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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000022533
Receipt No. R000025960
Scientific Title A comparative randomized study for the evaluation of the overlaying effect of Selegiline or Zonisamide over Levodopa in Parkinson's disease
Date of disclosure of the study information 2016/06/01
Last modified on 2018/12/14

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Basic information
Public title A comparative randomized study for the evaluation of the overlaying effect of Selegiline or Zonisamide over Levodopa in Parkinson's disease
Acronym The DAT-SPECT study for the benefit of Selegilline or Zonisamide in Parkinson's Disease(DATSZ-PD study)
Scientific Title A comparative randomized study for the evaluation of the overlaying effect of Selegiline or Zonisamide over Levodopa in Parkinson's disease
Scientific Title:Acronym The DAT-SPECT study for the benefit of Selegilline or Zonisamide in Parkinson's Disease(DATSZ-PD study)
Region
Japan

Condition
Condition Parkinson's disease
Classification by specialty
Neurology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The overlaying neuroprotective effect of selegiline or zonisamide with levodopa/DCI is investigated.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes The neuroprotective effect is evaluated by 123I-FP-CIT SPECT after 1 year.
Key secondary outcomes The clinical symptoms are evaluated by UPDRS partII, UPDRS partIII, PDQ-39

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 L-Dopa/DCI only
The drug is administered per oral at 150 to 300 mg/day. The treatment is started within 14days after registration and continued until day 365.
Interventions/Control_2 L-Dopa/DCI + selegiline
L-Dopa/DCI is administered per oral at 150 to 300 mg/day and selegiline is administered at 5mg/day. The treatment is started within 14days after registration and continued until day 365.
Interventions/Control_3 L-Dopa/DCI + zonisamide
L-Dopa/DCI is administered per oral at 150 to 300 mg/day and zonisamide is administered at 25mg/day. The treatment is started within 14days after registration and continued until day 365.
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
55 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria 1). Those who are at age between 55 and 79 years.
2).The patients should be within 3 years after the onset of motor symptoms
3). The patients should be treated with levodopa/DCI within 3 months and with levodopa/DCI exclusively one month right before starting the trial.
4) The dose of levodopa/DCI should be taken from 150mg/day to 300mg/day.
5)The participant's score of MMSE should be 24 or higher.
6) The patient should be judged by attendant doctor to be appropriate for registration.
7) The agreement with the study should be obtained by the document,
Key exclusion criteria Those who matched the following conditions should be excluded.
1). Those who had been treated with the anti-parkinsonian drugs except levodopa/DCI for more than 1month.
2).Those who are in pregnancy, or possible to be pregnant or those who are in the breast-feeding.
3) Those who have taken antidepressant and/or anti-psychotic drugs.
4) Those who have a history of stroke and cerebrovascular disorders.
5) Those who had a history of epilepsy or those who are in treatment of epilepsy
6) Those who have a history of alcohol intoxication, or have the treatment for alcoholic abuse
7) Those who have severe comorbidity( liver dysfunction, renal dysfunction and endocrinological disorders).
8) Those who have a familial history of Parkinson's disease
9) Those who have a history of allergic reaction with 123I- ioflupane.
Target sample size 180

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Makio Takahashi
Organization Japan Redcross Osaka Hospital
Division name Neurology
Zip code
Address 5-30, Fudegasaki-Cho, Tennoji-Ku, Osaka, Japan
TEL 06-6774-5111
Email ta@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hidefumi Ito
Organization Wakayama Prefectural Medical College
Division name Neurology
Zip code
Address 811-1, Kimiidera, Wakayama, Japan
TEL 073-447-2300
Homepage URL
Email itohid@kuhp.kyoto-u.ac.jp

Sponsor
Institute Osaka Redcross Hospital
Wakayama Prefectural Medical College
Institute
Department

Funding Source
Organization Nihon Medi-Physics Co.,Ltd.
Sumitomo Dainippon Pharma, Co.,Ltd.
FP Pharmaceutical Corp.
Organization
Division
Category of Funding Organization Profit organization
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 和歌山医科大学(和歌山県)、大阪赤十字病院(大阪府)、北野病院(大阪府)、関西医科大学(大阪府)、関西電力病院(大阪府)、済生会中津病院(大阪府)、富永病院(大阪府)、天理よろづ病院(奈良県)、住友病院(大阪府)、済生会野江病院(大阪府)、和歌山労災病院(和歌山県)、大阪市立総合医療センター(大阪府)、和歌山赤十字病院(和歌山)

Other administrative information
Date of disclosure of the study information
2016 Year 06 Month 01 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 Enrolling by invitation
Date of protocol fixation
2016 Year 05 Month 30 Day
Date of IRB
Anticipated trial start date
2016 Year 06 Month 01 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
2016 Year 05 Month 30 Day
Last modified on
2018 Year 12 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025960

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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