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Trial · Interventional

CompletedPhase 1Registry data

CNS Uptake of Intranasal Glutathione

NCTNCT02324426 (opens ClinicalTrials.gov in a new tab)Other id48273-A
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 1
Enrollment
15 participants (actual)
Sponsor
University of Washington · Other
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

United States

Start
Dec 2014
Primary completion
Mar 2015
Completion
Mar 2015
First posted
24 Dec 2014 (estimated)
Last update posted
30 Apr 2015 (estimated)
Conditions
Parkinson's Disease

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201420152016
  1. Ph 1

    CNS Uptake of Intranasal Glutathione

    NCT02324426

    Dec 2014 to Mar 2015

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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 glutathione augmentation. The aim of this study is to evaluate whether 200 mg of (in)GSH results in measurable changes in brain glutathione concentrations, as measured by magnetic resonance spectroscopy (MRS) in 15 individuals with PD.

Interventions

  • Reduced GlutathioneDrug

Arms1

  • Experimental

    Reduced Glutathione

    The study medication is packaged in sterile 1 ml pre-filled syringes, each containing 200 mg/ ml of reduced glutathione (GSH), which will be delivered intranasally.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. The concentration of metabolites before and after (in)GSH will be compared (change in mean GSH concentration)

    Time frame · 15 minutes after administration

    Registry description

    Describe the change in mean GSH concentration following administration of (in)GSH. The data analysis will be ipsative- results will be reported as percent change from the individual's own baseline GSH concentration.

Secondary outcomes(1)

  1. A ROC curve will be generated to compare MRS [glutathione] to peripheral measures of RBC glutathione.

    Time frame · 15 minutes after administration

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies3

Studies that cite this trial.

Studies with results

3 studies on this page

Indexing hint: Randomized controlled trial · 2009

6 results

Randomized, double-blind, pilot evaluation of intravenous glutathione in Parkinson's disease.

Hauser et al. 2009Movement disorders : official journal of the Movement Disorder Societycited by 88

PMID 19230029DOI 10.1002/mds.22401PUB-19230029

Full text at the publisher6 results
Publisher pageSee results (6)

Indexing hint: Clinical trial · 1996

2 results

Reduced intravenous glutathione in the treatment of early Parkinson's disease.

Sechi et al. 1996Progress in neuro-psychopharmacology & biological psychiatrycited by 109

PMID 8938817DOI 10.1016/s0278-5846(96)00103-0PUB-08938817

Full text at the publisher2 results
Publisher pageSee results (2)

PubMed tag: none · 1992

3 results

The systemic availability of oral glutathione.

Witschi et al. 1992European journal of clinical pharmacologycited by 159

PMID 1362956DOI 10.1007/bf02284971PUB-01362956

Full text at the publisher3 results
Publisher pageSee results (3)

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • ResultPocernich CB, Cardin AL, Racine CL, Lauderback CM, Butterfield DA. Glutathione elevation and its protective role in acrolein-induced protein damage in synaptosomal membranes: relevance to brain lipid peroxidation in neurodegenerative disease. Neurochem Int. 2001 Aug;39(2):141-9. doi: 10.1016/s0197-0186(01)00012-2. PMID 11408093
  • ResultSian 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. PMID 8080242
  • ResultSofic 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. PMID 1454205
  • ResultMischley LK SL, Samii A, Pollisar N, Lau R, Leverenz J, . Phase I Study of Intranasal Glutathione in Parkinson's Disease. Seattle: Bastyr University Research Instittue; 2013.
  • ResultLee M, Cho T, Jantaratnotai N, Wang YT, McGeer E, McGeer PL. Depletion of GSH in glial cells induces neurotoxicity: relevance to aging and degenerative neurological diseases. FASEB J. 2010 Jul;24(7):2533-45. doi: 10.1096/fj.09-149997. Epub 2010 Mar 12. PMID 20228251
  • ResultPearce 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. PMID 9444566
  • ResultDelleDonne A, Klos KJ, Fujishiro H, Ahmed Z, Parisi JE, Josephs KA, Frigerio R, Burnett M, Wszolek ZK, Uitti RJ, Ahlskog JE, Dickson DW. Incidental Lewy body disease and preclinical Parkinson disease. Arch Neurol. 2008 Aug;65(8):1074-80. doi: 10.1001/archneur.65.8.1074. PMID 18695057
  • ResultEmir UE, Raatz S, McPherson S, Hodges JS, Torkelson C, Tawfik P, White T, Terpstra M. Noninvasive quantification of ascorbate and glutathione concentration in the elderly human brain. NMR Biomed. 2011 Aug;24(7):888-94. doi: 10.1002/nbm.1646. Epub 2011 Jan 12. PMID 21834011
  • ResultGroger A, Chadzynski G, Godau J, Berg D, Klose U. Three-dimensional magnetic resonance spectroscopic imaging in the substantia nigra of healthy controls and patients with Parkinson's disease. Eur Radiol. 2011 Sep;21(9):1962-9. doi: 10.1007/s00330-011-2123-5. Epub 2011 Apr 12. PMID 21484351
  • ResultEmir UE, Deelchand D, Henry PG, Terpstra M. Noninvasive quantification of T2 and concentrations of ascorbate and glutathione in the human brain from the same double-edited spectra. NMR Biomed. 2011 Apr;24(3):263-9. doi: 10.1002/nbm.1583. Epub 2010 Oct 6. PMID 20925125
  • ResultSekhar RV, Patel SG, Guthikonda AP, Reid M, Balasubramanyam A, Taffet GE, Jahoor F. Deficient synthesis of glutathione underlies oxidative stress in aging and can be corrected by dietary cysteine and glycine supplementation. Am J Clin Nutr. 2011 Sep;94(3):847-53. doi: 10.3945/ajcn.110.003483. Epub 2011 Jul 27. PMID 21795440
  • ResultHolmay MJ, Terpstra M, Coles LD, Mishra U, Ahlskog M, Oz G, Cloyd JC, Tuite PJ. N-Acetylcysteine boosts brain and blood glutathione in Gaucher and Parkinson diseases. Clin Neuropharmacol. 2013 Jul-Aug;36(4):103-6. doi: 10.1097/WNF.0b013e31829ae713. PMID 23860343
  • ResultMischley LK, Vespignani MF, Finnell JS. Safety survey of intranasal glutathione. J Altern Complement Med. 2013 May;19(5):459-63. doi: 10.1089/acm.2011.0673. Epub 2012 Dec 16. PMID 23240940

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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.

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