hospital
Victoria, V9A 3P2
CanadaSite Not Available
Victoria Medical Rehab Consultants
Victoria, V9A 3P2
CanadaSite Not Available
Centre Les Capucins
Angers, 49100
FranceSite Not Available
Hôpital Pellegrin CHU Bordeaux
Bordeaux, 33000
FranceSite Not Available
Hopital Albert Chennevier (CHU Henri Mondor)
Créteil, 94000
FranceSite Not Available
Hopital Sud
Echirolles, 38434
FranceSite Not Available
Hôpital d'Instruction des Armées Laveran
Marseille, 13384
FranceSite Not Available
Hôpital Saint-Jacques (CHU Nantes)
Nantes, 44000
FranceSite Not Available
Hopital Archet (CHU de Nice)
Nice, 06202
FranceSite Not Available
Hopital Fernand Widal
Paris, 75010
FranceSite Not Available
Hôpital Sainte-Marie Paris - Groupe VYV
Paris,
FranceSite Not Available
Centre Mutualiste de Rééducation et de Réadaptation Fonction
Ploemeur,
FranceSite Not Available
Hôpital Jean Bernard (CHU Poitiers)
Poitiers, 86000
FranceSite Not Available
Hôpital Pontchaillou (CHU Rennes)
Rennes, 35033
FranceSite Not Available
Pole Saint Helier
Rennes, 35043
FranceSite Not Available
Centre de Perharidy
Roscoff, 29680
FranceSite Not Available
Centre Hospitalier de Saint Amand Montrond
Saint-Amand-Montrond, 18200
FranceSite Not Available
Centre Hospitalier de Saint-Amand-les-Eaux
Saint-Amand-Montrond, 18200
FranceSite Not Available
Centre Hospitalier de Saint-Amand-les-Eaux
Saint-Amand-les-Eaux, 59230
FranceSite Not Available
Hopital Henry Gabrielle (HCL)
Saint-Genis-Laval, 69230
FranceSite Not Available
Hopitaux Universitaires De Strasbourg
Strasbourg, 67091
FranceSite Not Available
Hopital de Rangueil
Toulouse, 31059
FranceSite Not Available
University of Puerto Rico
Santurce, 00912
Puerto RicoSite Not Available
University of Alabama
Birmingham, Alabama 25233
United StatesSite Not Available
HonorHealth Scottsdale Osborn Medical Center
Scottsdale, Arizona 85251
United StatesSite Not Available
Movement Disorders Center of Arizona
Scottsdale, Arizona 85258
United StatesSite Not Available
The University of Arizona
Tucson, Arizona 85724
United StatesSite Not Available
Rancho Los Amigos National Rehabilitation Center (RLANRC) - Neurology
Downey, California 90242
United StatesSite Not Available
Parkinson's & Movement Disorders Institute
Fountain Valley, California 92708
United StatesSite Not Available
Neuro-Pain Medical Center
Fresno, California 93710
United StatesSite Not Available
Loma Linda University Health Care
Loma Linda, California 92350
United StatesSite Not Available
Southland Neurologic Institute
Long Beach, California 90808
United StatesSite Not Available
University of California Los Angeles
Los Angeles, California 90095
United StatesSite Not Available
Hasbani And Hasbani Medical Group
New Haven, Connecticut 06511
United StatesSite Not Available
Ki Health Partners LLC D/B/A New England Institute for Clinical Research
Stamford, Connecticut 06905
United StatesSite Not Available
First Choice Neurology
Boca Raton, Florida 33428
United StatesSite Not Available
Parkinson's Disease Treatment Center of S.W. Florida
Port Charlotte, Florida 33980
United StatesSite Not Available
Suncoast Neuroscience Associates, Inc
Saint Petersburg, Florida 33713
United StatesSite Not Available
James A Haley Veterans Hospital
Tampa, Florida 33612
United StatesSite Not Available
University of South Florida Health-Morsani Center for Advanced Healthcare
Tampa, Florida 33612
United StatesSite Not Available
Emory University of School of Medicine
Atlanta, Georgia 30322
United StatesSite Not Available
Hawaii Pacific Neuroscience
Honolulu, Hawaii 96817
United StatesSite Not Available
Shirley Ryan Ability Lab
Chicago, Illinois 60611-3167
United StatesSite Not Available
Fort Wayne Neurological Center
Fort Wayne, Indiana 46804
United StatesSite Not Available
McFarland Clinic PC
Ames, Iowa 500101
United StatesSite Not Available
Kansas City Bone and Joint Clinic, P.A. (KCBJ) - Overland Pa
Leawood, Kansas 66211-1358
United StatesSite Not Available
Kansas City Bone and Joint Clinic, P.A. (KCBJ) - Overland Pa
Overland Park, Kansas 66211-1358
United StatesSite Not Available
University of Louisville
Louisville, Kentucky 40202
United StatesSite Not Available
Culicchia Neurological Clinic
New Orleans, Louisiana 70115
United StatesSite Not Available
LSU Healthcare network
New Orleans, Louisiana 70112
United StatesSite Not Available
University Medical Center New Orleans
New Orleans, Louisiana 70112
United StatesSite Not Available
UMass Memorial Medical Center - University Campus
Worcester, Massachusetts 01655
United StatesSite Not Available
Quest Research Institute
Bingham Farms, Michigan 48025
United StatesSite Not Available
William Beaumont Hospital
Dearborn, Michigan 48124
United StatesSite Not Available
Ascension Genesys Hospital
Grand Blanc, Michigan 48439
United StatesSite Not Available
Medical Rehabilitation Group, PC
Grand Blanc, Michigan 48439
United StatesSite Not Available
Mary Free Bed Rehabilitation Hospital
Grand Rapids, Michigan 49503
United StatesSite Not Available
Beaumont Hospital, Grosse Pointe
Grosse Pointe, Michigan 48230
United StatesSite Not Available
Michigan Center of Medical Research
Grosse Pointe, Michigan 48334
United StatesSite Not Available
Wayne Neurology PLC
Plymouth, Michigan 48170
United StatesSite Not Available
Rusk Rehabilitation Center
Columbia, Missouri 65203-3248
United StatesSite Not Available
Wr-Crcn, Llc
Las Vegas, Nevada 89106
United StatesSite Not Available
Cooper University Health Care
Cherry Hill, New Jersey 08003
United StatesSite Not Available
Montefiore Medical Center
Bronx, New York 10467
United StatesSite Not Available
North Suffolk Neurology
Commack, New York 11725
United StatesSite Not Available
Mount Sinai Medical Center
New York, New York 10029
United StatesSite Not Available
NY Neurology Institute
New York, New York 10003
United StatesSite Not Available
New York University
New York, New York 10016
United StatesSite Not Available
Weill Cornell Medicine Clinical and Translational Science Center
New York, New York 10065
United StatesSite Not Available
North Suffolk Neurology
Port Jefferson, New York 11725
United StatesSite Not Available
Mayo Clinic
Rochester, New York 55905
United StatesSite Not Available
Sunnyview Rehabilitation Hospital
Schenectady, New York 12308
United StatesSite Not Available
Stony Brook University Medical Center
Stony Brook, New York 11794
United StatesSite Not Available
Cleveland Clinic - Neurological Institute
Cleveland, Ohio 44195
United StatesSite Not Available
MossRehab - Einstein Medical Center
Elkins Park, Pennsylvania 20010
United StatesSite Not Available
Penn State Health Physical Medicine and Rehabilitation - Neurology
Hershey, Pennsylvania 17033
United StatesSite Not Available
Rehabilitation Associates of the Main Line
Paoli, Pennsylvania 19301
United StatesSite Not Available
Temple University Hospital
Philadelphia, Pennsylvania 19140
United StatesSite Not Available
University of Pittsburgh Medical Center (UPMC)
Pittsburgh, Pennsylvania 15213
United StatesSite Not Available
Albert D. Janerich M.D. and Associates
Plains, Pennsylvania 18705
United StatesSite Not Available
Aether Medicine
Wayne, Pennsylvania 19087
United StatesSite Not Available
Siskin Hospital for Rehabilitation - Neurology
Chattanooga, Tennessee 37403
United StatesSite Not Available
The Vanderbilt Clinic
Nashville, Tennessee 37232
United StatesSite Not Available
University of Texas Southwestern
Dallas, Texas 75390
United StatesSite Not Available
North Texas Institute of Neurology & Headache
Frisco, Texas 75034
United StatesSite Not Available
TIRR Memorial Hermann Research Center
Houston, Texas 77030
United StatesSite Not Available
UT Health San Antonio
San Antonio, Texas 78229
United StatesSite Not Available
Texas Institute for Neurological Disorders
Sherman, Texas 75093
United StatesSite Not Available
University of Utah School of Medicine
Salt Lake City, Utah 84132
United StatesSite Not Available
Carilion Clinic Institute of Orthopaedics and Neurosciences
Roanoke, Virginia 24016
United StatesSite Not Available
Virginia Tech - Carilion School of Medicine
Roanoke, Virginia 24016
United StatesSite Not Available
MedStar National Rehabilitation Network
Columbia, Washington 20010
United StatesSite Not Available
MedStar National Rehabilitation Network
Northwest, Washington 20010
United StatesSite Not Available
Swedish Neuroscience Institute
Seattle, Washington 98122
United StatesSite Not Available
Medical College of Wisconsin - Froedtert Hospital
Milwaukee, Wisconsin 53226
United StatesSite Not Available
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