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

Pharma Two B

Status and phase: Completed; Phase 3; Phase 2

Conditions: Parkinson's Disease

Treatments: 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),

Study type: Interventional

Funder types: Industry

Identifiers

NCT01968460

P2B001/001

Details and patient eligibility

About

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.

Enrollment: 149 patients

Sex: All

Ages: 35 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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149 participants in 3 patient groups, including a placebo group

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

Experimental group

Description:

Fixed Dose Combination of pramipexole 0.6 mg and rasagiline 0.75 mg once daily.

Treatment:

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

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

Experimental group

Description:

Fixed Dose Combination of pramipexole 0.3 mg and rasagiline 0.75 mg once daily

Treatment:

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

Placebo

Placebo Comparator group

Description:

Placebo once daily for 12 weeks.

Treatment:

Drug: Placebo