4006-776-356 出国就医服务电话

免费获得国外相关药品，最快 1 个工作日回馈药物信息

出境医 / 临床实验 / Clinical Trial to Evaluate the Safety and Tolerability of Hydrogen in Patients With Parkinson's Disease

Clinical Trial to Evaluate the Safety and Tolerability of Hydrogen in Patients With Parkinson's Disease

Study Description
Brief Summary:
This study is a placebo-controlled, double-blind trial that will investigate the safety and tolerability of molecular hydrogen, a promising antioxidant agent, in patients with early-stage Parkinson's Disease. The medication will be administered orally as 8 ounces of hydrogen-enriched drinking water twice a day over the course of one year.

Condition or disease Intervention/treatment Phase
Parkinson Disease Drug: Hydrogen Drug: Placebo oral tablet Phase 2 Phase 3

Detailed Description:

This study will investigate the safety and tolerability of molecular hydrogen, a promising antioxidant agent, in patients with early-stage Parkinson's Disease. Subjects will be sequentially randomized in a 1:1 ratio to receive hydrogen-enriched water or the corresponding placebo twice a day, in addition to all standard-of-care treatments. Enrollment goal is 70 subjects. Duration of therapy is 52 weeks.

The primary outcome measures are safety and tolerability of hydrogen-enriched water. Secondary outcome measures include: progression of motor symptoms, health-related quality of life, progression of cognitive decline, and progression of symptom burden.

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Safety and Tolerability of Molecular Hydrogen in Patients With Parkinson's Disease
Actual Study Start Date : May 29, 2019
Actual Primary Completion Date : April 29, 2021
Actual Study Completion Date : April 29, 2021
Arms and Interventions
Arm Intervention/treatment
Experimental: Hydrogen tablets
The ingredient in the tablet producing H2 is magnesium. Each tablet contains 80 mg magnesium, a safe level well below the recommended daily dietary allowance of 420 mg for men/ 320 mg for women. Dissolving one tablet in 250 mL of water will achieve a saturating H2 concentration of approximately 1.6 ppm. Twice a day subjects will dissolve a tablet into water and drink the effervescent water.
 Drug: Hydrogen
each hydrogen tablet contains 80mg magnesium
Placebo Comparator: Placebo tablets
effervescent placebo tablets will also contain 80 mg magnesium but do not generate hydrogen-enriched water
 Drug: Placebo oral tablet
matching placebo tablet
Outcome Measures
Primary Outcome Measures :
  1. To determine the incidence of treatment-emergent adverse events [safety and tolerability] of H2-enriched water in patients with Parkinson's disease (PD). [ Time Frame: 56 weeks ]
    Incidence of treatment-emergent adverse events will be assessed


Secondary Outcome Measures :
  1. Score on the Part III subscale of the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) [ Time Frame: 56 weeks ]
    Change from baseline to week 56 in motor examination, as assessed by score on Part III of the MDS-UPDRS. Part III of the MDS-UPDRS assesses the motor signs of PD. Scores range from 0-33 with a lower score indicating less severe impairment.

  2. Score on the Parkinson's Disease Quality of Life Questionnaire (PDQ-39) [ Time Frame: 56 weeks ]
    Change from baseline to week 56 in Parkinson's Disease-related quality of life, as assessed by PDQ-39. The PDQ-39 assesses how often patients experience difficulties across 8 quality of life dimensions. Scores for each dimension range from 0 to 100 with lower scores indicating more impaired quality of life. The overall score is an average of the scores for the 8 dimensions.

  3. Score on the Montreal Cognitive Assessment (MoCA) test [ Time Frame: 56 weeks ]
    Change from baseline to week 56 in overall cognitive function as assessed by MoCA score. Scores on the MoCA range from 0-30 with lower scores indicating more cognitive impairment.

  4. Score on the combined Part I, Part II, Part III, and Part IV subscales of the MDS-UPDRS [ Time Frame: 56 weeks ]
    Change from baseline to week 56 in non-motor experiences of daily living, motor experiences of daily living, motor symptoms, and motor complications, as assessed by scores on Parts I (score range 0-13), II (score range 0-13), III (score range 0-33) and IV (score range 0-6), respectively of the MDS-UPDRS. Total score ranges from 0-65 with lower scores indicating less severe impairment.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of Parkinson's Disease
  • Modified Hoehn & Yahr Stage < III
  • Diagnosis of Parkinson's Disease made within past 3 years•
  • Ability to complete questionnaires
  • Willingness to go off parkinsonian medication for 12 hours prior to baseline and 56-week assessments

Exclusion Criteria:

  • Other major diseases of the central nervous system
  • History of stroke
  • Use of antipsychotic neuroleptic medication within the last 6 months
  • Symptomatic (secondary) parkinsonism
  • Atypical parkinsonian variants
  • Unstable medical or psychiatric illness
  • Known kidney disease
  • History of stereotactic brain surgery
  • Significant cognitive impairment
  • Inability to safely tolerate 8 ounces of water twice daily associated with the study medication
  • Unable to avoid regular use of medications containing magnesium
  • Treatment with another investigational drug within the last 30 days that may interfere with the study medication
  • Pregnancy or nursing
Contacts and Locations

Locations
Layout table for location information
United States, New York
Stony Brook University Medical Center
Stony Brook, New York, United States, 11794-8121
Sponsors and Collaborators
Stony Brook University
Investigators
Layout table for investigator information
Principal Investigator: Carine Maurer, MD,PhD Stony Brook University
Tracking Information
First Submitted Date  ICMJE May 30, 2019
First Posted Date  ICMJE June 3, 2019
Last Update Posted Date May 10, 2021
Actual Study Start Date  ICMJE May 29, 2019
Actual Primary Completion Date April 29, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 31, 2019) 		To determine the incidence of treatment-emergent adverse events [safety and tolerability] of H2-enriched water in patients with Parkinson's disease (PD). [ Time Frame: 56 weeks ]
Incidence of treatment-emergent adverse events will be assessed
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 22, 2020)
  • Score on the Part III subscale of the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) [ Time Frame: 56 weeks ]
    Change from baseline to week 56 in motor examination, as assessed by score on Part III of the MDS-UPDRS. Part III of the MDS-UPDRS assesses the motor signs of PD. Scores range from 0-33 with a lower score indicating less severe impairment.
  • Score on the Parkinson's Disease Quality of Life Questionnaire (PDQ-39) [ Time Frame: 56 weeks ]
    Change from baseline to week 56 in Parkinson's Disease-related quality of life, as assessed by PDQ-39. The PDQ-39 assesses how often patients experience difficulties across 8 quality of life dimensions. Scores for each dimension range from 0 to 100 with lower scores indicating more impaired quality of life. The overall score is an average of the scores for the 8 dimensions.
  • Score on the Montreal Cognitive Assessment (MoCA) test [ Time Frame: 56 weeks ]
    Change from baseline to week 56 in overall cognitive function as assessed by MoCA score. Scores on the MoCA range from 0-30 with lower scores indicating more cognitive impairment.
  • Score on the combined Part I, Part II, Part III, and Part IV subscales of the MDS-UPDRS [ Time Frame: 56 weeks ]
    Change from baseline to week 56 in non-motor experiences of daily living, motor experiences of daily living, motor symptoms, and motor complications, as assessed by scores on Parts I (score range 0-13), II (score range 0-13), III (score range 0-33) and IV (score range 0-6), respectively of the MDS-UPDRS. Total score ranges from 0-65 with lower scores indicating less severe impairment.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 31, 2019)
  • Score on the Part III subscale of the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) [ Time Frame: 56 weeks ]
    Change from baseline to week 56 in motor examination, as assessed by score on Part III of the MDS-UPDRS
  • Score on the Parkinson's Disease Quality of Life Questionnaire (PDQ-39) [ Time Frame: 56 weeks ]
    Change from baseline to week 56 in Parkinson's Disease-related quality of life, as assessed by PDQ-39
  • Score on the Montreal Cognitive Assessment (MoCA) test [ Time Frame: 56 weeks ]
    Change from baseline to week 56 in overall cognitive function as assessed by MoCA score
  • Score on the combined Part I, Part II, Part III, and Part IV subscales of the MDS-UPDRS [ Time Frame: 56 weeks ]
    Change from baseline to week 56 in non-motor experiences of daily living, motor experiences of daily living, motor symptoms, and motor complications, as assessed by scores on Parts I, II, III and IV, respectively of the MDS-UPDRS
  • Progression of neuromelanin-related MRI signal [ Time Frame: 56 weeks ]
    Change from baseline to week 56 in neuromelanin-related MRI signal
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Trial to Evaluate the Safety and Tolerability of Hydrogen in Patients With Parkinson's Disease
Official Title  ICMJE A Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Safety and Tolerability of Molecular Hydrogen in Patients With Parkinson's Disease
Brief Summary This study is a placebo-controlled, double-blind trial that will investigate the safety and tolerability of molecular hydrogen, a promising antioxidant agent, in patients with early-stage Parkinson's Disease. The medication will be administered orally as 8 ounces of hydrogen-enriched drinking water twice a day over the course of one year.
Detailed Description

This study will investigate the safety and tolerability of molecular hydrogen, a promising antioxidant agent, in patients with early-stage Parkinson's Disease. Subjects will be sequentially randomized in a 1:1 ratio to receive hydrogen-enriched water or the corresponding placebo twice a day, in addition to all standard-of-care treatments. Enrollment goal is 70 subjects. Duration of therapy is 52 weeks.

The primary outcome measures are safety and tolerability of hydrogen-enriched water. Secondary outcome measures include: progression of motor symptoms, health-related quality of life, progression of cognitive decline, and progression of symptom burden.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Parkinson Disease
Intervention  ICMJE
  • Drug: Hydrogen
    each hydrogen tablet contains 80mg magnesium
  • Drug: Placebo oral tablet
    matching placebo tablet
Study Arms  ICMJE
  • Experimental: Hydrogen tablets
    The ingredient in the tablet producing H2 is magnesium. Each tablet contains 80 mg magnesium, a safe level well below the recommended daily dietary allowance of 420 mg for men/ 320 mg for women. Dissolving one tablet in 250 mL of water will achieve a saturating H2 concentration of approximately 1.6 ppm. Twice a day subjects will dissolve a tablet into water and drink the effervescent water.
    Intervention: Drug: Hydrogen
  • Placebo Comparator: Placebo tablets
    effervescent placebo tablets will also contain 80 mg magnesium but do not generate hydrogen-enriched water
    Intervention: Drug: Placebo oral tablet
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: May 5, 2021) 		2
Original Estimated Enrollment  ICMJE
 (submitted: May 31, 2019) 		70
Actual Study Completion Date  ICMJE April 29, 2021
Actual Primary Completion Date April 29, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosis of Parkinson's Disease
  • Modified Hoehn & Yahr Stage < III
  • Diagnosis of Parkinson's Disease made within past 3 years•
  • Ability to complete questionnaires
  • Willingness to go off parkinsonian medication for 12 hours prior to baseline and 56-week assessments

Exclusion Criteria:

  • Other major diseases of the central nervous system
  • History of stroke
  • Use of antipsychotic neuroleptic medication within the last 6 months
  • Symptomatic (secondary) parkinsonism
  • Atypical parkinsonian variants
  • Unstable medical or psychiatric illness
  • Known kidney disease
  • History of stereotactic brain surgery
  • Significant cognitive impairment
  • Inability to safely tolerate 8 ounces of water twice daily associated with the study medication
  • Unable to avoid regular use of medications containing magnesium
  • Treatment with another investigational drug within the last 30 days that may interfere with the study medication
  • Pregnancy or nursing
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03971617
Other Study ID Numbers  ICMJE H2PD
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Carine Maurer, Stony Brook University
Study Sponsor  ICMJE Stony Brook University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Carine Maurer, MD,PhD Stony Brook University
PRS Account Stony Brook University
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

治疗医院

新药特效药

前沿医讯