NCT01398748

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jul 2012

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 19, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 21, 2011

Completed
12 months until next milestone

Study Start

First participant enrolled

July 1, 2012

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

July 31, 2017

Status Verified

July 1, 2017

Enrollment Period

3.5 years

First QC Date

July 19, 2011

Last Update Submit

July 27, 2017

Conditions

Parkinson's Disease (PD)

Keywords

Parkinson's diseaseNeuroprotectionGlutathioneIntranasal

Outcome Measures

Primary Outcomes (2)

  • Determination of Safety

    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.

    12 weeks

  • Determination of Tolerability

    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.

    12 weeks

Secondary Outcomes (1)

  • Description of systemic absorption characteristics

    12 weeks

Study Arms (4)

Intranasal GSH 100mg/ml

ACTIVE COMPARATOR

Study participant will be provided with monthly supply of study medication and will be asked to intake 100mg/ml of intranasal glutathione (n=15) An amount of 1ml with a frequency 3x per days and duration of 12 weeks with a dosage of 2100mg

Drug: Intranasal glutathione - (in)GSH

Intranasal glutathione 200mg/ml

ACTIVE COMPARATOR

Study participant will be provided with monthly supply of study medication and will be asked to intake 200/ml of intranasal glutathione (n=15) An amount of 1ml with a frequency 3x per days and duration of 12 weeks with a dosage of 4200mg

Drug: Intranasal glutathione - (in)GSH

Saline intranasal delivery

PLACEBO COMPARATOR

Study participant will be provided with monthly supply of study medication and will be asked to intake Intranasal saline delivery (n=15) An amount of 1ml with a frequency 3x per day with a duration of 12 weeks

Drug: Saline Intranasal Delivery

Watchful waiting

NO INTERVENTION

No intervention, watchful waiting only (n=4)

Interventions

Intranasal glutathione - (in)GSHDRUG

Intranasal glutathione-Tripeptide glutathione 100 mg/ml. 1 ml 3x per day TID X 12 weeks at 2100mg in 15 participants

Intranasal GSH 100mg/ml
Saline Intranasal DeliveryDRUG

Saline administration 1ml 3x/day 12 weeks in 15 participants

Saline intranasal delivery

Eligibility Criteria

Age21 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of Parkinson's Disease made by neurologist within previous 10 years
  • Modified Hoehn and Yahr Stage \<3
  • Age \>20
  • Subjects must be able to attend study visits at screening, baseline, weeks 4, 8, 12, 16
  • Subjects must be able to demonstrate self-administration of study medication or have active caregiver who can administer daily.
  • Dose and frequency of all pharmaceutical medications must be stable for one month prior to enrollment.
  • Diet, exercise and supplementation must be kept constant throughout participation in study
  • Ability to read and speak English

You may not qualify if:

  • Dementia as evidenced by Montreal Cognitive Assessment (MoCA) \<24
  • Diseases with features common to Parkinson's Disease (eg. essential tremor, multiple system atrophy, progressive supranuclear palsy)
  • Epilepsy
  • History of stroke, CVA
  • Elevated levels of ALT, AST, BUN or creatinine
  • Chronic sinusitis as defined by SNOT-20 score \>1.0 on items 1-10.
  • Presence of other serious illness
  • History of brain surgery
  • History of structural brain damage
  • History of intranasal telangiectasia
  • Supplementation with glutathione and agents shown to increase glutathione will not be permitted and will require a 90 day washout period.
  • Pregnant or at risk of becoming pregnant.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bastyr Clinical Research Center

Kenmore, Washington, 98023, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Laurie Mischley, ND

    Bastyr University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 19, 2011

First Posted

July 21, 2011

Study Start

July 1, 2012

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

July 31, 2017

Record last verified: 2017-07

Locations

US(1)