Safety and Efficacy of Pramipexole and Bromocriptine Combined With L-dopa in Parkinson's Disease

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The objective of the study was to evaluate the efficacy and safety of SND 919 (pramipexole) tablets administered in combination with L-dopa in patients with Parkinson's disease using placebo and bromocriptine tablets as comparators in a double-blind design (phase III comparative study).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Bromocriptine; Pramipexole

Criteria

Inclusion Criteria:

• Patients with a diagnosis of Parkinson's disease (including juvenile parkinsonism)

• Patients who meet all of the following inclusion criteria

• Patients who were at least 20 years of age

• In- or outpatients of either sex

• Patients in any stage on the modified Hoehn and Yahr scale

• Patients being treated with L-dopa who have any of the following clinical conditions and problems

• Patients with the wearing-off phenomenon

• Patients with the on-off phenomenon

• Patients to whom a sufficient amount of L-dopa cannot be administered owing to the occurrence of an adverse event

• Patients in whom the effect of L-dopa is attenuated

• Patients in whom a dose increase of L-dopa has been refrained

• Patients with freezing phenomenon

Exclusion Criteria:

• Patients being treated with other dopamine agonists (bromocriptine, pergolide mesylate, talipexole hydrochloride). Patients who have been treated with other dopamine agonist for at least 4 weeks before the start of the study (the day of giving informed consent) are eligible for the study

• Patients with a history of hypersensitivity to ergot preparations

• Patients with psychiatric symptoms such as confusion, hallucination, delusion, excitement, delirium, and abnormal behaviour

• Patients with subjective symptoms derived from orthostatic hypotension

• Patients with hypotension (systolic blood pressure less than 100 mmHg)

• Patients wiht Raynaud disease

• Patients with peptic ulcer

• Patients with complications such as severe cardiac, renal, hepatic disease etc.

• Patients with a current or past history of epilepsy

• Women who are or may be pregnant and lactating women

• Patients who are receiving any other investigational products or who have received any other investigational product within 6 months of the study

• Patients who are incompetent to give consent

• Others judged by the investigator or co-investigator to be ineligible as subjects