Phase 4
N=535
Study of (Mirapex) Pramipexole for the Early Treatment of Parkinsons Disease (PD)
Parkinson Disease
Bottom Line
View on ClinicalTrials.gov: NCT00321854 ↗Enrolled (actual)
535
Serious AEs
9.4%
Results posted
Jan 2010
Primary outcome: Primary: Change From Baseline in the Blinded Rater Unified Parkinson's Disease Rating Scale (UPDRS) Total Score at Month 15 — 0.3; 0.7 Units on a scale — p=0.6503
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- pramipexole (Drug)
- Age
- Adult, Older Adult · 30+ yrs
- Sex
- All
- Sponsor
- Boehringer Ingelheim
- Primary completion
- Apr 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in the Blinded Rater Unified Parkinson's Disease Rating Scale (UPDRS) Total Score at Month 15 |
0.3; 0.7 | 0.6503 |
| SECONDARY Change From Baseline in the Investigator Rated UPDRS Total Score at Month 15 |
0.6; 0.5 | 0.9568 |
| SECONDARY Change From Baseline in the Investigator Rated UPDRS Total Score at Month 9 |
-0.5; 4.3 | <0.0001 sig |
| SECONDARY Change From Baseline in the Investigator Rated UPDRS Total Score at Month 6 |
-1.8; 2.6 | <0.0001 sig |
| SECONDARY Change From Baseline in the Investigator Rated UPDRS Total Score at Month 3 |
-2.9; -0.1 | <0.0001 sig |
| SECONDARY Change From Baseline in the Blinded Rater UPDRS Parts II+III Total Score at Month 15 |
0.6; 0.7 | 0.8693 |
| SECONDARY Change From Baseline in the Investigator Rated UPDRS Parts II+III Score at Month 15 |
0.8; 0.6 | 0.8155 |
| SECONDARY Change From Baseline in the Investigator Rated UPDRS Parts II+III Score at Month 9 |
-0.3; 4.2 | <0.0001 sig |
| SECONDARY Change From Baseline in the Investigator Rated UPDRS Parts II+III Score at Month 6 |
-1.5; 2.5 | <0.0001 sig |
| SECONDARY Change From Baseline in the Investigator Rated UPDRS Parts II+III Score at Month 3 |
-2.8; 0.0 | <0.0001 sig |
| SECONDARY Change From Baseline in the Blinded Rater UPDRS Part III Total Score at Month 15 |
0.1; 0.3 | 0.7999 |
| SECONDARY Change From Baseline in the Investigator Rated UPDRS Part III Score at Month 15 |
0.2; -0.1 | 0.7395 |
| SECONDARY Change From Baseline in the Investigator Rated UPDRS Part III Score at Month 9 |
-0.6; 2.7 | <0.0001 sig |
| SECONDARY Change From Baseline in the Investigator Rated UPDRS Part III Score at Month 6 |
-1.6; 1.3 | <0.0001 sig |
| SECONDARY Change From Baseline in the Investigator Rated UPDRS Part III Score at Month 3 |
-2.1; -0.3 | 0.0002 sig |
| SECONDARY Change From Baseline in the Blinded Rater UPDRS Part II Total Score at Month 15 |
0.5; 0.4 | 0.9256 |
| SECONDARY Change From Baseline in the Investigator Rated UPDRS Part II Score at Month 15 |
0.6; 0.6 | 0.9792 |
| SECONDARY Change From Baseline in the Investigator Rated UPDRS Part II Score at Month 9 |
0.4; 1.5 | 0.0001 sig |
| SECONDARY Change From Baseline in the Investigator Rated UPDRS Part II Score at Month 6 |
0.1; 1.2 | <0.0001 sig |
| SECONDARY Change From Baseline in the Investigator Rated UPDRS Part II Score at Month 3 |
-0.7; 0.3 | <0.0001 sig |
| SECONDARY Change From Baseline in the Blinded Rater UPDRS Part I Total Score at Month 15 |
-0.3; 0 | 0.0376 sig |
| SECONDARY Change From Baseline in the Investigator Rated UPDRS Part I Total Score at Month 15 |
-0.2; -0.1 | 0.1607 |
| SECONDARY Change From Baseline in the Investigator Rated UPDRS Part I Total Score at Month 9 |
-0.2; 0.1 | 0.0173 sig |
| SECONDARY Change From Baseline in the Investigator Rated UPDRS Part I Total Score at Month 6 |
-0.3; 0.1 | 0.0007 sig |
| SECONDARY Change From Baseline in the Investigator Rated UPDRS Part I Total Score at Month 3 |
-0.2; -0.1 | 0.4381 |
| SECONDARY Number of Responders Using the Blinded Rater Assessment of Clinical Global Impressions of Global Improvement (CGI-I) Score at Month 15 |
18; 21 | 0.5116 |
| SECONDARY Change From Baseline in Blinded Rater Assessment of Clinical Global Impressions of Severity of Illness (CGI-S) Category at Month 15 |
4; 3; 200; 191; 5; 4 | 0.7913 |
| SECONDARY Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Month 15 |
-1; -0.5 | 0.1702 |
| SECONDARY Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Month 9 |
-1.1; 0.3 | 0.0009 sig |
| SECONDARY Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Month 6 |
-1.2; 0.2 | 0.0005 sig |
| SECONDARY Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Month 3 |
-1; -0.3 | 0.0422 sig |
| SECONDARY Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Overall Index Score at Month 15 |
-0.4; 0.3 | 0.2149 |
| SECONDARY Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Overall Index Score at Month 9 |
-0.5; 1.4 | 0.0001 sig |
| SECONDARY Change From Baseline in the European Quality of Life Scale (EUROQOL (EQ)-5D) Overall Index Score at Month 15 |
0; 0 | 0.2605 |
| SECONDARY Change From Baseline in the European Quality of Life Scale (EUROQOL (EQ)-5D) Overall Index Score at Month 9 |
0; 0 | <0.0001 sig |
| SECONDARY Change From Baseline in the European Quality of Life Visual Analogue Scale (EUROQOL (EQ) VAS) Score at Month 15 |
0; 0 | 0.0489 sig |
| SECONDARY Change From Baseline in the European Quality of Life Visual Analogue Scale (EUROQOL (EQ) VAS) Score at Month 9 |
0; -0.5 | 0.0282 sig |
| SECONDARY Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 1 |
146; 133; 0; 0 | — |
| SECONDARY Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 6 |
146; 134; 0; 0 | — |
| SECONDARY Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 9 |
146; 134; 0; 0 | — |
| SECONDARY Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 12 |
143; 128; 0; 0 | — |
| SECONDARY Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 15 |
145; 132; 0; 0 | — |
| SECONDARY Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 1 |
146; 133; 0; 0 | — |
| SECONDARY Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 6 |
146; 134; 0; 0 | — |
| SECONDARY Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 9 |
146; 134; 0; 0 | — |
| SECONDARY Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 12 |
143; 126; 0; 2 | — |
| SECONDARY Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 15 |
145; 131; 0; 1 | — |
| SECONDARY Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 1 |
145; 133; 1; 0 | — |
| SECONDARY Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 6 |
144; 134; 2; 0 | — |
| SECONDARY Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 9 |
143; 134; 3; 0 | — |
| SECONDARY Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 12 |
141; 128; 2; 0 | — |
| SECONDARY Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 15 |
143; 132; 2; 0 | — |
| SECONDARY Percentage Change From Baseline in the Striatum Uptake at Month 15 |
-15.1; -14.6 | 0.8397 |
| SECONDARY Clinically Significant Abnormalities in Clinical Laboratory Measurements - Haematology and Electrolytes |
1.4; 1.0; 2.3; 0.9; 0.5; 0 | — |
| SECONDARY Clinically Significant Abnormalities in Clinical Laboratory Measurements - Enzymes |
0.5; 0; 1.4; 0 | — |
| SECONDARY Clinically Significant Abnormalities in Clinical Laboratory Measurements - Substrates |
0; 2.2; 3.6; 0; 1.4; 2.9 | — |
| SECONDARY Clinically Significant Abnormalities in Vital Signs |
0; 0.4; 0; 0.5 | — |
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
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00321854). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.