UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057026 |
|---|---|
| Receipt number | R000065177 |
| Scientific Title | Research on oral administration of CPZ and L-DOPA for obsessive-compulsive disorder in involuntary movements |
| Date of disclosure of the study information | 2025/03/01 |
| Last modified on | 2025/02/14 10:53:07 |
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Basic information
Public title
Research on oral administration of CPZ and
L-DOPA for obsessive-compulsive disorder in
involuntary movements
Acronym
Research on oral administration of CPZ and
L-DOPA for obsessive-compulsive disorder in
involuntary movements
Scientific Title
Research on oral administration of CPZ and
L-DOPA for obsessive-compulsive disorder in
involuntary movements
Scientific Title:Acronym
Research on oral administration of CPZ and
L-DOPA for obsessive-compulsive disorder in
involuntary movements
Region
| Japan |
Condition
Condition
Among the dystonias defined by Fahn in 1988, those diagnosed as primary oromandibular,
eyelid, cervical, upper limb, unilateral, or generalized dystonia as classified by Albanese
et al. in 2013. Also, those clinically diagnosed as having hemifacial spasm or upper and
lower limb spasticity. Patients who visited our outpatient department were enrolled.
2) Patients who have given written informed consent to participate in the study
3) Individuals who have not received botulinum treatment in the past three months.
4) Individuals who have not altered their oral medication in over three months.
Classification by specialty
| Neurology | Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the safety and efficacy of the combination therapy using CPZ
(Chlorpromazine) and L-DOPA for treating dystonia
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Before treatment (prior to enrollment), the prescribing doctor will take a video and record objective symptoms (
"pre-registration video").
Prior to tratment, a diagnostic doctor (video doctor) will asses motor an d psychiatric symptoms using scales such as the Burke-Fahn-Marsden Dystonia Movement Scale (BFMDMS) and YBOCS, The disgnodtic doctor will videotape and evaluates the objective symptoms before treatment ("Post-registration video")The prescribing doctor prescribes medication and instructs the patinet to visit the hospital in two weeks.
Two weeks after the start of the study, a diagnostic doctor will assess motor and psychiatric symptoms using scale such as the BFMDMS and YBOCS. The diagnostic doctor will nideotape and evaluates the objective symptoms " two weeks" after the start of the trial. The prescribing docor prescribes medication and instructs the patient to visit the doctor in two weeks.
Four weeks after the start of the study, a diagnostic doctor will assess motor and psychiatic symptoms using scales such as BFDMS and YBOCS. The diagnostic doctoe will videotape and evaluates the objective symptoms"four weeks"after the start of th etrial. The prescibing doctor prescribes medication and instructs the patients to visit the doctor in two weeks.
Eight weeks after the start of the study, a diagnostic doctor will assess motor and psychiatic symptoms using scales such as BFDMS and YBOCS. The diagnostic doctoe will videotape and evaluates the objective symptoms"eight weeks"after the start of the trial. The prescibing doctor will check for side effects and complete the tratmenta trial. If the patient wishes, the same oral tratment is continued, and motor and psychiatric symptoms are evaluated at a late date (assuming one year later) using the same evaluation methods("Evaluation of the efficacy on long-term tratment")
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Chlorpromazine (CPZ) monotherapy
Prescribe CPZ 5 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, 10 mg of CPZ 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, 15 mg of CPZ 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.
Interventions/Control_2
L-DOPA monotherapy
Prescribe 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, 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, 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.
Interventions/Control_3
CPZ+LDOPA combination therapy
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. If the patient wishes, oral treatment will be
continued.
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Eligibility Criteria
1) Among the dystonias defined by Fahn in 1988, those diagnosed as primary oromandibular,
eyelid, cervical, upper limb, unilateral, or generalized dystonia as classified by Albanese
et al. in 2013. Also, those clinically diagnosed as having hemifacial spasm or upper and
lower limb spasticity. Patients who visited our outpatient department were enrolled.
2) Patients who have given written informed consent to participate in the study
3) Individuals who have not received botulinum treatment in the past three months.
4) Individuals who have not altered their oral medication in over three months.
Key exclusion criteria
Under 15 years of age
2) Those with other diseases
3) Those with serious renal or hepatic impairment
4) Pregnant women and women of childbearing age who have not taken effective measures
Target sample size
60
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 Kumamoto 860-0811 Japan
TEL
0963723911
ninoue@knh.co.jp
Public contact
Name of contact person
| 1st name | Nobhiro |
| Middle name | |
| Last name | Inoue |
Organization
Kumamoto Neurosurgical Hospital
Division name
Neurosurgery
Zip code
8600811
Address
6-1-21 Honjyo Kumamoto 860-0811 Japan
TEL
0967723911
Homepage URL
ninoue@knh.co.jp
Sponsor or person
Institute
Kumamoto Neurosurgical Hospital
Institute
Department
Personal name
Funding Source
Organization
Kumamoto Neurosurgical Hospital
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 Honjyo Kumamoto 860-0811 Japan
Tel
0963723911
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
| 2025 | Year | 03 | 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
| 2025 | Year | 02 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 08 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 02 | Month | 14 | Day |
Last modified on
| 2025 | Year | 02 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065177
