UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A comparative randomized study for the evaluation of the overlaying effect of Selegiline or Zonisamide over Levodopa in Parkinson's disease
Title of the study (Brief title)	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	Makio Takahashi
Organization	Japan Redcross Osaka Hospital
Division name	Neurology
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	Hidefumi Ito
Organization	Wakayama Prefectural Medical College
Division name	Neurology
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)

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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2016 Year 05 Month 30 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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