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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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11 May 2015 |
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Main ID: |
NCT02324426 |
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Date of registration:
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04/12/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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CNS Uptake of Intranasal Glutathione
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Scientific title:
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Central Nervous System Uptake of Intranasal Glutathione in Parkinson's Disease |
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Date of first enrolment:
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December 2014 |
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Target sample size:
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15 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT02324426 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 1
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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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Kevin Conley, 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 Washington |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Age > 18 years.
- Ability to attend a 3 hour study visit in Seattle, WA.
- Ability to read and speak English.
- Have three or more of the required positive criteria for PD from Step 3 of the UK
Brain Bank Diagnostic Criteria for Parkinson's Disease.
- A modified Hoehn & Yahr Stage 2-3. (bilateral disease, not severely disabled.)
Exclusion Criteria:
- Any contra-indication to magnetic resonance imaging, including pacemaker, pacemaker
wires, aneurysm clip, or any electronic implant, weight over 136 kg (300 lb), metal
embedded in soft tissue or in the eye, prosthetic eye, claustrophobia, substance
abuse, use of recreational drugs, pregnancy, or other medical contraindications.
- A history of epilepsy, stroke, brain surgery, or structural brain disease.
- The presence of other serious illnesses (discretion of study clinician, e.g.
concurrent cancer treatment.)
- Pregnant.
- A history of sulfur sensitivity, e.g. reaction N-acetylcysteine, MSM, SAMe.
- A recent history of asthma.
- Supplementation with glutathione (oral, intravenous, intranasal, or nebulized) or the
glutathione precursor, N-acetylcysteine, for six months prior to baseline study
visit.
- History of sensitivity to sulfur containing medications/ supplements, i.e. NAC, MSM.
- Current drug or alcohol use or dependence.
- Inability/unwillingness to provide informed consent. (e.g. diagnosis of dementia,
confusion about study goals or participation.)
- Acute infection (e.g. upper respiratory, dermal) in the previous 30 days.
- Diagnosis of any mental illness, ever. (Mental illness has been associated with
glutathione depletion.)
- Diagnosis of any chronic disease, ever. (e.g. Hep C, autoimmune disease, etc.)
- Head tremor or head dyskinesia that cannot be comfortably controlled for 90 minutes.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Parkinson's Disease
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Intervention(s)
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Drug: Reduced Glutathione
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Primary Outcome(s)
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The concentration of metabolites before and after (in)GSH will be compared (change in mean GSH concentration)
[Time Frame: 15 minutes after administration]
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Secondary Outcome(s)
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A ROC curve will be generated to compare MRS [glutathione] to peripheral measures of RBC glutathione.
[Time Frame: 15 minutes after administration]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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