UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021899 |
|---|---|
| Receipt number | R000025115 |
| Scientific Title | Long-term efficacy and safety of istradefylline for the treatment of advanced Parkinson's disease |
| Date of disclosure of the study information | 2016/04/13 |
| Last modified on | 2016/07/27 10:56:34 |
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Basic information
Public title
Long-term efficacy and safety of istradefylline for the treatment of advanced Parkinson's disease
Acronym
Long-term efficacy and safety of istradefylline for the treatment of advanced Parkinson's disease
Scientific Title
Long-term efficacy and safety of istradefylline for the treatment of advanced Parkinson's disease
Scientific Title:Acronym
Long-term efficacy and safety of istradefylline for the treatment of advanced Parkinson's disease
Region
| Japan |
Condition
Condition
Parkinson's disease
Classification by specialty
| Neurology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the long-term efficacy and safety of istradefylline in patients with advanced Parkinson's disease, in an observational study setting, by using data collected from daily medical practice
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
UPDRS partIII(before treatment and at 3, 6 and 12 months after treatment)
Key secondary outcomes
off-time,UPDRS partII,CGI,BDI-II,JESS,MMSE,safety(before treatment and at 3, 6 and 12 months after treatment)
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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.Parkinson's disease patients experiencing the "wearing off" phenomenon while receiving therapy with L-dopa preparations
2.Outpatients of clinical research centers who had been taking istradefylline for more than 12 months
3.Patients at least 20 years of age during the reporting period
Key exclusion criteria
1.Patients with moderate or severe liver disorder or taking medications that strongly inhibit CYP3A4
2.Patients who are nursing or pregnant or might be pregnant
3.Patients in whom efficacy data were not collected at 6 and 12 months after oral treatment with istradefylline
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Abe |
Organization
Abe Neurology Clinic
Division name
Neurology
Zip code
Address
6-6,Sakanacho,morioka-shi,Iwate,Japan
TEL
019-606-3711
ryuabe@crest.ocn.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Sayumi Hasegawa |
Organization
QOL RD Co.,Ltd.
Division name
CRO Division
Zip code
Address
2-14-1,Nihonbashi,Chuo-ku,Tokyo,Japan
TEL
03-6386-9500
Homepage URL
s-hasegawa@qol-rd.co.jp
Sponsor or person
Institute
Abe Neurology Clinic
Institute
Department
Personal name
Funding Source
Organization
Kyowa Hakko Kirin Co., Ltd.
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 04 | 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
| 2016 | Year | 01 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 01 | Month | 21 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Among patients who had been visiting the clinical research centers between May 2013 and 30th September 2015, those receiving istradefylline, a Parkinson's disease treatment, for more than 12 months will be selected and the long-term clinical efficacy and safety of istradefylline will be evaluated based on patient demographic data (age, gender, drug history, medical history/concurrent conditions, H&Y stage, disease duration, history of DBS and others), clinical evaluation related to Parkinson's disease (UPDRS, CGI), non-motor symptoms, associated symptoms of the disease (BDI-II, JESS), MMSE, and clinical data related to safety.
Endpoints were evaluated before treatment and at 3, 6 and 12 months after treatment.
Management information
Registered date
| 2016 | Year | 04 | Month | 13 | Day |
Last modified on
| 2016 | Year | 07 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025115
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
