EUCTR2009-012073-34-NL
Active, Not Recruiting
Phase 1
Botulinum toxin for treating calf muscle spasticity in Hereditary Spastic Paraparesis (HSP): functional effects on dynamic balance and gait - FEBOCH
Radboud University Nijmegen Medical Centre0 sites20 target enrollmentMay 6, 2009
ConditionsSubjects with hereditary spastic paraparesis (HSP)MedDRA version: 9.1Level: LLTClassification code 10019903Term: Hereditary spastic paraplegia
DrugsDysport
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Subjects with hereditary spastic paraparesis (HSP)
- Sponsor
- Radboud University Nijmegen Medical Centre
- Enrollment
- 20
- Status
- Active, Not Recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
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
Outcomes
Primary Outcomes
Not specified
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