A Study of Efficacy and Safety of Idebenone vs. Placebo in Prodromal Parkinson Disease

2019-11-11 17:50:19 | BioPortfolio


To investigate whether 24 months of idebenone may reduce the progression from Prodromal Parkinson disease (PPD) to Parkinson disease (PD).


Number of people suffered from Parkinson disease (PD) is increasing every year. Contemporary medication has little neuroprotective effect, which may due to delayed treatment as over 50% neurons have lost when clinical diagnosed PD emerges. The concept of Prodromal Parkinson disease (PPD) is emphasized as it has become evident that there are several risk and clinical markers may occur years before the cardinal motor symptoms which allow clinical diagnosis. Rapid eye movement (REM) sleep behavior disorder and olfactory dysfunction are the most common PPD, and more than one third of patients may progress to PD and other neurodegenerative diseases. Mitochondrial injury is one of the pathogenesis of PD. Thus we design this trial to investigate whether idebenone, potent coenzyme Q10 analogue, could protect PPD develops into PD.

Study Design


REM Sleep Behavior Disorder


Idebenone, Placebo oral tablet


Second Affiliated Hospital of Zhejiang University School of Medicine


Not yet recruiting


Second Affiliated Hospital, School of Medicine, Zhejiang University

Results (where available)

View Results


Published on BioPortfolio: 2019-11-11T17:50:19-0500

Clinical Trials [6507 Associated Clinical Trials listed on BioPortfolio]

Idebenone for the Preventive Treatment of Migraine

Idebenone improves energy metabolism similarly to Coenzyme Q10, which is effective in migraine prophylaxis. The investigators compared idebenone (90 mg/day, 270 mg/day) and placebo in 180 ...

Study of Idebenone in the Treatment of Mitochondrial Encephalopathy Lactic Acidosis & Stroke-like Episodes

The purpose of this study is to compare the efficacy of two (2) different doses of idebenone with that of a placebo over a one month period on cerebral lactate concentration as measured by...

Establish a National Registry of REM Sleep Behavior Disorder

In this proposed study, the investigators aim to build up a large cohort of Rapid eye movement sleep behavior disorder (RBD) to study the etiology and risk factors of neurodegeneration.

Treatment of REM Sleep Behavior Disorder (RBD) With Sodium Oxybate

This study is the first clinical trial using sodium oxybate for the treatment of REM sleep behavior disorder (RBD). Sodium oxybate is a drug approved by FDA for the treatment of narcolepsy...

Search for Biomarkers of Neurodegenerative Diseases in Idiopathic REM Sleep Behavior Disorder

This study is a prospective study with a mean of 7-year follow-up interval, aims to monitor the progression of α-synucleinopathy neurodegeneration by the evolution of prodromal markers an...

PubMed Articles [15306 Associated PubMed Articles listed on BioPortfolio]

Clonazepam for probable REM sleep behavior disorder in Parkinson's disease: A randomized placebo-controlled trial.

Clonazepam is considered to be a first-line treatment for rapid eye movement sleep-related behavior disorder (RBD) in Parkinson's disease (PD). The purpose of this study was to determine the short-ter...

Assessment of cognitive profile as a prodromal marker of the evolution of REM sleep Behavior Disorder.

To search for a specific neuropsychological profile in idiopathic REM sleep Behavior Disorder (iRBD), able to predict the onset of neurodegenerative disorders.

Isolated rapid eye movement sleep behavior disorder and cyclic alternating pattern: is sleep microstructure a predictive parameter of neurodegeneration?

To evaluate the role of sleep cyclic alternating pattern (CAP) in patients with isolated REM sleep behavior disorder (IRBD) and ascertain whether CAP metrics might represent a marker of phenoconversio...

REM Sleep without atonia correlates with abnormal vestibular-evoked myogenic potentials in isolated REM sleep behavior disorder.

The neurophysiological hallmark of REM sleep behavior disorder (RBD) is loss of atonia during REM sleep. Indeed, signs and symptoms of neurodegeneration can occur after years, even decades, from its b...

Impaired sleep quality and cognition in patients of Parkinson's disease with REM sleep behavior disorder: a comparative study.

The present study was undertaken to evaluate the cognitive profile of Parkinson's disease (PD) patients with REM sleep behavior disorder (RBD) and to correlate with the clinical stage and polysomnogra...

Medical and Biotech [MESH] Definitions

A disorder characterized by episodes of vigorous and often violent motor activity during REM sleep (SLEEP, REM). The affected individual may inflict self injury or harm others, and is difficult to awaken from this condition. Episodes are usually followed by a vivid recollection of a dream that is consistent with the aggressive behavior. This condition primarily affects adult males. (From Adams et al., Principles of Neurology, 6th ed, p393)

Abnormal behavioral or physiologic events that are associated with REM sleep, including REM SLEEP BEHAVIOR DISORDER.

Dyssomnias (i.e., insomnias or hypersomnias) associated with dysfunction of internal sleep mechanisms or secondary to a sleep-related medical disorder (e.g., sleep apnea, post-traumatic sleep disorders, etc.). (From Thorpy, Sleep Disorders Medicine, 1994, p187)

A sleep disorder characterized by grinding and clenching of the teeth and forceful lateral or protrusive jaw movements. Sleep bruxism may be associated with TOOTH INJURIES; TEMPOROMANDIBULAR JOINT DISORDERS; sleep disturbances; and other conditions.

A sleep disorder of central nervous system origin characterized by prolonged nocturnal sleep and periods of daytime drowsiness. Affected individuals experience difficulty with awakening in the morning and may have associated sleep drunkenness, automatic behaviors, and memory disturbances. This condition differs from narcolepsy in that daytime sleep periods are longer, there is no association with CATAPLEXY, and the multiple sleep latency onset test does not record sleep-onset rapid eye movement sleep. (From Chokroverty, Sleep Disorders Medicine, 1994, pp319-20; Psychiatry Clin Neurosci 1998 Apr:52(2):125-129)

More From BioPortfolio on "A Study of Efficacy and Safety of Idebenone vs. Placebo in Prodromal Parkinson Disease"

Quick Search

Relevant Topics

Neurology - Central Nervous System (CNS)
Alzheimer's Disease Anesthesia Anxiety Disorders Autism Bipolar Disorders Dementia Epilepsy Multiple Sclerosis (MS) Neurology Pain Parkinson's Disease Sleep Disorders Neurology is the branch of me...

Pharmacy is the science and technique of preparing as well as dispensing drugs and medicines. It is a health profession that links health sciences with chemical sciences and aims to ensure the safe and effective use of pharmaceutical drugs. The scope of...

Parkinson's Disease
Parkinson's is a progressive neurological condition, affecting one person in every 500, 95% of which are over 40. It is caused by degeneration of more than 70% of the substantia nigra, which depletes the dopamine (the neurotransmitter involved in pro...

Searches Linking to this Trial