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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02212678 |
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Date of registration:
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04/08/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Repeated-Dose Oral N-acetylcysteine for the Treatment of Parkinson's Disease
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Scientific title:
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Repeated-Dose Oral N-acetylcysteine for the Treatment of Parkinson's Disease |
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Date of first enrolment:
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September 2014 |
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Target sample size:
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8 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02212678 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 2
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Countries of recruitment
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United States
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Contacts
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Name:
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Paul Tuite, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Minnesota |
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Name:
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Lisa Coles, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Minnesota |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. All participants must be 18 years or older
2. All enrollees must understand and cooperate with requirements of the study in the
opinion of the investigators and must be able to provide written informed consent
3. Individuals with medically stable Parkinson's disease (in the opinion of the
investigator)
4. All participants must not have taken antioxidants NAC, glutathione, coenzyme Q-10,
vitamin C, or vitamin E for 3 weeks prior to the study
5. Absence of dementia in all subjects
Exclusion Criteria:
1. Inability to undergo MRI scanning without sedation and other MRI counterindications,
such as metal in the body (see section 7.3)
2. Medically unstable conditions as determined by the investigators
3. Pregnant or lactating or those women of child-bearing age that are not using
acceptable forms of contraception
4. Diagnosis of asthma that is presently being treated with any medication, or past
history of asthma/bronchospasm resulting in an emergency room visit, hospitalization
or treatment
5. Unable to adhere to study protocol for whatever reason
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Parkinson Disease
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Intervention(s)
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Drug: N-acetylcysteine capsule
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Primary Outcome(s)
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Glutathione (GSH) Brain Levels
[Time Frame: pre-dose and after approximately 28 days of treatment]
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Secondary ID(s)
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123269
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1406M51207
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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