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

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.

Conditions

• Multi-System-Atrophy
• Minocycline

Interventions

DRUG

Minocyline

Sponsors & Collaborators

• Competence Network on Parkinson's Disease

  collaborator OTHER

• European MSA-Study Group

  collaborator UNKNOWN

• Federal Institute of Education and Sience

  collaborator UNKNOWN

• German Parkinson Study Group (GPS)

  lead OTHER

Principal Investigators

• Wolfgang H. Oertel, Prof. Dr. · Neurologische Klinik der Philipps-Universität Marburg

• Richard Dodel, PD Dr. · Neurologische Klinik, Rheinische Friedrich-Wilhelms-Universität Bonn

• Werner Poewe, Prof. Dr. · Neurologische Klinik der Universität Innsbruck

• Gregor Wenning, Prof. Dr. · Neurologische Klinik der Universität Innsbruck

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

40 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2003-12-31

Completion

2005-12-31

Countries

• Austria
• Germany

Study Locations