UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022533 |
|---|---|
| Receipt number | 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 14:06:35 |
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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
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
itohid@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Osaka Redcross Hospital
Wakayama Prefectural Medical College
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025960
