Early combined prolonged release ropinirole and rasagiline therapy in newly diagnosed patients with Parkinsons disease. A prospective, randomized, parallel groups, long-term follow-up study including delayed-start design of rasagiline - Early combined ropinirole and rasagiline therapy in patients with Parkinsons disease

• Conditions: Patients with Parkinson`s diesease; MedDRA version: 12.0Level: LLTClassification code 10061536Term: Parkinson's disease

• Registration Number: EUCTR2009-013004-31-IT
• Lead Sponsor: IVERSITA` DEGLI STUDI DI PARMA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11-02
• Last Update Posted: 14 March 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

?Duration of Parkinsons disease not longer than 24 months, Hoehn & Yahr stage I- II, patients age 40 to 75
?Patients on current non ergot DAagonist treatment for not longer than 6 months for ropinirole and not longer than 5 months for pramipexole, at minimum daily dosage of 8 mg for the former and of 1.5 mg for the latter, maintained stable for at least 4 weeks, or patients previously untreated with DAergic drugs de novo patients
?To have given informed written consent to participate in the study
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

?Diagnosis of secondary Parkinsonism or atipical degenerative Parkinsonism
?Pregnant or suckling female patients
?History of alcohol or other substance abuse during the last 12 months
?Contra-indication to the use of the drugs investigated in the study
?Patients previously exposed to rasagiline or other Daergic drugs, as l-dopa, selegiline, amantadine, apomorphine, ergot-derived DAergic agonists. Patients treated with anticholinergics will be accepted if these drugs will be discontinued at least 3 weeks before inclusion
?Current or previous therapy with neuroleptics or other DA-antagonists
?Current or previous diagnosis of psychosis or current diagnosis of mood depression of moderate to severe degree (score of Beck Depression Inventory scale >17) to require or to have required antidepressant medication
?Patients with behaviour disturbances, such as medication-related altered impulse control, repetitive behaviours and dopamine dysregulation syndrome
?Patient cognitively impaired (Mini Mental State score < 24)
?Current or remitting neoplastic diseases and other diseases involving the central or peripheral nervous system
?Inclusion of the patient in other clinical study in which the use of the same or other drugs is scheduled

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified