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

Primary Purpose

Extrapyramidal Syndrome

Status

Completed

Phase

Early Phase 1

Locations

China

Study Type

Interventional

Intervention

Pramipexole

Trihexyphenidyl hydrochloride

About this trial

This is an interventional treatment trial for Extrapyramidal Syndrome focused on measuring Extrapyramidal syndromes praminpexole pilot study

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age from 18-65 years old, male or female
Subjects who met DSM-IV-TR criteria for extrapyramidal symptoms
Scored 1 (mild) on at least two SAS items or 2 (moderate) on one of the items Exclusion Criteria are considered as antipsychotic induced parkinson ; Scored at least 2 (mild) on the BARS global item are considered as antipsychotic induced akathisia
Written informed consent provided by legal guardians or patients
Understand and voluntarily participate in this trail

Exclusion Criteria:

1 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 -

Sites / Locations

Shanghai Mental Health Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

pramipexole

Antan

Arm Description

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

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

Outcomes

Primary Outcome Measures

The change of SAS BARS AIMS from baseline

To compare the condition of the extrapyramidal symptoms between two groups

Secondary Outcome Measures

The change of PANSS CDSS CGI-S from baseline

To compare the change of the symptoms of chziophrenia between two groups

Full Information

NCT ID

NCT03430596

First Posted

February 6, 2018

Last Updated

June 24, 2022

Sponsor

Shanghai Mental Health Center

1. Study Identification

Unique Protocol Identification Number

NCT03430596

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2022

Overall Recruitment Status

Completed

Study Start Date

May 1, 2018 (Actual)

Primary Completion Date

October 30, 2021 (Actual)

Study Completion Date

December 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Shanghai Mental Health Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Extrapyramidal Syndrome

Keywords

Extrapyramidal syndromes praminpexole pilot study

7. Study Design

Primary Purpose

Treatment

Study Phase

Early Phase 1

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

pramipexole

Arm Type

Experimental

Arm Description

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

Arm Title

Antan

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Pramipexole

Other Intervention Name(s)

SenForro

Intervention Description

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 .

Intervention Type

Drug

Intervention Name(s)

Trihexyphenidyl hydrochloride

Other Intervention Name(s)

Antan

Intervention Description

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 .

Primary Outcome Measure Information:

Title

The change of SAS BARS AIMS from baseline

Description

To compare the condition of the extrapyramidal symptoms between two groups

Time Frame

8 weeks

Secondary Outcome Measure Information:

Title

The change of PANSS CDSS CGI-S from baseline

Description

To compare the change of the symptoms of chziophrenia between two groups

Time Frame

8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age from 18-65 years old, male or female Subjects who met DSM-IV-TR criteria for extrapyramidal symptoms Scored 1 (mild) on at least two SAS items or 2 (moderate) on one of the items Exclusion Criteria are considered as antipsychotic induced parkinson ; Scored at least 2 (mild) on the BARS global item are considered as antipsychotic induced akathisia Written informed consent provided by legal guardians or patients Understand and voluntarily participate in this trail Exclusion Criteria: 1 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 -

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Huafang Li, MD,Phd

Organizational Affiliation

Drug Clinical Trial Office, Shanghai Mental Health Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Shanghai Mental Health Center

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200030

Country

China

12. IPD Sharing Statement

Citations:

PubMed Identifier

22153972

Citation

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.

Results Reference

background

PubMed Identifier

9088887

Citation

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.

Results Reference

background

PubMed Identifier

20196139

Citation

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.

Results Reference

background

PubMed Identifier

26459182

Citation

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.

Results Reference

background

PubMed Identifier

10594343

Citation

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.

Results Reference

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

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