CLINICAL EFFECT OF BOTULINUM TOXIN TYPE A IN TREATMENT OF SPASTICITY
NCT ID: NCT04673240
Last Updated: 2020-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
70 participants
OBSERVATIONAL
2019-03-29
2022-06-30
Brief Summary
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The treatment goal of spasticity is Medical treatment generally combines physiotherapy with medications, depending on spasticity distribution. Systemic treatments such as oral or intrathecal baclofen are generally considered in case of generalized spasticity, whereas local treatments are considered in case of focal spasticity.
Local treatments such as Botulinum Toxin type A, phenol, and alcohol present several advantages, allowing to treat of selected muscles without the risk of sedation. As stated above, they are indicated for focal spasticity but might be helpful even in the presence of generalized spasticity with identified focal goals (Bethoux et al., 2015).
In particular, Botulinum Toxin type A (BoNT-A) is considered the gold standard treatment for focal spasticity, showing a level A evidence for spasticity reduction in upper- and lower-limb spasticity (Simpson et al., 2016).
However, current evidence is mainly focused on post-stroke spasticity (Franceschini et al., 2014), whereas it is still limited in spasticity as a consequence of other aetiologies, such as spinal cord injury (SCI), traumatic brain injury (TBI), or multiple sclerosis (MS).
Interestingly, spasticity is a major concern for the rehabilitation of these patients.
The aim of this observational study is the evaluation of the clinical efficacy of BoNT-A in spasticity reduction in patients affected by neurological conditions different from post-stroke spasticity, such as SCI, TBI, and MS.
Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Botulinum toxin type A injection
Adult patients with spasticity due to traumatic brain injury, spinal cord injury, or MS, treated with Botulinum Toxin type A.
As this is a non-interventional study, no diagnostic, therapeutic, or experimental intervention is involved. Subjects will receive clinical assessments, medications, and treatments solely as determined by their study physician.
Eligibility Criteria
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Inclusion Criteria
* Spasticity as a consequence of traumatic brain injury, spinal cord injury or MS (documented by clinical records)
* Muscle tone graded at least 1+ on the modified Ashworth scale in the relevant joints of the affected limb(s), which requires medical intervention
* BoNT naïve or pre-treated with any BoNT product. If previously treated with any BoNT, at least a 4 months interval between last injection and inclusion
Exclusion Criteria
* Changes in any oral antispastic medications or specific physiotherapy regimen \<4m before study entry or during the study.
* Other neurological or orthopaedic conditions involving the affected limbs.
* Sensitivity to BoNT-A or to its excipients
* Other contraindications as given in the local SmPC for BoNT-A
18 Years
ALL
No
Sponsors
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Ipsen
INDUSTRY
Azienda Ospedaliero Universitaria Maggiore della Carita
OTHER
SIRN
UNKNOWN
Università degli Studi del Piemonte Orientale Amedeo Avogadro
OTHER
Responsible Party
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Alessio Baricich
MD PhD
Principal Investigators
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Alessio Baricich
Role: STUDY_CHAIR
Università del Piemonte orientale "Amedeo Avogadro"
Locations
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Azienda Ospedaliero Universitaria Maggiore della Carità
Novara, , Italy
Countries
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Central Contacts
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Roberta Carozzi
Role: CONTACT
Phone: 0321 3734805
Facility Contacts
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Alessio Baricich, MDPhD
Role: primary
References
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Baricich A, Battaglia M, Cuneo D, Cosenza L, Millevolte M, Cosma M, Filippetti M, Dalise S, Azzollini V, Chisari C, Spina S, Cinone N, Scotti L, Invernizzi M, Paolucci S, Picelli A, Santamato A. Clinical efficacy of botulinum toxin type A in patients with traumatic brain injury, spinal cord injury, or multiple sclerosis: An observational longitudinal study. Front Neurol. 2023 Apr 6;14:1133390. doi: 10.3389/fneur.2023.1133390. eCollection 2023.
Other Identifiers
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NSS_BoNT-A
Identifier Type: -
Identifier Source: org_study_id