AbobotulinumtoxinA Versus OnabotulinumtoxinA in Adults with Upper Limb Spasticity: A Randomized, Double-Blind, Crossover Study Protocol.
AbobotulinumtoxinA
Botulinum toxin
Clinical trial
OnabotulinumtoxinA
Spasticity
Upper limb
Journal
Advances in therapy
ISSN: 1865-8652
Titre abrégé: Adv Ther
Pays: United States
ID NLM: 8611864
Informations de publication
Date de publication:
11 2021
11 2021
Historique:
received:
14
07
2021
accepted:
13
08
2021
pubmed:
26
9
2021
medline:
9
11
2021
entrez:
25
9
2021
Statut:
ppublish
Résumé
The safety and efficacy of both abobotulinumtoxinA and onabotulinumtoxinA for upper limb spasticity are well established, but head-to-head comparisons are lacking. DIRECTION is an international, randomized, double-blind, crossover study comparing the safety and efficacy of abobotulinumtoxinA with onabotulinumtoxinA in the management of upper limb spasticity at doses at or near maximum recommended in product labelling. Participants (18-75 years) will be randomized (1:1) to either one cycle of abobotulinumtoxinA (900U) followed by onabotulinumtoxinA (360U) or vice versa. To maintain blinding, a fixed volume (3.6 ml) will be injected into the target upper limb muscles (four wrist and finger flexors and biceps brachii). The second treatment cycle will begin at Week 12 if retreatment criteria are fulfilled, and if not, they will be reassessed every 4 weeks until they meet retreatment parameters. The primary hypothesis is that there is comparable safety between products; non-inferiority will be tested based on treatment-emergent adverse event (TEAE) rates from injection to Week 12. A secondary hypothesis is that abobotulinumtoxinA has longer duration of effect than onabotulinumtoxinA. This hypothesis will be tested with secondary efficacy endpoints, including injection cycle duration, Modified Ashworth Scale, Disability Assessment Scale and Physician Global Assessment. EudraCT ( http://eudract.ema.europa.eu ): 2021-000161-32 and Clinicaltrials.gov ( http://clinicaltrials.gov ): NCT04936542. Overview of the study protocol by the principal investigator (MP4 185265 KB).
Identifiants
pubmed: 34562231
doi: 10.1007/s12325-021-01896-3
pii: 10.1007/s12325-021-01896-3
pmc: PMC8475311
doi:
Substances chimiques
Neuromuscular Agents
0
Botulinum Toxins, Type A
EC 3.4.24.69
abobotulinumtoxinA
EC 3.4.24.69
Banques de données
ClinicalTrials.gov
['NCT04936542']
EudraCT
['2021-000161-32']
Types de publication
Clinical Trial Protocol
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Pagination
5623-5633Informations de copyright
© 2021. The Author(s).
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