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

Phase 4

Completed

Conditions: Parkinson Disease

Interventions: Drug: pramipexole

Registration Number: NCT00321854

Lead Sponsor: Boehringer Ingelheim

Brief Summary: 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

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 535

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Early Pramipexole	pramipexole	Patients were treated with pramipexole for 6 to 9 months then up-titrated to target dose of pramipexole (2.25 mg/day).
Delayed Pramipexole	pramipexole	Patients were treated with placebo for 6 to 9 months then up-titrated to target dose of pramipexole (2.25 mg/day).

Primary Outcome Measures

Name	Time	Method
Change From Baseline in the Blinded Rater Unified Parkinson's Disease Rating Scale (UPDRS) Total Score at Month 15	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 Outcome Measures

Name	Time	Method
Change From Baseline in the Investigator Rated UPDRS Total Score at Month 15	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)
Change From Baseline in the Investigator Rated UPDRS Total Score at Month 9	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)
Change From Baseline in the Investigator Rated UPDRS Total Score at Month 6	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)
Change From Baseline in the Investigator Rated UPDRS Total Score at Month 3	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)
Change From Baseline in the Blinded Rater UPDRS Parts II+III Total Score at Month 15	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)
Change From Baseline in the Investigator Rated UPDRS Parts II+III Score at Month 15	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)
Change From Baseline in the Investigator Rated UPDRS Parts II+III Score at Month 9	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)
Change From Baseline in the Investigator Rated UPDRS Parts II+III Score at Month 6	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)
Change From Baseline in the Investigator Rated UPDRS Parts II+III Score at Month 3	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)
Change From Baseline in the Blinded Rater UPDRS Part III Total Score at Month 15	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)
Change From Baseline in the Investigator Rated UPDRS Part III Score at Month 15	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)
Change From Baseline in the Investigator Rated UPDRS Part III Score at Month 9	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)
Change From Baseline in the Investigator Rated UPDRS Part III Score at Month 6	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)
Change From Baseline in the Investigator Rated UPDRS Part III Score at Month 3	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)
Change From Baseline in the Blinded Rater UPDRS Part II Total Score at Month 15	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)
Change From Baseline in the Investigator Rated UPDRS Part II Score at Month 15	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)
Change From Baseline in the Investigator Rated UPDRS Part II Score at Month 9	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)
Change From Baseline in the Investigator Rated UPDRS Part II Score at Month 6	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)
Change From Baseline in the Investigator Rated UPDRS Part II Score at Month 3	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)
Change From Baseline in the Blinded Rater UPDRS Part I Total Score at Month 15	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)
Change From Baseline in the Investigator Rated UPDRS Part I Total Score at Month 15	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)
Change From Baseline in the Investigator Rated UPDRS Part I Total Score at Month 9	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)
Change From Baseline in the Investigator Rated UPDRS Part I Total Score at Month 6	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)
Change From Baseline in the Investigator Rated UPDRS Part I Total Score at Month 3	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)
Number of Responders Using the Blinded Rater Assessment of Clinical Global Impressions of Global Improvement (CGI-I) Score at Month 15	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.
Change From Baseline in Blinded Rater Assessment of Clinical Global Impressions of Severity of Illness (CGI-S) Category at Month 15	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).
Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Month 15	Baseline and Month 15	The BDI measures symptoms of depression on an ordinal scale ranging from 0 (no symptoms) to 63 (worst symptoms)
Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Month 9	Baseline and Month 9	The BDI measures symptoms of depression on an ordinal scale ranging from 0 (no symptoms) to 63 (worst symptoms)
Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Month 6	Baseline and Month 6	The BDI measures symptoms of depression on an ordinal scale ranging from 0 (no symptoms) to 63 (worst symptoms)
Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Month 3	Baseline and Month 3	The BDI measures symptoms of depression on an ordinal scale ranging from 0 (no symptoms) to 63 (worst symptoms)
Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Overall Index Score at Month 15	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)
Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Overall Index Score at Month 9	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)
Change From Baseline in the European Quality of Life Scale (EUROQOL (EQ)-5D) Overall Index Score at Month 15	Baseline and Month 15	The EQ-5D measures health status on a continuous scale ranging from 0 (dead) to 1 (full health)
Change From Baseline in the European Quality of Life Scale (EUROQOL (EQ)-5D) Overall Index Score at Month 9	Baseline and Month 9	The EQ-5D measures health status on a continuous scale ranging from 0 (dead) to 1 (full health)
Change From Baseline in the European Quality of Life Visual Analogue Scale (EUROQOL (EQ) VAS) Score at Month 15	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)
Change From Baseline in the European Quality of Life Visual Analogue Scale (EUROQOL (EQ) VAS) Score at Month 9	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)
Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 1	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.
Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 6	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.
Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 9	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.
Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 12	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.
Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 15	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.
Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 1	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.
Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 6	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.
Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 9	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.
Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 12	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.
Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 15	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.
Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 1	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.
Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 6	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.
Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 9	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.
Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 12	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.
Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 15	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.
Percentage Change From Baseline in the Striatum Uptake at Month 15	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).
Clinically Significant Abnormalities in Clinical Laboratory Measurements - Haematology and Electrolytes	Baseline and Month 15
Clinically Significant Abnormalities in Clinical Laboratory Measurements - Enzymes	Baseline and Month 15
Clinically Significant Abnormalities in Clinical Laboratory Measurements - Substrates	Baseline and Month 15
Clinically Significant Abnormalities in Vital Signs	Baseline and Month 15

Trial Locations

Locations (99): 248.595.0122 Boehringer Ingelheim Investigational Site
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Brimingham, Alabama, United States
248.595.0104 Boehringer Ingelheim Investigational Site
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Scottsdale, Arizona, United States
248.595.0133 Boehringer Ingelheim Investigational Site
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La Jolla, California, United States
248.595.0140 Boehringer Ingelheim Investigational Site
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La Jolla, California, United States
248.595.0112 Boehringer Ingelheim Investigational Site
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New Haven, Connecticut, United States
248.595.0113 Boehringer Ingelheim Investigational Site
🇺🇸
Bradenton, Florida, United States
248.595.0105 Boehringer Ingelheim Investigational Site
🇺🇸
Gainesville, Florida, United States
248.595.0119 Boehringer Ingelheim Investigational Site
🇺🇸
Hollywood, Florida, United States
248.595.0124 Boehringer Ingelheim Investigational Site
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Palm Beach Gardens, Florida, United States
248.595.0123 Boehringer Ingelheim Investigational Site
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Panama City, Florida, United States
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248.595.0122 Boehringer Ingelheim Investigational Site
🇺🇸Brimingham, Alabama, United States