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Trial record 5 of 28 for:    PARKINSON DISEASE 12

A 12-week Study of Pramipexole Extended Release (ER) in Patients With Parkinson's Disease (PD), Followed by a 52-week Long-term Treatment Period

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00560508
First Posted: November 19, 2007
Last Update Posted: July 31, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Boehringer Ingelheim
November 16, 2007
November 19, 2007
November 25, 2010
February 10, 2011
July 31, 2014
November 2007
November 2009   (Final data collection date for primary outcome measure)
Percentage of Participants Who Experienced Adverse Events [ Time Frame: 12 weeks ]
An adverse event is defined as any untoward medical occurrence
No primary efficacy endpoints are set up, because the primary objective of this trial is to compare safety, tolerability and trough plasma drug concentration.
Complete list of historical versions of study NCT00560508 on ClinicalTrials.gov Archive Site
  • Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Parts II+III Total Score [ Time Frame: baseline and after 12 weeks treatment ]
    UPDRS II+III ranging from 0 point(normal) to 160 point (severe). UPDRS part II measures activities of daily living, part III measures motor symptoms
  • Change From Baseline in Percentage Off-time [ Time Frame: baseline and after 12 weeks treatment ]
    Percentage off-time during waking hours in the last two days based on patient diary data, percentage ranging from 0 (best case) to 100 (worst case). Off-time describes a period when the patient experiences increased parkinsonian symptoms (e.g. immobility or inability to move with ease).
  • Change From Baseline in Percentage On-time Without Dyskinesia [ Time Frame: baseline and after 12 weeks treatment ]
    Percentage on-time without dyskinesia during waking hours in the last two days based on patient diary data, percentage ranging from 0 (worst case) to 100 (best case). On-time describes a period when the patient has no symptoms of off-time and is not asleep.
  • Change From Baseline in Percentage On-time With Non-troublesome Dyskinesia [ Time Frame: baseline and after 12 weeks treatment ]
    Percentage on-time with non-troublesome dyskinesia during waking hours in the last two days based on patient diary data, percentage ranging from 0(worst case) to 100 (best case). On-time describes a period when the patient has no symptoms of off-time and is not asleep.
  • Change From Baseline in Percentage On-time Without Dyskinesia or With Non-troublesome Dyskinesia [ Time Frame: baseline and after 12 weeks treatment ]
    Percentage on-time without dyskinesia or non-troublesome dyskinesia during waking hours in the last two days based on patient diary data, percentage ranging from 0 (worst case) to 100 (best case). On-time describes a period when the patient has no symptoms of off-time and is not asleep.
  • Change From Baseline in Percentage On-time With Troublesome Dyskinesia [ Time Frame: baseline and after 12 weeks treatment ]
    Percentage on-time with troublesome dyskinesia during waking hours in the last two days based on patient diary data, percentage ranging from 0 (best case) to 100 (worst case). On-time describes a period when the patient has no symptoms of off-time and is not asleep.
  • Responder Rate For Clinical Global Impression of Improvement (CGI-I) [ Time Frame: baseline and after 12 weeks treatment ]
    CGI-I scores ranging from '1' (very much improved) to '7' (very much worse), CGI-I responder have scoring of 1 or 2 (at least much improved)
  • Responder Rate For Patient Global Impression of Improvement (PGI-I) [ Time Frame: baseline and after 12 weeks treatment ]
    PGI-I scores ranging from '1' (very much better) to '7' (very much worse), PGI-I responder have scoring of 1 or 2 (at least much better)
  • Change From Baseline in UPDRS Part I Score [ Time Frame: baseline and after 12 weeks treatment ]
    UPDRS Part I ranging from 0 (normal) to 16 (severe). UPDRS Part I measures Mentation, Behavior and Mood
  • Change From Baseline in UPDRS Part II Score [ Time Frame: baseline and after 12 weeks treatment ]
    UPDRS Part II ranging from 0 (normal) to 52 (severe). UPDRS Part II is calculated as the average of UPDRS Part II at on and UPDRS Part II at off-period for each of the 13 activities.
  • Change From Baseline in UPDRS Part III Score [ Time Frame: baseline and after 12 weeks treatment ]
    UPDRS Part III ranging from 0 (normal) to 108 (severe). UPDRS Part III measures motor symptoms
  • Change From Baseline in UPDRS Part IV Score [ Time Frame: baseline and after 12 weeks treatment ]
    UPDRS Part IV ranging from 0 (normal) to 23 (severe). UPDRS Part IV measures complications of therapy
  • UPDRS Parts II+III Total Score Responder Rate (at Least 20% Improvement) [ Time Frame: baseline and after 12 weeks treatment ]
    Responders are defined as at least 20% decrease in the UPDRS Parts II+III Total Score ranges 0-160 scores from best to worse
  • Change From Baseline in L-dopa Daily Dose [ Time Frame: baseline and after 12 weeks treatment ]
    The L-dopa daily dose was recorded in the electronic case report form (eCRF) at each trial visit.
  • Trough Plasma Concentration at Steady State [ Time Frame: at Visit 8 after pramipexole ER 4.5mg and IR 4.5mg treatment ]
    Geometric mean (gMean) was calculated for trough plasma concentrations of pramipexole at steady state after administration of pramipexole IR 4.5mg and pramipexole ER 4.5mg.
  • Dose Proportionality of Trough Plasma Concentration at Steady State After Pramipexole ER Treatment [ Time Frame: from Visit 1 to Visit 8 after pramipexole ER ]
    Dose proportionality of trough plasma concentrations at steady state is explored by using the power model that described the functional relationship between the dose and plasma concentration
  • Change From End of Double-Blind Period in UPDRS (Unified Parkinson's Disease Rating Scale) Parts II+III Total Score (Open-label: Dose Adjustment Phase) [ Time Frame: Week 12 to Week 16 ]
    UPDRS II+III ranging from 0 point(normal) to 160 point (severe). UPDRS part II measures activities of daily living, part III measures motor symptoms. Least square means and standard errors presented are from ANCOVA with factors treatment and covariate baseline.
  • Percentage of Patients With no Worsening of UPDRS Parts II+III Total Score by More Than 15% From Week 12 to Week 16 (Open-label: Dose Adjustment Phase) [ Time Frame: Week 12 to Week 16 ]
    Percentage of patients with no worsening of UPDRS Parts II+III Total Score by more than 15% from week 12 to week 16 (Open-label: Dose Adjustment Phase)
  • Clinical Global Impression of Improvement (CGI-I) at Week 16 Compared to Patient's CGI-I Status at Week 12 (Open-label: Dose Adjustment Phase) [ Time Frame: Week 12 to Week 16 ]
    Clinical Global Impression of Improvement (CGI-I) at week 16 compared to patient's CGI-I status at week 12. CGI-I scores ranging from '1' (very much improved) to '7' (very much worse)
  • Patient Global Impression of Improvement (PGI-I) at Week 16 Compared to Patient's PGI-I Status at Week 12 (Open-label: Dose Adjustment Phase) [ Time Frame: Week 12 to Week 16 ]
    Patient Global Impression of Improvement (PGI-I) at week 16 compared to patient's PGI-I status at week 12. PGI-I scores ranging from '1' (very much better) to '7' (very much worse).
  • Change From Baseline in UPDRS (Unified Parkinson's Disease Rating Scale) Parts II+III Total Score (Open-label: Maintenance Phase) [ Time Frame: Baseline and after 64 weeks treatment ]
    UPDRS II+III ranging from 0 point(normal) to 160 point (severe). UPDRS part II measures activities of daily living, part III measures motor symptoms
  • UPDRS Parts II+III Total Score Responder Rate (at Least 20% Improvement) (Open-label: Maintenance Phase) [ Time Frame: baseline and after 64 weeks treatment ]
    Responders are defined as at least 20% decrease in the UPDRS Parts II+III Total Score ranges 0-160 scores from best to worse
  • Change From Baseline in Percentage Off-time (Open-label: Maintenance Phase) [ Time Frame: baseline and after 64 weeks treatment ]
    Percentage off-time during waking hours in the last two days based on patient diary data, percentage ranging from 0 (best case) to 100 (worst case). Off-time describes a period when the patient experiences increased parkinsonian symptoms (e.g. immobility or inability to move with ease).
  • Change From Baseline in Percentage On-time Without Dyskinesia (Open-label: Maintenance Phase) [ Time Frame: baseline and after 64 weeks treatment ]
    Percentage on-time without dyskinesia during waking hours in the last two days based on patient diary data, percentage ranging from 0 (worst case) to 100 (best case). On-time describes a period when the patient has no symptoms of off-time and is not asleep.
  • Change From Baseline in Percentage On-time With Non-troublesome Dyskinesia (Open-label Maintenance Phase) [ Time Frame: baseline and after 64 weeks treatment ]
    Percentage on-time with non-troublesome dyskinesia during waking hours in the last two days based on patient diary data, percentage ranging from 0(worst case) to 100 (best case). On-time describes a period when the patient has no symptoms of off-time and is not asleep.
  • Change From Baseline in Percentage On-time Without Dyskinesia or With Non-troublesome Dyskinesia (Open-label Maintenance Phase) [ Time Frame: baseline and after 64 weeks treatment ]
    Percentage on-time without dyskinesia or non-troublesome dyskinesia during waking hours in the last two days based on patient diary data, percentage ranging from 0 (worst case) to 100 (best case). On-time describes a period when the patient has no symptoms of off-time and is not asleep.
  • Change From Baseline in Percentage On-time With Troublesome Dyskinesia (Open-label Maintenance Phase) [ Time Frame: baseline and after 64 weeks treatment ]
    Percentage on-time with troublesome dyskinesia during waking hours in the last two days based on patient diary data, percentage ranging from 0 (best case) to 100 (worst case). On-time describes a period when the patient has no symptoms of off-time and is not asleep.
  • Change From Baseline in L-dopa Daily Dose (Open-label Maintenance Phase) [ Time Frame: baseline and after 64 weeks treatment ]
    The L-dopa daily dose was recorded in the electronic case report form (eCRF) at each trial visit.
  • Change From Baseline in UPDRS Part I Score (Open-label: Maintenance Phase) [ Time Frame: baseline and after 64 weeks treatment ]
    UPDRS Part I ranging from 0 (normal) to 16 (severe). UPDRS Part I measures Mentation, Behavior and Mood
  • Change From Baseline in UPDRS Part II Score (Open-label: Maintenance Phase) [ Time Frame: baseline and after 64 weeks treatment ]
    UPDRS Part II ranging from 0 (normal) to 52 (severe). UPDRS Part II is calculated as the average of UPDRS Part II at on and UPDRS Part II at off-period for each of the 13 activities.
  • Change From Baseline in UPDRS Part III Score (Open-label: Maintenance Phase) [ Time Frame: baseline and after 64 weeks treatment ]
    UPDRS Part III ranging from 0 (normal) to 108 (severe). UPDRS Part III measures motor symptoms
  • Change From Baseline in UPDRS Part IV Score (Open-label: Maintenance Phase) [ Time Frame: baseline and after 64 weeks treatment ]
    UPDRS Part IV ranging from 0 (normal) to 23 (severe). UPDRS Part IV measures complications of therapy
Double blind period: UPDRS parts II plus III score (change from baseline), Percentage off time during waking hours (change from baseline), Open label periold: UPDRS parts II plus III score change from Visit 8
Not Provided
Not Provided
 
A 12-week Study of Pramipexole Extended Release (ER) in Patients With Parkinson's Disease (PD), Followed by a 52-week Long-term Treatment Period
A Double-blind, Double-dummy, Randomised, Parallel-group Study to Investigate the Safety, Tolerability, Trough Plasma Concentration, and Efficacy of Pramipexole ER Versus Pramipexole Immediate Release (IR) Administered Orally for 12 Weeks in Patients With Parkinson's Disease (PD) on L-dopa Therapy, Followed by a 52-week Open-label Long-term Treatment Period to Evaluate the Long-term Safety and Efficacy of Pramipexole ER
The objective of this trial is to investigate the safety, tolerability, trough plasma concentration, and efficacy of pramipexole ER in comparison with those of pramipexole IR administrated orally for 12 weeks in patients with PD on levodopa (L-DOPA) therapy (the double-blind period). The double-blind period will be followed by the open-label 52 week administration of pramipexole ER to evaluate the long term safety and efficacy (the open-label period).
Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Parkinson Disease
  • Drug: Pramipexole Immediate Release
    titrated as individually needed (0.25 mg - 4.5 mg daily)
  • Drug: Pramipexole Extended Release
    titration as individually needed (0.375 mg -4.5 mg daily)
  • Experimental: Pramipexole Extended Release
    patient to receive a tablet containing 0.375 mg Pramipexole ER once a day plus containing 0.125 mg Pramipexole IR placebo twice a day -> a tablet containing 1.5 mg Pramipexole ER three times daily (TID) plus 0.5 mg Pramipexole IR placebo TID
    Intervention: Drug: Pramipexole Extended Release
  • Active Comparator: Pramipexole Immediate Release
    patient to receive a tablet containing 0.125 mg Pramipexole IR twice a day plus containing 0.375 mg Pramipexole ER placebo once a day -> a tablet containing 0.5 mg Pramipexole IR three times daily (TID) plus 1.5 mg Pramipexole ER placebo TID
    Intervention: Drug: Pramipexole Immediate Release
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
112
Not Provided
November 2009   (Final data collection date for primary outcome measure)

Inclusion criteria

  1. Male or female patients with diagnosis of PD including juvenile Parkinsonism, in whom the onset began at the age of forty or younger.
  2. Patients with a modified Hoehn and Yahr scale of II to IV at "on" time.
  3. Patients who have received an individual dosage of L-DOPA (either standard L-DOPA or L-DOPA with dopa-decarboxylase inhibitor) at a stable dose for at least 4 weeks before the baseline visit (Visit 2).
  4. Patients who exhibit any therapeutically problematic issues or status based on L-DOPA therapy:

    • wearing-off phenomena
    • no on /delayed on
    • dystonia at off time
    • on-off phenomena
    • freezing phenomena at off time
    • the sub-optimal dose of L-DOPA had been administered due to side effects (such as dyskinesia), or therapeutical strategy

Exclusion criteria

  1. Atypical parkinsonian syndromes due to drugs, metabolic disorders, encephalitis or degenerative diseases.
  2. Dementia, as defined by a Mini-Mental State Examination (MMSE) score <24 at screening visit.
  3. Any psychiatric disorder according to DSM-IV criteria that could prevent compliance or completion of the trial and/or put the patient at risk if he/she takes part in the trial.
  4. History of psychosis, except history of drug induced hallucinations (provided the investigator considers that participation in the trial would not represent a significant risk for the patient).
  5. Clinically significant ECG abnormalities at screening visit, according to investigator's judgement.
  6. Clinically significant hypotension or symptomatic orthostatic hypotension (i.e., clinical symptoms of orthostatic hypotension such as dizziness postural etc associated with a decline >=20 mmHg in systolic blood pressure and a decline >=10 mmHg in diastolic blood pressure, at one minute after standing compared with the previous supine systolic and diastolic blood pressure obtained after 5 minutes of quiet rest) either at screening visit or at baseline visit.
  7. Any other clinically significant disease, whether treated or not, that could put the patient at risk or could prevent compliance or completion of the trial.
  8. Pregnancy (to be excluded by serum pregnancy test at screening visit) or breast-feeding.
  9. Sexually active female of childbearing potential not using a medically approved method of birth control within one month before to the screening visit and throughout the trial period.
  10. Serum levels of AST, ALT, alkaline phosphatases or bilirubin >2 upper limits of normal .
  11. Patients with a creatinine clearance <50 mL/min
  12. Patients with a complication or signs of malignant tumours or those within 5 years after the treatment.
Sexes Eligible for Study: All
1 Year and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT00560508
248.610
Not Provided
Not Provided
Not Provided
Boehringer Ingelheim
Boehringer Ingelheim
Not Provided
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP