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Completed

NCT Number: NCT00577460

Long-term Safety Study of Open-label Pramipexole ER in Patients With Advanced PD

The general aim of this study is to obtain long-term safety and tolerability data on pramipexole extended release (ER), in daily doses from 0.375mg to 4.5mg once daily (qd), in patients who have previously completed a pramipexole double-blind study in advanced Parkinson's disease (PD) (248.525 trial).

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

32 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

248.634.43005 Boehringer Ingelheim Investigational Site, Linz, Austria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Completion of the double-blind trial 248.525
  • Male or female patient with advanced idiopathic Parkinson's disease (PD), with a Modified Hoehn and Yahr stage of 2 to 4 at on-time, and a concomitant treatment with standard or controlled release L-Dopa+, or a combination of L-Dopa+ and entacapone.
  • Patient willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures. In particular the patient should be able to recognise the off-time and on-time periods during waking hours and the patient (or a family member or a guardian) should be able to record them accurately in the patient diary.
  • Signed informed consent obtained before any study procedures are carried out (in accordance with International Conference of Harmonization - Good Clinical Practice (ICH-GCP) guidelines and local legislation).

Exclusion criteria

  • Patients prematurely withdrawn from the double-blind trial 248.525
  • Atypical parkinsonian syndromes due to drugs, metabolic disorders, encephalitis or degenerative diseases
  • Any psychiatric disorder according to Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV 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
  • History of deep brain stimulation
  • Clinically significant ECG abnormalities at baseline
  • Clinically significant hypotension and/or symptomatic orthostatic hypotension at baseline
  • Malignant melanoma or history of previously treated malignant melanoma
  • 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
  • Pregnancy or breast-feeding
  • Sexually active female of childbearing potential not using a medically approved method of birth control
  • Serum levels of aspartate transaminase (AST) (serum glutamic oxaloacetic transaminase (SGOT)), alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase) (SGPT)), alkaline phosphatase (AP) or bilirubin > 2 upper limit normal (ULN) at baseline
  • Patients with a creatinine clearance < 50 mL/min at baseline
  • Any medication with central dopaminergic antagonist activity within 4 weeks prior to the baseline visit
  • Any of the following drugs within 4 weeks prior to baseline visit: methylphenidate, cinnarizine, amphetamines
  • Flunarizine within 3 months prior to baseline
  • Known hypersensitivity to pramipexole or its excipients
  • Drug abuse, according to investigators judgement, within 2 years prior to baseline
  • Participation in investigational drug studies other than the trial 248.525, or use of other investigational drugs within one month or five times the half-life of the investigational drug (whichever is longer) prior to baseline

Treatment and study plan

Pramipexole

Drug

Pramipexole ER 0.375 -4.5 mg

Placebo

Drug

Placebo tablets identical to Pramipexole ER tablets

Primary outcomes

  1. Percentage of Patients With Adverse Events, Adverse Drug Reactions, Serious Adverse Events

    Time frame: 80 weeks

    The aim of this study was to obtain long-term safety and tolerability data on pramipexole ER, in patients who have previously completed a pramipexole double blind study in advanced Parkinson's Disease (PD) (248.525 (NCT00466167)). Therefore these items were considered as a safety evaluation.

Secondary outcomes

  1. Patients Successfully Switched From Pramipexole (PPX) IR or ER to ER Assessed on UPDRS II+III

    Time frame: One week

    Unified Parkinson's Disease Rating Scale (UPDRS) Successfully switched means: UPDRS II+III baseline score >20 without a relative worsening of UPDRS II+III score > 15% from baseline or UPDRS II+III baseline score <=20 without an absolute worsening of UPDRS II+III score > 3 from baseline UPDRS II+III ranging from 0 (normal) to 160 (severe). UPDRS part II measures activities of daily living, part III measures motor symptoms

  2. UPDRS II+III Change From Open Label (OL) Baseline

    Time frame: OL Baseline and week 80

    UPDRS II+III ranging from 0 (normal) to 160 (severe). UPDRS part II measures activities of daily living, part III measures motor symptoms

  3. Number of Participants With UPDRS II+III Response

    Time frame: Week 80

    A response means an improvement of >=20% in UPDRS II+III from OL baseline UPDRS II+III ranging from 0 (normal) to 160 (severe). UPDRS part II measures activities of daily living, part III measures motor symptoms

  4. Number of Patients Successfully Switched From PPX IR or ER to ER Assessed on Off-time

    Time frame: One week

    A patient was considered as successfully switched if he/she has converted to ER without a worsening of off time by more than 12.5% from baseline. Off-time is based on patient diary data and describes a period when the patient experiences increased parkinsonian symptoms (e.g. immobility or inability to move with ease).

  5. Percentage Off Time During Waking Hours Total Score: Change From Baseline

    Time frame: Baseline and week 80

    Percentage off-time 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).

    A negative change implies improvement

  6. Number of Participants With Response in Percentage Off Time During Waking Hours

    Time frame: 80 weeks

    Response means >=20% improvement relative to OL baseline in the % off-time during waking hours

  7. Percentage on Time Without Dyskinesia During Waking Hours: Change From Baseline After 80 Weeks

    Time frame: Baseline and week 80

    Percentage on-time 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. A positive change implies improvement.

  8. Percentage on Time With Non Troublesome Dyskinesia During Waking Hours: Change From Baseline After 80 Weeks

    Time frame: Baseline and week 80

    Percentage on-time with non troublesome dyskinesia 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. A positive change implies improvement

  9. Percentage on Time Without Dyskinesia or With Non Troublesome Dyskinesia During Waking Hours: Change From Baseline After 80 Weeks

    Time frame: Baseline and week 80

    Percentage on-time without dyskinesia or with non troublesome dyskinesia 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. A positive change implies improvement

  10. Percentage on Time With Troublesome Dyskinesia During Waking Hours: Change From Baseline After 80 Weeks

    Time frame: Baseline and week 80

    Percentage on-time with troublesome dyskinesia 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. A positive change implies improvement

  11. Number of Participants With Response in CGI-I

    Time frame: 32 weeks

    Clinical Global Impression of Improvement (CGI-I), CGI-I scores ranging from '1' (very much improved) to '7' (very much worse). For patients previously treated with Placebo, all patients with at least "much improved" were considered as responders. For patients previously treated with PPX ER or IR, all patients with no change to very much improved were considered as responders

  12. Number of Participants With Response in PGI-I

    Time frame: 32 weeks

    Patient Global Impression of Improvement (PGI-I), PGI-I scores ranging from '1' (very much better) to '7' (very much worse). For patients previously treated with Placebo, all patients with at least "much better" were considered as responders. For patients previously treated with PPX ER or IR, all patients with no change to very much better were considered as responders

  13. Number of Participants With Response in PGI-I for Early Morning Off Symptoms

    Time frame: 32 weeks

    Patient Global Impression of Improvement (PGI-I) for early morning off symptoms, PGI-I scores ranging from '1' (very much better) to '7' (very much worse). For patients previously treated with Placebo, all patients with at least "much better" were considered as responders. For patients previously treated with PPX ER or IR, all patients with no change to very much better were considered as responders

  14. UPDRS I Total Score and Change From OL Baseline at Week 80

    Time frame: OL baseline and week 80

    UPDRS I ranging from 0 (normal) to 16 (severe). UPDRS I measures Mentation, Behavior and Mood

  15. UPDRS II Total Score and Change From OL Baseline at Week 80

    Time frame: OL baseline and week 80

    UPDRS 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

  16. UPDRS III Total Score and Change From OL Baseline at Week 80

    Time frame: OL baseline and week 80

    UPDRS III ranging from 0 (normal) to 108 (severe). UPDRS part III measures motor symptoms

  17. UPDRS IV Total Score and Change From OL Baseline at Week 80

    Time frame: OL baseline and week 80

    UPDRS IV ranging from 0 (normal) to 23 (severe). UPDRS IV measures complications of therapy

  18. Parkinson Fatigue Scale (PFS-16) Score and Change From OL Baseline at Week 80

    Time frame: OL baseline and week 80

    PFS-16 (Parkinson fatigue scale) ranging from 16 (better perceived health status) to 80 (severe symptoms of the disease) measuring aspects of fatigue that are relevant to patients with PD

  19. Number of Participants With L-dopa Daily Dose Change: Change From OL Baseline at Week 80

    Time frame: OL baseline and week 80

  20. Number of Participants With Changes in Pramipexole Doses After 80 Weeks Compared to Pramipexole Dose at OL Baseline

    Time frame: OL baseline and week 80

  21. Number of Participants With Serious Adverse Events

    Time frame: 80 weeks

  22. Supine Diastolic Blood Pressure, Baseline and Week 80, Vital Signs Treated Set

    Time frame: OL Baseline and Week 80

  23. Standing Diastolic Blood Pressure, Baseline and Week 80, Vital Signs Treated Set

    Time frame: OL Baseline and Week 80

  24. Supine Systolic Blood Pressure, Baseline and Week 80, Vital Signs Treated Set

    Time frame: OL Baseline and Week 80

  25. Standing Systolic Blood Pressure, Baseline and Week 80, Vital Signs Treated Set

    Time frame: OL Baseline and Week 80

  26. Supine Pulse Rate, Baseline and Week 80, Vital Signs Treated Set

    Time frame: OL Baseline and Week 80

  27. Standing Pulse Rate, Baseline and Week 80, Vital Signs Treated Set

    Time frame: OL Baseline and Week 80

  28. Body Weight of Female Patients, Baseline and Week 80, Vital Signs Treated Set

    Time frame: OL Baseline and Week 80

  29. Body Weight of Male Patients, Baseline and Week 80, Vital Signs Treated Set

    Time frame: OL Baseline and Week 80

  30. Epworth Sleepiness Scale (ESS), Baseline and End of Open Label, Treated Set

    Time frame: OL Baseline and Week 80

    ESS Total score ranges from zero (best) to 24 (worst); scale has 8 items, each rated from zero (no chance of dozing) to 3 (high chance of dozing)

  31. Modified Minnesota Impulsive Disorder Interview (mMIDI), Frequency of Patients With at Least One Abnormal Behavior, Treated Set

    Time frame: Baseline, 80 weeks

    The mMIDI is a semi-structured interview designed to assess impulsive control disorders. The scale was modified to focus behaviors of: pathological gambling, compulsive buying and compulsive sexual behavioral.

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

Long-term Safety Study of Open-label Pramipexole Extended Release (ER) in Patients With Advanced Parkinson's Disease (PD)

Important dates

Study start
2007
Primary completion
2010
First posted
Dec 20, 2007
Registry last updated
May 16, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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