UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014988 |
|---|---|
| Receipt number | 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 20:55:26 |
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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
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
kanahara@faculty.chiba-u.jp
Sponsor or person
Institute
Department of Psychiatry, Chiba University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017289
