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Trial · Interventional

CompletedPhase 2Registry data

Phase IIb Study of Intranasal Glutathione in Parkinson's Disease

Short name (in)GSH

NCTNCT02424708 (opens ClinicalTrials.gov in a new tab)Other id14-1443
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 2
Enrollment
45 participants (actual)
Sponsor
Bastyr University · Other
Design
Randomized · Double masking
Countries
1 country

United States

Start
Apr 2015
Primary completion
Mar 2016
Completion
Apr 2016
First posted
23 Apr 2015 (estimated)
Last update posted
24 Jun 2016 (estimated)
Conditions
Parkinson's Disease

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201520162017
  1. Ph 2

    (in)GSH

    NCT02424708

    Apr 2015 to Apr 2016

Registry summary

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

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).

Interventions

  • Reduced Glutathione 100mgDrug
  • Reduced Glutathione 200mgDrug
  • PlaceboDrug

Arms3

  • Placebo comparator

    Placebo

    The study medication is packaged in sterile 1 ml pre-filled syringes, containing saline, which will be delivered intranasally.

  • Active comparator

    Reduced Glutathione 100mg

    The study medication is packaged in sterile 1 ml pre-filled syringes, containing 100 mg/ml of reduced glutathione (GSH), which will be delivered intranasally.

  • Active comparator

    Reduced Glutathione 200mg

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

Primary outcomes1

Outcomes the sponsor listed as primary.

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

    Time frame · 12 weeks

Secondary outcomes(1)

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

    Time frame · up to 16 weeks

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

Studies2

Studies that cite this trial.

Studies with results

1 study on this page

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)

More studies

1 study on this page

Indexing hint: Review · 2008

Inhaled glutathione for the prevention of air pollution-related health effects: a brief review.

Allen et al. 2008Alternative therapies in health and medicinecited by 6

PMID 18517105PUB-18517105

Full text at the publisher
Publisher page

Other registry references

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

  • ResultMerkus 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. PMID 12771261
  • 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
  • ResultRiederer 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. PMID 2911028
  • ResultSakhi 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. PMID 16376913
  • 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
  • ResultWinter 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. PMID 20345926
  • ResultWolfe TR, Hillman TA, Bossart PJ. The comparative risks of bacterial contamination between a venturi atomizer and a positive displacement atomizer. Am J Rhinol. 2002 Jul-Aug;16(4):181-6; discussion 186. PMID 12222941

Eligibility

Who could join, as posted.

Sex
All
Age
from 21 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * 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. * 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. Exclusion Criteria: * 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) * 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.

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