a Pilot Study of Pramipexole to Treat Extrapyramidal Symptoms Induced by Antipsychotics

NCT03430596 | Completed Early Phase 1

• 1 other identifier: 17411970300
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Extrapyramidal Syndrome

Keywords

Extrapyramidal syndromes praminpexole pilot study

Outcome Measures

Primary Outcomes (1)

• The change of SAS BARS AIMS from baseline

  To compare the condition of the extrapyramidal symptoms between two groups

  8 weeks

Secondary Outcomes (1)

• The change of PANSS CDSS CGI-S from baseline

  8 weeks

Study Arms (2)

pramipexole

EXPERIMENTAL

pramipexole ,flexible dose (0.375mg/d-0.75mg/d)

Drug: Pramipexole

Antan

ACTIVE COMPARATOR

Antan,flexible dose (2-4mg/d)

Drug: Trihexyphenidyl hydrochloride

Interventions

Pramipexole DRUG

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 .

Also known as: SenForro

pramipexole

Trihexyphenidyl hydrochloride DRUG

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 .

Also known as: Antan

Antan

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age from 18-65 years old, male or female
• Subjects who met DSM-IV-TR criteria for extrapyramidal symptoms

You may not qualify if:

• Written informed consent provided by legal guardians or patients
• Understand and voluntarily participate in this trail
• A history of severe nervous system disease or nervous system injury 2 A history of severe or unstable heart, liver, kidney, endocrine (including thyroid function), hematological (such as those with hemorrhagic tendency) condition 3 Subjects who have an imminent risk of suicideor who can be a threat to himself others which judged by investigator 4 Substance or alcohol dependence at enrolment 5 Pregnancy or lactation or willing to pregnant during the trial 6 Low compliance to the doctor 7 Subjects who can't take drug in time according to doctors' advice 8 scored (mild) on at least two AIMS items or 3 (moderate) on one of the items are considered as tardive dyskesia Withdrawl Criteria
• An adverse sffecr or serious adverse effect occured so that the intervention needs to be stopped
• Subjects with poor compliance or who didn't take drugs for 4 days
• Obvious plan violation ,or the safety codition and symptoms of the patients are deteriorating
• scored (mild) on at least two AIMS items or 3 (moderate) on one of the items are considered as tardive dyskesia
• Researcher's decision of the withdrawl of the subjects -

Sponsors & Collaborators

• Shanghai Mental Health Center: lead

Study Sites (1)

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, 200030, China

Location

Related Publications (5)

• 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.

  PMID: 22153972 BACKGROUND

• 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.

  PMID: 9088887 BACKGROUND

• 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.

  PMID: 20196139 BACKGROUND

• 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.

  PMID: 26459182 BACKGROUND

• 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.

  PMID: 10594343 BACKGROUND

MeSH Terms

Conditions

Basal Ganglia Diseases

Interventions

Pramipexole; Trihexyphenidyl

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Benzothiazoles; Thiazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Piperidines

Study Officials

• Huafang Li, MD,Phd

  Drug Clinical Trial Office, Shanghai Mental Health Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: director

Study Record Dates

• First Submitted: February 6, 2018
• First Posted: February 13, 2018
• Study Start: May 1, 2018
• Primary Completion: October 30, 2021
• Study Completion: December 30, 2021
• Last Updated: June 27, 2022

Record last verified: 2022-06

Locations

CN (1)