Efficiency and tolerability of L-Dopa in patients with Hereditary Spastic Paraplegia (HSP)

• Conditions: Hereditary spastic paraplegias (HSP) are a rare neurodegenerative group of disorders characterised by slowly progressive symmetric spastic paraparesis, distal pallhypaesthesia of the lower limbs, and urinary dysfunction. Based on clinical hallmarks, noncomplicated HSP and complicated forms are known. Clinically, HSP forms are similar but genetically even more heterogeneous.

• Registration Number: EUCTR2004-004509-11-DE
• Lead Sponsor: niversity hospital of the University of Ulm

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-09-06
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1.) patients (Females and males) aged between 18 to 80 years.
2.) definite noncomplicated spastic paraplegia
3.) ability to understanding the written patients information
4.) ability to cive a written consent
5.) normal electrocardiogramm
6.) females of childbearing age: use of pregnancy preventing arrangements

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

1.) participation in a clinical trial in the past 12 month using other medicinical pharmaceuticals
2.) contraindications for a therapy with Levodopa: pregnancy, lactation period
3.) Use of Levodopa or dopamine agonists in the past 3 months
4.) any diseases in which the release of functional testing could be impaired
5.) noncomplained patients
6) therapy with phenytoine, papaverine, inhibitors of monoaminooxidase A and B, drugs containing iron sulphit
7) coronary heart disease and cardiac arrhythmias
8) pregnancy, lactation period

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified