UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056138 |
|---|---|
| Receipt number | R000062198 |
| Scientific Title | Levodopa and chlorpromazine combination therapy for treatment of primary dystonia |
| Date of disclosure of the study information | 2024/12/01 |
| Last modified on | 2024/11/13 10:49:40 |
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Basic information
Public title
Levodopa and chlorpromazine combination therapy for treatment of primary dystonia
Acronym
Levodopa and chlorpromazine combination therapy for treatment of primary dystonia
Scientific Title
Levodopa and chlorpromazine combination therapy for treatment of primary dystonia
Scientific Title:Acronym
Levodopa and chlorpromazine combination therapy for treatment of primary dystonia
Region
| Japan |
Condition
Condition
Levodopa and chlorpromazine combination therapy for treatment of primary dystonia
Classification by specialty
| Neurology | Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In the present study, we examined whether an levodopa and chlorpromazine combination therapy would be usefuful for the treatment of primary dystonia.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
A single movement disorder specialist recorded the participants clinical symptoms with a video camera to assess the objective signs. Aftere that, participants evaluated their subjective clinical signs usinga a visual analog scale (VAS)
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
chlorpromazine group
On the first day, we prescribe after breakfast, and order to continue for 2 weeks. After 2 weeks continuous tratmenta, CP 5mg after breakfast, CP 5mg aftre linch, a total of CP 10mg/day was prescribed. After 2 weeks continuous treatment, CP 5mg after breakfast, CP 5mg after lunch, CP 5mg after dinner, atotal of 15mg/day was prescribed.
Interventions/Control_2
levodopa(LDOPA)group
On the first day, we prescribed LDOPA 50mg aftere breadfast, and order to continue for 2 weeks. After 2weeks continuous treatment, LDOPA 50 mg after breakfast, LDOPA 50 mg after lunch, a total of LDOPA 100mg/day was prescribed. After 2weeks continuous treatmenta,LDOPA 50mg after breakfast,LDOPA 50mg after lunch,LDOPA 50 mg after dinner, a total of LDOPA 150mg/day was prescribed.
Interventions/Control_3
LDOPA in combination with CP group
On the first day,we prescribed LDOPA 50mg+CP5mg after breakfast,and order to continue for 2weeks. After 2weeks continous tratment,LDOPA 50mg+CP 5mg after breakfast,LDOPA 50mg + CP 5mg after lunch, a total of LDOPA 100mg+ CP10mg/day was prescribed. After 2weeks continuous treatment, LDOPA 50mg+CP5mg/day after lunch,a total of LDOPA 100mg +CP 10mg/day was prescribed. After 2weeks continuous treatmenta,LDOPA 50mg+CP5mg after breakfast,LDOPA 50mg+CP5mg after lunch,LDOPA50mg+CP5mg after dinner, a total of LDOPA150mg+CP15mg/day was prescribed.
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
Cervical dystonia and blepharospasm was clinically diagnosed according to the definition by Fahn.
(Fahn S.Concept and classification of dystonia. Adv Neurol 1988;50:1-8)
Written informed consent was obtained.
Key exclusion criteria
All participants were examined by a single movement disorder specialist who performed general physical and neurological examinations,laboratory tests, and brain magnetic resonance imaging to exclude othe cause of dystonia, includinga birth injury anf head trauma.
Target sample size
96
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
860-0811
Address
6-1-21 Honjyo Kumamoto Japan
TEL
09023926337
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
860-0811
Address
6-1-21 Honjyo Kumamoto Japan
TEL
09023926337
Homepage URL
ninoue@knh.co.jp
Sponsor or person
Institute
Kumamoto Neurosurgical Hospital
Institute
Department
Personal name
Nobuhiro Inoue
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 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
| 2024 | Year | 12 | 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
| 2024 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 12 | Month | 01 | 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
| 2024 | Year | 11 | Month | 13 | Day |
Last modified on
| 2024 | Year | 11 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062198
