Main
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
|
JPRN |
Last refreshed on:
|
17 October 2023 |
Main ID: |
JPRN-UMIN000007896 |
Date of registration:
|
07/05/2012 |
Prospective Registration:
|
No |
Primary sponsor: |
|
Public title:
|
Levodopa challenge test for Parkinson's disease and other parkinsonian syndromes
|
Scientific title:
|
Levodopa challenge test for Parkinson's disease and other parkinsonian syndromes - Levodopa challenge test for Parkinson's disease and other parkinsonian syndromes |
Date of first enrolment:
|
2012/05/01 |
Target sample size:
|
100 |
Recruitment status: |
Recruiting |
URL:
|
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009302 |
Study type:
|
Interventional |
Study design:
|
Cross-over Randomized
|
Phase:
|
Not selected
|
|
Countries of recruitment
|
Japan
| | | | | | | |
Contacts
|
Name:
|
Reika Wate |
Address:
|
10-15, Fumizono-cho, Moriguchi-shi, Osaka 570-8507
Japan |
Telephone:
|
|
Email:
|
|
Affiliation:
|
Kansai Medical University Dept. of Neurology |
|
Name:
|
Hirofumi Kusaka, Reika Wate |
Address:
|
10-15, Fumizono-cho, Moriguchi-shi, Osaka 570-8507
Japan |
Telephone:
|
|
Email:
|
|
Affiliation:
|
Kansai Medical University Dept. of Neurology |
| |
Key inclusion & exclusion criteria
|
Inclusion criteria:
Exclusion criteria: None
Age minimum:
Not applicable
Age maximum:
Not applicable
Gender:
Male and Female
|
Health Condition(s) or Problem(s) studied
|
Parkinson's disease and other parkinsonian syndromes
|
Intervention(s)
|
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 When a patient is already on any anti-parkinson drugs, these drugs were withdrawn from the night before of the evaluation day.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. 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 When a patient is already on any anti-parkinson drugs, these drugs were withdrawn from the night before of the evaluation day.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.
|
Primary Outcome(s)
|
The improvement of Unified Parkinson's Disease Rating Scale motor scores
|
Source(s) of Monetary Support
|
None
|
Ethics review
|
Status: YES
Approval date:
Contact:
|
Results
|
Results available:
|
|
Date Posted:
|
|
Date Completed:
|
|
URL:
|
|
|
|