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

NCT ID: NCT04936542

Last Updated: 2025-11-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 464 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-23
• Study Completion Date: 2025-08-26

Brief 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.

Conditions

Upper Limb Spasticity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Sequence 1

Participants will receive one cycle of aboBoNT-A followed by one cycle of onaBoNT-A in the selected overactive upper limb muscles

Group Type: OTHER

AboBoNT-A

Intervention Type: BIOLOGICAL

AbobotulinumtoxinA for injection: 500 Unit vial. Dose: 900 Units (3.6 mL)

OnaBoNT-A

Intervention Type: BIOLOGICAL

OnabotulinumtoxinA for injection: 200 Unit vial. Dose: 360 Units (3.6 mL)

Sequence 2

Participants will receive one cycle of onaBoNT-A followed by one cycle of aboBoNT-A in the selected overactive upper limb muscles

Group Type: OTHER

AboBoNT-A

Intervention Type: BIOLOGICAL

AbobotulinumtoxinA for injection: 500 Unit vial. Dose: 900 Units (3.6 mL)

OnaBoNT-A

Intervention Type: BIOLOGICAL

OnabotulinumtoxinA for injection: 200 Unit vial. Dose: 360 Units (3.6 mL)

Interventions

AboBoNT-A

AbobotulinumtoxinA for injection: 500 Unit vial. Dose: 900 Units (3.6 mL)

Intervention Type: BIOLOGICAL

OnaBoNT-A

OnabotulinumtoxinA for injection: 200 Unit vial. Dose: 360 Units (3.6 mL)

Intervention Type: BIOLOGICAL

Other Intervention Names

Dysport®; Botox®

Eligibility Criteria

Inclusion Criteria

• Participant must be 18 to 80 years of age inclusive, at the time of signing the informed consent
• 2a. [US/France] Participants with stable Upper Limb Spasticity (ULS) for at least 3 months, in whom treatment of only one upper limb is necessary for the duration of the study;
• 2b. [Canada] Participants with stable post-stroke ULS for at least 3 months, in whom treatment 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 who have been previously treated with BoNT-A for ULS;
• Participants with MAS score of at least 2 at two muscle groups (one of these two muscles 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: flexor carpi radialis, flexor carpi ulnaris, flexor digitorum profundus, flexor digitorum superficialis and biceps brachii;
• Participants for whom injection of a total dose of 900 Units aboBoNT-A or 360 Units onaBoNT-A is considered by the investigator to be clinically appropriate;
• Participants who have been stable for at least 3 months prior to study entry in terms of oral antispasticity, anticoagulant and/or anticholinergic medication if treated are considered by the investigator likely to remain stable for the duration of the study;

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 affect functional performance;
• Participants clinically requiring injection into any upper limb muscles other than the five muscles of one arm listed in Section 5.1, or requiring injection into both arms 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 or neuromuscular junction disorders (e.g. myasthenia gravis or Lambert-Eaton syndrome);
• Any medical condition (including dysphagia or breathing difficulties/compromised respiratory function) that in the opinion of the investigator, might jeopardize the participant's safety;
• Women who are pregnant or lactating
• Participants treated with BoNT of any type for any indication (e.g. bladder injection, headache or cosmetic) within the previous 12 weeks or planned/likely to be 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 months or earlier from study enrolment or planned/likely to be treated during the course of the study;
• Participants treated with intrathecal baclofen (except if treatment has reached a stable 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 to be treated during the course of the study
• BoNT naïve participants with a history of facial neurogenic disorder (facial paralysis, polyradiculoneuropathy) (only for France).
• Participants receiving concomitant medication treatment with the following PT/OT interventions on the study limb: new splinting/orthotics/casting, serial casting, shockwave therapy, dry needling and needle tenotomies. However, PT/OT interventions not intended to reduce study limb spasticity (e.g. functional training exercises) or with a transient (<1 day) reduction of study limb spasticity (e.g. stretching, weight bearing) are allowed.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ipsen

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ipsen Medical Director

Role: STUDY_DIRECTOR

Ipsen

Locations

University of Alabama

Birmingham, Alabama, United States

HonorHealth Scottsdale Osborn Medical Center

Scottsdale, Arizona, United States

Movement Disorders Center of Arizona

Scottsdale, Arizona, United States

The University of Arizona

Tucson, Arizona, United States

Rancho Los Amigos National Rehabilitation Center (RLANRC) - Neurology

Downey, California, United States

Parkinson's & Movement Disorders Institute

Fountain Valley, California, United States

Neuro-Pain Medical Center

Fresno, California, United States

Loma Linda University Health Care

Loma Linda, California, United States

Southland Neurologic Institute

Long Beach, California, United States

University of California Los Angeles

Los Angeles, California, United States

Hasbani And Hasbani Medical Group

New Haven, Connecticut, United States

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

Stamford, Connecticut, United States

First Choice Neurology

Boca Raton, Florida, United States

James A Haley Veterans Hospital

Tampa, Florida, United States

University of South Florida Health-Morsani Center for Advanced Healthcare

Tampa, Florida, United States

Emory University of School of Medicine

Atlanta, Georgia, United States

Hawaii Pacific Neuroscience

Honolulu, Hawaii, United States

Shirley Ryan Ability Lab

Chicago, Illinois, United States

Fort Wayne Neurological Center

Fort Wayne, Indiana, United States

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

Overland Park, Kansas, United States

University of Louisville

Louisville, Kentucky, United States

LSU Healthcare network

New Orleans, Louisiana, United States

UMass Memorial Medical Center - University Campus

Worcester, Massachusetts, United States

William Beaumont Hospital

Dearborn, Michigan, United States

Medical Rehabilitation Group, PC

Grand Blanc, Michigan, United States

Mary Free Bed Rehabilitation Hospital

Grand Rapids, Michigan, United States

Beaumont Hospital, Grosse Pointe

Grosse Pointe, Michigan, United States

Michigan Center of Medical Research

Grosse Pointe, Michigan, United States

Rusk Rehabilitation Center

Columbia, Missouri, United States

Wr-Crcn, Llc

Las Vegas, Nevada, United States

Cooper University Health Care

Cherry Hill, New Jersey, United States

New York University

New York, New York, United States

Weill Cornell Medicine Clinical and Translational Science Center

New York, New York, United States

North Suffolk Neurology

Port Jefferson, New York, United States

Mayo Clinic

Rochester, New York, United States

Sunnyview Rehabilitation Hospital

Schenectady, New York, United States

Stony Brook University Medical Center

Stony Brook, New York, United States

Montefiore Medical Center

The Bronx, New York, United States

Cleveland Clinic - Neurological Institute

Cleveland, Ohio, United States

MossRehab - Einstein Medical Center

Elkins Park, Pennsylvania, United States

Penn State Health Physical Medicine and Rehabilitation - Neurology

Hershey, Pennsylvania, United States

University of Pittsburgh Medical Center (UPMC)

Pittsburgh, Pennsylvania, United States

Aether Medicine

Wayne, Pennsylvania, United States

Siskin Hospital for Rehabilitation - Neurology

Chattanooga, Tennessee, United States

The Vanderbilt Clinic

Nashville, Tennessee, United States

University of Texas Southwestern

Dallas, Texas, United States

TIRR Memorial Hermann Research Center

Houston, Texas, United States

UT Health San Antonio

San Antonio, Texas, United States

Texas Institute for Neurological Disorders

Sherman, Texas, United States

University of Utah School of Medicine

Salt Lake City, Utah, United States

Carilion Clinic Institute of Orthopaedics and Neurosciences

Roanoke, Virginia, United States

MedStar National Rehabilitation Network

Columbia, Washington, United States

Swedish Neuroscience Institute

Seattle, Washington, United States

Medical College of Wisconsin - Froedtert Hospital

Milwaukee, Wisconsin, United States

Lawson Health Research Institute

London, Ontario, Canada

Moncton Hospital

Moncton, , Canada

Genge Partners

Montreal, , Canada

Victoria General Hospital

Victoria, , Canada

Centre Les Capucins

Angers, , France

Hôpital Pellegrin CHU Bordeaux

Bordeaux, , France

Hopital Sud

Échirolles, , France

Hôpital d'Instruction des Armées Laveran

Marseille, , France

Hôpital Saint-Jacques (CHU Nantes)

Nantes, , France

Hopital Archet (CHU de Nice)

Nice, , France

Hopital Fernand Widal

Paris, , France

Centre Mutualiste de Rééducation et de Réadaptation Fonction

Ploemeur, , France

Hôpital Jean Bernard (CHU Poitiers)

Poitiers, , France

Hôpital Pontchaillou (CHU Rennes)

Rennes, , France

Pole Saint Helier

Rennes, , France

Centre de Perharidy

Roscoff, , France

Centre Hospitalier de Saint-Amand-les-Eaux

Saint-Amand-les-Eaux, , France

Centre Hospitalier de Saint Amand Montrond

Saint-Amand-Montrond, , France

Hopital Henry Gabrielle (HCL)

Saint-Genis-Laval, , France

Hopitaux Universitaires De Strasbourg

Strasbourg, , France

Hopital de Rangueil

Toulouse, , France

University of Puerto Rico

Santurce, , Puerto Rico

Countries

United States; Canada; France; Puerto Rico

References

Esquenazi A, Ayyoub Z, Verduzco-Gutierrez M, Maisonobe P, Otto J, Patel AT. AbobotulinumtoxinA Versus OnabotulinumtoxinA in Adults with Upper Limb Spasticity: A Randomized, Double-Blind, Crossover Study Protocol. Adv Ther. 2021 Nov;38(11):5623-5633. doi: 10.1007/s12325-021-01896-3. Epub 2021 Sep 25.

Reference Type: DERIVED

PMID: 34562231 (View on PubMed)

Other Identifiers

2021-000161-32

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CLIN-52120-452

Identifier Type: -

Identifier Source: org_study_id