Ignite Creation Date:
2025-12-24 @ 11:28 PM
Ignite Modification Date:
2026-01-02 @ 1:00 AM
Study NCT ID:
NCT00329056
Status:
COMPLETED
Last Update Posted:
2010-07-21
First Post:
2006-05-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Trial of MitoQ for the Treatment of People With Parkinson's Disease
Sponsor:
Antipodean Pharmaceuticals, Inc.
Organization:
Study Overview
Official Title:
A Double-Blind, Prospective, Randomized Comparison of 2 Doses of MitoQ and Placebo for the Treatment of Patients With Parkinson's Disease
Status:
COMPLETED
Status Verified Date:
2010-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In Parkinson's Disease, the mitochondrial membranes in cells that produce dopamine become damaged by oxidants, leading to the death of these cells and progressive tremor, slowness of movement and the loss of neurons in the substantia nigra (a part of the brain that is involved in movement). Mitoquinone is targeted to reach the membrane of mitochondria and provide protection from damaging oxidants. There are no treatments currently available to slow the progression of PD and this trial will help advance the development of this unique disease modifying drug.
This trial will enroll 120 participants with untreated early onset of PD. Participants will be randomized to receive 1 of 3 treatments: 40 mg of MitoQ tablets, 80 mg of MitoQ tablets or placebo. The researchers, participants and sponsor will all be blinded to the treatment allocation. Participants will be assessed after 1, 2, 3, 6, 9, 12 months of treatment and again 28 days after their last dose. The effectiveness of the trial drug will be measured via the Unified Parkinson's Disease Rating Scale (UPDRS). The safety of the trial drug will be monitored via regular participant examinations, blood tests, ECG and collecting information on adverse events.
This trial will enroll 120 participants with untreated early onset of PD. Participants will be randomized to receive 1 of 3 treatments: 40 mg of MitoQ tablets, 80 mg of MitoQ tablets or placebo. The researchers, participants and sponsor will all be blinded to the treatment allocation. Participants will be assessed after 1, 2, 3, 6, 9, 12 months of treatment and again 28 days after their last dose. The effectiveness of the trial drug will be measured via the Unified Parkinson's Disease Rating Scale (UPDRS). The safety of the trial drug will be monitored via regular participant examinations, blood tests, ECG and collecting information on adverse events.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: