A Study to Compare the Safety and Efficacy of Dysport® and Botox® in Adults With Upper Limb Spasticity.
- Conditions
- Upper Limb Spasticity
- Interventions
- Biological: AboBoNT-ABiological: OnaBoNT-A
- Registration Number
- NCT04936542
- Lead Sponsor
- Ipsen
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 464
- 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;
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Sequence 2 OnaBoNT-A Participants will receive one cycle of onaBoNT-A followed by one cycle of aboBoNT-A in the selected overactive upper limb muscles Sequence 1 AboBoNT-A Participants will receive one cycle of aboBoNT-A followed by one cycle of onaBoNT-A in the selected overactive upper limb muscles Sequence 1 OnaBoNT-A Participants will receive one cycle of aboBoNT-A followed by one cycle of onaBoNT-A in the selected overactive upper limb muscles Sequence 2 AboBoNT-A Participants will receive one cycle of onaBoNT-A followed by one cycle of aboBoNT-A in the selected overactive upper limb muscles
- Primary Outcome Measures
Name Time Method Rate of Treatment-emergent Adverse Events (TEAEs) from baseline (injection) to 12 weeks (injection cycle 1 and 2, each cycle is a maximum 24 weeks))
- Secondary Outcome Measures
Name Time Method Duration of response baseline (injection) to retreatment criteria met, from week 10 up to week 24 (for each cycle, 1&2) or baseline to withdrawal or end of study if retreatment criteria not met, up to 24 weeks (for each cycle,1&2, each cycle is a maximum 24 weeks) Rate of Adverse Drug Reactions (ADRs), Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) from baseline (injection) to 12 weeks (injection cycle 1 and 2, each cycle is a maximum 24 weeks)) Muscle tone assessed by Modified Ashworth scale (MAS) total score at baseline (injection), 1 week, 4 weeks, 10 weeks, 12 weeks and additional visits at 16 weeks, 20 weeks, 24 weeks (injection cycle 1 and 2; each cycle is a maximum 24 weeks) MAS is a scale which represents improvement in spasticity. This tool assesses muscle tone using a six-point scale from 0 = no change to 4 = considerable increase of affected/rigid region.
Perceived function and pain assessed by the Disability Assessment Scale (DAS) total score at baseline (injection), 1 week, 4 weeks, 10 weeks, 12 weeks and additional visits at 16 weeks, 20 weeks, 24 weeks (injection cycle 1 and 2; each cycle is a maximum 24 weeks) DAS scale to determine the extent of functional impairment in four domains: hygiene, dressing, limb position and pain. Impairment will be assessed on a four-point scale (range 0 to 3, where 0 indicates no disability and 3 indicates severe disability). The four domain ratings will be added to give an overall score between 0 and 12.
Change in Quality of Life (QoL) using the SF-12 perceived health score at baseline (injection), 4 weeks, 12 weeks and at end of each cycle (injection cycle 1 and 2; each cycle is a maximum 24 weeks) 12-Item Short-form Health Survey (SF-12) is a health survey that will assess general health and wellbeing. The SF-12 summary score is between 0 and 100, with higher scores indicating better self-reported health.
Change in Quality of Life (QoL) using SQoL-6D at baseline (injection), 4 weeks, 12 weeks and at end of each cycle (injection cycle 1 and 2; each cycle is a maximum 24 weeks) Spasticity-related Quality of Life Tool (SQoL-6D) is a brief questionnaire in six domains (pain/discomfort, involuntary movements or spasms, restricted range of movement, caring for the affected limb, using the affected limb and mobility/balance) using a five-level scale ranging from 0 to 4, with higher scores meaning worse condition.
Physician global assessment (PGA) of treatment response at baseline (injection), 1 week, 4 weeks, 10 weeks, 12 weeks and additional visits at 16 weeks, 20 weeks, 24 weeks (injection cycle 1 and 2; each cycle is a maximum 24 weeks) PGA answers will be made on a nine-point rating scale (from -4 = markedly worse, to +4 = markedly improved).
Trial Locations
- Locations (76)
Victoria General Hospital
🇨🇦Victoria, Canada
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
Montefiore Medical Center
🇺🇸Bronx, New York, 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
Aether Medicine
🇺🇸Wayne, Pennsylvania, 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
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
🇨🇦Montréal, Canada
Centre Les Capucins
🇫🇷Angers, France
Hôpital Pellegrin CHU Bordeaux
🇫🇷Bordeaux, France
Hopital Sud
🇫🇷Echirolles, 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