UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000010014
Receipt number R000010386
Scientific Title Randomized Double-blind, Placebo-controlled multi-center trial on molecular hydrogen water in Parkinson Disease
Date of disclosure of the study information 2013/02/13
Last modified on 2017/05/02 12:15:43

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Basic information

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

Condition

Parkinson's disesase

Classification by specialty

Neurology

Classification by malignancy

Others

Genomic information

NO


Objectives

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



Assessment

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.


Base

Study type

Interventional


Study design

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


Intervention

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



Eligibility

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


Research contact person

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


Public contact

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


Sponsor or person

Institute

Juntendo University School of Medicine, Neurology

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

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


Other administrative information

Date of disclosure of the study information

2013 Year 02 Month 13 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

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



Progress

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

Other related information



Management 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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name
2016/08/16 BMC Neurology 2016 H2multicenter protocol.pdf