Intranasal Glutathione in Parkinson's Disease (inGSH in PD)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Bastyr University
ClinicalTrials.gov Identifier:
NCT01398748
First received: July 19, 2011
Last updated: January 6, 2014
Last verified: January 2014
  Purpose

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 delivery for this popular CAM therapy in patients with PD, and bypasses the obstacles associated with other delivery methods. It has been used in clinical practice since 2005. The aim of this study is to evaluate safety, tolerability, and preliminary absorption data of (in)GSH in volunteers with PD in a Phase I single ascending dose escalation study.


Condition Intervention Phase
Parkinson's Disease (PD)
Drug: Intranasal glutathione - (in)GSH
Drug: Saline Intranasal Delivery
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 1 Study of Intranasal Reduced Glutathione in Parkinson's Disease

Resource links provided by NLM:


Further study details as provided by Bastyr University:

Primary Outcome Measures:
  • Determination of Safety [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

    1a. Laboratory monitoring for adverse events will include CBC, ALT, AST, BUN, creatinine, uric acid, and urinalysis. Data will be collected throughout the 12-week intervention and at 1-mo following cessation of the study medication.

    1b. Clinical adverse events will be measured using a daily patient diary and record score cards specifically screening for sinus irritation. Monitoring of Side Effects System (MOSES) will be used to screen for systemic and generalized adverse events.

    1c. Effect on PD symptoms will be measured by the UPDRS to screen for accelerated disease activity.


  • Determination of Tolerability [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Participants will be asked to keep a daily log and unused study medication will be measured at each clinical visit. Tolerability will be measured by frequency and severity of reported adverse events and withdrawal from study. The goal will be to identify the maximum tolerated dose (MTD) which will be defined as the highest dose achieving adherence, as defined as 80% of the group taking the prescribed dose 80% of the time.


Secondary Outcome Measures:
  • Description of systemic absorption characteristics [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Red blood cell GSH levels will be measured at baseline, 4 weeks, and 12 weeks.


Enrollment: 34
Study Start Date: July 2012
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Intranasal GSH 100mg/ml
100mg/ml of intranasal glutathione (n=10)
Drug: Intranasal glutathione - (in)GSH
Tripeptide glutathione 100 mg/ml. 1ml TID X 12 weeks
Active Comparator: Intranasal glutathione 200mg/ml
200mg/ml of intranasal glutathione (n=10)
Drug: Intranasal glutathione - (in)GSH
Tripeptide glutathione - 200mg/ml. 1 ml TID X 12 weeks
Placebo Comparator: Saline intranasal delivery
Intranasal saline delivery (n=10)
Drug: Saline Intranasal Delivery
Saline administration
No Intervention: Watchful waiting
No intervention, watchful waiting only (n=4)

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01398748

Locations
United States, Washington
Bastyr Clinical Research Center
Kenmore, Washington, United States, 98023
Sponsors and Collaborators
Bastyr University
Investigators
Principal Investigator: Laurie Mischley, ND Bastyr University
  More Information

Additional Information:
No publications provided

Responsible Party: Bastyr University
ClinicalTrials.gov Identifier: NCT01398748     History of Changes
Other Study ID Numbers: BU-H32B11, 5K01AT004404
Study First Received: July 19, 2011
Last Updated: January 6, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Bastyr University:
Parkinson's disease
Neuroprotection
Glutathione
Intranasal

Additional relevant MeSH terms:
Parkinson Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Movement Disorders
Nervous System Diseases
Neurodegenerative Diseases
Parkinsonian Disorders

ClinicalTrials.gov processed this record on October 20, 2014