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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Pharma Two B Ltd.
Sponsor:
Information provided by (Responsible Party):
Pharma Two B Ltd.
ClinicalTrials.gov Identifier:
NCT01968460
First received: October 15, 2013
Last updated: July 2, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Parkinson's Disease
Drug: Pramipexole / Rasagiline Mesylate once daily
Drug: Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Pharma Two B Ltd.:

Primary Outcome Measures:
  • Total UPDRS I, II, III scores [ Time Frame: Week 12 ] [ Designated as safety issue: Yes ]
    Change from baseline to final visit (week 12) in total UPDRS score (defined as sum of parts I, II and III, scores (0-176).


Secondary Outcome Measures:
  • UPDRS ADL (part II) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    Change from baseline in individual UPDRS ADL (part II)

  • CGI-S [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Change from baseline in individual Clinical Global Impression - Severity

  • UPDRS Motor (part III) [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    Change from baseline in individual UPDRS motor (part III)

  • PDQ39 [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    Change from baseline in individual Parkinson's Disease Questionnaire - 39


Estimated Enrollment: 150
Study Start Date: December 2013
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: P2B001 treatment A Drug: Pramipexole / Rasagiline Mesylate once daily
Experimental: P2B001 Treatment B Drug: Pramipexole / Rasagiline Mesylate once daily
Placebo Comparator: Placebo Drug: Placebo

  Eligibility

Ages Eligible for Study:   35 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01968460

Contacts
Contact: Christopher Verf +1 250.483.4597 VerfChristopher@PRAIntl.com

  Show 25 Study Locations
Sponsors and Collaborators
Pharma Two B Ltd.
  More Information

No publications provided

Responsible Party: Pharma Two B Ltd.
ClinicalTrials.gov Identifier: NCT01968460     History of Changes
Other Study ID Numbers: P2B001/001
Study First Received: October 15, 2013
Last Updated: July 2, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Pharma Two B Ltd.:
Parkinson's Disease, Rasagiline, Pramipexole

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Pramipexole
Rasagiline
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Monoamine Oxidase Inhibitors
Enzyme Inhibitors
Neuroprotective Agents

ClinicalTrials.gov processed this record on September 16, 2014