UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038397 |
|---|---|
| Receipt number | R000043753 |
| Scientific Title | An open-label single-arm study on efficacy and safety of dopamine replacement therapy for drug-induced parkinsonism |
| Date of disclosure of the study information | 2019/10/28 |
| Last modified on | 2024/04/30 10:12:38 |
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Basic information
Public title
A clinical study on efficacy and safety of dopamine replacement therapy for drug-induced parkinsonism
Acronym
Dopamine replacement therapy for drug-induced parkinsonism
Scientific Title
An open-label single-arm study on efficacy and safety of dopamine replacement therapy for drug-induced parkinsonism
Scientific Title:Acronym
An open-label single-arm study on efficacy and safety of dopamine replacement therapy for drug-induced parkinsonism
Region
| Japan |
Condition
Condition
Drug-induced parkinsonism
Classification by specialty
| Neurology | Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy and safety of dopamine replacement therapy for drug-induced parkinsonism in patients with schizophrenia, bipolar disorder, or schizoaffective disorder.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Total score of Movement Disorder Society Unified Parkinson's Disease Rating Scale Part 3
Key secondary outcomes
Total score of Unified Dystonia Scale,
Total score of Abnormal Involuntary Movement Scale,
Total score of Mini-mental State Examination,
Total score of Montogomery-Aperg Depression Rating Scale,
Total score of Young Mania Rating Scale,
Total score of PANSS-6
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Levodopa/carbidopa 300-600mg/day for 2 weeks or more
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. Patients with schizophrenia, bipolar disorder, or schizoaffective disorder who receive antipsychotics and/or mood stabilizers.
2. Parkinsonism diagnosed by board-certified neurologists
Key exclusion criteria
1. Orthopedic conditions which preclude quantitative neurological assessments, such as fractures and severe arthralgia.
2. Severe intellectual disabilities which preclude accurate neurological assessments.
3. History of alcohol or other substance abuse.
4. Patients who are already diagnosed as having organic neurological diseases, or whose CT/MRI scans demonstrate cerebrovascular diseases (excluding a few to several numbers of small infarcts or microbleeds) or severe brain atrophy.
5. Patients who take levodopa or dopamine receptor agonists at the baseline assessment.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Yoshiyuki |
| Middle name | |
| Last name | Nishio |
Organization
Tokyo Metropolitan Matsuzawa Hospital
Division name
Department of Psychiatry and Neurology
Zip code
156-0057
Address
2-1-1 Kamikitazawa, Setagaya-ku, Tokyo
TEL
03-3303-7211
nishiokov@gmail.com
Public contact
Name of contact person
| 1st name | Yoshiyuki |
| Middle name | |
| Last name | Nishio |
Organization
Tokyo Metropolitan Matsuzawa Hospital
Division name
Department of Psychiatry and Neurology
Zip code
156-0057
Address
2-1-1 Kamikitazawa, Setagaya-ku, Tokyo
TEL
03-3303-7211
Homepage URL
nishiokov@gmail.com
Sponsor or person
Institute
Tokyo Metropolitan Matsuzawa Hospital
Institute
Department
Personal name
Funding Source
Organization
Tokyo Metropolitan Government
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Metropolitan Matsuzawa Hospital
Address
2-1-1 Kamikitazawa, Setagaya-ku, Tokyo
Tel
03-3303-7211
nishiokov@gmail.com
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
| 2019 | Year | 10 | Month | 28 | Day |
Related information
URL releasing protocol
https://www.medrxiv.org/content/10.1101/2024.02.23.24303233v1
Publication of results
Partially published
Result
URL related to results and publications
https://www.medrxiv.org/content/10.1101/2024.02.23.24303233v1
Number of participants that the trial has enrolled
4
Results
Of the 4 cases, motor symptoms were improved in only 1 case, as assessed by the UPDRS part 3 total score. This case had an abnormal pre-treatment DAT-SPECT (Table 4). However, his motor symptoms did not worsen when levodopa was discontinued 2 years later, suggesting that the observed improvement may not be due to levodopa treatment. Levodopa was well tolerated in all cases, and no worsening of psychiatric symptoms as assessed by MADRS, YMRS, and PANSS was observed.
Results date posted
| 2024 | Year | 04 | Month | 30 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2024 | Year | 02 | Month | 17 | Day |
Baseline Characteristics
Sixteen patients with BD and parkinsonism were recruited from consecutive patients who were referred to a neurology clinic at a tertiary psychiatric center.Four out of the 16 participants received 300-600mg of levodopa.
Participant flow
Sixteen patients with BD and parkinsonism were recruited from consecutive patients who were referred to a neurology clinic at a tertiary psychiatric center.Four out of the 16 participants received 300-600mg of levodopa.
Adverse events
None
Outcome measures
the Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part 3 (UPDRS)
Montgomery-Asberg Depression Rating Scale (MADRS) [14]
Young Mania Rating Scale (YMRS) [15]
the 6-item version of the Positive and Negative Syndrome Scale (PANSS)
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2019 | Year | 10 | Month | 19 | Day |
Date of IRB
| 2019 | Year | 04 | Month | 19 | Day |
Anticipated trial start date
| 2019 | Year | 10 | Month | 20 | Day |
Last follow-up date
| 2022 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 10 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 10 | Month | 27 | Day |
Last modified on
| 2024 | Year | 04 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043753
