Status:
UNKNOWN
CLINICAL EFFECT OF BOTULINUM TOXIN TYPE A IN TREATMENT OF SPASTICITY
Lead Sponsor:
Università degli Studi del Piemonte Orientale Amedeo Avogadro
Collaborating Sponsors:
Ipsen
Azienda Ospedaliero Universitaria Maggiore della Carita
Conditions:
Spasticity
Brain Injuries
Eligibility:
All Genders
18+ years
Brief Summary
Spasticity has been defined as a disorder of the sensorimotor system characterized by a velocity-dependent increase in tonic stretch reflexes (muscle tone) with exaggerated tendon jerks, resulting fro...
Eligibility Criteria
Inclusion
- Age \>18 years
- 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
- Presence of fixed contractures or bony deformities in the affected limb
- 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
Key Trial Info
Start Date :
March 29 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 30 2022
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT04673240
Start Date
March 29 2019
End Date
June 30 2022
Last Update
December 17 2020
Active Locations (1)
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1
Azienda Ospedaliero Universitaria Maggiore della Carità
Novara, Italy, 28100