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| ID | Type | Description | Link |
|---|---|---|---|
| PramiBID |
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Primary objective: to assess the efficacy of pramipexole given two times daily compared to placebo.
Secondary objectives: to assess the effects of pramipexole on mood, cognition, fatigue, impulse control, daytime sleepiness and nighttime sleep compared to placebo; to compare the tolerability among the treatment groups over 12 weeks
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Other |
| |
| Pramipexole 0.5 mg Tid | Other | Pramipexole 0.5 mg tid (three times a day) |
|
| Pramipexole 0.5 mg Bid | Other | Pramipexole 0.5 mg bid (bis in die (two times a day)) |
|
| Pramipexole 0.75 mg Bid | Other | Pramipexole 0.75 mg bid (bis in die (two times a day)) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pramipexole | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Unified Parkinson's Disease Rating Scale (UPDRS) Total Score | Total score ranges from zero (best) to 176 (worst), as the sum of Parts I (Mental questions), II (Activity of Daily Living questions), and III (Motor examination) | From baseline to week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Modified Hoehn and Yahr Stage | Score ranges from best 0 (no signs of disease) to worst 5 (wheelchair bound or bedridden unless aided) | From baseline to week 12 |
| Epworth Sleepiness Scale | 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) |
Not provided
Inclusion Criteria:
Potential subjects must meet all of the following inclusion criteria to be eligible for enrollment into this study:
Exclusion Criteria:
Individuals with any of the following characteristics will not be eligible for entry into this study:
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 248.622.170 Boehringer Ingelheim Investigational Site | Phoenix | Arizona | United States | |||
| 248.622.112 Boehringer Ingelheim Investigational Site |
There were 312 patients enrolled and 311 patients entered
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | matching tablet |
| FG001 | Mirapex (Pramipexole 0.5 mg Tid) | Week 1: Pramipexole 0.125 mg tid, Week 2: Pramipexole 0.25 mg tid, Week 3: Pramipexole 0.5 mg tid, Week 4 to Week 12: Pramipexole 0.5 mg tid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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| Drug |
|
| From baseline to week 12 |
| Beck Depression Inventory II | Total score ranges from zero (best) to 63 (worst); scale has 21 items, each rated from zero (absent) to 3 (severe) | From baseline to week 12 |
| Little Rock |
| Arkansas |
| United States |
| 248.622.69 Boehringer Ingelheim Investigational Site | Fountain Valley | California | United States |
| 248.622.198 Boehringer Ingelheim Investigational Site | La Jolla | California | United States |
| 248.622.111 Boehringer Ingelheim Investigational Site | Oxnard | California | United States |
| 248.622.61 Boehringer Ingelheim Investigational Site | Sacramento | California | United States |
| 248.622.23 Boehringer Ingelheim Investigational Site | San Diego | California | United States |
| 248.622.73 Boehringer Ingelheim Investigational Site | San Francisco | California | United States |
| 248.622.108 Boehringer Ingelheim Investigational Site | Denver | Colorado | United States |
| 248.622.190 Boehringer Ingelheim Investigational Site | Danbury | Connecticut | United States |
| 248.622.215 Boehringer Ingelheim Investigational Site | Manchester | Connecticut | United States |
| 248.622.196 Boehringer Ingelheim Investigational Site | Boca Raton | Florida | United States |
| 248.622.14 Boehringer Ingelheim Investigational Site | Miami | Florida | United States |
| 248.622.149 Boehringer Ingelheim Investigational Site | Weston | Florida | United States |
| 248.622.139 Boehringer Ingelheim Investigational Site | Honolulu | Hawaii | United States |
| 248.622.5 Boehringer Ingelheim Investigational Site | Chicago | Illinois | United States |
| 248.622.138 Boehringer Ingelheim Investigational Site | Springfield | Illinois | United States |
| 248.622.87 Boehringer Ingelheim Investigational Site | Louisville | Kentucky | United States |
| 248.622.207 Boehringer Ingelheim Investigational Site | New Orleans | Louisiana | United States |
| 248.622.132 Boehringer Ingelheim Investigational Site | Shreveport | Louisiana | United States |
| 248.622.17 Boehringer Ingelheim Investigational Site | Boston | Massachusetts | United States |
| 248.622.40 Boehringer Ingelheim Investigational Site | Boston | Massachusetts | United States |
| 248.622.76 Boehringer Ingelheim Investigational Site | Boston | Massachusetts | United States |
| 248.622.186 Boehringer Ingelheim Investigational Site | East Lansing | Michigan | United States |
| 248.622.77 Boehringer Ingelheim Investigational Site | Omaha | Nebraska | United States |
| 248.622.155 Boehringer Ingelheim Investigational Site | Lebanon | New Hampshire | United States |
| 248.622.135 Boehringer Ingelheim Investigational Site | Brooklyn | New York | United States |
| 248.622.216 Boehringer Ingelheim Investigational Site | Kingston | New York | United States |
| 248.622.202 Boehringer Ingelheim Investigational Site | New York | New York | United States |
| 248.622.86 Boehringer Ingelheim Investigational Site | New York | New York | United States |
| 248.622.1 Boehringer Ingelheim Investigational Site | Rochester | New York | United States |
| 248.622.89 Boehringer Ingelheim Investigational Site | Cincinnati | Ohio | United States |
| 248.622.20 Boehringer Ingelheim Investigational Site | Columbus | Ohio | United States |
| 248.622.169 Boehringer Ingelheim Investigational Site | Hershey | Pennsylvania | United States |
| 248.622.18 Boehringer Ingelheim Investigational Site | Philadelphia | Pennsylvania | United States |
| 248.622.199 Boehringer Ingelheim Investigational Site | Houston | Texas | United States |
| 248.622.7 Boehringer Ingelheim Investigational Site | Houston | Texas | United States |
| 248.622.213 Boehringer Ingelheim Investigational Site | Spokane | Washington | United States |
| 248.622.104 Boehringer Ingelheim Investigational Site | Milwaukee | Wisconsin | United States |
| FG002 | Mirapex (Pramipexole 0.5 mg Bid) | Week 1: Pramipexole 0.125 mg bid, Week 2: Pramipexole 0.25 mg bid, Week 3: Pramipexole 0.5 mg bid, Week 4 to Week 12: Pramipexole 0.5 mg bid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period. |
| FG003 | Mirapex (Pramipexole 0.75 mg Bid) | Week 1: Pramipexole 0.125 mg bid, Week 2: Pramipexole 0.25 mg bid, Week 3: Pramipexole 0.5 mg bid, Week 4 to Week 12: Pramipexole 0.75 mg bid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | matching tablet |
| BG001 | Mirapex (Pramipexole 0.5 mg Tid) | Week 1: Pramipexole 0.125 mg tid, Week 2: Pramipexole 0.25 mg tid, Week 3: Pramipexole 0.5 mg tid, Week 4 to Week 12: Pramipexole 0.5 mg tid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period. |
| BG002 | Mirapex (Pramipexole 0.5 mg Bid) | Week 1: Pramipexole 0.125 mg bid, Week 2: Pramipexole 0.25 mg bid, Week 3: Pramipexole 0.5 mg bid, Week 4 to Week 12: Pramipexole 0.5 mg bid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period. |
| BG003 | Mirapex (Pramipexole 0.75 mg Bid) | Week 1: Pramipexole 0.125 mg bid, Week 2: Pramipexole 0.25 mg bid, Week 3: Pramipexole 0.5 mg bid, Week 4 to Week 12: Pramipexole 0.75 mg bid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Unified Parkinson's Disease Rating Scale (UPDRS) Total Score | Total score ranges from zero (best) to 176 (worst), as the sum of Parts I (Mental questions), II (Activity of Daily Living questions), and III (Motor examination) | Treated set | Posted | Mean | Standard Deviation | units on a scale | From baseline to week 12 |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Modified Hoehn and Yahr Stage | Score ranges from best 0 (no signs of disease) to worst 5 (wheelchair bound or bedridden unless aided) | Treated set | Posted | Mean | Standard Deviation | units on a scale | From baseline to week 12 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Epworth Sleepiness Scale | 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) | Treated set | Posted | Mean | Standard Deviation | units on a scale | From baseline to week 12 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Beck Depression Inventory II | Total score ranges from zero (best) to 63 (worst); scale has 21 items, each rated from zero (absent) to 3 (severe) | Treated set | Posted | Mean | Standard Deviation | units on a scale | From baseline to week 12 |
|
12 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | matching tablet | 0 | 77 | 27 | 77 | ||
| EG001 | Mirapex (Pramipexole 0.5 mg Bid) | Week 1: Pramipexole 0.125 mg bid, Week 2: Pramipexole 0.25 mg bid, Week 3: Pramipexole 0.5 mg bid, Week 4 to Week 12: Pramipexole 0.5 mg bid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period. | 0 | 81 | 42 | 81 | ||
| EG002 | Mirapex (Pramipexole 0.75 mg Bid) | Week 1: Pramipexole 0.125 mg bid, Week 2: Pramipexole 0.25 mg bid, Week 3: Pramipexole 0.5 mg bid, Week 4 to Week 12: Pramipexole 0.75 mg bid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period. | 2 | 73 | 37 | 73 | ||
| EG003 | Mirapex (Pramipexole 0.5 mg Tid) | Week 1: Pramipexole 0.125 mg tid, Week 2: Pramipexole 0.25 mg tid, Week 3: Pramipexole 0.5 mg tid, Week 4 to Week 12: Pramipexole 0.5 mg tid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period. | 1 | 80 | 43 | 80 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Coronary Artery Disease | Cardiac disorders | MEDRA 12.0 | Systematic Assessment |
| |
| Cerebral Infarction, Hemiparesis | Nervous system disorders | MEDRA 12.0 | Systematic Assessment |
| |
| ileus (patient stopped drugs 2 days prior) | Gastrointestinal disorders | MEDRA 12.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| somnolence | Nervous system disorders | MEDRA 12.0 | Systematic Assessment |
| |
| dizziness | Nervous system disorders | MEDRA 12.0 | Systematic Assessment |
| |
| headache | Nervous system disorders | MEDRA 12.0 | Systematic Assessment |
| |
| tremor | Nervous system disorders | MEDRA 12.0 | Systematic Assessment |
| |
| nausea | Gastrointestinal disorders | MEDRA 12.0 | Systematic Assessment |
| |
| constipation | Gastrointestinal disorders | MEDRA 12.0 | Systematic Assessment |
| |
| insomnia | Psychiatric disorders | MEDRA 12.0 | Systematic Assessment |
| |
| abnormal dreams | Psychiatric disorders | MEDRA 12.0 | Systematic Assessment |
| |
| fatigue | General disorders | MEDRA 12.0 | Systematic Assessment |
| |
| oedema peripheral | General disorders | MEDRA 12.0 | Systematic Assessment |
|
Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim Call Center | Boehringer Ingelheim Pharmaceuticals | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
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| ID | Term |
|---|---|
| D000077487 | Pramipexole |
| ID | Term |
|---|---|
| D052160 | Benzothiazoles |
| D013844 | Thiazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Male |
|
| UPDRS at week 12 |
|
| Mean Difference (Final Values) |
| -4.41 |
| 95 |
| -6.54 |
| -2.28 |
| No |
| Superiority or Other |
| ANCOVA | <0.0001 | Mean Difference (Final Values) | -4.72 | 95 | -6.91 | -2.52 | No | Superiority or Other |
Week 1: Pramipexole 0.125 mg bid, Week 2: Pramipexole 0.25 mg bid, Week 3: Pramipexole 0.5 mg bid, Week 4 to Week 12: Pramipexole 0.75 mg bid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period. |
|
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|
Week 1: Pramipexole 0.125 mg bid, Week 2: Pramipexole 0.25 mg bid, Week 3: Pramipexole 0.5 mg bid, Week 4 to Week 12: Pramipexole 0.75 mg bid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period. |
|
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Week 1: Pramipexole 0.125 mg bid, Week 2: Pramipexole 0.25 mg bid, Week 3: Pramipexole 0.5 mg bid, Week 4 to Week 12: Pramipexole 0.75 mg bid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period. |
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