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The SUSTAIN Study Compares the Effects of Sustained and Immediate-release Pramipexole on the noctUrnal Symptoms of paTients With Advanced ParkInsoN's Disease Who Also Take L-Dopa

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ClinicalTrials.gov Identifier: NCT03521635
Recruitment Status : Recruiting
First Posted : May 10, 2018
Last Update Posted : April 16, 2019
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
The main objective of the study is to explore firstly, then further evaluate and confirm the efficacy between Pramipexole Sustained Release (SR) versus Pramipexole Immediate Release (IR) on nocturnal symptoms (as measured by the change from baseline to the end of the maintenance period in Parkinson's Disease Sleep Scale 2nd version (PDSS-2) score) in L-dopa+ treated patients with advanced Parkinson's disease (PD).

Condition or disease Intervention/treatment Phase
Parkinson Disease Drug: Pramipexole SR Drug: Pramipexole IR Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 86 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Two- Stage Multicenter, Open-label, Randomized, Active Controlled Parallel Group Study Comparing the Efficacy and Safety of Pramipexole SR Versus Pramipexole IR Administered Orally Over an 18-week Treatment on Nocturnal Symptoms in L-Dopa+ Treated Patients With Advanced Parkinson's Disease (PD)
Actual Study Start Date : July 3, 2018
Estimated Primary Completion Date : December 7, 2019
Estimated Study Completion Date : December 16, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Pramipexole SR Drug: Pramipexole SR
Tablets
Other Name: MIRAPEX®/SIFROL

Active Comparator: Pramipexole IR Drug: Pramipexole IR
Tablets
Other Name: MIRAPEX®/SIFROL




Primary Outcome Measures :
  1. Change from baseline to week 18 in Parkinson's Disease Sleep Scale 2nd version (PDSS-2) total score [ Time Frame: Baseline and Week 18 ]
    PDSS-2 means Parkinson's Disease Sleep Scale 2nd version


Secondary Outcome Measures :
  1. Scale for outcomes in Parkinson's disease (SCOPA)-Sleep score (change from baseline) [ Time Frame: Baseline and Week 18 ]
    SCOPA means Scale for outcomes in Parkinson's disease

  2. Early Morning Off (EMO) score (change from baseline) [ Time Frame: Baseline and Week 18 ]
    EMO means Early Morning Off

  3. Responder rate for Parkinson's Disease Sleep Scale 2nd version (PDSS-2) total score<18 [ Time Frame: Week 18 ]
    PDSS-2 means Responder rate for Parkinson's Disease Sleep Scale 2nd version

  4. Responder rate for Early Morning Off (EMO) score [ Time Frame: Week 18 ]
    EMO means Early Morning Off

  5. The Parkinson's Disease Questionnaire (PDQ)-8 score (change from baseline) [ Time Frame: Baseline and Week 18 ]
    PDQ means Parkinson's Disease Questionnaire

  6. Responder rate for Clinical Global Impression of Improvement (CGI-I) [ Time Frame: Week 18 ]
  7. Responder rate for Patient Global Impression of Improvement (PGI-I) [ Time Frame: Week 18 ]
  8. Epworth Sleepiness Scale (ESS) score (change from baseline) [ Time Frame: Baseline and Week 18 ]
    ESS means Epworth Sleepiness Scale

  9. Nocturnal Hypokinesia Questionnaire (NHQ) score (change from baseline) [ Time Frame: Baseline and Week 18 ]
    NHQ means Nocturnal Hypokinesia Questionnaire



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female patient with advanced idiopathic Parkinson's disease (PD) confirmed by at least bradykinesia and one of the following signs: resting tremor, rigidity.
  • Diagnosed as Parkinson's disease, with at least 2 years' PD history.
  • Of age ≥ 30 years at time of diagnosis.
  • Modified Hoehn and Yahr stage of 2 to 4 at on-time.
  • They must have clinically relevant sleep disturbances (i.e. Parkinson's Disease Sleep Scale 2nd version (PDSS-2) total score ≥18 at baseline).
  • They must feel uncomfortable at night because they were unable to turn around in bed or move due to immobility (i.e. the scoring of question 9 in PDSS-2 ≥ 2, that means frequency is at least 2 to 3 days during the past week).
  • They must have early morning off (i.e. the frequency of "feeling like bodily movements are poor when you wake up?" is at least 2 to 3 days during the past week).
  • Patient must have motor fluctuations (at least 2 cumulative hours of off-time every day during waking hours, documented on a patient diary completed for 2 consecutive days before randomization visit).
  • Patients must be treated with Levodopa combined with a Dopa-Decarboxylase-inhibitor (L-Dopa+) (i.e. standard and/or controlled release Levodopa/DDC inhibitor), or with a combination of L-Dopa+ and entacapone, at an optimized dose according to investigator's judgment, this dose being stable for at least 4 weeks prior to randomization visit.
  • Patients must not have been treated with sustained release dopaminergic drug (i.e. sustained release Levodopa/Dopa-Decarboxylase (DDC) inhibitor) after supper, or any anti-PD medication after 9pm within 4 weeks prior to randomization visit.
  • Patients must not have been treated with dopamine agonists within 4 weeks prior to randomization visit. A concomitant treatment with one or more of the following drugs will be allowed (at a stable dose for at least 4 weeks prior to randomization visit and the investigator does not intend to change this treatment during the treatment phase):

    • Anti-parkinsonian anticholinergics;
    • Selegiline, rasagiline, or other Monoamine Oxydase (MAO)-B-Inhibitor;
    • Amantadine;
    • Entacapone (or other Catechol-O-Methyltransferase (COMT)-Inhibitor).
  • Male or female patients. Women of childbearing potential (WOCBP) and men able to father a child must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in the patient information.
  • Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.

Exclusion criteria:

  • Secondary parkinsonian syndromes due to drugs (e.g., metoclopramide, flunarizine), metabolic disorders (e.g., Wilson's disease), encephalitis or degenerative diseases (e.g., progressive supranuclear palsy).
  • Dementia, as defined by a Mini-Mental State Exam score < 24 at screening visit.
  • Any psychiatric disorder according to DSM-V Diagnostic and Statistical Manual of Mental Disorders, 5th edition criteria that could prevent compliance or completion of the study and/or put the patient at risk if he/she takes part in the study.
  • History of psychosis, except history of drug induced hallucinations (provided the investigator considers that participation to the trial would not represent a significant risk for the patient).
  • History of deep brain stimulation.
  • History of nucleus lesioning.
  • Clinically significant electrocardiogram (ECG) abnormalities at screening visit, according to investigator's judgement.
  • Clinically significant hypotension (i.e. supine systolic blood pressure < 90 mmHg) and/or symptomatic orthostatic hypotension (i.e. clinical symptoms of orthostatic hypotension associated with a decline ≥ 20 mmHg in systolic blood pressure and a decline ≥ 10 mmHg in diastolic blood pressure, at 1 minute after standing compared with the previous supine systolic and diastolic blood pressure obtained after 5 minutes of quiet rest) at screening or randomization visit.
  • Major surgery (major according to the investigator's assessment) performed within 12 weeks prior to randomization or planned within 12 months after screening, e.g. hip replacement.
  • Any other clinically significant disease, whether treated or not, that could put the patient at risk or could prevent compliance or completion of the study.
  • Serious Sleep Apnea Hypopnea Syndrome (i.e. the scoring of question 15 in Parkinson's Disease Sleep Scale 2nd version (PDSS-2)≥ 3, that means frequency is at least 4 to 5 days during the past week )
  • Any documented active or suspected malignancy or history of malignancy within 5 years prior to screening, except appropriately treated basal cell carcinoma of the skin or in situ carcinoma of uterine cervix.
  • Serum levels of Aspartate Aminotransferase (AST)(SGOT), Alanine Aminotransferase (ALT)(SGPT), alkaline phosphatases or total bilirubin >2 ULN (on screening lab test).
  • Patients with a creatinine clearance < 50 mL/min (estimated by the local lab / the investigator using the Modification of Diet in Renal Disease (MDRD, please refer to Appendix 10.1), and calculated on screening lab test).
  • Any hypnotic medication within 4 weeks prior to the randomization visit (i.e. diazepam, clonazepam, estazolam, alprazolam, zolpidem, etc.).
  • Any medication (including intra-muscular formulations) with central dopaminergic antagonist activity within 4 weeks prior to the randomization visit (i.e. typical neuroleptics, atypical antipsychotics, reserpine, methyldopa, centrally-active antiemetics, etc.).
  • Any of the following drugs within 4 weeks prior to randomization visit: methylphenidate, cinnarizine, amphetamines.
  • Flunarizine within 3 months prior to randomization visit.
  • Known hypersensitivity to Pramipexole or its excipients.
  • Patients who must or wish to continue the intake of restricted medications or any drug considered likely to interfere with the safe conduct of the trial.
  • Previous enrolment in this trial.
  • Currently enrolled in another investigational device or drug trial, or less than 30 days since ending another investigational device or drug trial(s), or receiving other investigational treatment(s).
  • Chronic alcohol or drug abuse or any condition that, in the investigator's opinion, makes them an unreliable trial patient or unlikely to complete the trial.
  • Women who are pregnant, nursing, or who plan to become pregnant in the trial.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03521635


Contacts
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Contact: Boehringer Ingelheim 1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com

Locations
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China
Peking Union Medical College Hospital Recruiting
Beijing, China, 100032
Contact: Xinhua Wan    0086(010)69151360    13021099528@163.com   
Beijing Hospital Recruiting
Beijing, China
Contact: Haibo Chen    0086 (010) 85136182    chenhbneuro@263.net   
The First Afiliated Hospital, Sun Yet-sen University Recruiting
Guangzhou, China, 510080
Contact: Ling Chen    +86 13543433955    1678270523@qq.com   
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine Recruiting
Shanghai, China, 200025
Contact: Shengdi Chen    86-21-64370045/64315052    ruijincsd@126.com   
The First Hospital of Chinese Medical University Recruiting
Shenyang, China
Contact: Hongmei Yu    15242490738    69081302@qq.com   
The Second Affiliated Hospital of Soochow University Recruiting
Suzhou City, China, 215004
Contact: Chunfeng Liu    0512-67783307    liuchunfeng@suda.edu.cn   
Tianjin Medical University General Hospital Recruiting
Tianjin, China, 30052
Contact: Fudong Shi    0086(022)60362255    sfdclinicalstudy@sina.com   
Wuhan Union Hospital Recruiting
Wuhan, China, 430022
Contact: Shenggang Sun    027-85726925    Sunshenggang@126.com   
Sponsors and Collaborators
Boehringer Ingelheim

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT03521635     History of Changes
Other Study ID Numbers: 0248-0686
First Posted: May 10, 2018    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Pramipexole
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents