UMIN-CTR Clinical Trial

Public title

Randomized Double-blind, Placebo-controlled multi-center trial on molecular hydrogen water in Parkinson Disease

Acronym

Randomized Double-blind, Placebo-controlled trial on hydrogen water in Parkinson Disease

Scientific Title

Randomized Double-blind, Placebo-controlled multi-center trial on molecular hydrogen water in Parkinson Disease

Scientific Title:Acronym

Randomized Double-blind, Placebo-controlled trial on hydrogen water in Parkinson Disease

Region

Japan

Condition

Parkinson's disesase

Classification by specialty

Neurology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

We tested whether H2-water can modify the progression of PD from the baseline to the 72th week visit as the primary end point.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Developmental phase

Primary outcomes

The primary endpoint with efficacy in PD was the change of total score of UPDRS(I~IV) from baseline to the 72th week.

Key secondary outcomes

Additional analysis
1.The change of total UPDRS part II, III, each scores, and modified Hoehn and Yahr staging from baseline to 8th, 24th, 48th, and 72th weeks and post 8th weeks. The changes of total score of UPDRS from baseline to 8th, 24th, 48th and post 8th week.
2.The change of total PDQ39, each scores, and subtotal scores.
3.The duration to protocol ended because of addition of levodopa or progression of disease.
Safety analysis
1) Adverse events except dyskinesia.
2) Screening laboratory studies included level of total protein, albumin, alkaline phosphatase, aspartate transaminase, alanine transaminase, serum urea nitrogen, calcium, chloride, creatinine, glucose, lactate dehydrogenase, potassium, sodium, creatinine kinase, uric acid, choline esterase, LDL-cholestrol, HDL-cholestrol and triglyceride.

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

YES

Dynamic allocation

Institution consideration

Blocking

Concealment

Central registration

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

hydrogen water made by "Suisosui5.0"

Interventions/Control_2

placebo-water (nitrogen filling water)

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1) Subjects had received the diagnosis of PD according to the United Kingdom Brain Bank criteria.
2) No change on medication, levodopa, dopamin agonist, and other limited drugs for eight weeks.
3) Modified Hoehn and Yahr staging (H&Y stage) on on-phase under 4.
4) Without dementia (MMSE >= 25).
5) Without dysphagia for water.
6) Outpatients are better than admitted patietns.
7) The subjects are over 20 years-old.
8) Written informed consent must be obtained.

Key exclusion criteria

1. The patient has parkinsonism due to corticobasal syndrome, multiple system atrophy, drug parkinsonism, hydrocephalus, or essential tremor.
2. The presence of other serious disease.
3. The presence of malignant tumor.
4. The presence of adverse event caused by levodopa or dopamine agonist.
5. Pregnant woman
6. Allergy for drugs.
7.The subjects who is inappropriate for the study according to our judgment.

Target sample size

200

Name of lead principal investigator

1st name
Middle name
Last name	Asako Yoritaka

Organization

Juntendo University Koshigaya Hospital

Division name

Neurology

Zip code

Address

Koshigaya-shi Fukuroyama 560, Saitama, Japan

TEL

-81-48-975-0321

Email

ayori@juntendo.ac.jp

Name of contact person

1st name
Middle name
Last name	Shimo Y, Hatano T, Ohyama G, Ando M, Yoritaka A.

Organization

Juntendo University School of Medicine

Division name

Neurology

Zip code

Address

Hongo3-1-3, Bunky-ku, Tokyo, Japan

TEL

03-3813-3111

Homepage URL

Email

ayori@juntendo.ac.jp

Institute

Juntendo University School of Medicine, Neurology

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

順天堂大学医学部附属順天堂医院（東京都）　脳神経内科　外来
順天堂大学医学部附属静岡病院（静岡県）　脳神経内科　外来
順天堂大学医学部附属浦安病院（千葉県）　脳神経内科　外来
順天堂大学医学部附属練馬病院（東京都）　脳神経内科　外来
順天堂大学医学部附属江東高齢者医療センター（東京都）　脳神経内科　外来
順天堂大学医学部附属越谷病院（埼玉県）　神経内科　外来
岩手医科大学附属病院（岩手県）　神経内科　外来
青森県立中央病院（青森県）　脳神経センター　外来
秋田県立脳血管研究センター（秋田県）　神経内科　外来
名古屋大学（愛知県）　神経内科　外来
洛和会みささぎ病院（京都府）　神経内科　外来
広島大学（広島県）　神経内科　外来
福岡大学（福岡県）　神経内科　外来
東京臨海病院（東京都）　神経内科　外来
北野病院（大阪府）　神経内科外来
あべ神経内科クリニック（岩手県）　神経内科外来

Date of disclosure of the study information

2013

Year

02

Month

13

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2013

Year

02

Month

01

Day

Date of IRB

Anticipated trial start date

2013

Year

02

Month

28

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2013

Year

02

Month

12

Day

Last modified on

2017

Year

05

Month

02

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010386