Trial · NCT03329508
A Phase 3 Study With P2B001 in Subjects With Early Parkinson's
NCT03329508, Phase 3, Completed, Pharma Two B Ltd.; results first posted 2023-03-21
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. A Phase 3 Study With P2B001 in Subjects With Early Parkinson's. Trials, record NCT03329508. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03329508
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase 3 Study With P2B001 in Subjects With Early Parkinson's
- NCT number
- NCT03329508
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 544 participants, actual
- Lead sponsor
- Pharma Two B Ltd.
- Conditions
- Parkinson Disease, Early Parkinson's Disease
- Interventions
- P2B001 0.6/0.75 mg, Rasagiline 0.75 mg, Pramipexole 0.6 mg, Marketed Pramipexole ER
- First posted
- 2017-11-06
- Last updated
- 2023-03-21
- Results first posted
- 2023-03-21
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Total Unified Parkinson's Disease Rating Scale (UPDRS) Score (Defined as Sum of Parts II and III, Scores (0-160). | baseline to week 12 | Differences between P2B 0.6/0.75 mg as compared to its individual components in the change of total UPDRS score (defined as sum of parts II and III, scores (0-160). UPDRS- Unified Parkinson's Disease Rating Scale, minimum value is 0 points and maximum value is 160. High score mean worse outcome. |
| Secondary | Change in Epworth Sleepiness Scale (ESS) Score. | baseline to week 12 | Differences between P2B 0.6/0.75 mg as compared to pramipexole ER tablets in the change of Epworth Sleepiness Scale (ESS) score. Scale is 0-24 , when 24 is worse outcome |
| Secondary | Change From Baseline to Week 12 in Total UPDRS III Motor | baseline to week 12 | Differences between P2B 0.6/0.75 mg as compared to its individual components in the change of Motor UPDRS score (UPDRS Part III ). UPDRS- Unified Parkinson's Disease Rating Scale, part III motor . min is 0 and Max is 108 (Worse outcome) |
| Secondary | Change From Baseline to Week 12 in Total UPDRS II ADL | Baseline to week 12 | Differences between of P2B 0.6/0.75 mg as compared to its individual components in the change of ADL UPDRS score (UPDRS part II) Activity of daily Life UPDRS part II minimum is 0 point and max is 52 point (worse outcome) |
| Secondary | Change From Baseline to End of Week 12 Visit in ADL Subscale of PDQ39 | Baseline to week 12 | The efficacy of P2B 0.6/0.75 mg as compared to Pramipexole ER tablet titrated to optimal dose. ADL PDQ39- Activity of daily life part in Parkinson's Disease Questionaries' 39 Score 0-100 when 100 is the worse outcome |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Total Unified Parkinson's Disease Rating Scale (UPDRS) Score (Defined as Sum of Parts II and III, Scores (0-160). | baseline to week 12 | mITT | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change in Epworth Sleepiness Scale (ESS) Score. | baseline to week 12 | mITT | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to Week 12 in Total UPDRS III Motor | baseline to week 12 | mITT | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to Week 12 in Total UPDRS II ADL | Baseline to week 12 | mITT | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to End of Week 12 Visit in ADL Subscale of PDQ39 | Baseline to week 12 | mITT | score on a scale | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Total Unified Parkinson's Disease Rating Scale (UPDRS) Score (Defined as Sum of Parts II and III, Scores (0-160). | P2B001 | -7.98 | Standard Error 0.60 | score on a scale | |
| Change in Total Unified Parkinson's Disease Rating Scale (UPDRS) Score (Defined as Sum of Parts II and III, Scores (0-160). | Rasagiline Capsule | -4.69 | Standard Error 0.61 | score on a scale | |
| Change in Total Unified Parkinson's Disease Rating Scale (UPDRS) Score (Defined as Sum of Parts II and III, Scores (0-160). | Pramipexole Capsule | -5.32 | Standard Error 0.61 | score on a scale | |
| Change in Total Unified Parkinson's Disease Rating Scale (UPDRS) Score (Defined as Sum of Parts II and III, Scores (0-160). | Pramipexole Extended Release | -8.35 | Standard Error 0.86 | score on a scale | |
| Change in Epworth Sleepiness Scale (ESS) Score. | P2B001 | -0.33 | Standard Error 0.25 | score on a scale | |
| Change in Epworth Sleepiness Scale (ESS) Score. | Rasagiline Capsule | -0.81 | Standard Error 0.26 | score on a scale | |
| Change in Epworth Sleepiness Scale (ESS) Score. | Pramipexole Capsule | 0.39 | Standard Error 0.25 | score on a scale | |
| Change in Epworth Sleepiness Scale (ESS) Score. | Pramipexole Extended Release | 2.33 | Standard Error 0.36 | score on a scale | |
| Change From Baseline to Week 12 in Total UPDRS III Motor | P2B001 | -5.82 | Standard Error 0.47 | score on a scale | |
| Change From Baseline to Week 12 in Total UPDRS III Motor | Rasagiline Capsule | -4.07 | Standard Error 0.48 | score on a scale |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | P2B001 | 157 | |
| Overall Study | STARTED | Rasagiline Capsule | 154 | |
| Overall Study | STARTED | Pramipexole Capsule | 156 | |
| Overall Study | STARTED | Pramipexole Extended Release | 77 | |
| Overall Study | COMPLETED | P2B001 | 137 | |
| Overall Study | COMPLETED | Rasagiline Capsule | 134 | |
| Overall Study | COMPLETED | Pramipexole Capsule | 137 | |
| Overall Study | COMPLETED | Pramipexole Extended Release | 67 | |
| Overall Study | NOT COMPLETED | P2B001 | 20 | |
| Overall Study | NOT COMPLETED | Rasagiline Capsule | 20 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events96
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | nausea | Gastrointestinal disorders | P2B001 | 28 | 150 | 33 |
| other | nausea | Gastrointestinal disorders | Rasagiline Capsule | 10 | 147 | 10 |
| other | nausea | Gastrointestinal disorders | Pramipexole Capsule | 24 | 148 | 29 |
| other | nausea | Gastrointestinal disorders | Pramipexole Extended Release | 17 | 74 | 22 |
| other | fatigue | General disorders | P2B001 | 23 | 150 | 27 |
| other | fatigue | General disorders | Rasagiline Capsule | 2 | 147 | 2 |
| other | fatigue | General disorders | Pramipexole Capsule | 22 | 148 | 25 |
| other | fatigue | General disorders | Pramipexole Extended Release | 13 | 74 | 14 |
| other | somnolence | Nervous system disorders | P2B001 | 22 | 150 | 25 |
| other | somnolence | Nervous system disorders | Rasagiline Capsule | 7 | 147 | 7 |
1 to 10 of 96Source ClinicalTrials.gov
See all 96 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | P2B001 | 0 | 150 |
| Total, all-cause mortality | Rasagiline Capsule | 0 | 147 |
| Total, all-cause mortality | Pramipexole Capsule | 0 | 148 |
| Total, all-cause mortality | Pramipexole Extended Release | 0 | 74 |
| Total, other adverse events | P2B001 | 78 | 150 |
| Total, other adverse events | Rasagiline Capsule | 52 | 147 |
| Total, other adverse events | Pramipexole Capsule | 86 | 148 |
| Total, other adverse events | Pramipexole Extended Release | 54 | 74 |
| Total, serious adverse events | P2B001 | 3 | 150 |
| Total, serious adverse events | Rasagiline Capsule | 2 | 147 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03329508
GET https://conductscience.org/api/trials/v1/NCT03329508/events?page=2