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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000014988
Receipt No. R000017289
Scientific Title An open-label, randomized controlled study evaluating the effectiveness of pramipexole extended-release tablets for tardive dystonia.
Date of disclosure of the study information 2014/09/01
Last modified on 2020/03/03

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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/ctr_e/ctr_view.cgi?recptno=R000017289

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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