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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: Kansai Medical University
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 When a patient is already on any anti-parkinson drugs, these drugs were withdrawn from the night before of the evaluation day.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 When a patient is already on any anti-parkinson drugs, these drugs were withdrawn from the night before of the evaluation day.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
Secondary Outcome(s)
Secondary ID(s)
Source(s) of Monetary Support
None
Secondary Sponsor(s)
Ethics review
Status: YES
Approval date:
Contact:
Results
Results available:
Date Posted:
Date Completed:
URL:
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