Extrapyramidal SyndromeEarly Phase 1NCT03430596
a Pilot Study of Pramipexole to Treat Extrapyramidal Symptoms Induced by Antipsychotics
A Early Phase 1 study testing Pramipexole and Trihexyphenidyl hydrochloride in people with Extrapyramidal Syndrome, run by Shanghai Mental Health Center at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Extrapyramidal Syndrome
- What is being tested?
- Pramipexole and Trihexyphenidyl hydrochloride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2018to 30 Dec 2021
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 -
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, 200030
About this study
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
- Being tested
- Pramipexole, Trihexyphenidyl hydrochloride
- Keywords
- Extrapyramidal syndromes praminpexole pilot study
- Medical subject headings
- Basal Ganglia Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PramipexoleDrug
Also called SenForro
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 .
Trihexyphenidyl hydrochlorideDrug
Also called Antan
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 .
| Study group | Role | What they receive |
|---|---|---|
| pramipexole | Experimental | pramipexole ,flexible dose (0.375mg/d-0.75mg/d) Receives: Drug: Pramipexole |
| Antan | Active comparator | Antan,flexible dose (2-4mg/d) Receives: Drug: Trihexyphenidyl hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of SAS BARS AIMS from baseline
To compare the condition of the extrapyramidal symptoms between two groups
Measured: 8 weeks
Secondary outcomes (1)
The change of PANSS CDSS CGI-S from baseline
To compare the change of the symptoms of chziophrenia between two groups
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2018
- Study start1 May 2018
- Primary completion30 Oct 2021
- Study completion30 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Extrapyramidal SyndromeStudies of the same condition, open and under way.
- More trials run by Shanghai Mental Health CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wenjuan YU, Shanghai Mental Health Center
- Investigators
- Huafang Li, MD,Phd, Principal investigator, Drug Clinical Trial Office, Shanghai Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03430596
- Sponsor's protocol ID
- 17411970300
- Status last verified
- Jun 2022
- First submitted
- 6 Feb 2018
- Last updated
- 27 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 22153972Kasper 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.
PubMed 9088887Ferger 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.
PubMed 20196139Kosmowska 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.
PubMed 26459182Lorenc-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.
PubMed 10594343
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- a Pilot Study of Pramipexole to Treat Extrapyramidal Symptoms Induced by Antipsychotics
- ClinicalTrials.gov ID
- NCT03430596
- Acronym / sponsor ID
- 17411970300
- Conditions
- Extrapyramidal Syndrome
- Keywords
- Extrapyramidal syndromes praminpexole pilot study
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 30 Oct 2021 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 13 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pramipexole | Experimental | Drug: Pramipexolepramipexole ,flexible dose (0.375mg/d-0.75mg/d) |
| Antan | Active comparator | Drug: Trihexyphenidyl hydrochlorideAntan,flexible dose (2-4mg/d) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PramipexoleAlso: SenForroThe 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 . | Drug | pramipexole |
| Trihexyphenidyl hydrochlorideAlso: Antanhe 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 . | Drug | Antan |
Primary outcome
The change of SAS BARS AIMS from baseline
Time frame: 8 weeks
To compare the condition of the extrapyramidal symptoms between two groups
1 secondary outcome
The change of PANSS CDSS CGI-S from baseline
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2022.
- Background: PubMed 22153972Kelleher 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.
- Background: PubMed 9088887Kasper 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.
- Background: PubMed 20196139Ferger 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.
- Background: PubMed 26459182Kosmowska 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.
- Background: PubMed 10594343Lorenc-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Huafang Li, MD,Phd principal investigator
Drug Clinical Trial Office, Shanghai Mental Health Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Pramipexole and Trihexyphenidyl hydrochloride in people with Extrapyramidal Syndrome, run by Shanghai Mental Health Center at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change of SAS BARS AIMS from baseline (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03430596, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2022.