NCT04152655

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

A Study of Efficacy and Safety of Idebenone Vs. Placebo in Prodromal Parkinson Disease (SEASEiPPD)

• Status: Withdrawn
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• REM Sleep Behavior Disorder
• Parkinson Disease

Interventions

Type	Name	Description
DRUG	Idebenone	30mg tablets three times a day
DRUG	Placebo oral tablet	placebo tablets three times a day

Timeline

• Start date: 2020-01-01
• Primary completion: 2022-01-01
• Completion: 2023-01-01
• First posted: 2019-11-05
• Last updated: 2025-01-07

Locations

1 site across 1 country: China