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

NCT00146809 | Completed Phase 3

• 2 other identifiers: MEMSA-StudyGrant 01 GI 0201/01 GI 0401
• Study Type: interventional
• Target: 60
• Locations: 2 countries
• Sites: 10

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 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

Keywords

Multi-System-Atrophy; Minocycline

Outcome Measures

Primary Outcomes (1)

• Change in motor function: Difference between the UMSARS II baseline score and the UMSARS II score 48 weeks after start of therapy

Secondary Outcomes (5)

• Difference between the UMSARS II baseline score and the UMSARS II score 24 weeks after start of therapy

• Difference between the UMSARS I, III, IV baseline score and the UMSARS I, III, IV score 24 and 48 weeks after start of therapy

• Difference between the UPDRS I-III baseline score and the UPDRS I-III score 24 and 48 weeks after start of therapy

• Difference between the SF-12 baseline score and the SF-12 score 24 and 48 weeks after start of therapy

• Difference between the EQ-5D baseline score and the EQ-5D score 24 and 48 weeks after start of therapy

Interventions

Minocyline DRUG

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Severe kidney insufficiency (Creatinine \>3 mg/dl; Urea \> 150 mg/dl)
• Hepatic insufficiency (GOT \> 3 x ULN; GPT \> 3 x ULN)

Sponsors & Collaborators

• German Parkinson Study Group (GPS): lead
• Competence Network on Parkinson's Disease: collaborator
• European MSA-Study Group: collaborator
• Federal Institute of Education and Sience: collaborator

Study Sites (10)

Neurologische Klinik der Universität Innsbruck

Innsbruck, A-6020, Austria

Location

Universitätsklinikum Heidelberg, Neurologische Klinik

Heidelberg, Baden-Wurttemberg, 69120, Germany

Location

Universitätsklinikum Tübingen, Neurologische Klinik

Tübingen, Baden-Wurttemberg, 72076, Germany

Location

Neurologische Klinik am Klinikum der BJM-Universität

Würzburg, Bavaria, 97080, Germany

Location

Paracelsus-Elena-Klinik

Kassel, Hesse, 34128, Germany

Location

Neurologische Klinik der Philipps-Universität Marburg

Marburg, Hesse, 35033, Germany

Location

Neurologische Universitätsklinik, Universitätsklinikum Carl-Gustav-Carus der Technischen Universität Dresden

Dresden, Saxony, 01307, Germany

Location

Universitätsklinikum Schleswig-Holstein, Campus Kiel, Klinik für Neurologie

Kiel, Schleswig-Holstein, 24105, Germany

Location

Neurologische Poliklinik, Charité Campus Virchow

Berlin, 13353, Germany

Location

Neurologische Universitätsklinik am Klinikum der Friedrich-Wilhelm-Universität Bonn

Bonn, 53105, Germany

Location

Related Links

• Homepage Coordination Center for Clinical Studies to MEMSA Study, Language: German
• Homepage Competence Network on Parkinson´s disease (Language: German and English)

MeSH Terms

Conditions

cyclopia sequence

Study Officials

• Wolfgang H. Oertel, Prof. Dr.

  Neurologische Klinik der Philipps-Universität Marburg

  PRINCIPAL INVESTIGATOR

• Richard Dodel, PD Dr.

  Neurologische Klinik, Rheinische Friedrich-Wilhelms-Universität Bonn

  STUDY DIRECTOR

• Werner Poewe, Prof. Dr.

  Neurologische Klinik der Universität Innsbruck

  STUDY CHAIR

• Gregor Wenning, Prof. Dr.

  Neurologische Klinik der Universität Innsbruck

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 31, 2005
• First Posted: September 7, 2005
• Study Start: December 1, 2003
• Study Completion: December 1, 2005
• Last Updated: February 19, 2018

Record last verified: 2018-02

Locations

AU (1); DE (9)