Study About Efficacy and Safety to Treat Multi-System-Atrophy

• Status: Completed
• Trial end date: 2005-12-01
• Target enrollment: 0
• Participant gender: All

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 Parkinson-Syndrome which is characterised by the clinical triad akinesis, rigor and passive tremor, is caused by Parkinson's disease (PD) in about 70 % of the cases (Oertel et al., 2003). However, beside the Parkinson's disease there are several, to some extent rare, so-called atypical Parkinson's syndromes. The two most frequent of these atypical Parkinson-Syndromes are the

• Multi-System-Atrophy (MSA) and the Progressive Supranuclear Palsy (PSP). Due to the often much varying courses and since they are not well known, these diseases are frequently diagnosed late or not diagnosed at all. Nevertheless, an early diagnosis is substantial for further treatment, since the prognosis and therapy of atypical Parkinson Syndromes differ essentially from those of PD. Whereas the neuronal death of cells in PD is restricted essentially to the Substantia nigra, a dominant destruction of neurons in brain stem, Cerebellum and Striatum additionally happens in cases of MSA and PSP.

• Up to now no adequate treatment strategies are at disposal. Initially the giving of L-Dopa can lead to an improvement for < 10% of the patients only.

• Minocycline is an antibiotic belonging to the group of the Tetracyclines.

• Recently, it could be demonstrated that Minocycline has a neuroprotective impact besides the anti-inflammatory impact.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: German Parkinson Study Group (GPS)
• Collaborators: Competence Network on Parkinson's Disease; European MSA-Study Group; Federal Institute of Education and Sience
• Treatments: Minocycline

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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