Phase 3
Completed N=149
Safety, Tolerability and Efficacy of Two Doses of Once Daily P2B001 in Subjects With Early Parkinson's Disease
Source: ClinicalTrials.gov NCT01968460 ↗Enrolled (actual)
149
Serious AEs
0.7%
Results posted
Apr 2023
Primary outcomePrimary: Total UPDRS I, II, III Scores — -5.97; -5.15; -1.31 units on a scale — p=0.0004
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total UPDRS I, II, III Scores |
-5.97; -5.15; -1.31 | 0.0004 sig |
| SECONDARY UPDRS ADL (Part II) |
-1.49; -1.06; 0.36 | 0.0004 sig |
| SECONDARY CGI-S |
13; 9; 3 | 0.0165 sig |
| SECONDARY UPDRS Motor (Part III) |
-4.43; -3.95; -1.62 | 0.0058 sig |
| SECONDARY PDQ39 |
-3.01; -2.19; 0.26 | 0.0097 sig |
Eligibility Criteria
Inclusion Criteria
- Subject is male or female ≥35 years of age to ≤75 years of age at the time of enrollment.
- Subject has idiopathic Parkinson's disease consistent with the UK Brain Bank Criteria; must have bradykinesia with sequence effect and rest tremor or prominent motor asymmetry.
- Subject with disease duration no longer than 3 years and 0 months.
- Subject has a Hoehn & Yahr (H&Y) stage score of < 3.
- Subject has a MMSE score ≥ 26
Exclusion Criteria
- Subject has an atypical parkinsonian syndrome or secondary parkinsonism (e.g., due to drugs, metabolic neurogenetic disorders, encephalitis, cerebrovascular disease or degenerative disease).
- Subject has a history of psychosis or hallucinations within the previous 12 months.
- Subject who is taking anticholinergic drugs.
- Subject has previous exposure to levodopa or a dopamine agonist for longer than 4 weeks; if previous exposure was less than 4 weeks then it must not be within 2 months prior to the baseline visit.
- Subject has previous exposure to a MAO-B inhibitor for longer than 4 weeks; if previous exposure was less than 4 weeks then it must not be within 3 months prior to the baseline visit.
- Subject who is taking MAO inhibitors, potent CYP1A2 inhibitors, e,g, Ciprofloxacin, Dextromethorphan or antitussive agent, analgesic agents such as tramadol, meperidine, methadone and propoxyphene, strong 3A4 inducers, e.g., St. John's Wort or cyclobenzaprine (tricyclic muscle relaxant), dopamine antagonists, such as the neuroleptics (phenothiazines, butyrophenones, thioxanthenes) or metoclopramide. Probenecid, cimetidine, ranitidine, diltiazem, verapamil and quinidine.
Data sourced from ClinicalTrials.gov (NCT01968460). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.