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Completed

NCT Number: NCT00321854

Study of (Mirapex) Pramipexole for the Early Treatment of Parkinsons Disease (PD)

This is a double blind, placebo-controlled clinical trial of 15 months duration designed to examine early Mirapex (pramipexole) treatment vs. delayed Mirapex (pramipexole) treatment in patients with new onset Parkinsons disease

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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

30 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

248.595.43005 Boehringer Ingelheim Investigational Site, Bruck A. D. Mur, Austria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Ability to provide written informed consent in accordance with Good Clinical Practice (GCP) and local legislation;
  • Male or female patient with idiopathic Parkinson Disease (PD) confirmed by at least three of the following signs: resting tremor, bradykinesia, rigidity, and asymmetry (must have bradykinesia);
  • Parkinsons disease newly diagnosed within the past 2 years;
  • Patients with idiopathic PD characterized as Stage I-II by the Modified Hoehn and Yahr Scale who do not require PD medication and will not likely need PD medication for at least 6 months in the opinion of the investigator; Age 30 to 75 years at screening (Visit 1);
  • Women of childbearing potential must have a negative serum Beta-HumanChorionGonadotropin (Beta-HCG) pregnancy test at the Screening (Baseline) visit unless surgically sterile or post-menopausal (last menstruation 12 months prior to signing Informed Consent). Women of childbearing potential must be using a medically accepted contraceptive method. Acceptable methods of birth control are limited to: Intra-Uterine Device (IUD), oral, implantable, or injectable contraceptives, estrogen patch, and double barrier method (spermicide + diaphragm); and Patients who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion criteria

  • Previous history of allergic response or complications with pramipexole (PPX) or its excipients;
  • Atypical PD syndromes due to either drugs (e.g., metoclopramide, flunarizine) or metabolic disorders (e.g., Wilsons Disease), encephalitis, or degenerative diseases (e.g., progressive supranuclear palsy);
  • The patient is currently on L-dopa, dopamine agonists or other PD medication at baseline;
  • The patient has been on L-dopa, dopamine agonists or other PD medications for greater than 14 consecutive days prior to baseline;
  • If on L-dopa, dopamine agonists or other PD medications prior to baseline, the patient stopped treatment less than 30 days prior to baseline;
  • The patient has clinically significant abnormal laboratory values, and/or medical or psychiatric illness other than as seen in Parkinsons disease;
  • The patient has a clinically significant deviation from normal in the physical examination other than as seen in Parkinsons disease;
  • The patient has any disorder that may interfere with drug absorption, distribution, metabolism, or excretion (including gastrointestinal surgery);
  • History of stereotactic brain surgery;
  • Surgery within 6 months of randomization, which in the opinion of the investigator, would negatively impact the patients participation in the study;
  • History of active epilepsy (i.e., occurrence of a seizure) within the past year;
  • Symptomatic orthostatic hypotension prior to randomization;
  • Malignant melanoma or history of previously treated malignant melanoma;
  • Patients who have received any of the following drugs (all time periods are calculated from randomization): Amantadine;
  • Electroconvulsive therapy during 180 days preceding the screening visit (Visit 1);
  • Patients who are currently pregnant or planning pregnancy during the study, or lactating;
  • Participation in other investigational drug studies or use of other investigational drugs within the previous 30 days prior to randomization;
  • History of psychosis;
  • A diagnosis of dementia

Treatment and study plan

Pramipexole

Drug

Primary outcomes

  1. Change From Baseline in the Blinded Rater Unified Parkinson's Disease Rating Scale (UPDRS) Total Score at Month 15

    Time frame: Baseline and Month 15

    The UPDRS total score (Parts I+II+III) measures the impact of PD on mentation, behaviour and mood, activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 176 (worst disability)

Secondary outcomes

  1. Change From Baseline in the Investigator Rated UPDRS Total Score at Month 15

    Time frame: Baseline and Month 15

    The UPDRS total score (Parts I+II+III) measures the impact of PD on mentation, behaviour and mood, activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 176 (worst disability)

  2. Change From Baseline in the Investigator Rated UPDRS Total Score at Month 9

    Time frame: Baseline and Month 9

    The UPDRS total score (Parts I+II+III) measures the impact of PD on mentation, behaviour and mood, activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 176 (worst disability)

  3. Change From Baseline in the Investigator Rated UPDRS Total Score at Month 6

    Time frame: Baseline and Month 6

    The UPDRS total score (Parts I+II+III) measures the impact of PD on mentation, behaviour and mood, activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 176 (worst disability)

  4. Change From Baseline in the Investigator Rated UPDRS Total Score at Month 3

    Time frame: Baseline and Month 3

    The UPDRS total score (Parts I+II+III) measures the impact of PD on mentation, behaviour and mood, activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 176 (worst disability)

  5. Change From Baseline in the Blinded Rater UPDRS Parts II+III Total Score at Month 15

    Time frame: Baseline and Month 15

    The UPDRS Parts II+III total score measures the impact of PD on activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 160 (worst disability)

  6. Change From Baseline in the Investigator Rated UPDRS Parts II+III Score at Month 15

    Time frame: Baseline and Month 15

    The UPDRS Parts II+III total score measures the impact of PD on activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 160 (worst disability)

  7. Change From Baseline in the Investigator Rated UPDRS Parts II+III Score at Month 9

    Time frame: Baseline and Month 9

    The UPDRS Parts II+III total score measures the impact of PD on activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 160 (worst disability)

  8. Change From Baseline in the Investigator Rated UPDRS Parts II+III Score at Month 6

    Time frame: Baseline and Month 6

    The UPDRS Parts II+III total score measures the impact of PD on activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 160 (worst disability)

  9. Change From Baseline in the Investigator Rated UPDRS Parts II+III Score at Month 3

    Time frame: Baseline and Month 3

    The UPDRS Parts II+III total score measures the impact of PD on activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 160 (worst disability)

  10. Change From Baseline in the Blinded Rater UPDRS Part III Total Score at Month 15

    Time frame: Baseline and Month 15

    The UPDRS Part III total score measures the impact of PD on motor skills on an ordinal scale ranging from 0 (no disability) to 108 (worst disability)

  11. Change From Baseline in the Investigator Rated UPDRS Part III Score at Month 15

    Time frame: Baseline and Month 15

    The UPDRS Part III total score measures the impact of PD on motor skills on an ordinal scale ranging from 0 (no disability) to 108 (worst disability)

  12. Change From Baseline in the Investigator Rated UPDRS Part III Score at Month 9

    Time frame: Baseline and Month 9

    The UPDRS Part III total score measures the impact of PD on motor skills on an ordinal scale ranging from 0 (no disability) to 108 (worst disability)

  13. Change From Baseline in the Investigator Rated UPDRS Part III Score at Month 6

    Time frame: Baseline and Month 6

    The UPDRS Part III total score measures the impact of PD on motor skills on an ordinal scale ranging from 0 (no disability) to 108 (worst disability)

  14. Change From Baseline in the Investigator Rated UPDRS Part III Score at Month 3

    Time frame: Baseline and Month 3

    The UPDRS Part III total score measures the impact of PD on motor skills on an ordinal scale ranging from 0 (no disability) to 108 (worst disability)

  15. Change From Baseline in the Blinded Rater UPDRS Part II Total Score at Month 15

    Time frame: Baseline and Month 15

    The UPDRS Part II total score measures the impact of PD on activities of daily living on an ordinal scale ranging from 0 (no disability) to 52 (worst disability)

  16. Change From Baseline in the Investigator Rated UPDRS Part II Score at Month 15

    Time frame: Baseline and Month 15

    The UPDRS Part II total score measures the impact of PD on activities of daily living on an ordinal scale ranging from 0 (no disability) to 52 (worst disability)

  17. Change From Baseline in the Investigator Rated UPDRS Part II Score at Month 9

    Time frame: Baseline and Month 9

    The UPDRS Part II total score measures the impact of PD on activities of daily living on an ordinal scale ranging from 0 (no disability) to 52 (worst disability)

  18. Change From Baseline in the Investigator Rated UPDRS Part II Score at Month 6

    Time frame: Baseline and Month 6

    The UPDRS Part II total score measures the impact of PD on activities of daily living on an ordinal scale ranging from 0 (no disability) to 52 (worst disability)

  19. Change From Baseline in the Investigator Rated UPDRS Part II Score at Month 3

    Time frame: Baseline and Month 3

    The UPDRS Part II total score measures the impact of PD on activities of daily living on an ordinal scale ranging from 0 (no disability) to 52 (worst disability)

  20. Change From Baseline in the Blinded Rater UPDRS Part I Total Score at Month 15

    Time frame: Baseline and Month 15

    The UPDRS Part I total score measures the impact of PD on mentation, behaviour and mood on an ordinal scale ranging from 0 (no disability) to 16 (worst disability)

  21. Change From Baseline in the Investigator Rated UPDRS Part I Total Score at Month 15

    Time frame: Baseline and Month 15

    The UPDRS Part I total score measures the impact of PD on mentation, behaviour and mood on an ordinal scale ranging from 0 (no disability) to 16 (worst disability)

  22. Change From Baseline in the Investigator Rated UPDRS Part I Total Score at Month 9

    Time frame: Baseline and Month 9

    The UPDRS Part I total score measures the impact of PD on mentation, behaviour and mood on an ordinal scale ranging from 0 (no disability) to 16 (worst disability)

  23. Change From Baseline in the Investigator Rated UPDRS Part I Total Score at Month 6

    Time frame: Baseline and Month 6

    The UPDRS Part I total score measures the impact of PD on mentation, behaviour and mood on an ordinal scale ranging from 0 (no disability) to 16 (worst disability)

  24. Change From Baseline in the Investigator Rated UPDRS Part I Total Score at Month 3

    Time frame: Baseline and Month 3

    The UPDRS Part I total score measures the impact of PD on mentation, behaviour and mood on an ordinal scale ranging from 0 (no disability) to 16 (worst disability)

  25. Number of Responders Using the Blinded Rater Assessment of Clinical Global Impressions of Global Improvement (CGI-I) Score at Month 15

    Time frame: Month 15

    The CGI-I measures the overall improvement in the participants condition from baseline on an ordinal scale ranging from 1 (very much improved) to 7 (very much worse). Responders are defined as those patients with a CGI-I of 1 or 2.

  26. Change From Baseline in Blinded Rater Assessment of Clinical Global Impressions of Severity of Illness (CGI-S) Category at Month 15

    Time frame: Baseline and Month 15

    The CGI-S measures the participants severity of illness on an ordinal scale ranging from 1 (normal) to 7 (extremely ill). At Month 15 participants were categorised to 'Improved' (>1 category improvement), 'Unchanged' or 'Worsened' (>1 category worsening).

  27. Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Month 15

    Time frame: Baseline and Month 15

    The BDI measures symptoms of depression on an ordinal scale ranging from 0 (no symptoms) to 63 (worst symptoms)

  28. Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Month 9

    Time frame: Baseline and Month 9

    The BDI measures symptoms of depression on an ordinal scale ranging from 0 (no symptoms) to 63 (worst symptoms)

  29. Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Month 6

    Time frame: Baseline and Month 6

    The BDI measures symptoms of depression on an ordinal scale ranging from 0 (no symptoms) to 63 (worst symptoms)

  30. Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Month 3

    Time frame: Baseline and Month 3

    The BDI measures symptoms of depression on an ordinal scale ranging from 0 (no symptoms) to 63 (worst symptoms)

  31. Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Overall Index Score at Month 15

    Time frame: Baseline and Month 15

    The PDQ-39 measures aspects of health in PD participants, the overall index score is the mean of the eight individual domain scores measured on a continuous scale ranging from 0 (no problem at all) to 100 (maximum level of the problem)

  32. Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Overall Index Score at Month 9

    Time frame: Baseline and Month 9

    The PDQ-39 measures aspects of health in PD participants, the overall index score is the mean of the eight individual domain scores measured on a continuous scale ranging from 0 (no problem at all) to 100 (maximum level of the problem)

  33. Change From Baseline in the European Quality of Life Scale (EUROQOL (EQ)-5D) Overall Index Score at Month 15

    Time frame: Baseline and Month 15

    The EQ-5D measures health status on a continuous scale ranging from 0 (dead) to 1 (full health)

  34. Change From Baseline in the European Quality of Life Scale (EUROQOL (EQ)-5D) Overall Index Score at Month 9

    Time frame: Baseline and Month 9

    The EQ-5D measures health status on a continuous scale ranging from 0 (dead) to 1 (full health)

  35. Change From Baseline in the European Quality of Life Visual Analogue Scale (EUROQOL (EQ) VAS) Score at Month 15

    Time frame: Baseline and Month 15

    The EQ-VAS is a self rating of current health-related quality of life measured on a continuous scale ranging from 0 (worst imaginable health state) to 100 (best imaginable health state)

  36. Change From Baseline in the European Quality of Life Visual Analogue Scale (EUROQOL (EQ) VAS) Score at Month 9

    Time frame: Baseline and Month 9

    The EQ-VAS is a self rating of current health-related quality of life measured on a continuous scale ranging from 0 (worst imaginable health state) to 100 (best imaginable health state)

  37. Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 1

    Time frame: Month 1

    The MMIDI is a semi-structured interview designed to assess impulse control disorders; risk of gambling is assessed via 12 questions, a participant is considered at risk if answering 'Yes' to Q1 and 'Yes' to 5 or more of Q2 to Q12.

  38. Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 6

    Time frame: Month 6

    The MMIDI is a semi-structured interview designed to assess impulse control disorders; risk of gambling is assessed via 12 questions, a participant is considered at risk if answering 'Yes' to Q1 and 'Yes' to 5 or more of Q2 to Q12.

  39. Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 9

    Time frame: Month 9

    The MMIDI is a semi-structured interview designed to assess impulse control disorders; risk of gambling is assessed via 12 questions, a participant is considered at risk if answering 'Yes' to Q1 and 'Yes' to 5 or more of Q2 to Q12.

  40. Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 12

    Time frame: Month 12

    The MMIDI is a semi-structured interview designed to assess impulse control disorders; risk of gambling is assessed via 12 questions, a participant is considered at risk if answering 'Yes' to Q1 and 'Yes' to 5 or more of Q2 to Q12.

  41. Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 15

    Time frame: Month 15

    The MMIDI is a semi-structured interview designed to assess impulse control disorders; risk of gambling is assessed via 12 questions, a participant is considered at risk if answering 'Yes' to Q1 and 'Yes' to 5 or more of Q2 to Q12.

  42. Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 1

    Time frame: Month 1

    The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive sexual behaviour is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1 and 'Yes' to 1 or more of Q2 to Q4.

  43. Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 6

    Time frame: Month 6

    The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive sexual behaviour is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1 and 'Yes' to 1 or more of Q2 to Q4.

  44. Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 9

    Time frame: Month 9

    The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive sexual behaviour is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1 and 'Yes' to 1 or more of Q2 to Q4.

  45. Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 12

    Time frame: Month 12

    The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive sexual behaviour is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1 and 'Yes' to 1 or more of Q2 to Q4.

  46. Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 15

    Time frame: Month 15

    The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive sexual behaviour is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1 and 'Yes' to 1 or more of Q2 to Q4.

  47. Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 1

    Time frame: Month 1

    The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive buying is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1a and 'Yes' to 1 or more of Q2a, Q3a and Q4a.

  48. Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 6

    Time frame: Month 6

    The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive buying is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1a and 'Yes' to 1 or more of Q2a, Q3a and Q4a.

  49. Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 9

    Time frame: Month 9

    The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive buying is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1a and 'Yes' to 1 or more of Q2a, Q3a and Q4a.

  50. Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 12

    Time frame: Month 12

    The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive buying is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1a and 'Yes' to 1 or more of Q2a, Q3a and Q4a.

  51. Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 15

    Time frame: Month 15

    The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive buying is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1a and 'Yes' to 1 or more of Q2a, Q3a and Q4a.

  52. Percentage Change From Baseline in the Striatum Uptake at Month 15

    Time frame: Baseline and Month 15

    The striatum beta-carbomethoxy-iodophenyl-tropane (beta-CIT) uptake was calculated as mean of the left and right caudate and putamen regions; measured by the Single-Photon Emission Computed Tomography (SPECT).

  53. Clinically Significant Abnormalities in Clinical Laboratory Measurements - Haematology and Electrolytes

    Time frame: Baseline and Month 15

  54. Clinically Significant Abnormalities in Clinical Laboratory Measurements - Enzymes

    Time frame: Baseline and Month 15

  55. Clinically Significant Abnormalities in Clinical Laboratory Measurements - Substrates

    Time frame: Baseline and Month 15

  56. Clinically Significant Abnormalities in Vital Signs

    Time frame: Baseline and Month 15

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

A Randomized, Double-blind, Placebo-controlled, Parallel-group Clinical Trial to Examine the Efficacy and Safety of Early Pramipexole (PPX) Treatment Versus Delayed Pramipexole Treatment in Patients With New Onset Parkinson's Disease.

Important dates

Study start
2006
Primary completion
2009
First posted
May 4, 2006
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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