UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062079 |
|---|---|
| Receipt number | R000071030 |
| Scientific Title | Research on the treatment of tic disorders and Tourette's syndrome with Chlorpromazine and LDOPA. |
| Date of disclosure of the study information | 2026/08/01 |
| Last modified on | 2026/06/27 13:15:03 |
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Basic information
Public title
Research on the treatment of tic disorders and Tourette's syndrome with
Chlorpromazine and LDOPA.
Acronym
Research on the treatment of tic disorders and Tourette's syndrome with
Chlorpromazine and LDOPA.
Scientific Title
Research on the treatment of tic disorders and Tourette's syndrome with
Chlorpromazine and LDOPA.
Scientific Title:Acronym
Research on the treatment of tic disorders and Tourette's syndrome with
Chlorpromazine and LDOPA.
Region
| Japan |
Condition
Condition
Chronic tic disorder is a condition characterized by involuntary movements that begin in
childhood and may persist into adulthood. Many individuals with this disorder also
experience obsessive-compulsive disorder (OCD).
Classification by specialty
| Neurology | Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We are
planning a new study that will evaluate the treatment of both motor and vocal tics using
Chlorpromazine and L-DOPA.
Purpose:
To investigate the safety and efficacy of the combination therapy using Chlorpromazine and
L-DOPA for treating tic disorders and Tourette's syndrome.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
prescribe CPZ 5mg andLDOPA 50mg per day and schedule a check up in two weeks. Two weeks after the clinical trial begins , we evaluate the symptoms and side effects. At that time, 5mg of CPZ and 100mg of LDOPA will be prescribed. The patient will then be asked to return for a follow up visit two weeks later.
Four weeks after the clinical trial begins, we will evaluate the symptoms and side effects. At that time, 115 mg of CPZ and 150 mg of LDOPA willbe prescribed. The patient will then be asked to return for a follow-up visit two weeks later. After eight weeks from the start of the clinical trial, symptoms and side effects will be evaluated, and the trial will be terminated. Patients will then transition to standard treatment. If the patient wishes, we will continue the same treatment.
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
Prescribe CPZ 5mg and LDOPA 50 mg per day and schedule a checkup in two weeks.
Two weeks after the clinical trial begins, we will evaluate the symptoms and side effects.
At that time, 5mg of CPZ and 100 mg of LDOPA will be prescribed. The patient will
then be asked to return for a follow-up visit two weeks later.
Four weeks after the clinical trial begins, we will evaluate the symptoms and side effects.
At that time, 115mg of CPZ and 150 mg of LDOPA will be prescribed. The patient will
then be asked to return for a follow-up visit two weeks later.
After eight weeks from the start of the clinical trial, symptoms and side effects will be
evaluated, and the trial will be terminated. Patients will then transition to standard
treatment. If the patient wishes, we will continue the same treatment.
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
| 10 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Chronic tic disorder is a condition characterized by involuntary movements that begin in
childhood and may persist into adulthood. Many individuals with this disorder also
experience obsessive-compulsive disorder (OCD).
Key exclusion criteria
mental retardation
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Nobuhiro |
| Middle name | |
| Last name | Inoue |
Organization
Kumamoto Neurosurgical Hospital
Division name
Neurosurgery
Zip code
8600811
Address
6-1-21 Honjyo Chuo-Ku Kumamoto
TEL
096-372-3911
ninoue@knh.co.jp
Public contact
Name of contact person
| 1st name | Nobuhiro |
| Middle name | |
| Last name | Inoue |
Organization
Kumamoto Neurosurgical Hospital Neurosurgery
Division name
Kumamoto Neurosurgical Hospital Neurosurgery
Zip code
860-0811
Address
6-1-21 Honjyo Chuo-Ku Kumamoto
TEL
0963723911
Homepage URL
ninoue@knh.co.jp
Sponsor or person
Institute
Kumamoto Neurosurgial Hospital
Institute
Department
Personal name
Funding Source
Organization
Kumamoto Neurosurgical Hospital Neurosurgery
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
Kumamoto Neurosurgical Hospital
Address
6-1-21 Honjo Chuo-Ku Kumamoto
Tel
096-372-3911
ninoue@knh.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
| 2026 | Year | 08 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 07 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2031 | Year | 08 | Month | 14 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 06 | Month | 27 | Day |
Last modified on
| 2026 | Year | 06 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071030
