Experimental:
alpha-methyl-paratyrosine (AMPT, trade name: Demser), body-weight adjusted dosage (40 mg/kg body weight, maximum 4000mg) at 4 time points over 24 hours

Diphenhydramine (25mg, trade name in Switzerland: Benocten) at the first medication intake time point, placebo at the second to fourth intake time point (medication intake over 24 hours)

Bulimia Nervosa

Eating Disorders

Dopamine

Reward

Catechol-O-methyltransferase

alpha-methyl-paratyrosine (AMPT, trade name: Demser) body-weight adjusted dosage (40 mg/kg body weight, maximum 4000mg) at 4 medication intake time points over 24 hours

AMPT/ Demser

Diphenhydramine (25mg) at the first medication intake time point

Diphenhydramine

Placebo at the second, third and fourth medication intake time point

Placebo

University Hospital of Psychiatry, University of Bern

Neural Response to Catecholamine Depletion in Subjects Suffering From Bulimia Nervosa in Their Past and Healthy Controls

Neuronal Correlates of Catecholamine Depletion in Patients With Bulimia Nervosa Off Medication and Healthy Controls

University of Bern

University Hospital Inselspital, Berne

University of Zurich

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

Multiple System Atrophy

EGCG as putative neuroprotective agent

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

Intravenous Dexamethasone 3mg diluted in saline 0.9% up to 10 ml

Intravenous Dexamethasone 6mg diluted in saline 0.9% up to 10 ml

Intravenous Dexamethasone 12mg diluted in saline 0.9% up to 10 ml

Postoperative Nausea and Vomiting

Vomiting

Dexamethasone 3 mg

Dexamethasone 6 mg

Dexamethasone 12 mg

University Hospital of Lausanne (CHUV), Division of Anaesthesiology,

University Hospitals of Geneva

Hôpital HNE-Pourtales

Hôpital d'Yverdon-les-Bains

Dexamethasone for the Treatment of Established Postoperative Nausea and Vomiting

Dexamethasone for the Treatment of Established Postoperative Nausea and Vomiting - a Randomised, Placebo-controlled, Dose-finding Study

Complete absence of any nausea and/or vomiting (including retching) in a previously nauseated or vomiting patient within 24 hours after administration of the study treatment.

Number of patients staying PONV free after rescue antiemetic during the first 24 postoperative hours

quality of sleep during the first postoperative night (numerical rating scale ranging from 0 = no sleep at all to 10 = excellent sleep)

any minor or major adverse effects during 24h.

Christoph Czarnetzki

Responsable Investigator

University Hospital, Geneva

Swiss National Science Foundation

A database/ repository will be constructed for future research, analysis, and recruitment. De-identified study subjects' genetic information and their responses to pain and pain medications, side-effects will be included in the database. Blood specimens will be included in the repository for exploring potentially important SNPs and biomarkers in future. No patient identifiers will be included in the repository and there will be a confidential (access limited to investigators only) code or link between the repository/database and other information about the participant.

Pain

Children's Hospital of Los Angeles

Stanford University Medical Center

The Children's Hospital, Denver

University of Miami - Miller School of Medicine

Children's Memorial Hospital

Ochsner Medical Center for Children

The Johns Hopkins Hospital

Boston Children's Hospital

C.S. Mott Children's Hospital

St. Louis Children's Hospital

Cincinnati Children's Hospital Medical Center

St. Christopher's Hospital for Children

Texas Children's Hospital

Seattle Children's Hospital

UW Health-American Family Children's Hospital

Multicenter Perioperative Opioid Pharmacogenetic Study

Predicting Perioperative Opioid Adverse Effects and Personalizing Analgesia in Children: A Multicenter Pharmacogenetic Study

Incidence of serious opioid related adverse effects including respiratory depression, excessive sedation, nausea and vomiting in recovery room.

Number of opioid interventions required in the recovery room

Total opioid requirement will be measured

Pain scores as measured by the Numerical Rating Scale (NRS) and the Facial expression, Leg movement, Activity, Cry, and Consolability (FLACC) Scale

catechol/vomito

Neural Response to Catecholamine Depletion in Subjects Suffering From Bulimia Nervosa in Their Past and Healthy Controls

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

Dexamethasone for the Treatment of Established Postoperative Nausea and Vomiting

Multicenter Perioperative Opioid Pharmacogenetic Study

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