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

Boehringer Ingelheim535 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

535

Conditions

Parkinson Disease

Interventions

pramipexoleDRUG

Eligibility

Sex: ALLMin age: 30 YearsMax age: 79 Years

Medical Language ↔ Plain English

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

Locations (99)

Outcomes

Primary Outcomes

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

Time frame: Baseline and Month 15

Secondary Outcomes

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

Time frame: Baseline and Month 15

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

Time frame: Baseline and Month 9

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

Time frame: Baseline and Month 6

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

Time frame: Baseline and Month 3

Data from ClinicalTrials.gov

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248.595.0122 Boehringer Ingelheim Investigational Site

Brimingham, Alabama, United States

248.595.0104 Boehringer Ingelheim Investigational Site

Scottsdale, Arizona, United States

248.595.0133 Boehringer Ingelheim Investigational Site

La Jolla, California, United States

248.595.0140 Boehringer Ingelheim Investigational Site

La Jolla, California, United States

248.595.0112 Boehringer Ingelheim Investigational Site

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

Palm Beach Gardens, Florida, United States

248.595.0123 Boehringer Ingelheim Investigational Site

Panama City, Florida, United States

...and 89 more locations

Change From Baseline in the Blinded Rater UPDRS Parts II+III Total Score at 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)

Time frame: Baseline and Month 15

Change From Baseline in the Investigator Rated UPDRS Parts II+III Score at 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)

Time frame: Baseline and Month 15

Change From Baseline in the Investigator Rated UPDRS Parts II+III Score at 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)

Time frame: Baseline and Month 9

Change From Baseline in the Investigator Rated UPDRS Parts II+III Score at 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)

Time frame: Baseline and Month 6

Change From Baseline in the Investigator Rated UPDRS Parts II+III Score at 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)

Time frame: Baseline and Month 3

Change From Baseline in the Blinded Rater UPDRS Part III Total Score at 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)

Time frame: Baseline and Month 15

Change From Baseline in the Investigator Rated UPDRS Part III Score at 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)

Time frame: Baseline and Month 15

Change From Baseline in the Investigator Rated UPDRS Part III Score at 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)

Time frame: Baseline and Month 9

Change From Baseline in the Investigator Rated UPDRS Part III Score at 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)

Time frame: Baseline and Month 6

Change From Baseline in the Investigator Rated UPDRS Part III Score at 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)

Time frame: Baseline and Month 3

Change From Baseline in the Blinded Rater UPDRS Part II Total Score at 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)

Time frame: Baseline and Month 15

Change From Baseline in the Investigator Rated UPDRS Part II Score at 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)

Time frame: Baseline and Month 15

Change From Baseline in the Investigator Rated UPDRS Part II Score at 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)

Time frame: Baseline and Month 9

Change From Baseline in the Investigator Rated UPDRS Part II Score at 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)

Time frame: Baseline and Month 6

Change From Baseline in the Investigator Rated UPDRS Part II Score at 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)

Time frame: Baseline and Month 3

Change From Baseline in the Blinded Rater UPDRS Part I Total Score at 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)

Time frame: Baseline and Month 15

Change From Baseline in the Investigator Rated UPDRS Part I Total Score at 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)

Time frame: Baseline and Month 15

Change From Baseline in the Investigator Rated UPDRS Part I Total Score at 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)

Time frame: Baseline and Month 9

Change From Baseline in the Investigator Rated UPDRS Part I Total Score at 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)

Time frame: Baseline and Month 6

Change From Baseline in the Investigator Rated UPDRS Part I Total Score at 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)

Time frame: Baseline and Month 3

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

Time frame: Month 15

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

Time frame: Baseline and Month 15

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

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

Time frame: Baseline and Month 15

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

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

Time frame: Baseline and Month 9

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

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

Time frame: Baseline and Month 6

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

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

Time frame: Baseline and Month 3

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

Time frame: Baseline and Month 15

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

Time frame: Baseline and Month 9

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

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

Time frame: Baseline and Month 15

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

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

Time frame: Baseline and Month 9

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

Time frame: Baseline and Month 15

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

Time frame: Baseline and Month 9

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

Time frame: Month 1

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

Time frame: Month 6

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

Time frame: Month 9

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

Time frame: Month 12

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

Time frame: Month 15

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

Time frame: Month 1

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

Time frame: Month 6

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

Time frame: Month 9

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

Time frame: Month 12

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

Time frame: Month 15

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

Time frame: Month 1

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

Time frame: Month 6

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

Time frame: Month 9

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

Time frame: Month 12

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

Time frame: Month 15

Percentage Change From Baseline in the Striatum Uptake at 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).

Time frame: Baseline and Month 15

Clinically Significant Abnormalities in Clinical Laboratory Measurements - Haematology and Electrolytes

Time frame: Baseline and Month 15

Clinically Significant Abnormalities in Clinical Laboratory Measurements - Enzymes

Time frame: Baseline and Month 15

Clinically Significant Abnormalities in Clinical Laboratory Measurements - Substrates

Time frame: Baseline and Month 15

Clinically Significant Abnormalities in Vital Signs

Time frame: Baseline and Month 15