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Parkinson's DiseasePhase 2(in)GSHNCT02424708

Phase IIb Study of Intranasal Glutathione in Parkinson's Disease

A Phase 2 study testing Reduced Glutathione 100mg and Reduced Glutathione 200mg in people with Parkinson's Disease, run by Bastyr University at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Glutathione is an important nutrient for brain function and loss of glutathione has been implicated in Parkinson's disease. Glutathione is an antioxidant made in the body out of three amino acids, the nutrients that make up protein. Read more about this study

Who is it for?
Ages 21 years and older
Conditions the study is for
Parkinson's Disease
What is being tested?
Reduced Glutathione 100mg and Reduced Glutathione 200mg
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
45 participants
Where
2 sitesUnited States
Study dates
Apr 2015to Apr 2016
Phase
Phase 2
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of PD made by a clinical neurologist within the previous 10 years
  • A modified Hoehn \& Yahr Stage <3
  • Age >21
  • Subjects must be able to attend study visits at baseline, weeks 4, 8, 12, and 16.
  • Subjects must be able to demonstrate, or have a caregiver administer, medication.
  • Dose and frequency of pharmaceutical medications must be stable for 1 month prior to enrollment.
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  • Dose and frequency of naturopathic medications must be stable for 1 month prior to enrollment.
  • Diet, exercise, and medications must be kept constant throughout participation in the study. (Medication changes considered essential by a participant's physician will be permitted and recorded).
  • Ability to read and speak English.
  • MRI cohort: Additional inclusion criteria specific to MRI.

Who cannot join

  • Dementia as evidenced by a Montreal Cognitive Assessment score of less than 24.
  • Diseases with features common to PD (e.g., essential tremor, multiple system atrophy, progressive supranuclear palsy)
  • Epilepsy
  • A history of stroke
  • The presence of other serious illnesses
  • Respiratory disease (e.g. asthma, COPD)
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  • A history of brain surgery
  • A history of structural brain disease
  • A history of intranasal telangiectasia
  • Supplementation with glutathione, and agents shown to increase glutathione, will not be permitted and their use will necessitate a 90-day washout period; this will be required for all forms of glutathione and the glutathione precursor, N-acetylcysteine.
  • Pregnant or at risk of becoming pregnant (i.e., unwilling to use birth control if a sexually active, pre-menopausal female). Urine pregnancy tests will be administered to pre-menopausal women.
  • MRI cohort: Additional exclusion criteria specific to MRI.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Bastyr University

    Kenmore, Washington, 98028

  • University of Washington

    Seattle, Washington, 98195

Other trials in United States

About this study

Glutathione is an important nutrient for brain function and loss of glutathione has been implicated in Parkinson's disease. Glutathione is an antioxidant made in the body out of three amino acids, the nutrients that make up protein. This study will determine whether administration of either dose of glutathione, as a nasal spray, improves PD symptoms over time in a population of individuals with Parkinson's disease (PD).

Read the detailed description

The study begins with a pre-screening telephone interview. During this conversation participants will be asked a series of questions that will help us identify whether they are eligible for participation in this study. The pre-screening interview process will take approximately 10 minutes and will include all screening criteria that does not require clinical or laboratory examination

All routine research visits will take place at Bastyr University Campus (Kenmore, WA). Participants will be asked to schedule visits at approximately the same time of day each visit .If they are on medications, we would like them to take their medications as they normally would on the day of the visit. Participants will be randomly assigned to one of three different study groups- a low dose group, a high dose group, or a placebo group.

Study participants will invited to volunteer for two magnetic resonance imagine (MRI) scans as part of this study, an optional part of study participation. For those who volunteer and qualify, MRIs will be performed at the University of Washington Radiology Department early in the morning. One scan will be taken at baseline before taking glutathione and the second upon completion of the study medication. There will be a separate consent form for those who participate in the imaging portion of this study. Among the participants who volunteer, the first 15 to qualify for an MRI scan will be scheduled according to MRI availability.

If participants are enrolled in the study, they will be asked to keep a daily log of actual frequency of administration of study medication, if any, as well as any changes in their PD symptoms, any adverse events they might experience, and their general well-being. We are giving participants enough medication to last four weeks, until the date of their next appointment. The medication should be taken three times a day (morning, afternoon, and evening).

Visit 1- Baseline: (Approximately 1 hour)

  • Urine sample
  • Venipuncture (blood draw, (40 mL / ~3 Tbsp) to assess blood antioxidant status..
  • Clinical assessment of PD severity: Unified Parkinson's Disease Rating Scale (UPDRS), which involves assessing degree of tremor, ability to walk across the room, questions about ability to function independently (i.e. button your own shirt, feed yourself), and questions about mental health, including depression and intellectual impairment.
  • Participant will be taught how and when to administer the study medication and be given a 1-month supply.

Visit 2- Week 4 follow-up: (Approximately 1 hour)

  • Urine sample
  • Venipuncture (blood draw, (40 mL / ~3 Tbsp) to assess blood antioxidant status..
  • Clinical assessment of PD severity: Unified Parkinson's Disease Rating Scale (UPDRS) and Webster-Step Second test involve assessing degree of tremor, ability to walk across the room, questions about ability to function independently (i.e. button your own shirt, feed yourself), and questions about mental health, including depression and intellectual impairment.
  • Participant will be asked to return any unused study medication and applicator tips from the first month of the study and be given the next 1-month supply.
  • We will inquire about medication changes and collect medication use logs.

Visit 3- Week 8 follow-up: (Approximately 1/2 hour)

  • Participant will be asked to return any unused study medication from the second month of the study and be given the next 1-month supply.
  • We will inquire about medication changes and collect medication use logs.

Visit 4- Week 12 follow-up: (Approximately 1 hour)

  • Urine sample
  • Venipuncture (blood draw, (40 mL / ~3 Tbsp) to assess blood antioxidant status..
  • Clinical assessment of PD severity: Unified Parkinson's Disease Rating Scale (UPDRS) to assess degree of tremor, ability to walk across the room, questions about ability to function independently (i.e. button your own shirt, feed yourself), and questions about mental health, including depression and intellectual impairment.
  • Participants will be asked to return any unused study medication from the third month of the study.
  • We will inquire about medication changes and collect medication use logs.

Visit 5- Week 16 follow-up: (Approximately 1 hour)

This visit is included to determine whether there are any lasting effects of the study medication one month following discontinuation of use. The visit will include:

  • Urine sample
  • Venipuncture (blood draw, (40 mL / ~3 Tbsp) to assess blood antioxidant status..
  • Clinical assessment of PD severity: Unified Parkinson's Disease Rating Scale (UPDRS) which involves assessing degree of tremor, ability to walk across the room, questions about ability to function independently (i.e. button your own shirt, feed yourself), and questions about mental health, including depression and intellectual impairment.

Overall, approximately 5 hours will be required for study participation. Blood draws will occur at most, but not all visits, and will not exceed 4 Tbsp per month.

Being tested
Reduced Glutathione 100mg, Reduced Glutathione 200mg, Placebo
Keywords
Reduced Glutathione, Intranasal, (in)GSH, Parkinson's Disease, Glutathione, Uptake, central nervous system
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Reduced Glutathione 100mgDrug

    Also called (in)GSH

    100mg GSH delivered intranasally, three times a day for 12 weeks, in 1 cc sterile saline using a syringe with a Mucosal Atomization Device (MAD) tip.

  • Reduced Glutathione 200mgDrug

    Also called (in)GSH

    200mg GSH delivered intranasally, three times a day for 12 weeks, in 1 cc sterile saline using a syringe with a Mucosal Atomization Device (MAD) tip.

  • PlaceboDrug

    Also called Saline

    Saline delivered intranasally, three times a day for 12 weeks, in 1 cc sterile saline using a syringe with a Mucosal Atomization Device (MAD) tip.

Study groups in NCT02424708
Study groupRoleWhat they receive
PlaceboPlacebo comparatorThe study medication is packaged in sterile 1 ml pre-filled syringes, containing saline, which will be delivered intranasally.
Receives: Drug: Placebo
Reduced Glutathione 100mgActive comparatorThe study medication is packaged in sterile 1 ml pre-filled syringes, containing 100 mg/ml of reduced glutathione (GSH), which will be delivered intranasally.
Receives: Drug: Reduced Glutathione 100mg
Reduced Glutathione 200mgActive comparatorThe study medication is packaged in sterile 1 ml pre-filled syringes, containing 200 mg/ml of reduced glutathione (GSH), which will be delivered intranasally.
Receives: Drug: Reduced Glutathione 200mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Unified Parkinson's Disease Rating Scale (UPDRS) Score

    Measured: 12 weeks

Secondary outcomes (1)

  1. Red blood cell (RBC) GSH levels will be measured at baseline, week 4, week 12, and 16.

    Measured: up to 16 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Apr 2015 (estimated)
  2. Study startApr 2015
  3. Primary completionMar 2016
  4. Study completionApr 2016

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
45 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02424708
Sponsor's protocol ID
14-1443
Acronym
(in)GSH
Status last verified
Jun 2016
First submitted
15 Apr 2015
Last updated
24 Jun 2016
Results posted
No
Data monitoring committee
No

Publications

  • Allen J. Inhaled glutathione for the prevention of air pollution-related health effects: a brief review. Altern Ther Health Med. 2008 May-Jun;14(3):42-4.

    PubMed 18517105

  • Baker MA, Cerniglia GJ, Zaman A. Microtiter plate assay for the measurement of glutathione and glutathione disulfide in large numbers of biological samples. Anal Biochem. 1990 Nov 1;190(2):360-5. doi: 10.1016/0003-2697(90)90208-q.

    PubMed 2291479

  • Chinta SJ, Andersen JK. Reversible inhibition of mitochondrial complex I activity following chronic dopaminergic glutathione depletion in vitro: implications for Parkinson's disease. Free Radic Biol Med. 2006 Nov 1;41(9):1442-8. doi: 10.1016/j.freeradbiomed.2006.08.002. Epub 2006 Aug 7.

    PubMed 17023271

  • Dexter DT, Sian J, Rose S, Hindmarsh JG, Mann VM, Cooper JM, Wells FR, Daniel SE, Lees AJ, Schapira AH, et al. Indices of oxidative stress and mitochondrial function in individuals with incidental Lewy body disease. Ann Neurol. 1994 Jan;35(1):38-44. doi: 10.1002/ana.410350107.

    PubMed 8285590

  • Eyer P, Podhradsky D. Evaluation of the micromethod for determination of glutathione using enzymatic cycling and Ellman's reagent. Anal Biochem. 1986 Feb 15;153(1):57-66. doi: 10.1016/0003-2697(86)90061-8.

    PubMed 3963383

  • Schapira AH. Progress in neuroprotection in Parkinson's disease. Eur J Neurol. 2008 Apr;15 Suppl 1:5-13. doi: 10.1111/j.1468-1331.2008.02055.x.

    PubMed 18353131

  • Schulz JB, Lindenau J, Seyfried J, Dichgans J. Glutathione, oxidative stress and neurodegeneration. Eur J Biochem. 2000 Aug;267(16):4904-11. doi: 10.1046/j.1432-1327.2000.01595.x.

    PubMed 10931172

  • Merkus P, Guchelaar HJ, Bosch DA, Merkus FW. Direct access of drugs to the human brain after intranasal drug administration? Neurology. 2003 May 27;60(10):1669-71. doi: 10.1212/01.wnl.0000067993.60735.77.

    PubMed 12771261

  • Pearce RK, Owen A, Daniel S, Jenner P, Marsden CD. Alterations in the distribution of glutathione in the substantia nigra in Parkinson's disease. J Neural Transm (Vienna). 1997;104(6-7):661-77. doi: 10.1007/BF01291884.

    PubMed 9444566

  • Riederer P, Sofic E, Rausch WD, Schmidt B, Reynolds GP, Jellinger K, Youdim MB. Transition metals, ferritin, glutathione, and ascorbic acid in parkinsonian brains. J Neurochem. 1989 Feb;52(2):515-20. doi: 10.1111/j.1471-4159.1989.tb09150.x.

    PubMed 2911028

  • Sakhi AK, Russnes KM, Smeland S, Blomhoff R, Gundersen TE. Simultaneous quantification of reduced and oxidized glutathione in plasma using a two-dimensional chromatographic system with parallel porous graphitized carbon columns coupled with fluorescence and coulometric electrochemical detection. J Chromatogr A. 2006 Feb 3;1104(1-2):179-89. doi: 10.1016/j.chroma.2005.11.129.

    PubMed 16376913

  • Sechi G, Deledda MG, Bua G, Satta WM, Deiana GA, Pes GM, Rosati G. Reduced intravenous glutathione in the treatment of early Parkinson's disease. Prog Neuropsychopharmacol Biol Psychiatry. 1996 Oct;20(7):1159-70. doi: 10.1016/s0278-5846(96)00103-0.

    PubMed 8938817

  • Sian J, Dexter DT, Lees AJ, Daniel S, Agid Y, Javoy-Agid F, Jenner P, Marsden CD. Alterations in glutathione levels in Parkinson's disease and other neurodegenerative disorders affecting basal ganglia. Ann Neurol. 1994 Sep;36(3):348-55. doi: 10.1002/ana.410360305.

    PubMed 8080242

  • Sofic E, Lange KW, Jellinger K, Riederer P. Reduced and oxidized glutathione in the substantia nigra of patients with Parkinson's disease. Neurosci Lett. 1992 Aug 17;142(2):128-30. doi: 10.1016/0304-3940(92)90355-b.

    PubMed 1454205

  • Winter Y, Balzer-Geldsetzer M, Spottke A, Reese JP, Baum E, Klotsche J, Rieke J, Simonow A, Eggert K, Oertel WH, Dodel R. Longitudinal study of the socioeconomic burden of Parkinson's disease in Germany. Eur J Neurol. 2010 Sep;17(9):1156-1163. doi: 10.1111/j.1468-1331.2010.02984.x. Epub 2010 Mar 22.

    PubMed 20345926

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Reduced Glutathione 100mg and Reduced Glutathione 200mg in people with Parkinson's Disease, run by Bastyr University at 2 sites 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 10 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 24 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Change in Unified Parkinson's Disease Rating Scale (UPDRS) Score (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02424708, which also lists 16 linked publications.

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 24 Jun 2016.

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