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

• ClinicalTrials.gov Identifier: NCT01968460
• Recruitment Status: Completed
• First Posted: October 24, 2013
• Last Update Posted: October 31, 2017
• Sponsor: Pharma Two B Ltd.
• Information provided by (Responsible Party): Pharma Two B Ltd.

Tracking Information

• First Submitted Date: October 15, 2013
• First Posted Date: October 24, 2013
• Last Update Posted Date: October 31, 2017
• Study Start Date: December 2013
• Actual Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 18, 2013)

Total UPDRS I, II, III scores [ Time Frame: 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).

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: October 18, 2013)

• UPDRS ADL (part II) [ Time Frame: Week 12 ]
  Change from baseline in individual UPDRS ADL (part II)
• CGI-S [ Time Frame: 12 weeks ]
  Change from baseline in individual Clinical Global Impression - Severity
• UPDRS Motor (part III) [ Time Frame: 12 weeks ]
  Change from baseline in individual UPDRS motor (part III)
• PDQ39 [ Time Frame: 12 weeks ]
  Change from baseline in individual Parkinson's Disease Questionnaire - 39

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Safety, Tolerability and Efficacy of Two Doses of Once Daily P2B001 in Subjects With Early Parkinson's Disease
• Official Title: A Phase 2B, Twelve-week Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study, To Determine the Safety, Tolerability and Efficacy of Two Doses of Once Daily P2B001 in Subjects With Early Parkinson's Disease

Brief 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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2; Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Treatment
• Condition: Parkinson's Disease

Intervention

• Drug: 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
• Drug: Placebo
  placebo
• Drug: 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

Study Arms

• Experimental: P2B001 Treatment A
  Fixed Dose Combination of pramipexole 0.6 mg and rasagiline 0.75 mg once daily.
  Intervention: Drug: P2B001 once daily (pramipexole 0.6 mg / rasagiline 0.75 mg),
• Experimental: P2B001 Treatment B
  Fixed Dose Combination of pramipexole 0.3 mg and rasagiline 0.75 mg once daily
  Intervention: Drug: P2B001 once daily (pramipexole 0.3 mg / rasagiline 0.75 mg),
• Placebo Comparator: Placebo
  Placebo once daily for 12 weeks.
  Intervention: Drug: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 30, 2017): 149
• Original Estimated Enrollment (submitted: October 18, 2013): 150
• Actual Study Completion Date: June 2015
• Actual Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 35 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Israel, United States

Administrative Information

• NCT Number: NCT01968460
• Other Study ID Numbers: P2B001/001
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Pharma Two B Ltd.
• Original Responsible Party: Same as current
• Current Study Sponsor: Pharma Two B Ltd.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: pninit litman, Ph.D; Pharma Two B Ltd.

• PRS Account: Pharma Two B Ltd.
• Verification Date: February 2015