UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000054201 |
|---|---|
| Receipt number | R000061834 |
| Scientific Title | Low-dose L-DOPA treatment for drug-induced dystonia |
| Date of disclosure of the study information | 2024/04/19 |
| Last modified on | 2024/04/19 16:08:32 |
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Basic information
Public title
Low-dose L-DOPA treatment for drug-induced dystonia
Acronym
Low-dose L-DOPA treatment for drug-induced dystonia
Scientific Title
Low-dose L-DOPA treatment for drug-induced dystonia
Scientific Title:Acronym
Low-dose L-DOPA treatment for drug-induced dystonia
Region
| Japan |
Condition
Condition
Drug-induced dystonia
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to demonstrate the effectiveness of low-dose LDOPA oral treatment in relieving the motor and psychiatric symptoms caused by drug-induced dystonia.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Yale Brown Obsessive Compulsive Scale (Y-BOCS)
Burke Fahn Marsden Dystonia Movement Scale (BFMDMS).
Key secondary outcomes
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
Patients who meet the selection criteria will be prescribed low doses of LDOPA.
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
| 16 | years-old | <= |
Age-upper limit
| 120 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The subjects in our study were patients diagnosed with drug-induced dystonia based on the DSM-V diagnostic criteria.
Key exclusion criteria
Other cases considered unsuitable for this study
Target sample size
9
Research contact person
Name of lead principal investigator
| 1st name | Shinichi |
| Middle name | |
| Last name | Matsumoto |
Organization
Osaka Neurological Institute
Division name
Neurology
Zip code
5610836
Address
2-6-23 Shounai Takaramachi Toyonaka Osaka
TEL
0663330086
dyt1mc@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Shinichi |
| Middle name | |
| Last name | Matsumoto |
Organization
Osaka Neurological Institute
Division name
Neurolody
Zip code
5610836
Address
2-6-23 Shounai Takaramachi Toyonaka Osaka
TEL
0663330086
Homepage URL
dyt1mc@yahoo.co.jp
Sponsor or person
Institute
Osaka Neurological Institute
Institute
Department
Personal name
Funding Source
Organization
Osaka Neurological Institute
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
Osaka Neurological Institute / IRB
Address
2-6-23 Shounai Takaramachi Toyonaka Osaka
Tel
0663330086
dyt99mc@yahoo.co.jp
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
| 2024 | Year | 04 | Month | 19 | 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
| 2024 | Year | 04 | Month | 18 | Day |
Date of IRB
| 2024 | Year | 04 | Month | 18 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 18 | Day |
Last follow-up date
| 2026 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 04 | Month | 19 | Day |
Last modified on
| 2024 | Year | 04 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061834
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
