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

Ipsen76 sites in 1 country464 target enrollmentJune 23, 2021

ConditionsUpper Limb Spasticity

InterventionsAboBoNT-A OnaBoNT-A

DrugsAboBoNT-A OnaBoNT-A

Overview

Phase: Phase 4
Intervention: AboBoNT-A
Conditions: Upper Limb Spasticity
Sponsor: Ipsen
Enrollment: 464
Locations: 76
Primary Endpoint: Rate of Treatment-emergent Adverse Events (TEAEs)
Status: Completed
Last Updated: 5 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 23, 2021

End Date

August 26, 2025

Last Updated

5 months ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Ipsen

Responsible Party

Sponsor

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;

Arms & Interventions

Sequence 1

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

Intervention: AboBoNT-A

Sequence 1

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

Intervention: OnaBoNT-A

Sequence 2

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

Intervention: AboBoNT-A

Sequence 2

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

Intervention: OnaBoNT-A

Outcomes

Primary Outcomes

Rate of Treatment-emergent Adverse Events (TEAEs)

Time Frame: from baseline (injection) to 12 weeks (injection cycle 1 and 2, each cycle is a maximum 24 weeks))

Secondary Outcomes

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))
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))
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))
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))
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))