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

Boehringer Ingelheim

Status and phase: Completed; Phase 3

Conditions: Parkinson Disease

Treatments: Drug: Pramipexole; Drug: Bromocriptine; Drug: Placebo bromocriptine; Drug: Placebo pramipexole

Study type: Interventional

Funder types: Industry

Identifiers

NCT02172573

248.505

Details and patient eligibility

About

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).

Enrollment: 315 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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315 participants in 3 patient groups, including a placebo group

Pramipexole

Experimental group

Treatment:

Drug: Pramipexole

Bromocriptine

Experimental group

Treatment:

Drug: Bromocriptine

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo bromocriptine

Drug: Placebo pramipexole