Status:
COMPLETED
Study About Efficacy and Safety to Treat Multi-System-Atrophy
Lead Sponsor:
German Parkinson Study Group (GPS)
Collaborating Sponsors:
Competence Network on Parkinson's Disease
European MSA-Study Group
Conditions:
Multi-System-Atrophy
Minocycline
Eligibility:
All Genders
40-75 years
Phase:
PHASE3
Brief Summary
Study Hypothesis: \- Does a treatment with Minocycline of 2 x daily 2 x 50 mg effect the progression of clinical symptoms and diagnosis in patients with MSA? Background and Rationale: * The Parkins...
Detailed Description
Study Hypothesis: * Does a treatment with Minocycline of 2 x daily 2 x 50 mg effect the progression of clinical symptoms and diagnosis in patients with MSA? * Minocycline is an antibiotic belonging t...
Eligibility Criteria
Inclusion
- age ≥ 40 and \<= 75 years
- Diagnosis of MSA-P in accordance with consensus criteria (Gilman et al., 1999; appendix)
- UMSARS IV \<= 3
- Patient must be capable of understanding informed consent
- Written consent to participation in the study
Exclusion
- Diseases associated with a demential syndrome
- Dimming of consciousness
- Any other chronical inflammatory disease (Crohn's disease, ulcerative colitis, C.a. hepatitis, C.a. pancreatitis)
- Any malignant tumour disease
- Chronical alcohol addiction
- Severe Diabetes mellitus Type I and II (HbA1c \> 8 %)
- AV-Block ≥ 2nd degree
- Atrial flutter, atrial fibrillation
- Tachycardia (\> 100 bpm)
- Bradycardia (\< 60 bpm)
- High-blood pressure (systolic \> 180 mm Hg, diastolic: \> 110 mg HG)
- Heart insufficiency (NYHA \>2)
- Pericarditis, pericardial effusion
- Heart attack within the last six months before inclusion in the study, ACVB, C.a. myocarditis
- Severe kidney insufficiency (Creatinine \>3 mg/dl; Urea \> 150 mg/dl)
- Hepatic insufficiency (GOT \> 3 x ULN; GPT \> 3 x ULN)
- Ulcer disease
- Pneumonia, meningitis within 12 weeks before inclusion into study
- Any immunosuppressive or cytotoxic therapy within the last year before inclusion in study
- Any antibacterial and antiviral therapy within the last six weeks before inclusion in the study
- Any systemic fungal infection within the last year before inclusion in the study
- Any positive family anamnesis for autoimmune diseases
- Pregnancy or nursing
- Severe psychiatric disease within the last six months requiring hospitalisation, attempted suicide in the anamnesis, florid psychosis
- Seizure disorder
- Concomitant taking of the following drugs: Riluzole, Carbamazepine, Phenytoine, Primidone, Colestyramine, activated charcoal, cumarin, Cyclosporine, Methotrexate, Methoxyflurane, Theophylline, Phenobarbital; or drug classes: Antacids (containing Al, Mg, Ca), Retinoids, Digitalis Glycosides
- Known hypersensitivity against Minocycline or other Tetracyclines
- Simultaneous participation in another clinical trial
Key Trial Info
Start Date :
December 1 2003
Trial Type :
INTERVENTIONAL
End Date :
December 1 2005
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00146809
Start Date
December 1 2003
End Date
December 1 2005
Last Update
February 19 2018
Active Locations (10)
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1
Neurologische Klinik der Universität Innsbruck
Innsbruck, Austria, A-6020
2
Universitätsklinikum Heidelberg, Neurologische Klinik
Heidelberg, Baden-Wurttemberg, Germany, 69120
3
Universitätsklinikum Tübingen, Neurologische Klinik
Tübingen, Baden-Wurttemberg, Germany, 72076
4
Neurologische Klinik am Klinikum der BJM-Universität
Würzburg, Bavaria, Germany, 97080