Clinical trial on the effectiveness and safety of botulinum toxin type A (incobotulinumtoxin) in doses adapted to the individual needs of patients with severe spasticity
interventional
N/A
1 country
1
To determine the efficacy and safety of the administration of IncobotulinumtoxinA at individualized doses, selected based on the individual needs of patients (spasticity patterns) with severe spasticity and involvement of the upper and lower limbs.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Not reported
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 20, 2024
Actual (reported)Asworth scale at 6 weeks of treatment
Pain: Variation on the VAS scale (0-10) at 6 and 12 weeks of treatment
Effect on the Asworth scale at 12 weeks from drug infiltration
Barthel scale at 6 and 12 weeks after injection
Satisfaction with treatment
Assess the safety and tolerability of the treatment
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These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Formulated product
BOTULINUM TOXIN TYPE A
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
SOLUTION FOR INJECTION
View registry recordThe registry names these ingredients. The formulation’s exact chemical form has not been confirmed.
BOTULINUM TOXIN TYPE A
Named ingredient: Botulinum toxin type a
View registry recordHospital Doctor Moliner
Serra, 46118, Spain
Nuria Gutiérrez
First Submitted
September 20, 2024
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Source: European Medicines Agency (EMA), Clinical Trials Information System (CTIS). Original record and public documents are available on CTIS.
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Source retrieved:
A clinical study to investigate the efficacy and safety of NT 201 in the treatment of lower limb spasticity in children and adolescents with cerebral palsy.
Contact the study team to confirm eligibility.