NIPH Clinical Trials Search

JRCT ID: jRCTs031180316

Registered date:18/03/2019

An open-label, randomized controlled study evaluating the effectiveness of Pramipexole extended-release tablets for tardive dystonia patients

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedTardive dystonia
Date of first enrollment06/02/2015
Target sample size24
Countries of recruitment
Study typeInterventional
Intervention(s)Randomization of the study drug


Primary OutcomeBurke-Fahn-Marsden scale at 16th week
Secondary OutcomeBurke-Fahn-Marsden scale at 4th week Extrapyramidal Symptom Rating Scale (ESRS) EuroQOL(EQ-5D)Japanese version Brief Psychiatric Rating Scale (BPRS)

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximum<= 60age old
Include criteriaThe 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 psychotropic drugs used were not changed. Occasional use of such drugs is accepted. (4) The patient's age at the time of consent is between 20 and 60 years old. (5) The patient understands all aspect 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.
Exclude 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 history of deep brain stimulation (DBS) (5) With treatment history of electroconvulsive 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) Participation 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 women, and women 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 enrolment (13) Assessed as unsuitable for participation in the study by the study physician

Related Information


Public contact
Name Nobuhisa Kanahara
Address 1-8-1 Inohana, Chuo-ku, Chiba City, Chiba,Japan Chiba Japan 260-8670
Telephone +81-43-222-7171
Affiliation Chiba University Center for Forensic Mental Health
Scientific contact
Name Masaomi Iyo
Address 1-8-1 Inohana, Chuo-ku, Chiba City, Chiba,Japan Chiba Japan 260-8670
Telephone +81-43-222-7171
Affiliation Chiba University Hospital