NCT01177319

Brief Summary

This is an investigator initiated pilot study to examine the effects of GSH in PD. The goal of this study is to acquire some basic data regarding side effects and efficacy of this compound to determine if this is a possible treatment option that could be recommended to interested PD patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Sep 2003

Typical duration for phase_2

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2003

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

August 5, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 9, 2010

Completed
Last Updated

August 9, 2010

Status Verified

January 1, 2007

Enrollment Period

3.5 years

First QC Date

August 5, 2010

Last Update Submit

August 6, 2010

Conditions

Parkinson's Disease

Keywords

Parkinson's DiseaseGlutathione

Outcome Measures

Primary Outcomes (2)

  • Timed walking test

  • Tapping test

Secondary Outcomes (3)

  • CGI-clinical global assessment by both the physician and the patient

  • Patient diaries

  • Parkinson's Disease Questionnaire, a quality of life measurement

Interventions

GlutathioneDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Idiopathic Parkinson's disease (2 of 3 of the cardinal symptoms:tremor, bradykinesia, rigidity)
  • Mini Mental State Examination \> 24
  • Anti-parkinsonian medications stable for one month
  • Hoehn and Yahr II-IV
  • Age 18 and above

You may not qualify if:

  • Atypical parkinsonism
  • History of seizure, drug addiction
  • Use of typical neuroleptics
  • Previous use of glutathione

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

USF Parkinson's Disease and Movement Disorders Center

Tampa, Florida, 33606, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Glutathione

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

OligopeptidesPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Robert A Hauser, MD, MBA

    University of South Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 5, 2010

First Posted

August 9, 2010

Study Start

September 1, 2003

Primary Completion

March 1, 2007

Study Completion

March 1, 2007

Last Updated

August 9, 2010

Record last verified: 2007-01

Locations

US(1)