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

INTERVENTION: Randomization of the study drug CONDITION: Drug‐induced extrapyramidal syndrome Tardive dystonia ; Drug‐induced extrapyramidal syndrome 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) INCLUSION 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