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Botox vs dysport: which lasts longer for stiff muscles?

NCT ID NCT04936542

Symptom relief Sponsor: Ipsen Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 10, 2026 · Updated 2 times

Summary

This study compared two botulinum toxin injections, Dysport and Botox, in 464 adults with upper limb spasticity (stiff muscles in the arm). The goal was to see if Dysport is as safe as Botox and whether it provides a longer duration of effect. Participants received both treatments in a crossover design, and researchers measured side effects and how long muscle relaxation lasted.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
botulinum toxin type A (Dysport or Botox)
What this could lead to
If it works, this could show that Dysport provides longer-lasting relief from arm muscle stiffness than Botox, with similar safety.
What could go wrong
This is a completed Phase 4 study, so results are already in. However, it compares two existing treatments, so no new breakthrough is expected. Individual responses may vary.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

464 people

The number who actually took part.

Started

Jun 2021

Finished

Aug 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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; * 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. 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; * 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

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Upper limb spasticity

Contacts and locations

Locations

  • Aether Medicine

    Wayne, Pennsylvania, 19087, United States

  • Beaumont Hospital, Grosse Pointe

    Grosse Pointe, Michigan, 48230, United States

  • Carilion Clinic Institute of Orthopaedics and Neurosciences

    Roanoke, Virginia, 24016, United States

  • Centre Hospitalier de Saint Amand Montrond

    Saint-Amand-Montrond, 18200, France

  • Centre Hospitalier de Saint-Amand-les-Eaux

    Saint-Amand-les-Eaux, 59230, France

  • Centre Les Capucins

    Angers, 49100, France

  • Centre Mutualiste de Rééducation et de Réadaptation Fonction

    Ploemeur, France

  • Centre de Perharidy

    Roscoff, 29680, France

  • Cleveland Clinic - Neurological Institute

    Cleveland, Ohio, 44195, United States

  • Cooper University Health Care

    Cherry Hill, New Jersey, 08003, United States

  • Emory University of School of Medicine

    Atlanta, Georgia, 30322, United States

  • First Choice Neurology

    Boca Raton, Florida, 33428, United States

  • Fort Wayne Neurological Center

    Fort Wayne, Indiana, 46804, United States

  • Genge Partners

    Montreal, H3A 2B4, Canada

  • Hasbani And Hasbani Medical Group

    New Haven, Connecticut, 06511, United States

  • Hawaii Pacific Neuroscience

    Honolulu, Hawaii, 96817, United States

  • HonorHealth Scottsdale Osborn Medical Center

    Scottsdale, Arizona, 85251, United States

  • Hopital Archet (CHU de Nice)

    Nice, 06202, France

  • Hopital Fernand Widal

    Paris, 75010, France

  • Hopital Henry Gabrielle (HCL)

    Saint-Genis-Laval, 69230, France

  • Hopital Sud

    Échirolles, 38434, France

  • Hopital de Rangueil

    Toulouse, 31059, France

  • Hopitaux Universitaires De Strasbourg

    Strasbourg, 67091, France

  • Hôpital Jean Bernard (CHU Poitiers)

    Poitiers, 86000, France

  • Hôpital Pellegrin CHU Bordeaux

    Bordeaux, 33000, France

  • Hôpital Pontchaillou (CHU Rennes)

    Rennes, 35033, France

  • Hôpital Saint-Jacques (CHU Nantes)

    Nantes, 44000, France

  • Hôpital d'Instruction des Armées Laveran

    Marseille, 13384, France

  • James A Haley Veterans Hospital

    Tampa, Florida, 33612, United States

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

    Overland Park, Kansas, 66211-1358, United States

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

    Stamford, Connecticut, 06905, United States

  • LSU Healthcare network

    New Orleans, Louisiana, 70112, United States

  • Lawson Health Research Institute

    London, Ontario, N6C 5J1, Canada

  • Loma Linda University Health Care

    Loma Linda, California, 92350, United States

  • Mary Free Bed Rehabilitation Hospital

    Grand Rapids, Michigan, 49503, United States

  • Mayo Clinic

    Rochester, New York, 55905, United States

  • MedStar National Rehabilitation Network

    Columbia, Washington, 20010, United States

  • Medical College of Wisconsin - Froedtert Hospital

    Milwaukee, Wisconsin, 53226, United States

  • Medical Rehabilitation Group, PC

    Grand Blanc, Michigan, 48439, United States

  • Michigan Center of Medical Research

    Grosse Pointe, Michigan, 48334, United States

  • Moncton Hospital

    Moncton, E1C 6Z8, Canada

  • Montefiore Medical Center

    The Bronx, New York, 10467, United States

  • MossRehab - Einstein Medical Center

    Elkins Park, Pennsylvania, 20010, United States

  • Movement Disorders Center of Arizona

    Scottsdale, Arizona, 85258, United States

  • Neuro-Pain Medical Center

    Fresno, California, 93710, United States

  • New York University

    New York, New York, 10016, United States

  • North Suffolk Neurology

    Port Jefferson, New York, 11725, United States

  • Parkinson's & Movement Disorders Institute

    Fountain Valley, California, 92708, United States

  • Penn State Health Physical Medicine and Rehabilitation - Neurology

    Hershey, Pennsylvania, 17033, United States

  • Pole Saint Helier

    Rennes, 35043, France

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

    Downey, California, 90242, United States

  • Rusk Rehabilitation Center

    Columbia, Missouri, 65203-3248, United States

  • Shirley Ryan Ability Lab

    Chicago, Illinois, 60611-3167, United States

  • Siskin Hospital for Rehabilitation - Neurology

    Chattanooga, Tennessee, 37403, United States

  • Southland Neurologic Institute

    Long Beach, California, 90808, United States

  • Stony Brook University Medical Center

    Stony Brook, New York, 11794, United States

  • Sunnyview Rehabilitation Hospital

    Schenectady, New York, 12308, United States

  • Swedish Neuroscience Institute

    Seattle, Washington, 98122, United States

  • TIRR Memorial Hermann Research Center

    Houston, Texas, 77030, United States

  • Texas Institute for Neurological Disorders

    Sherman, Texas, 75093, United States

  • The University of Arizona

    Tucson, Arizona, 85724, United States

  • The Vanderbilt Clinic

    Nashville, Tennessee, 37232, United States

  • UMass Memorial Medical Center - University Campus

    Worcester, Massachusetts, 01655, United States

  • UT Health San Antonio

    San Antonio, Texas, 78229, United States

  • University of Alabama

    Birmingham, Alabama, 25233, United States

  • University of California Los Angeles

    Los Angeles, California, 90095, United States

  • University of Louisville

    Louisville, Kentucky, 40202, United States

  • University of Pittsburgh Medical Center (UPMC)

    Pittsburgh, Pennsylvania, 15213, United States

  • University of Puerto Rico

    Santurce, Puerto Rico, 00912, Puerto Rico

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

    Tampa, Florida, 33612, United States

  • University of Texas Southwestern

    Dallas, Texas, 75390, United States

  • University of Utah School of Medicine

    Salt Lake City, Utah, 84132, United States

  • Victoria General Hospital

    Victoria, V9A 3P2, Canada

  • Weill Cornell Medicine Clinical and Translational Science Center

    New York, New York, 10065, United States

  • William Beaumont Hospital

    Dearborn, Michigan, 48124, United States

  • Wr-Crcn, Llc

    Las Vegas, Nevada, 89106, United States

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