UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007896 |
|---|---|
| Receipt number | R000009302 |
| Scientific Title | Levodopa challenge test for Parkinson's disease and other parkinsonian syndromes |
| Date of disclosure of the study information | 2012/05/07 |
| Last modified on | 2012/05/07 11:38:39 |
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Basic information
Public title
Levodopa challenge test for Parkinson's disease and other parkinsonian syndromes
Acronym
Levodopa challenge test for Parkinson's disease and other parkinsonian syndromes
Scientific Title
Levodopa challenge test for Parkinson's disease and other parkinsonian syndromes
Scientific Title:Acronym
Levodopa challenge test for Parkinson's disease and other parkinsonian syndromes
Region
| Japan |
Condition
Condition
Parkinson's disease and other parkinsonian syndromes
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To explore the possibility of an applicable tool for diagnosis of Parkinson's disease and other parkinsonian disease
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The improvement of Unified Parkinson's Disease Rating Scale motor scores
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
The patients are given domperidone 30 mg/day for 3 days. When a patient is already on any anti-parkinson drugs, these drugs were withdrawn from the night before of the evaluation day. On the fourth day lactose powder is given to the patients and levodopa (250 mg)/carbidopa (25 mg) is given on the fifth day in a double-blind manner. On fourth and fifth day, motor symptoms of the patients are examined using the Unified Parkinson's Disease Rating Scale motor scores by a clinician who is blind to the test drug.
Interventions/Control_2
The patients are given domperidone 30 mg/day (standard dose in Japan) for 3 days. When a patient is already on any anti-parkinson drugs, these drugs were withdrawn from the night before of the evaluation day. On the fourth day levodopa (250 mg)/carbidopa (25 mg) is given to the patients and lactose powder is given on the fifth day in a double-blind manner. Motor symptoms of the patients are examined using the Unified Parkinson's Disease Rating Scale motor scores by a clinician who is blind to the test drug.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
A consecutive series of patients admitted to our hospital for diagnostic and/or treatment purpose, who presented with extrapyramidal symptoms
Key exclusion criteria
None
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Reika Wate |
Organization
Kansai Medical University
Division name
Dept. of Neurology
Zip code
Address
10-15, Fumizono-cho, Moriguchi-shi, Osaka 570-8507
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hirofumi Kusaka, Reika Wate |
Organization
Kansai Medical University
Division name
Dept. of Neurology
Zip code
Address
10-15, Fumizono-cho, Moriguchi-shi, Osaka 570-8507
TEL
Homepage URL
Sponsor or person
Institute
Kansai Medical University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
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
| 2012 | Year | 05 | Month | 07 | 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
| 2012 | Year | 05 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 05 | 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
| 2012 | Year | 05 | Month | 07 | Day |
Last modified on
| 2012 | Year | 05 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009302
