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Sponsor study identifier
interventional
50
1 country
1
Study Start
May 1, 2018
Actual (reported)Primary Completion
October 30, 2021
Actual (reported)Study Completion
December 30, 2021
Actual (reported)This study is a pilot phased interventional clinical trial . The first stage will recruit 10 patients with antipsychotic induced extrapyramidal symptoms.The patients will take pramipexole for 8 weeks. The inital dose of pramipexole will be 0.375 mg/d, and the adjustment of drug dose will be depended on the the doctor's decision and patients' condition. The second stage was a randomized, rater blindness and Antan controlled clinical study. Researchers will recruit another 40 patients with extrapyramidal symptoms (tradive dyskinesia will be excluded). The patients will randomly be divided into artane group or pramipexole group, and the efficacy and safety condition of pramipexole and artane for different kinds of EPS will be compared. The pramipexole group will have 20 cases, and 20 cases of artane group. The dose of pramipexole group group range from 0.375mg/d to 0.75mg/d dose .The dose of artane range from 2 mg/d to 4 mg/d,.The accurate drug doses can be adjusted by the doctor according to the patients' condition . Researchers will evualate patients' symptom at baseline, after three days' of baseline, 2 weeks,4 weeks, 6 weeks and 8 weeks. The Simpson-Angus Scale(SAS) 、Barnes Akathisia Rating Scale(BARS),Abnormal Involuntary Movement Scale (AIMS), Positive and Negative Syndrome Scale(PANSS), Calgary Depression Scale for Schizophrenia(CDSS), Clinical Global Impression-severity of Illness Scale(CGI-S) will be evualated by the trained raters indicated as the drug's efficacy of the extrapyramidal symptoms and schizophrenia .The adverse events, laboratory parameters, vital signs, ECG will be recorded as the safety indicators of the study drugs.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 30, 2021
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 6, 2018
Actual (reported)February 13, 2018
Actual (reported)May 1, 2018
Actual (reported)October 30, 2021
Actual (reported)December 30, 2021
Actual (reported)The change of SAS BARS AIMS from baseline
To compare the condition of the extrapyramidal symptoms between two groups
8 weeks
The change of PANSS CDSS CGI-S from baseline
8 weeks
pramipexole ,flexible dose (0.375mg/d-0.75mg/d)
Antan,flexible dose (2-4mg/d)
The dose of pramipexole range from 0.375mg/d to 0.75mg/d , The accurate dose of pramipexole can be adjusted by the patient's condition and tolerance .
he dose of Antan range from 2 mg/d to 4 mg/d , The accurate dose of pramipexole can be adjusted by the patient's condition and tolerance .
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, 200030, China
Kelleher JP, Centorrino F, Huxley NA, Bates JA, Drake JK, Egli S, Baldessarini RJ. Pilot randomized, controlled trial of pramipexole to augment antipsychotic treatment. Eur Neuropsychopharmacol. 2012 Jun;22(6):415-8. doi: 10.1016/j.euroneuro.2011.10.002. Epub 2011 Dec 7.
Kasper S, Barnas C, Heiden A, Volz HP, Laakmann G, Zeit H, Pfolz H. Pramipexole as adjunct to haloperidol in schizophrenia. Safety and efficacy. Eur Neuropsychopharmacol. 1997 Feb;7(1):65-70. doi: 10.1016/s0924-977x(96)00393-8.
Huafang Li, MD,Phd
Drug Clinical Trial Office, Shanghai Mental Health Center
50 participants (actual enrollment reported by the registry).
First Submitted
February 6, 2018
First Posted
February 13, 2018
Study Start
May 1, 2018
Actual (reported)Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Ferger B, Buck K, Shimasaki M, Koros E, Voehringer P, Buerger E. Continuous dopaminergic stimulation by pramipexole is effective to treat early morning akinesia in animal models of Parkinson's disease: A pharmacokinetic-pharmacodynamic study using in vivo microdialysis in rats. Synapse. 2010 Jul;64(7):533-41. doi: 10.1002/syn.20759.
Kosmowska B, Wardas J, Glowacka U, Ananthan S, Ossowska K. Pramipexole at a Low Dose Induces Beneficial Effect in the Harmaline-induced Model of Essential Tremor in Rats. CNS Neurosci Ther. 2016 Jan;22(1):53-62. doi: 10.1111/cns.12467. Epub 2015 Oct 13.
Lorenc-Koci E, Wolfarth S. Efficacy of pramipexole, a new dopamine receptor agonist, to relieve the parkinsonian-like muscle rigidity in rats. Eur J Pharmacol. 1999 Nov 26;385(1):39-46. doi: 10.1016/s0014-2999(99)00704-9.
Primary Completion
October 30, 2021
Actual (reported)Study Completion
December 30, 2021
Actual (reported)Last Updated
June 27, 2022
Record last verified: 2022-06
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Source: ClinicalTrials.gov.
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