A Phase 3 interventional study of P2B001 0.6/0.75 mg and Rasagiline 0.75 mg in Parkinson Disease and Early Parkinson's Disease, sponsored by Pharma Two B Ltd.. Completed at 72 sites in 4 countries. Open to participants aged 35 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-03-21.
Sponsored by Pharma Two B Ltd. · Phase 3, Interventional, and Treatment
Among 37 studies testing rasagiline in Parkinson Disease — none open to participants now, none under way, none of them phase 3. rasagiline · Parkinson Disease.
Among the 37 studies testing rasagiline in Parkinson Disease, this one is the 2nd largest by enrollment, is the only one that started in 2018, is one of 15 in phase 3, and was the 35th registered.
4,576 studies on the registry are indexed under Parkinson Disease; 1,087 are open to participants now.
Browse Parkinson Disease studies →None of the 37 studies testing rasagiline in Parkinson Disease is open now. The open studies under Parkinson Disease, anywhere →
rasagiline: first FDA approval 2006 (AZILECT), first EMA approval 2005. What it is approved for, and how studies give it, is on its page →
Of the 749 Parkinson Disease studies recruiting now, 311 (42%) set no upper age limit and 127 (17%) stop at 75 or younger; 64 take children under 18; 189 take healthy volunteers.
This study: 35 Years to 80 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
37 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 2 · Phase 2 3 · Phase 3 17 · Phase 4 16
First in 1997; this study’s year is marked. 1 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 544 is above the median of 40 across 3,355 interventional studies indexed under Parkinson Disease.
Median enrollment 121 across the 37 interventional studies. Of the 31 that completed or were terminated, 13 (42%) have results posted.
This tab as a report to print or save as PDF → With an account.
22 of 37 have an industry lead sponsor. The 10 most frequent:
Pharma Two B Ltd. is the lead sponsor of 2 studies on the registry; none are open to participants now.
Pharma Two B Ltd. has 2 studies filed under Parkinson Disease — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 37 studies testing rasagiline in Parkinson Disease, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
P2B001 is an investigational drug that comprised of low doses of two drugs, pramipexole and rasagiline, which are both approved drugs and routinely used in standard therapy for Parkinson's disease. The two drugs work in two different mechanisms that help each other, so there is a reason to believe that their combined activity will be better than each individual drug, and that lower doses can be used without losing the therapeutic effect. Thus, the development of P2B001 is intended to provide a combination of low doses of these two drugs, in an improved formulation, that is hoped to be more effective in controlling Parkinson's disease symptoms and with less side effects than each of the drugs taken alone or the current available commercial drugs taken together. In a previously completed clinical trial a significant improvement in Parkinson's disease symptoms was seen in patients treated with P2B001 compared to patients that were treated with placebo.
In this phase 3 study , the safety and efficacy of P2B001 will be assessed by comparing P2B001 to its individual components pramipexole and rasagiline. This will be done by monitoring the motor and non-motor symptoms, evaluating responses participants provide on questionnaires relating to Parkinson's disease and quality of life that will be completed on every visit. In addition, this study will also compare P2B001 to a marketed drug of pramipexole ER. Approximately 525 patients will participate in this research study and the participation in this study will last between 14 to 18 weeks.
A total of 525 eligible subjects with early untreated Parkinson's disease (PD), will be randomized to 4 treatment groups. Each subject will participate in the study for approximately 18 weeks including a 30 day screening period, 12 week treatment period, and 2 weeks follow-up period. Subjects will be requested to take one capsule and 1-3 tablets of study drug by mouth with a glass of water every day for 13 weeks. The study requires seven visits to the clinic one every 2-4 weeks.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Fixed dose combination once daily capsule of pramipexole 0.6mg and rasagiline 0.75mg, + matching placebo tablet
Drug: P2B001 0.6/0.75 mg
Rasagiline 0.75mg Once daily capsule, component of P2B001, + matching placebo tablet
Drug: Rasagiline 0.75 mg
Pramipexole 0.6mg once daily capsule, component of P2B001 + matching placebo tablet
Drug: Pramipexole 0.6 mg
Marketed pramipexole ER tablet titrated to optimal dose of 1.5, 3.0 or 4.5mg + matching placebo capsule
Drug: Marketed Pramipexole ER
Fixed low dose extended release combination capsule of pramipexole and rasagiline
Also known as: P2B001 capsule
Rasagiline 0.75 mg oral extended release capsule, component
Also known as: RAS 0.75
Pramipexole 0.6 mg oral extended release capsule, component
Also known as: PPX 0.6
Marketed Pramipexole ER titrated to optimal dose of 1.5, 3 or 4.5 mg tablet
Also known as: PramiER
Change in Total Unified Parkinson's Disease Rating Scale (UPDRS) Score (Defined as Sum of Parts II and III, Scores (0-160).
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.
Time frame: baseline to week 12
Change in Epworth Sleepiness Scale (ESS) Score.
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
Time frame: baseline to week 12
Change From Baseline to Week 12 in Total UPDRS III Motor
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)
Time frame: baseline to week 12
Change From Baseline to Week 12 in Total UPDRS II ADL
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)
Time frame: Baseline to week 12
Change From Baseline to End of Week 12 Visit in ADL Subscale of PDQ39
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
Time frame: Baseline to week 12
| Milestone | P2B001 | Rasagiline Capsule | Pramipexole Capsule | Pramipexole Extended Release |
|---|---|---|---|---|
| Started | 157 | 154 | 156 | 77 |
| Completed | 137 | 134 | 137 | 67 |
| Not completed | 20 | 20 | 19 | 10 |
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.
| score on a scale | P2B001 | Rasagiline Capsule | Pramipexole Capsule | Pramipexole Extended Release |
|---|---|---|---|---|
| Change in Total Unified Parkinson's Disease Rating Scale (UPDRS) Score (Defined as Sum of Parts II and III, Scores (0-160). | -7.98 ± 0.60 | -4.69 ± 0.61 | -5.32 ± 0.61 | -8.35 ± 0.86 |
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
| score on a scale | P2B001 | Rasagiline Capsule | Pramipexole Capsule | Pramipexole Extended Release |
|---|---|---|---|---|
| Change in Epworth Sleepiness Scale (ESS) Score. | -0.33 ± 0.25 | -0.81 ± 0.26 | 0.39 ± 0.25 | 2.33 ± 0.36 |
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)
| score on a scale | P2B001 | Rasagiline Capsule | Pramipexole Capsule | Pramipexole Extended Release |
|---|---|---|---|---|
| Change From Baseline to Week 12 in Total UPDRS III Motor | -5.82 ± 0.47 | -4.07 ± 0.48 | -4.30 ± 0.48 | -6.36 ± 0.68 |
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)
| score on a scale | P2B001 | Rasagiline Capsule | Pramipexole Capsule | Pramipexole Extended Release |
|---|---|---|---|---|
| Change From Baseline to Week 12 in Total UPDRS II ADL | -2.14 ± 0.22 | -0.62 ± 0.22 | -0.97 ± 0.22 | -2.02 ± 0.31 |
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
| score on a scale | P2B001 | Rasagiline Capsule | Pramipexole Capsule | Pramipexole Extended Release |
|---|---|---|---|---|
| Change From Baseline to End of Week 12 Visit in ADL Subscale of PDQ39 | -5.30 ± 0.89 | -2.04 ± 0.92 | -3.40 ± 0.90 | -3.12 ± 1.27 |
Collected over 14 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| P2B001 | 0/150 (0%) | 3/150 (2%) | 78/150 (52%) |
| Rasagiline Capsule | 0/147 (0%) | 2/147 (1.4%) | 52/147 (35.4%) |
| Pramipexole Capsule | 0/148 (0%) | 3/148 (2%) | 86/148 (58.1%) |
| Pramipexole Extended Release | 0/74 (0%) | 0/74 (0%) | 54/74 (73%) |
| Event | P2B001 | Rasagiline Capsule | Pramipexole Capsule | Pramipexole Extended Release |
|---|---|---|---|---|
| Klebsiella sepsisInfections and infestations | 0/150 | 1/147 | 0/148 | 0/74 |
| SepsisInfections and infestations | 0/150 | 1/147 | 0/148 | 0/74 |
| Acute kidney injuryRenal and urinary disorders | 0/150 | 1/147 | 0/148 | 0/74 |
| AnaemiaBlood and lymphatic system disorders | 0/150 | 0/147 | 1/148 | 0/74 |
| Gastrointestinal haemorrhageGastrointestinal disorders | 0/150 | 0/147 | 1/148 | 0/74 |
| corona virusInfections and infestations | 0/150 | 0/147 | 1/148 | 0/74 |
| Muscle haemorrhageMusculoskeletal and connective tissue disorders | 0/150 | 0/147 | 1/148 | 0/74 |
| HaematocheziaGastrointestinal disorders | 0/150 | 0/147 | 1/148 | 0/74 |
| ProstatitisReproductive system and breast disorders | 0/150 | 0/147 | 1/148 | 0/74 |
| HypokalaemiaMetabolism and nutrition disorders | 1/150 | 0/147 | 0/148 | 0/74 |
| Event | P2B001 | Rasagiline Capsule | Pramipexole Capsule | Pramipexole Extended Release |
|---|---|---|---|---|
| somnolenceNervous system disorders | 22/150 | 7/147 | 27/148 | 23/74 |
| nauseaGastrointestinal disorders | 28/150 | 10/147 | 24/148 | 17/74 |
| fatigueGeneral disorders | 23/150 | 2/147 | 22/148 | 13/74 |
| dizzinessNervous system disorders | 16/150 | 19/147 | 14/148 | 7/74 |
| Orthostatic hypotensionVascular disorders | 4/150 | 4/147 | 5/148 | 9/74 |
| insomniaPsychiatric disorders | 13/150 | 4/147 | 9/148 | 7/74 |
| headacheNervous system disorders | 9/150 | 9/147 | 14/148 | 5/74 |
| constipationGastrointestinal disorders | 6/150 | 9/147 | 11/148 | 7/74 |
| pain in extremityMusculoskeletal and connective tissue disorders | 2/150 | 2/147 | 10/148 | 4/74 |
| fallInjury, poisoning and procedural complications | 6/150 | 5/147 | 8/148 | 1/74 |
The dispensing of the investigational product was based on a "just-in-time" shipping strategy per subject. Randomization was done at the end of the Screening period and before the Baseline Visit to allow for shipping of the kit to the site. Twenty-five (25) subjects were enrolled and randomized into treatment groups, but withdrew from study prior to first dose. They did not came to baseline visit , receive study drug nor did they receive a post-randomization evaluation.
| Age, Categorical(Participants) | P2B001 | Rasagiline Capsule | Pramipexole Capsule | Pramipexole Extended Release | Total |
|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 79 | 71 | 77 | 41 | 268 |
| >=65 years | 78 | 83 | 79 | 36 | 276 |
| Age, Continuous(Years) | P2B001 | Rasagiline Capsule | Pramipexole Capsule | Pramipexole Extended Release | Total |
|---|---|---|---|---|---|
| Mean | 63 ± 9 | 65 ± 1 | 64 ± 9 | 63 ± 9 | 64 ± 6 |
| Sex: Female, Male(Participants) | P2B001 | Rasagiline Capsule | Pramipexole Capsule | Pramipexole Extended Release | Total |
|---|---|---|---|---|---|
| Female | 51 | 48 | 52 | 24 | 175 |
| Male | 106 | 106 | 104 | 53 | 369 |
| Race (NIH/OMB)(Participants) | P2B001 | Rasagiline Capsule | Pramipexole Capsule | Pramipexole Extended Release | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 2 | 1 | 0 | 0 | 3 |
| Asian | 0 | 3 | 0 | 1 | 4 |
| Native Hawaiian or Other Pacific Islander | 1 | 2 | 2 | 0 | 5 |
| Black or African American | 2 | 3 | 5 | 1 | 11 |
| White | 150 | 145 | 147 | 74 | 516 |
| More than one race | 0 | 0 | 1 | 0 | 1 |
| Unknown or Not Reported | 2 | 0 | 1 | 1 | 4 |
| Region of Enrollment(participants) | P2B001 | Rasagiline Capsule | Pramipexole Capsule | Pramipexole Extended Release | Total |
|---|---|---|---|---|---|
| Canada | 1 | 0 | 1 | 0 | 2 |
| United States | 109 | 109 | 108 | 54 | 380 |
| Germany | 29 | 29 | 30 | 15 | 103 |
| Spain | 18 | 16 | 17 | 8 | 59 |
| Total UPDRS(units on a scale) | P2B001 | Rasagiline Capsule | Pramipexole Capsule | Pramipexole Extended Release | Total |
|---|---|---|---|---|---|
| Mean | 30.7 ± 9.9 | 31.3 ± 10.2 | 31.3 ± 11.0 | 28.8 ± 10.0 | 30.8 ± 10.3 |
| Epworth Sleepiness Score(units on a scale) | P2B001 | Rasagiline Capsule | Pramipexole Capsule | Pramipexole Extended Release | Total |
|---|---|---|---|---|---|
| Mean | 5.5 ± 4.0 | 5.7 ± 4.3 | 6.2 ± 4.0 | 6.1 ± 4.1 | 5.8 ± 4.1 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Jan 2018 to primary completion in Aug 2021, 43 months.
Results were first posted in Mar 2023, 1 year 6 months after primary completion.
Of 39 industry-sponsored phase 3 interventional studies under Parkinson Disease, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 54. This study's 43 months is above that.
Counting every sponsor, half of 67 studies reached it within 35 months; a quarter within 22 and three quarters within 56.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Rasagiline · Pramipexole
Pharma Two B Ltd.