UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057016 |
|---|---|
| Receipt number | R000065156 |
| Scientific Title | A study of combination therapy with Chlorpromazine and L-DOPA in dystonia |
| Date of disclosure of the study information | 2025/03/01 |
| Last modified on | 2025/11/28 16:15:29 |
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Basic information
Public title
A study of combination therapy with
Chlorpromazine and L-DOPA in dystonia
Acronym
A study of combination therapy with
Chlorpromazine and L-DOPA in dystonia
Scientific Title
A study of combination therapy with
Chlorpromazine and L-DOPA in dystonia
Scientific Title:Acronym
A study of combination therapy with
Chlorpromazine and L-DOPA in dystonia
Region
| Japan |
Condition
Condition
Dystonia as defined by Fahn in 1988, diagnosed as primary oromandibular, eyelid,
cervical, upper limb, unilateral, or generalized dystonia as classified by Bressman et al. in
2006
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 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
Prescribe CPZ 5mg and LDOPA 50mg 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 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, 115mg of CPZ and 150mg 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.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Pseudo-randomization
Intervention
No. of arms
3
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.
Interventions/Control_2
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. Patients will then transition to standard
treatment.
Interventions/Control_3
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. Patients will then transition to standard
treatment.
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
1) Dystonia as defined by Fahn in 1988, diagnosed as primary oromandibular, eyelid,
cervical, upper limb, unilateral, or generalized dystonia as classified by Bressman et al. in
2006
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.
5) Patients aged 50 years or older. For women, this includes postmenopausal patients,
defined as those who have not menstruated for at least 12 consecutive months or those
who have had both ovaries removed.
Key exclusion criteria
1) 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
for contraception
5) Other materials that are judged to be unsuitable for this research
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
860081
Address
6-1-21 Honjyo Kumamoto 8600811 Japan
TEL
0963723911
ninoue@knh.co.jp
Public contact
Name of contact person
| 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
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
00963723911
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
Partially published
Result
URL related to results and publications
https://doi.org/10.14802/jmd.25177
Number of participants that the trial has enrolled
1
Results
writers cramp, a task-specific focal hand dystonia, is treatable with dopaminergic modulation targeting atriatal striosomes: a case report
Results date posted
| 2025 | Year | 11 | Month | 28 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2025 | Year | 09 | Month | 11 | Day |
Baseline Characteristics
writers cramp, a task-specific focal hand dystonia, is treatable with dopaminergic modulation targeting atriatal striosomes: a case report
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 | 13 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 02 | Month | 13 | Day |
Last follow-up date
| 2025 | 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
| 2025 | Year | 02 | Month | 13 | Day |
Last modified on
| 2025 | Year | 11 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065156
