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

Upper Limb Spasticity Clinical Trial

— DIRECTION  

Official title:

A Multicentre, Interventional, Post-marketing, Randomised, Double-blind, Crossover Study to Evaluate the Clinical Safety and Efficacy of AbobotulinumtoxinA (Dysport®) in Comparison With OnabotulinumtoxinA (Botox®) When Treating Adults With Upper Limb Spasticity

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04936542
• Other study ID #: CLIN-52120-452
• Secondary ID: 2021-000161-32
• Status: Recruiting
• Phase: Phase 4
• Start date: June 23, 2021
• Est. completion date: June 28, 2025

Study information

• Verified date: May 2024
• Source: Ipsen
• Contact: Ipsen Recruitment Enquiries
• Phone: see email
• Email: clinical.trials[@]ipsen.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 298
• Est. completion date: June 28, 2025
• Est. primary completion date: June 28, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Muscle Spasticity
• Upper Limb Spasticity

Intervention

Biological:
• AboBoNT-A
AbobotulinumtoxinA for injection: 500 Unit vial. Dose: 900 Units (3.6 mL)
• OnaBoNT-A
OnabotulinumtoxinA for injection: 200 Unit vial. Dose: 360 Units (3.6 mL)

Locations

Country	Name	City	State
Canada	Glenrose Rehabilitation Hospital	Edmonton
Canada	CDHA	Halifax
Canada	Lawson Health Research Institute	London	Ontario
Canada	Moncton Hospital	Moncton
Canada	Genge Partners	Montréal
Canada	McGill University Health Center	Montréal
Canada	Royal Columbian Hospital	New Westminster
Canada	Hotel Dieu Shaver Health And Rehabilitation Centre	Saint Catharines
Canada	West Park Healthcare Centre	Toronto
Canada	Victoria Medical Rehab Consultants	Victoria
France	Centre Les Capucins	Angers
France	Hôpital Pellegrin CHU Bordeaux	Bordeaux
France	Hopital Albert Chennevier (CHU Henri Mondor)	Créteil
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	Hôpital Sainte-Marie Paris - Groupe VYV	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
Puerto Rico	University of Puerto Rico	Santurce
United States	McFarland Clinic PC	Ames	Iowa
United States	Emory University of School of Medicine	Atlanta	Georgia
United States	Quest Research Institute	Bingham Farms	Michigan
United States	University of Alabama	Birmingham	Alabama
United States	First Choice Neurology	Boca Raton	Florida
United States	Montefiore Medical Center	Bronx	New York
United States	Siskin Hospital for Rehabilitation - Neurology	Chattanooga	Tennessee
United States	Cooper University Health Care	Cherry Hill	New Jersey
United States	Shirley Ryan Ability Lab	Chicago	Illinois
United States	Cleveland Clinic - Neurological Institute	Cleveland	Ohio
United States	MedStar National Rehabilitation Network	Columbia	Washington
United States	Rusk Rehabilitation Center	Columbia	Missouri
United States	University of Texas Southwestern	Dallas	Texas
United States	William Beaumont Hospital	Dearborn	Michigan
United States	Rancho Los Amigos National Rehabilitation Center (RLANRC) - Neurology	Downey	California
United States	MossRehab - Einstein Medical Center	Elkins Park	Pennsylvania
United States	Fort Wayne Neurological Center	Fort Wayne	Indiana
United States	Parkinson's & Movement Disorders Institute	Fountain Valley	California
United States	Neuro-Pain Medical Center	Fresno	California
United States	North Texas Institute of Neurology & Headache	Frisco	Texas
United States	Ascension Genesys Hospital	Grand Blanc	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	Penn State Health Physical Medicine and Rehabilitation - Neurology	Hershey	Pennsylvania
United States	Hawaii Pacific Neuroscience	Honolulu	Hawaii
United States	TIRR Memorial Hermann Research Center	Houston	Texas
United States	Wr-Crcn, Llc	Las Vegas	Nevada
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	University of Louisville	Louisville	Kentucky
United States	Medical College of Wisconsin - Froedtert Hospital	Milwaukee	Wisconsin
United States	The Vanderbilt Clinic	Nashville	Tennessee
United States	Hasbani And Hasbani Medical Group	New Haven	Connecticut
United States	Culicchia Neurological Clinic	New Orleans	Louisiana
United States	LSU Healthcare network	New Orleans	Louisiana
United States	University Medical Center New Orleans	New Orleans	Louisiana
United States	Mount Sinai Medical Center	New York	New York
United States	New York University	New York	New York
United States	NY Neurology Institute	New York	New York
United States	Weill Cornell Medicine Clinical and Translational Science Center	New York	New York
United States	Kansas City Bone and Joint Clinic, P.A. (KCBJ) - Overland Pa	Overland Park	Kansas
United States	Rehabilitation Associates of the Main Line	Paoli	Pennsylvania
United States	Temple University Hospital	Philadelphia	Pennsylvania
United States	University of Pittsburgh Medical Center (UPMC)	Pittsburgh	Pennsylvania
United States	Albert D. Janerich M.D. and Associates	Plains	Pennsylvania
United States	Wayne Neurology PLC	Plymouth	Michigan
United States	Parkinson's Disease Treatment Center of S.W. Florida	Port Charlotte	Florida
United States	North Suffolk Neurology	Port Jefferson	New York
United States	Carilion Clinic Institute of Orthopaedics and Neurosciences	Roanoke	Virginia
United States	Virginia Tech - Carilion School of Medicine	Roanoke	Virginia
United States	Mayo Clinic	Rochester	New York
United States	Suncoast Neuroscience Associates, Inc	Saint Petersburg	Florida
United States	University of Utah School of Medicine	Salt Lake City	Utah
United States	UT Health San Antonio	San Antonio	Texas
United States	Sunnyview Rehabilitation Hospital	Schenectady	New York
United States	HonorHealth Scottsdale Osborn Medical Center	Scottsdale	Arizona
United States	Movement Disorders Center of Arizona	Scottsdale	Arizona
United States	Swedish Neuroscience Institute	Seattle	Washington
United States	Texas Institute for Neurological Disorders	Sherman	Texas
United States	Ki Health Partners LLC D/B/A New England Institute for Clinical Research	Stamford	Connecticut
United States	Stony Brook University Medical Center	Stony Brook	New York
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	The University of Arizona	Tucson	Arizona
United States	Aether Medicine	Wayne	Pennsylvania
United States	UMass Memorial Medical Center - University Campus	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Ipsen

Countries where clinical trial is conducted

United States,  Canada,  France,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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))
Secondary	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)
Secondary	Muscle tone assessed by Modified Ashworth scale (MAS) total score	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.	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)
Secondary	Perceived function and pain assessed by the Disability Assessment Scale (DAS) total score	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.	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)
Secondary	Physician global assessment (PGA) of treatment response	PGA answers will be made on a nine-point rating scale (from -4 = markedly worse, to +4 = markedly improved).	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)
Secondary	Change in Quality of Life (QoL) using the SF-12 perceived health score	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.	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)
Secondary	Change in Quality of Life (QoL) using SQoL-6D	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.	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)