UMIN-CTR Clinical Trial

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

primary dystonia

Classification by specialty

Neurology

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

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

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

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

110

Name of lead principal investigator

1st name	Shinichi
Middle name
Last name	Matsumoto

Organization

Shinko Hospital

Division name

Department of Neurology

Zip code

5610836

Address

Wakihamacho Chuouku, Kobe 651-0072, Japan

TEL

0663330086

Email

dyt1mc@yahoo.co.jp

Name of contact person

1st name	Shinichi
Middle name
Last name	Matsumoto

Organization

Shinko Hospital

Division name

Department of Neurology

Zip code

5610836

Address

Wakihamacho Chuouku, Kobe 651-0072, Japan

TEL

0663330086

Homepage URL

Email

dyt1mc@yahoo.co.jp

Institute

Department of Neurology, Shinko Hospital,

Institute

Department

Personal name

Organization

Department of Neurology, Shinko Hospital,

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Osaka Neurological Institute / IRB

Address

2-6-23 Shounai Takaramachi Toyonaka Osaka

Tel

0663330086

Email

dyt1mc@yahoo.co.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

神鋼記念病院　神経内科

Date of disclosure of the study information

2017

Year

06

Month

01

Day

URL releasing protocol

https://center6.umin.ac.jp/cgi-bin/icdr/ctr_up_reg_f3.cgi

Publication of results

Partially published

URL related to results and publications

https://www.neurology.org/doi/10.1212/CPJ.0000000000200254

Number of participants that the trial has enrolled

21

Results

Wintamin group: no effect
LDOPA group: no effect
LDOPA+wintamin group: effective

Results date posted

2024

Year

01

Month

12

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Idiopathic dystonia

Participant flow

Patients who visit our hospital and wish to undergo a clinical trial

Adverse events

non

Outcome measures

FMDRS

Plan to share IPD

IPD sharing Plan description

Recruitment status

Enrolling by invitation

Date of protocol fixation

2017

Year

06

Month

01

Day

Date of IRB

2017

Year

06

Month

01

Day

Anticipated trial start date

2017

Year

06

Month

01

Day

Last follow-up date

2026

Year

01

Month

31

Day

Date of closure to data entry

2026

Year

01

Month

31

Day

Date trial data considered complete

Date analysis concluded

2026

Year

01

Month

31

Day

Other related information

Registered date

2017

Year

05

Month

21

Day

Last modified on

2024

Year

04

Month

14

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031428