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.
Conditions
Interventions
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Levodopa / Carbidopa 100 mg/25mg
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-25
Pharmaceutical form
Sponsors
University hospital of the University of Ulm
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To date, no causal therapy of the hereditary spastic paraplegias (HSP) is yet available. It is impossible to stop disease progression and to minimize the extent of clinical deficits. Therefore symptomatic therapy trails are necessary and important in the course of the patients´ treatment. Symptomatic approaches include physiotherapy and antispastic medication. However, side effects of antispastic drugs are often intolerable. In the planned clinical study, the effect of L-DOPA on the spasticity and mobility and, consecutively, on the patients´ daily activities and quality of life is to be investigated. In addition, own casuistic findings in HSP patients receiving L-DOPA for reasons such as RLS support these reports. ;Secondary Objective: - improvements in muscle strength (British Medical Research Council, BMRC) - occurrence of adverse effects using ”Fischer Somatische Symptome oder Unerwünschte Effekte Check List" (FSUCL). - blood pressure below 150 mmHg/90 mmHg - depression score (Beck´s Depression Inventory): occurence of depression - Hamilton Depression Scale (HAMD): occurence of depression - Quality of Life (SF-36) ;Primary end point(s): objectives of the study: a) primary objectives and end points: - improvements in HSP Rating Scale up to 10 points b) secondary objectives: - muscle strength (British Medical Research Council, BMRC) - occurrence of adverse effects using ”Fischer Somatische Symptome oder Unerwünschte Effekte Check List" (FSUCL). - blood pressure below 150 mmHg/90 mmHg - depression score (Beck´s Depression Inventory) - Hamilton Depression Scale (HAMD) - Lebensqualität oder allgemeine Befindlichkeit (Fragebogen SF-36) | — |
Countries
Germany
Outcome results
None listed