Phase IIb Study of Intranasal Glutathione in Parkinson's Disease

• Register: ClinicalTrials.gov
• Last refreshed on: 4 July 2016
• Main ID: NCT02424708
• Date of registration: 15/04/2015
• Prospective Registration: No
• Primary sponsor: Bastyr University
• Public title: Phase IIb Study of Intranasal Glutathione in Parkinson's Disease (in)GSH
• Scientific title: Phase IIb Study of Intranasal Glutathione in Parkinson's Disease
• Date of first enrolment: April 2015
• Target sample size: 45
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02424708
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Laurie K Mischley, NDMPHPhD(c)
• Affiliation: Bastyr University

Key inclusion & exclusion criteria

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.



Age minimum: 21 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Parkinson's Disease

Intervention(s)

Drug: Reduced Glutathione 100mg

Drug: Reduced Glutathione 200mg

Drug: Placebo

Primary Outcome(s)

Change in Unified Parkinson's Disease Rating Scale (UPDRS) Score [Time Frame: 12 weeks]

Secondary Outcome(s)

Red blood cell (RBC) GSH levels will be measured at baseline, week 4, week 12, and 16. [Time Frame: up to 16 weeks]

Secondary ID(s)

14-1443

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Michael J. Fox Foundation for Parkinson's Research