Intranasal Glutathione in Parkinson's Disease

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT01398748
• Date of registration: 19/07/2011
• Prospective Registration: Yes
• Primary sponsor: Bastyr University
• Public title: Intranasal Glutathione in Parkinson's Disease
• Scientific title: A Phase 1 Study of Intranasal Reduced Glutathione in Parkinson's Disease
• Date of first enrolment: July 2012
• Target sample size: 34
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01398748
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 1

Countries of recruitment

United States

Contacts

• Name: Laurie Mischley, ND
• Affiliation: Bastyr University

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Diagnosis of Parkinson's Disease made by neurologist within previous 10 years

2. Modified Hoehn and Yahr Stage <3

3. Age >20

4. Subjects must be able to attend study visits at screening, baseline, weeks 4, 8, 12,
16

5. Subjects must be able to demonstrate self-administration of study medication or have
active caregiver who can administer daily.

6. Dose and frequency of all pharmaceutical medications must be stable for one month
prior to enrollment.

7. Diet, exercise and supplementation must be kept constant throughout participation in
study

8. Ability to read and speak English

Exclusion Criteria:

1. Dementia as evidenced by Montreal Cognitive Assessment (MoCA) <24

2. Diseases with features common to Parkinson's Disease (eg. essential tremor, multiple
system atrophy, progressive supranuclear palsy)

3. Epilepsy

4. History of stroke, CVA

5. Elevated levels of ALT, AST, BUN or creatinine

6. Chronic sinusitis as defined by SNOT-20 score >1.0 on items 1-10.

7. Presence of other serious illness

8. History of brain surgery

9. History of structural brain damage

10. History of intranasal telangiectasia

11. Supplementation with glutathione and agents shown to increase glutathione will not be
permitted and will require a 90 day washout period.

12. Pregnant or at risk of becoming pregnant.



Age minimum: 21 Years
Age maximum: 100 Years
Gender: All

Health Condition(s) or Problem(s) studied

Parkinson's Disease (PD)

Intervention(s)

Drug: Saline Intranasal Delivery

Drug: Intranasal glutathione - (in)GSH

Primary Outcome(s)

Determination of Safety [Time Frame: 12 weeks]

Determination of Tolerability [Time Frame: 12 weeks]

Secondary Outcome(s)

Description of systemic absorption characteristics [Time Frame: 12 weeks]

Secondary ID(s)

BU-H32B11

5K01AT004404

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Center for Complementary and Integrative Health (NCCIH)