Botulinum toxin for treating calf muscle spasticity in Hereditary Spastic Paraparesis (HSP): functional effects on dynamic balance and gait - FEBOCH

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-012073-34-NL

Enrollment

Registered

2009-05-06

Start date

2009-07-08

Completion date

Unknown

Last updated

2021-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Subjects with hereditary spastic paraparesis (HSP) MedDRA version: 9.1 Level: LLT Classification code 10019903 Term: Hereditary spastic paraplegia

Interventions

Trade Name: Dysport Product Name: Dysport Pharmaceutical Form: Powder for injection*

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - diagnosis based on molecular diagnosis (e.g. SPG-4 mutations) - age between 18 and 70 years - disabling bilateral calf muscle spasticity (including clonus) without excessive passive stiffness or contracture (i.e. Modified Ashworth Scale 1-3 / 5) - comfortable walking speed greater than 1 km/hr (using a 10m walking test) - being able to stand and walk for 10m without aids Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - impaired tactile and joint motion perception, or cerebellar signs, suggesting ‘complicated’ HSP - other disorders of the neuro-musculo-skeletal system - prior treatment with botulinum toxin or neurolysis of the lower limbs within 6 months - unwillingness or impossibility to keep any oral spasmolytic drugs constant - severe (> 15 degrees) contracture at the knees or hip joints - being unable to load the heels while standing with extended knees (due to ankle contracture) - pregnancy - addiction to drugs or alcohol - any inability to cooperate with the assessments and to give written informed consent

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of this study is to investigate whether optimal dosages of BTX-A, injected bilaterally in the spastic lower leg muscles of patients with HSP (750 U Dysport® in each dorsal muscle group), can improve their dynamic balance capacity while preserving or improving their capacity to ambulate. Dynamic balance is selected as the primary outcome, because clinical experience indicates that, above all, balance problems determine the incapacity to perform basic skills such as standing, turning and making transfers as well as various gait skills.;Secondary Objective: A secondary objective is to better understand through what mechanisms functional balance and gait (at the ICF level of (dis)abilities) are optimized and how such functional improvements are associated with changes in spasticity and voluntary force at the level of the muscles (ICF level of impairments).;Primary end point(s): Dynamic balance is selected as the primary outcome, because clinical experience indicates that, above all, balance problems determine the incapacity to perform basic skills such as standing, turning and making transfers as well as various gait skills. Therefore, the primary outcome is expressed as the success rate after external perturbations, i.e. the percentage of successful trials during which upright standing can be maintained without making a step or grabbing for support.	—

Measure

Time frame

Main Objective: The primary objective of this study is to investigate whether optimal dosages of BTX-A, injected bilaterally in the spastic lower leg muscles of patients with HSP (750 U Dysport® in each dorsal muscle group), can improve their dynamic balance capacity while preserving or improving their capacity to ambulate. Dynamic balance is selected as the primary outcome, because clinical experience indicates that, above all, balance problems determine the incapacity to perform basic skills such as standing, turning and making transfers as well as various gait skills.;Secondary Objective: A secondary objective is to better understand through what mechanisms functional balance and gait (at the ICF level of (dis)abilities) are optimized and how such functional improvements are associated with changes in spasticity and voluntary force at the level of the muscles (ICF level of impairments).;Primary end point(s): Dynamic balance is selected as the primary outcome, because clinical experience indicates that, above all, balance problems determine the incapacity to perform basic skills such as standing, turning and making transfers as well as various gait skills. Therefore, the primary outcome is expressed as the success rate after external perturbations, i.e. the percentage of successful trials during which upright standing can be maintained without making a step or grabbing for support.

—

Countries

Netherlands

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026