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

JRCT ID: jRCTs031180316

Registered date:18/03/2019

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Tardive dystonia
• Date of first enrollment: 06/02/2015
• Target sample size: 24
• Study type: Interventional
• Intervention(s): Randomization of the study drug

Outcome(s)

• Primary Outcome: Burke-Fahn-Marsden scale at 16th week

Secondary Outcome

Burke-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
• Gender: Both

Include criteria

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 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

• Primary Sponsor: Kanahara Nobuhisa
• Secondary ID(s): UMIN000014988