Treatment with 800 mg - 1200 mg EGCG as putative neuroprotective agent

Multiple System Atrophy

EGCG as putative neuroprotective agent

Placebo

Fox trial finder of the Michael J Fox foundation

Neurology Department, Ludwig-Maximilians University

Department of Neurology, Klinikum rechts der Isar, Technische Universität München

Kliniken Beelitz GmbH, Neurologisches Fachkrankenhaus für Bewegungsstörungen

Charité - Universitätsmedizin Berlin

Technische Universität Dresden

Heinrich-Heine-Universität, Neurologische Klinik

Paracelsus-Elena-Klinik Kassel

Universität Leipzig

Universitätsklinikum Schleswig-Holstein, Campus Lübeck

Philipps Universität Marburg

Eberhard Karls Universität Tübingen

Universitätsklinikum Ulm

Progression Rate of MSA Under EGCG Supplementation as Anti-Aggregation-Approach

Double-blind, Randomised, Placebo-controlled Parallel Group Study to Investigate the Effect of EGCG Supplementation on Disease Progression of Patients With Multiple System Atrophy (MSA)

To assess the efficacy of EGCG vs. Placebo to reduce the progression in the motor examination (ME) of the Unified MSA Rating Scale (UMSARS-ME) from V1 to V7, (80% power, 5% P-level, 50% effect size, i.e. an expected mean yearly UMSARS-ME increase of 3.9 under verum treatment compared to 7.8 ± 6.8 (mean ± standard deviation) under Placebo-treatment.

To assess the efficacy of EGCG vs. Placebo to reduce the progression from V1 to V7 in UMSARS total score

To assess the efficacy of EGCG vs. Placebo to reduce the progression from V1 to V7 in clinical global impression

To assess the efficacy of EGCG vs. Placebo to reduce the progression from V1 to V7 in global and regional cerebral atrophy (3D MP-RAGE MRI volumetry, 3D FLAIR)

To assess the efficacy of EGCG vs. Placebo to reduce the progression from V1 to V7 in global and regional cerebral iron deposition in pons and striatum (T2* MRI)

Clinical safety and tolerability of EGCG (physical and neurological examination, laboratory parameters, adverse events, vital signs, drop-out rates, survival rates and survival time)

To assess any effect of EGCG vs. Placebo on the evolution of the above mentioned parameters during the wash-out phase (from V6 to V7) to explore possible symptomatic effects.

To assess the efficacy of EGCG vs. Placebo to reduce the progression from V1 to V7 in Albumine, total protein, ferritin, iron, transferrin

Dr. Johannes Levin

Sponsor delegated person

German Center for Neurodegenerative Diseases (DZNE)

Deutsche Parkinson Vereinigung

German Foundation for Neurology

ParkinsonFonds Deutschland gGmbH

Ataxia

Chorea

Dystonia

Parkinsonism

Fatigue

amantadine 5/mg/kg for 2 month- tapered up during 2 weeks at 1 month possibility to increase dosage to 8 mg/kg or reduce it if there are side effects

amantadine sulphate

Sheba Medical Center

Amantadine for Improving Neurologic Symptoms in Ataxia-Telangiectasia

The Effect of Amantadine on Movement Disorder in Ataxia-Telangiectasia

Andreea Nissenkorn, MD, Pediatric Neurologist, Director National A-T Clinic

First Episode Psychosis

Minocycline + treatment as usual. 50 mg twice daily increasing to 200 mgs per day, increments of 50 mgs every 2 weeks.

Minocycline

Department of Neurology, Psychiatry and Psychological Medicine, University of San Paulo

Civil Hospital Karachi

Karwan e Hayat

Institute of Psychiatry, Rawalpindi medical College

Role of Minocycline in First Episode Psychosis

A Randomised, Double Blind Pilot Study of Minocycline and Placebo Added to Treatment-as-Usual (TAU) in First-Episode Psychosis

Dr Imran B Chaudhry

Stanley Medical Research Institute

Rawalpindi Medical College, Pakistan

Pakistan Institute of Living and Learning

University of Sao Paulo

Open-label minocycline treatment at 1.4 mg/kg/day

Sex: Female, Male

Region of Enrollment

The Mann-Whitney U-test was used to compare pre-/post-treatment differences in analyte concentrations in serum, plasma and CSF. The Mann-Whitney U test generates a z-score test statistic with an associated p value. A negative z-statistic reflects a decrease in analyte level from pre- to post-treatment. Statistical significance level was set at 0.05. There is one test statistic (z-score) per analyte, reflecting the pre-post comparison across all subjects.
Pre and post treatment measurements of csf analytes: TNF alpha, Il-6, CCL-2(MCP-1), CCL3 (MIP-1alpha), CCL5(RANTES), CXCL(IL-8), BDNF, CD40L, GDNF, HGF, Leptin

z Score

This instrument has two scales - Severity (CGI-S). The CGI-S is a seven point scale with a minimum score of 1 and a maximum score as 7 as follows: 1 = normal, not at all ill; 2 = borderline ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill patients.

Clinical Global Impressions Scale-Severity (CGI). (Connors & Barkley, 1985)

Overall Study

Dr. Susan Swedo

Overall Study/Minocycline

Autism

Regressive Autism

Childrens National Medical Center

National Institutes of Health Clinical Center, 9000 Rockville Pike

Minocycline to Treat Childhood Regressive Autism

Treatment of Childhood Regressive Autism With Minocycline: an Anti-Inflammatory Agent Active Within the CNS

National Institute of Mental Health (NIMH)