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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000027430
Receipt No. R000031428
Scientific Title Levodopa and chlorpromazine combination therapy for treatment of primary dystonia
Date of disclosure of the study information 2017/06/01
Last modified on 2017/05/21

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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 primary dystonia
Classification by specialty
Neurology
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 useful for the treatment of primary dystonia.
This was a double-blind study, as the participants and evaluators were blinded to the identity of the drug (LDOPA, CP, LDOPA in combination with CP).
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes First day of examination, a single movement disorder specialist recorded the participants clinical symptoms with a video camera to assess the objective signs. After that, participants evaluated their subjective clinical signs using a visual analog scale (VAS). We explained to the participants that the left end of the scale indicated the worst possible state, whereas the right end of the scale indicated a healthy state without cervical dystonia or blepharospasm. Participants were directed to self-evaluate their clinical signs separately from any side effects.
Second, we recorded the participants clinical symptoms with a video camera again. The second video recording was taken by another doctor who was blinded to the patient back ground and the treatment.
Six weeks after the therapy, patients evaluated subjective score by VAS. Six weeks after the therapy, video camera was recorded by the doctor who were blinded to the patients background and the treatment, to assess the objective signs.
Three movement disorder specialists who were blinded to the treatment and purpose of the examination independently evaluated the objective symptoms from the videos before treatment and after treatment which were randomly presented. We took two videos before treatment (reference video, pre-treatment video), and one video after treatment (post-treatment video). We made one slide with reference video and pre-treatment video, and named A. We also made one slide with reference video and post-treatment video, and named B. A and B presented randomly, and we also randomly presented these sets of videos LDOPA group, CP group, and LDOPA in combination with CP group to the specialists.
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 (CP) group
On the first day, we prescribe after breakfast, and order to continue for 2 weeks. After 2 weeks continuous treatment, CP 5mg after breakfast, CP 5mg after lunch, 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, a total of CP 15mg / day was prescribed.
Interventions/Control_2 levodopa (LDOPA) group
On the first day, we prescribed LDOPA 50 mg after breakfast, and order to continue for 2 weeks. After 2 weeks continuous treatment, LDOPA 50mg after breakfast, LDOPA 50mg after lunch, a total of LDOPA 100mg / day was prescribed. After 2 weeks continuous treatment, LDOPA 50mg after breakfast, LDOPA 50mg after lunch, LDOPA 50mg 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 50 mg + CP 5mg after breakfast, and order to continue for 2 weeks. After 2 weeks continuous treatment, LDOPA 50mg + CP 5mg after breakfast, LDOPA 50mg + CP 5mg after lunch, a total of LDOPA 100mg + CP 10mg / day was prescribed. After 2 weeks continuous treatment, LDOPA 50mg + CP 5mg after breakfast, LDOPA 50mg + CP 5mg after lunch, LDOPA 50mg + CP 5mg after dinner, a total of LDOPA 150mg + CP 15mg / 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 other causes of dystonia, including birth injury and head trauma.
Target sample size 30

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Shinichi Matsumoto
Organization Shinko Hospital
Division name Department of Neurology
Zip code
Address Wakihamacho Chuouku, Kobe 651-0072, Japan
TEL 81-782-61-6711
Email matsumoto.shinichi@shinko-hp.ne.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Shinichi Matsumoto
Organization Shinko Hospital
Division name Department of Neurology
Zip code
Address Wakihamacho Chuouku, Kobe 651-0072, Japan
TEL 81-782-61-6711
Homepage URL
Email matsumoto.shinichi@shinko-hp.ne.jp

Sponsor
Institute Department of Neurology, Shinko Hospital,
Institute
Department

Funding Source
Organization Department of Neurology, Shinko Hospital,
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 神鋼記念病院 神経内科

Other administrative information
Date of disclosure of the study information
2017 Year 06 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 Enrolling by invitation
Date of protocol fixation
2017 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 06 Month 01 Day
Last follow-up date
2019 Year 05 Month 31 Day
Date of closure to data entry
2019 Year 08 Month 01 Day
Date trial data considered complete
2019 Year 08 Month 01 Day
Date analysis concluded
2019 Year 08 Month 01 Day

Other
Other related information

Management information
Registered date
2017 Year 05 Month 21 Day
Last modified on
2017 Year 05 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031428

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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