Intranasal Glutathione in Parkinson's Disease
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|ClinicalTrials.gov Identifier: NCT01398748|
Recruitment Status : Completed
First Posted : July 21, 2011
Last Update Posted : July 31, 2017
|Condition or disease||Intervention/treatment||Phase|
|Parkinson's Disease (PD)||Drug: Intranasal glutathione - (in)GSH Drug: Saline Intranasal Delivery||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||34 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Phase 1 Study of Intranasal Reduced Glutathione in Parkinson's Disease|
|Study Start Date :||July 2012|
|Actual Primary Completion Date :||January 2016|
|Actual Study Completion Date :||January 2016|
Active Comparator: Intranasal GSH 100mg/ml
Study participant will be provided with monthly supply of study medication and will be asked to intake 100mg/ml of intranasal glutathione (n=15) An amount of 1ml with a frequency 3x per days and duration of 12 weeks with a dosage of 2100mg
Drug: Intranasal glutathione - (in)GSH
Intranasal glutathione-Tripeptide glutathione 100 mg/ml. 1 ml 3x per day TID X 12 weeks at 2100mg in 15 participants
Active Comparator: Intranasal glutathione 200mg/ml
Study participant will be provided with monthly supply of study medication and will be asked to intake 200/ml of intranasal glutathione (n=15) An amount of 1ml with a frequency 3x per days and duration of 12 weeks with a dosage of 4200mg
Drug: Intranasal glutathione - (in)GSH
Intranasal Glutathione-Tripeptide glutathione - 200mg/ml. 1 ml 3x per day TID X 12 weeks at 4200mg in 15 participants
Placebo Comparator: Saline intranasal delivery
Study participant will be provided with monthly supply of study medication and will be asked to intake Intranasal saline delivery (n=15) An amount of 1ml with a frequency 3x per day with a duration of 12 weeks
Drug: Saline Intranasal Delivery
Saline administration 1ml 3x/day 12 weeks in 15 participants
No Intervention: Watchful waiting
No intervention, watchful waiting only (n=4)
- Determination of Safety [ Time Frame: 12 weeks ]
1a. Laboratory monitoring for adverse events will include CBC, ALT, AST, BUN, creatinine, uric acid, and urinalysis. Data will be collected throughout the 12-week intervention and at 1-mo following cessation of the study medication.
1b. Clinical adverse events will be measured using a daily patient diary and record score cards specifically screening for sinus irritation. Monitoring of Side Effects System (MOSES) will be used to screen for systemic and generalized adverse events.
1c. Effect on PD symptoms will be measured by the UPDRS to screen for accelerated disease activity.
- Determination of Tolerability [ Time Frame: 12 weeks ]Participants will be asked to keep a daily log and unused study medication will be measured at each clinical visit. Tolerability will be measured by frequency and severity of reported adverse events and withdrawal from study. The goal will be to identify the maximum tolerated dose (MTD) which will be defined as the highest dose achieving adherence, as defined as 80% of the group taking the prescribed dose 80% of the time.
- Description of systemic absorption characteristics [ Time Frame: 12 weeks ]Red blood cell GSH levels will be measured at baseline, 4 weeks, and 12 weeks.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01398748
|United States, Washington|
|Bastyr Clinical Research Center|
|Kenmore, Washington, United States, 98023|
|Principal Investigator:||Laurie Mischley, ND||Bastyr University|