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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
464
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))
Rate of Adverse Drug Reactions (ADRs), Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs)
Time frame: from baseline (injection) to 12 weeks (injection cycle 1 and 2, each cycle is a maximum 24 weeks))
Duration of response
Time frame: 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)
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.
Time frame: 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
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.
Time frame: 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)
Physician global assessment (PGA) of treatment response
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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
...and 66 more locations
PGA answers will be made on a nine-point rating scale (from -4 = markedly worse, to +4 = markedly improved).
Time frame: 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
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.
Time frame: 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
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.
Time frame: 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)