Parkinson's Disease (PD)Phase 1NCT01398748
Intranasal Glutathione in Parkinson's Disease
A Phase 1 study testing Intranasal glutathione - (in)GSH and Saline Intranasal Delivery in people with Parkinson's Disease (PD), run by Bastyr University at 1 site in United States.
Trial summary
Excessive free radical formation and depletion of the brain's primary antioxidant, glutathione, are established components of Parkinson's disease (PD) pathophysiology. While there is rationale for the therapeutic use of reduced glutathione (GSH) in PD, and even some preliminary evidence to suggest the use of GSH can… Read more about this study
- Who is it for?
- Ages 21 to 100 years
- Conditions the study is for
- Parkinson's Disease (PD)
- What is being tested?
- Intranasal glutathione - (in)GSH and Saline Intranasal Delivery
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2012to Jan 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of Parkinson's Disease made by neurologist within previous 10 years
- Modified Hoehn and Yahr Stage <3
- Age >20
- Subjects must be able to attend study visits at screening, baseline, weeks 4, 8, 12, 16
- Subjects must be able to demonstrate self-administration of study medication or have active caregiver who can administer daily.
- Dose and frequency of all pharmaceutical medications must be stable for one month prior to enrollment.
- Diet, exercise and supplementation must be kept constant throughout participation in study
- Ability to read and speak English
Who cannot join
- Dementia as evidenced by Montreal Cognitive Assessment (MoCA) <24
- Diseases with features common to Parkinson's Disease (eg. essential tremor, multiple system atrophy, progressive supranuclear palsy)
- Epilepsy
- History of stroke, CVA
- Elevated levels of ALT, AST, BUN or creatinine
- Chronic sinusitis as defined by SNOT-20 score >1.0 on items 1-10.
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- Presence of other serious illness
- History of brain surgery
- History of structural brain damage
- History of intranasal telangiectasia
- Supplementation with glutathione and agents shown to increase glutathione will not be permitted and will require a 90 day washout period.
- Pregnant or at risk of becoming pregnant.
Trial locations and contacts
1 site in 1 country.
United States1 site
Bastyr Clinical Research Center
Kenmore, Washington, 98023
About this study
Official title: A Phase 1 Study of Intranasal Reduced Glutathione in Parkinson's Disease
Excessive free radical formation and depletion of the brain's primary antioxidant, glutathione, are established components of Parkinson's disease (PD) pathophysiology. While there is rationale for the therapeutic use of reduced glutathione (GSH) in PD, and even some preliminary evidence to suggest the use of GSH can lead to symptomatic improvement, obstacles surrounding currently employed delivery methods have hindered the clinical utility of this therapy. Intranasal GSH, (in)GSH, is a novel method of delivery for this popular CAM therapy in patients with PD, and bypasses the obstacles associated with other delivery methods. It has been used in clinical practice since 2005. The aim of this study is to evaluate safety, tolerability, and preliminary absorption data of (in)GSH in volunteers with PD in a Phase I single ascending dose escalation study.
Read the detailed description
Individuals will be randomized to one of three treatment (100 mg GSH/ ml, 200 mg GSH/ ml, or placebo) arms in a double-blind fashion. All study medication will be administered 1 ml three times daily for three months, with a one-month wash out.
- Conditions
- Parkinson's Disease (PD)
- Being tested
- Intranasal glutathione - (in)GSH, Saline Intranasal Delivery
- Keywords
- Parkinson's disease, Neuroprotection, Glutathione, Intranasal
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intranasal glutathione - (in)GSHDrug
Intranasal glutathione-Tripeptide glutathione 100 mg/ml. 1 ml 3x per day TID X 12 weeks at 2100mg in 15 participants
Intranasal glutathione - (in)GSHDrug
Intranasal Glutathione-Tripeptide glutathione - 200mg/ml. 1 ml 3x per day TID X 12 weeks at 4200mg in 15 participants
Saline Intranasal DeliveryDrug
Saline administration 1ml 3x/day 12 weeks in 15 participants
| Study group | Role | What they receive |
|---|---|---|
| Intranasal GSH 100mg/ml | Active comparator | 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 Receives: Drug: Intranasal glutathione - (in)GSH |
| Intranasal glutathione 200mg/ml | Active comparator | 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 Receives: Drug: Intranasal glutathione - (in)GSH |
| Saline intranasal delivery | Placebo comparator | 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 Receives: Drug: Saline Intranasal Delivery |
| Watchful waiting | No intervention | No intervention, watchful waiting only (n=4) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of Safety
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.
Measured: 12 weeks
Determination of Tolerability
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.
Measured: 12 weeks
Secondary outcomes (1)
Description of systemic absorption characteristics
Red blood cell GSH levels will be measured at baseline, 4 weeks, and 12 weeks.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2011 (estimated)
- Study startJul 2012
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's Disease (PD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bastyr University
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Sponsor
- Investigators
- Laurie Mischley, ND, Principal investigator, Bastyr University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01398748
- Sponsor's protocol ID
- BU-H32B11
- Other IDs
- 5K01AT004404
- Status last verified
- Jul 2017
- First submitted
- 19 Jul 2011
- Last updated
- 31 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of Intranasal Reduced Glutathione in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT01398748
- Acronym / sponsor ID
- BU-H32B11
- Conditions
- Parkinson's Disease (PD)
- Keywords
- Parkinson's disease, Neuroprotection, Glutathione, Intranasal
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Bastyr UniversityUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- Jul 2012
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 21 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Excessive free radical formation and depletion of the brain's primary antioxidant, glutathione, are established components of Parkinson's disease (PD) pathophysiology. While there is rationale for the therapeutic use of reduced glutathione (GSH) in PD, and even some preliminary evidence to suggest the use of GSH can lead to symptomatic improvement, obstacles surrounding currently employed delivery methods have hindered the clinical utility of this therapy. Intranasal GSH, (in)GSH, is a novel method of delivery for this popular CAM therapy in patients with PD, and bypasses the obstacles associated with other delivery methods. It has been used in clinical practice since 2005. The aim of this study is to evaluate safety, tolerability, and preliminary absorption data of (in)GSH in volunteers with PD in a Phase I single ascending dose escalation study.
Detailed description
Individuals will be randomized to one of three treatment (100 mg GSH/ ml, 200 mg GSH/ ml, or placebo) arms in a double-blind fashion. All study medication will be administered 1 ml three times daily for three months, with a one-month wash out.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Intranasal GSH 100mg/ml | Active comparator | Drug: Intranasal glutathione - (in)GSHStudy 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 |
| Intranasal glutathione 200mg/ml | Active comparator | Drug: Intranasal glutathione - (in)GSHStudy 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 |
| Saline intranasal delivery | Placebo comparator | Drug: Saline Intranasal DeliveryStudy 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 |
| Watchful waiting | No intervention | –No intervention, watchful waiting only (n=4) |
Who may qualify
- Ages
- 21 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Diagnosis of Parkinson's Disease made by neurologist within previous 10 years
- Modified Hoehn and Yahr Stage <3
- Age >20
- Subjects must be able to attend study visits at screening, baseline, weeks 4, 8, 12, 16
- Subjects must be able to demonstrate self-administration of study medication or have active caregiver who can administer daily.
Key exclusion criteria (12 listed)
- Dementia as evidenced by Montreal Cognitive Assessment (MoCA) <24
- Diseases with features common to Parkinson's Disease (eg. essential tremor, multiple system atrophy, progressive supranuclear palsy)
- Epilepsy
- History of stroke, CVA
- Elevated levels of ALT, AST, BUN or creatinine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intranasal glutathione - (in)GSHIntranasal glutathione-Tripeptide glutathione 100 mg/ml. 1 ml 3x per day TID X 12 weeks at 2100mg in 15 participants | Drug | Intranasal GSH 100mg/ml |
| Intranasal glutathione - (in)GSHIntranasal Glutathione-Tripeptide glutathione - 200mg/ml. 1 ml 3x per day TID X 12 weeks at 4200mg in 15 participants | Drug | Intranasal glutathione 200mg/ml |
| Saline Intranasal DeliverySaline administration 1ml 3x/day 12 weeks in 15 participants | Drug | Saline intranasal delivery |
Primary outcome
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.
1 secondary outcome
Description of systemic absorption characteristics
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laurie Mischley, ND principal investigator
Bastyr University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Intranasal glutathione - (in)GSH and Saline Intranasal Delivery in people with Parkinson's Disease (PD), run by Bastyr University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determination of Safety (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2017.