Trial · NCT01968460

Safety, Tolerability and Efficacy of Two Doses of Once Daily P2B001 in Subjects With Early Parkinson's Disease

NCT01968460, Phase 2, Phase 3, Completed, Pharma Two B Ltd.; results first posted 2023-04-07

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Safety, Tolerability and Efficacy of Two Doses of Once Daily P2B001 in Subjects With Early Parkinson's Disease. Trials, record NCT01968460. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01968460

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Safety, Tolerability and Efficacy of Two Doses of Once Daily P2B001 in Subjects With Early Parkinson's Disease
NCT number: NCT01968460
Status: Completed
Phases: Phase 2, Phase 3
Enrollment: 149 participants, actual
Lead sponsor: Pharma Two B Ltd.
Conditions: Parkinson's Disease
Interventions: P2B001 once daily (pramipexole 0.6 mg / rasagiline 0.75 mg),, Placebo, P2B001 once daily (pramipexole 0.3 mg / rasagiline 0.75 mg),
First posted: 2013-10-24
Last updated: 2023-04-07
Results first posted: 2023-04-07

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Total UPDRS I, II, III Scores	Week 12	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.
Secondary	UPDRS ADL (Part II)	Week 12	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)
Secondary	CGI-S	12 weeks	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.
Secondary	UPDRS Motor (Part III)	12 weeks	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)
Secondary	PDQ39	12 weeks	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.

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	Total UPDRS I, II, III Scores	Week 12	ITT analyis	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	UPDRS ADL (Part II)	Week 12	ITT analysis	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	CGI-S	12 weeks	ITT	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	UPDRS Motor (Part III)	12 weeks	ITT anlysis	units on a scale	MEAN
SECONDARY	PDQ39	12 weeks	ITT Analysis	units on a scale	LEAST_SQUARES_MEAN

Source ClinicalTrials.gov

Results by group15

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Total UPDRS I, II, III Scores	P2B001 Treatment A	-5.97	Standard Error 0.94	units on a scale
Total UPDRS I, II, III Scores	P2B001 Treatment B	-5.15	Standard Error 0.9	units on a scale
Total UPDRS I, II, III Scores	Placebo	-1.31	Standard Error 0.88	units on a scale
UPDRS ADL (Part II)	P2B001 Treatment A	-1.49	Standard Error 0.37	units on a scale
UPDRS ADL (Part II)	P2B001 Treatment B	-1.06	Standard Error 0.36	units on a scale
UPDRS ADL (Part II)	Placebo	0.36	Standard Error 0.39	units on a scale
CGI-S	P2B001 Treatment A	13		Participants
CGI-S	P2B001 Treatment B	9		Participants
CGI-S	Placebo	3		Participants
UPDRS Motor (Part III)	P2B001 Treatment A	-4.43	Standard Error 0.74	units on a scale

1 to 10 of 15Source ClinicalTrials.gov

See all 15 results by group

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	P2B001 Treatment A	49
Overall Study	STARTED	P2B001 Treatment B	50
Overall Study	STARTED	Placebo	50
Overall Study	COMPLETED	P2B001 Treatment A	43
Overall Study	COMPLETED	P2B001 Treatment B	45
Overall Study	COMPLETED	Placebo	48
Overall Study	NOT COMPLETED	P2B001 Treatment A	6
Overall Study	NOT COMPLETED	P2B001 Treatment B	5
Overall Study	NOT COMPLETED	Placebo	2

Source ClinicalTrials.gov

Adverse events30

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 Treatment A	10	49	12
other	NAUSEA	Gastrointestinal disorders	P2B001 Treatment B	6	50	6
other	NAUSEA	Gastrointestinal disorders	Placebo	1	50	1
other	SOMNOLENCE	Nervous system disorders	P2B001 Treatment A	8	49	9
other	SOMNOLENCE	Nervous system disorders	P2B001 Treatment B	4	50	5
other	SOMNOLENCE	Nervous system disorders	Placebo	0	50	0
other	DIZZINESS	Nervous system disorders	P2B001 Treatment A	5	49	6
other	DIZZINESS	Nervous system disorders	P2B001 Treatment B	2	50	2
other	DIZZINESS	Nervous system disorders	Placebo	4	50	4
other	fatigue	General disorders	P2B001 Treatment A	4	49	4

1 to 10 of 30Source ClinicalTrials.gov

See all 30 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	P2B001 Treatment A	0	49
Total, all-cause mortality	P2B001 Treatment B	0	50
Total, all-cause mortality	Placebo	0	50
Total, other adverse events	P2B001 Treatment A	37	49
Total, other adverse events	P2B001 Treatment B	20	50
Total, other adverse events	Placebo	24	50
Total, serious adverse events	P2B001 Treatment A	1	49
Total, serious adverse events	P2B001 Treatment B	0	50
Total, serious adverse events	Placebo	0	50

Source ClinicalTrials.gov

Papers0

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT01968460

GET https://conductscience.org/api/trials/v1/NCT01968460/events?page=2

API reference For AI assistants