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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT01968460
• Date of registration: 15/10/2013
• Prospective Registration: Yes
• Primary sponsor: Pharma Two B Ltd.
• Public title: Safety, Tolerability and Efficacy of Two Doses of Once Daily P2B001 in Subjects With Early Parkinson's Disease
• Scientific 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
• Date of first enrolment: December 2013
• Target sample size: 149
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01968460
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
• Phase: Phase 2/Phase 3

Countries of recruitment

Israel, United States

Contacts

• Name: pninit litman, Ph.D
• Affiliation: Pharma Two B Ltd.

Key inclusion & exclusion 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.



Age minimum: 35 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Parkinson's Disease

Intervention(s)

Drug: Placebo

Drug: P2B001 once daily (pramipexole 0.6 mg / rasagiline 0.75 mg),

Drug: P2B001 once daily (pramipexole 0.3 mg / rasagiline 0.75 mg),

Primary Outcome(s)

Total UPDRS I, II, III scores [Time Frame: Week 12]

Secondary Outcome(s)

UPDRS ADL (part II) [Time Frame: Week 12]

PDQ39 [Time Frame: 12 weeks]

CGI-S [Time Frame: 12 weeks]

UPDRS Motor (part III) [Time Frame: 12 weeks]

Secondary ID(s)

P2B001/001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors