In this arm, the study participants will receive DA-9701 30mg + placebo domperidone tablet tid ac for 4 weeks.

(This study is a randomized, double-blinded, non-inferiority trial. Thus it is designed to have no placebo arm.) In this arm, the study participants will receive domperidone 10mg + placebo DA-9701 tablet tid ac +for 4 weeks.

Parkinson's Disease,Idiopathic

Following 2-week screening period, study participants in this group will be given a standard dose of DA-9701 (30 mg t.i.d). Concomitant anti-PD medication will be continued without modification during the trial. The investigators will evaluate dyspepsia and constipation symptoms, gastric emptying by MRI, UPDRS and clinical variables at baseline and at the end of the study.

DA-9701

Following 2-week screening period, study participants in this group will be given a standard dose of domperidone (10 mg t.i.d). Concomitant anti-PD medication will be continued without modification during the trial. The investigators will evaluate dyspepsia and constipation symptoms, gastric emptying by MRI, UPDRS and clinical variables at baseline and at the end of the study.

Domperidone

Placebo domperidone

Placebo DA-9701

Cheol Min Shin

Comparing the Therapeutic Efficacy and Safety of DA-9701 With Domperidone in Patients With Parkinson's Disease

Therapeutic Efficacy of DA-9701 on Gastric Motility in Patients With Parkinson's Disease Evaluated by Magnetic Resonance Imaging: A Randomized Controlled, Double-Blind, Non-Inferiority Trial

MRI is known to be accurate and useful in evaluating gastric motility. Gastric emptying rate (GER) evaluated using MRI will be compared before and after the treatment, and between the groups.

The study participants will fill up the gastrointestinal symptom diary before and during the treatment period. In addition, the investigators will assess the Patient's Global Assessment (PGA) for dyspeptic symptoms at the end of the treatment period.

Plasma levodopa concentrations will be determined 30 minutes after L-dopa dose administration before and after treatment.

To evaluate any deteriorations in Parkinson's disease, the investigators will assess Unified Parkinson's Disease Rating Scale (UPDRS) score before and after treatment in the 2 groups.

Seoul National University Hospital

placebo capsule for oral use 6,0 mg BID during 24 months of follow-up

rivastigmine capsule for oral use 6,0 mg BID during 24 months of follow-up

Parkinson's Disease

Rivastigmine

Placebo (for rivastigmine)

Related info, instructions for inclusion and study protocol

Academic Medical Center

University Medical Center Groningen

Atrium Medical Center

University Medical Center St Radboud

Cholinesterase Inhibitors to Slow Progression of Visual Hallucinations in Parkinson&Apos;s Disease

Cholinesterase Inhibitors to Slow Progression of Visual Hallucinations in Parkinson's Disease:a Multi-center Placebo-controlled Trial.

the time until Parkinson's disease patients with minor visual hallucinations progress to major visual hallucinations without insight (according to UPDRS 1 - MDS). The clinical endpoint is defined as the start with antipsychotic treatment.

change in motor control measured by UPDRS 3 - MDS

change in occurence or severity of psychotic symptoms according to Scale of Assessment of Positive Symptoms (SAPS) and UPDRS 1 MDS.

change in cognitive function as measured by Mini Mental State Examination, Montreal Cognitive Assessment, Parkinson's Disease - Cognitive Rating Scale

Mood disturbance according to the Hospital Anxiety and Depression Scale

Daytime sleepiness on the Epworth Sleepiness Scale

Cholinergic deficiency, as a possible predictor for response to treatment, measured with the Cholinersterase Inhibitor Prognosticator

Compliance to treatment measured by the number of remaining capsules after every 6 months of follow-up

Disability based on the AMC Linear Disability Score

Caregiver burden according to the Zarit Caregiver Burden Inventory

functional connectivity (phase lag index)

topological network organisation (minimum spanning tree)

direction of information flow (directed phase lag index)

Tom van Mierlo

drs T.J.M. van Mierlo

VU University Medical Center

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Leiden University Medical Center

University Medical Center Nijmegen

International Parkinson Fonds Germany GmbH

ZonMw: The Netherlands Organisation for Health Research and Development

Crossover design Placebo first followed by carbidopa

Crossover design carbidopa first followed by placebo

All Study Subjects

Sex: Female, Male

Daily scores were reported on a modified version of the Rhodes Index of Nausea, Vomiting and Retching, which included all 5 items relating to nausea and retching. Items addressing vomiting/throwing up were omitted, as all participants had antireflux surgery that prevented vomiting (Nissen fundoplication). Retching distress, nausea distress, number of nausea episodes per day, number of retching episodes per day, and the amount of time spent feeling nauseous were graded on a 5-point scale. Scores range from 0 (no nausea/distress) to 20 (most nausea/distress).

Carbidopa

Placebo

Composite Daily Score

Number of Episodes of Daily Nausea

Assay of 24 hour dopamine level excretion in urine

24 Hour Dopamine Levels

Subjects will be given placebo first (4 weeks), followed by carbidopa (4 weeks).

Placebo (First), Carbidopa (Second)

Subjects will be given Carbidopa for a 4 week period followed by placebo for a 4 week period.

Carbidopa (First), Placebo (Second)

Carbidopa Titration Period (4 Weeks)

First Intervention (4 Weeks)

Second Intervention (4 Weeks)

Horacio Kaufmann, MD; director of Dysautonomia Center

carbidopa
Carbidopa : The trial will be divided into two consecutive, but independent parts. Phase 1, will address the safety and tolerability of carbidopa in patients with FD using an open-label dose titration phase followed by 4-weeks of open-label treatment. Phase 2, will address the efficacy of carbidopa for the treatment of nausea in patients with FD using a randomized, placebo controlled, double blind, 4-week cross over design.

Placebo
Placebo : The trial will be divided into two consecutive, but independent parts. Phase 1, will address the safety and tolerability of carbidopa in patients with FD using an open-label dose titration phase followed by 4-weeks of open-label treatment. Phase 2, will address the efficacy of carbidopa for the treatment of nausea in patients with FD using a randomized, placebo controlled, double blind, 4-week cross over design.

Familial Dysautonomia

The trial will be divided into two consecutive, but independent parts. Phase 1, will address the safety and tolerability of carbidopa in patients with FD using an open-label dose titration phase followed by 4-weeks of open-label treatment. Phase 2, will address the efficacy of carbidopa for the treatment of nausea in patients with FD using a randomized, placebo controlled, double blind, 4-week cross over design.

dopa/vomiting

Comparing the Therapeutic Efficacy and Safety of DA-9701 With Domperidone in Patients With Parkinson's Disease

Cholinesterase Inhibitors to Slow Progression of Visual Hallucinations in Parkinson&Apos;s Disease

Carbidopa for the Treatment of Nausea and Vomiting in Familial Dysautonomia

Select Stim: Selective Stimulation of the Subthalamic Nucleus in Parkinson's Disease. "A Feasibility Study"

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