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

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

Tracking Information
First Submitted Date  ICMJE October 15, 2013
First Posted Date  ICMJE October 24, 2013
Last Update Posted Date October 31, 2017
Study Start Date  ICMJE December 2013
Actual Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History Complete list of historical versions of study NCT01968460 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety, Tolerability and Efficacy of Two Doses of Once Daily P2B001 in Subjects With Early Parkinson's Disease
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Parkinson's Disease
Intervention  ICMJE
  • 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  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 30, 2017)
149
Original Estimated Enrollment  ICMJE
 (submitted: October 18, 2013)
150
Actual Study Completion Date  ICMJE June 2015
Actual Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 35 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01968460
Other Study ID Numbers  ICMJE P2B001/001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pharma Two B Ltd.
Study Sponsor  ICMJE Pharma Two B Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: pninit litman, Ph.D Pharma Two B Ltd.
PRS Account Pharma Two B Ltd.
Verification Date February 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP