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This study will evaluate an oral fixed-dose, once daily product that combines pramipexole and rasagiline for the treatment of early Parkinson's disease.
Animal studies support the therapeutic advantage of combining low doses of rasagiline and pramipexole and suggest further improvement when both are administered in a sustained fashion. Both rasagiline and pramipexole are well known marketed drugs for Parkinson's disease with a good safety profile. combining the drugs in low doses and controlled release may provide better symptom management than the existing drugs alone or together.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| P2B001 once daily (pramipexole 0.6 mg / rasagiline 0.75 mg), | Experimental | Fixed Dose Combination of pramipexole 0.6 mg and rasagiline 0.75 mg once daily. |
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| P2B001 once daily (pramipexole 0.3 mg / rasagiline 0.75 mg), | Experimental | Fixed Dose Combination of pramipexole 0.3 mg and rasagiline 0.75 mg once daily |
|
| Placebo | Placebo Comparator | Placebo once daily for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| P2B001 once daily (pramipexole 0.6 mg / rasagiline 0.75 mg), | Drug | Fixed Dose Combination of pramipexole 0.6 mg and rasagiline 0.75 mg once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total UPDRS I, II, III Scores | Change from baseline to final visit (week 12) in total UPDRS score (defined as sum of parts I, II and III, scores (0-176). UPDRS- Unified Parkinson's Disease Rating Scale, minimum value is 0 points and maximum value is 176. High score mean worse outcome. | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| UPDRS ADL (Part II) | Change from baseline in individual UPDRS ADL (part II). Activity of daily Life UPDRS part II minimum is 0 point and max is 52 point (worse outcome) | Week 12 |
| CGI-S | Change from baseline in individual Clinical Global Impression - Severity. Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness (Parkinson's Disease) at the time of assessment relative to the clinician's past experience with patients who have the same diagnosis as one of the following:. 1 is normal and 7 is the most extremely ill patients. A subject defined as a treatment responder when the improvement from baseline to the Week12 / Last Observed Value (LOV) was of at least 1 point or more. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| pninit litman, Ph.D | Pharma Two B Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| P2B001 Site Birmingham | Birmingham | Alabama | United States | |||
| P2B001 Site Los Angeles |
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| ID | Title | Description |
|---|---|---|
| FG000 | P2B001 Treatment A | Fixed Dose Combination of pramipexole 0.6 mg and rasagiline 0.75 mg once daily. P2B001 once daily (pramipexole 0.6 mg / rasagiline 0.75 mg), : Fixed Dose Combination of pramipexole 0.6 mg and rasagiline 0.75 mg once daily |
| FG001 | P2B001 Treatment B |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo | Drug | placebo |
|
| P2B001 once daily (pramipexole 0.3 mg / rasagiline 0.75 mg), | Drug | Fixed Dose Combination of pramipexole 0.3 mg and rasagiline 0.75 mg once daily |
|
| 12 weeks |
| UPDRS Motor (Part III) | Change from baseline in individual UPDRS motor (part III). UPDRS- Unified Parkinson's Disease Rating Scale, part III motor . min is 0 and Max is 108 (Worse outcome) | 12 weeks |
| PDQ39 | Change from baseline in individual Parkinson's Disease Questionnaire - 39. Score 0-100 where 0 is indicative of no problem at all and 100 is the maximum level of problem. | 12 weeks |
| Los Angeles |
| California |
| United States |
| P2B001 Site Aurora | Aurora | Colorado | United States |
| P2B001 Manchester | Manchester | Connecticut | United States |
| P2B001 Site New Haven | New Haven | Connecticut | United States |
| P2B001 Site Boca Raton | Boca Raton | Florida | United States |
| P2B001 Site Port Charlotte | Port Charlotte | Florida | United States |
| P2B001 Site Tampa | Tampa | Florida | United States |
| P2B001 Site Augusta | Augusta | Georgia | United States |
| P2B001 site Chicago | Chicago | Illinois | 60612 | United States |
| P2B001 Site Kansas City | Kansas City | Kansas | United States |
| P2B001 Site Boston | Boston | Massachusetts | United States |
| P2B001 Site west Bloomfield | West Bloomfield | Michigan | United States |
| P2B001 Site Golden Valley | Golden Valley | Minnesota | United States |
| P2B001 Site Camden | Camden | New Jersey | United States |
| P2B001 Site New Brunswick | New Brunswick | New Jersey | United States |
| P2B001 site Commack | Commack | New York | United States |
| P2B001 Site New York | New York | New York | United States |
| P2B001 Site Durham | Durham | North Carolina | United States |
| P2B001 Site Cincinnati | Cincinnati | Ohio | United States |
| P2B001 Site Toledo | Toledo | Ohio | United States |
| P2B001 Site Tulsa | Tulsa | Oklahoma | United States |
| P2B001 Site Houston | Houston | Texas | United States |
| P2B001 Site Roanoke | Roanoke | Virginia | United States |
| P2B001 Site Rambam Israel | Haifa | Israel |
| P2B001 Site Belinson | Pethch Tikva | Israel |
| P2B001 Site Sheba Medical Center | Ramat Gan | Israel |
| P2B001 Site Asaf Harofe | Rishon LeZiyyon | Israel |
| P2B001 Site Sourasky Medical Center | Tel Aviv | Israel |
Fixed Dose Combination of pramipexole 0.3 mg and rasagiline 0.75 mg once daily P2B001 once daily (pramipexole 0.3 mg / rasagiline 0.75 mg), : Fixed Dose Combination of pramipexole 0.3 mg and rasagiline 0.75 mg once daily |
| FG002 | Placebo | Placebo once daily for 12 weeks. Placebo: placebo |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | P2B001 Treatment A | Fixed Dose Combination of pramipexole 0.6 mg and rasagiline 0.75 mg once daily. P2B001 once daily (pramipexole 0.6 mg / rasagiline 0.75 mg), : Fixed Dose Combination of pramipexole 0.6 mg and rasagiline 0.75 mg once daily |
| BG001 | P2B001 Treatment B | Fixed Dose Combination of pramipexole 0.3 mg and rasagiline 0.75 mg once daily P2B001 once daily (pramipexole 0.3 mg / rasagiline 0.75 mg), : Fixed Dose Combination of pramipexole 0.3 mg and rasagiline 0.75 mg once daily |
| BG002 | Placebo | Placebo once daily for 12 weeks. Placebo: placebo |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | Total UPDRS I, II, III Scores | Change from baseline to final visit (week 12) in total UPDRS score (defined as sum of parts I, II and III, scores (0-176). UPDRS- Unified Parkinson's Disease Rating Scale, minimum value is 0 points and maximum value is 176. High score mean worse outcome. | ITT analyis | Posted | Least Squares Mean | Standard Error | units on a scale | Week 12 |
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| Secondary | UPDRS ADL (Part II) | Change from baseline in individual UPDRS ADL (part II). Activity of daily Life UPDRS part II minimum is 0 point and max is 52 point (worse outcome) | ITT analysis | Posted | Least Squares Mean | Standard Error | units on a scale | Week 12 |
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| Secondary | CGI-S | Change from baseline in individual Clinical Global Impression - Severity. Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness (Parkinson's Disease) at the time of assessment relative to the clinician's past experience with patients who have the same diagnosis as one of the following:. 1 is normal and 7 is the most extremely ill patients. A subject defined as a treatment responder when the improvement from baseline to the Week12 / Last Observed Value (LOV) was of at least 1 point or more. | ITT | Posted | Count of Participants | Participants | 12 weeks |
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| Secondary | UPDRS Motor (Part III) | Change from baseline in individual UPDRS motor (part III). UPDRS- Unified Parkinson's Disease Rating Scale, part III motor . min is 0 and Max is 108 (Worse outcome) | ITT anlysis | Posted | Mean | Standard Error | units on a scale | 12 weeks |
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| Secondary | PDQ39 | Change from baseline in individual Parkinson's Disease Questionnaire - 39. Score 0-100 where 0 is indicative of no problem at all and 100 is the maximum level of problem. | ITT Analysis | Posted | Least Squares Mean | Standard Error | units on a scale | 12 weeks |
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14 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 | P2B001 Treatment A | Fixed Dose Combination of pramipexole 0.6 mg and rasagiline 0.75 mg once daily. P2B001 once daily (pramipexole 0.6 mg / rasagiline 0.75 mg), : Fixed Dose Combination of pramipexole 0.6 mg and rasagiline 0.75 mg once daily | 0 | 49 | 1 | 49 | 37 | 49 |
| EG001 | P2B001 Treatment B | Fixed Dose Combination of pramipexole 0.3 mg and rasagiline 0.75 mg once daily P2B001 once daily (pramipexole 0.3 mg / rasagiline 0.75 mg), : Fixed Dose Combination of pramipexole 0.3 mg and rasagiline 0.75 mg once daily | 0 | 50 | 0 | 50 | 20 | 50 |
| EG002 | Placebo | Placebo once daily for 12 weeks. Placebo: placebo | 0 | 50 | 0 | 50 | 24 | 50 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ACUTE MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA (16.1) | Systematic Assessment | NON-ST ELEVATION MYOCARDIAL INFARCTION |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| NAUSEA | Gastrointestinal disorders | MedDRA (16.1) | Systematic Assessment | NAUSEA |
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| SOMNOLENCE | Nervous system disorders | MedDRA (16.1) | Systematic Assessment | SOMNOLENCE |
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| DIZZINESS | Nervous system disorders | MedDRA (16.1) | Systematic Assessment | DIZZINESS |
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| fatigue | General disorders | MedDRA (16.1) | Systematic Assessment |
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| nasopharyngitis | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
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| headache | Nervous system disorders | MedDRA (16.1) | Systematic Assessment |
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| tremor | Nervous system disorders | MedDRA (16.1) | Systematic Assessment |
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| insomnia | Psychiatric disorders | MedDRA (16.1) | Systematic Assessment |
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| orthostatic hypotension | Vascular disorders | MedDRA (16.1) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pninit Litman study director | Pharma 2B LTD | +972 8 9472672 | pninit@pharma2b.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 |
| C031967 | rasagiline |
| 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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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Israel |
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| MMRM |
| 0.0027 |
The overall significance level for this study will be 5% using two-tailed tests utilizing the hierarchical gate keeping approach to control the overall Type-I error rate in the strong sense. |
| Mean Difference (Net) |
| -3.84 |
| Standard Error of the Mean |
| 1.25 |
| 2-Sided |
| 95 |
| -6.32 |
| -1.36 |
| Superiority |
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| Participants |
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