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

Completed · Phase 4

Conditions studied: Upper Limb Spasticity

In brief

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.

Key facts

Study ID: NCT04936542
Run by: Ipsen
People needed: 464
Starts: 2021-06-23
Expected to finish: 2025-08-26
Last updated by the study team: 2026-07-09

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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;
Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
Male participants: Male participants must agree that, if their partner is at risk of becoming pregnant, they will use an effective method of contraception. The participants must agree to use the contraception during the whole period of the study.
Female participants:A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies:
Is a woman of non-childbearing potential, defined as postmenopausal for at least
1 year; surgical sterilisation at least 3 months before entering the study; or hysterectomy. or
Is a woman of childbearing potential (WOCBP) and using an acceptable contraceptive method during the entire study period.A WOCBP must have a negative highly sensitive pregnancy test at screening (urine or serum) as required by local regulations.

You may not qualify if…

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;
abnormal screening/baseline findings or any other medical condition(s) that, in the opinion of the investigator, might jeopardise the participant's safety
Women who are pregnant or lactating
In the clinical judgement of the investigator, BoNT treatment is inappropriate
BoNT naïve participants with a history of facial neurogenic disorder (facial paralysis, polyradiculoneuropathy) (only for France)
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
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.
Participants previously randomised for this study
Participants unwilling or unable to understand the nature, scope and possible consequences of the study and to comply with study procedures and requirements
Participants currently enrolled in any other clinical study or have participated in one within the 12 weeks (or 5 half-lives of the investigational product of that study, whichever is longer) prior to enrolment/inclusion visit, or are scheduled to receive a new investigational drug while the study is ongoing

Where it is running

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
University of Alabama — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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