UMIN-CTR Clinical Trial

Basic information
Public title	An open-label, randomized controlled study evaluating the effectiveness of pramipexole extended-release tablets for tardive dystonia.
Acronym	REDUCTION Trail
Scientific Title	An open-label, randomized controlled study evaluating the effectiveness of pramipexole extended-release tablets for tardive dystonia.
Scientific Title:Acronym	REDUCTION Trail
Region	Japan

Condition
Condition	Tardive dystonia
Classification by specialty	Psychiatry Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the effectiveness of pramipexole extended-release tablets for tardive dystonia.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Burke-Fahn-Marsden Dystonia Rating Scale
Key secondary outcomes	Extrapyramidal Symptom Rating Scale(ESRS), Brief Psychiatric Rating Scale(BPRS), Euro Qol 5 demensions(EQ-5D)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Active drug group: In the "active drug group", a fixed daily dose of 0.375 mg of pramipexole extended-release tablet is administered to each patient for the first 4 weeks, after which physician can adjust the trial drug's dosage within the range of 0.375-1.50 mg per day, based on a clinical assessment. If the physician increases the dosage of the drug, the adjustment must be at an interval of at least 1 week. Maximum dose is no more than 1.50 mg per day. Each patient is observed for a total of 16 weeks, during which time the psysician treats the patient in accords with this study protocol.
Interventions/Control_2	Usual care group: In the "usual care group", each patient's previous medication (such as anticholonergic agents) for tardive dystonia continues to be administered to the patient throughout the trial period of 16 weeks. The addition of any agent and/or adjustment of the treatment drug's dosage are not allowed in this group.
Interventions/Control_3
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	20 years-old <=
Age-upper limit	60 years-old >=
Gender	Male and Female
Key inclusion criteria	To participate in this study, all of the following items must be met by the patient. 1) The patient's dystonia has been confirmed to have been caused by any agent with a blocking effect of dopamine receptor (i.e., tardive dystonia): the dystonia was not observed before the patient took the offending drug, and it emerged following medication with the drug for at least one month. 2) Medication with an anticholinergic agent (such as biperiden, trihexyphenidyl) at a sufficient dose has been provided at least once, but was not effective for the tardive dystonia. In addition, at the time that the patient's consent to participate in the study was obtained, the Global Assessment of Functioning score of the patient did not reach 60 points due to his/her dystonia and the symptoms caused the patient profound distress. 3) Within the 4 weeks before the patient's consent was obtained, the type and dosage of any psychotoropic drugs used were not changed. Occasional use of such drugs is accepted. 4) The patient's age at the time of consent is > 20 and < 60 years old. 5) The patient undestands all aspects of the study and gives written consent. If he/she is not able to understand the study due to his/her psychiatric disease, his/her representative gives written consent.
Key exclusion criteria	1) With blepharospasm or oculogyric crisis alone as a symptom of tardive dystonia 2) Without a treatment history with anticholinergic agent 3) Under treatment with clozapine 4) With treatment histroy of deep brain stimulation (DBS) 5) With treatment history of electroconvulsove therapy (ECT) within 3 months prior to the study enrollment 6) With treatment history of botulinum toxin within 3 months prior to the study enrollment 7) Particition history of a clinical trial with any intervention ( i.e., except for observational study), within the most recent 3 months prior to the study enrollment 8) Without notification of a diagnosis of psychiatric disease 9) pregnant or childbearing-potential woman, and woman who are breast-feeding 10) With renal dysfunction: serum creatinine > 2.0 mg/dl 11) With hypersensitivity to any ingredient of the trial drug 12) With a suicide history within the most recent 1 year prior to the study enrollment 13) Assessed as unsuitable for participation in the study by the study physician
Target sample size	24

Research contact person
Name of lead principal investigator	1st name Middle name Last name Masaomi Iyo
Organization	Chiba University Graduate School of Medicine
Division name	Department of Psychiatry
Zip code
Address	1-8-1 Inohana, Chuou-ku, Chiba City, Chiba, Japan
TEL	043-222-7171
Email	iyom@faculty.chiba-u.jp

Public contact
Name of contact person	1st name Middle name Last name Nobuhisa Kanahara
Organization	Chiba University Center for Forensic Mental Health
Division name	Division of Medical Treatment and Rehabilitation
Zip code
Address	1-8-1 Inohana, Chuou-ku, Chiba City, Chiba, Japan
TEL	043-222-7171
Homepage URL
Email	kanahara@faculty.chiba-u.jp

Sponsor
Institute	Department of Psychiatry, Chiba University Graduate School of Medicine
Institute
Department

Funding Source
Organization	General grant from Chiba University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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	Shoushin-kai Mobara Psychiatric Hospital(Chiba), Chiba Psychiatric Medical Center (Chiba), Satsuki-kai Sodegaura-Satsukidai Hospital (Chiba), Douwa-kai Chiba Hospital (Chiba), Doujin-kai Kisaradzu Hospital (Chiba)

Other administrative information
Date of disclosure of the study information	2014 Year 09 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	Open public recruiting
Date of protocol fixation	2014 Year 09 Month 01 Day
Date of IRB	2014 Year 05 Month 21 Day
Anticipated trial start date	2014 Year 09 Month 01 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2014 Year 08 Month 29 Day
Last modified on	2020 Year 03 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000017289