Ophthalmologic Safety of Long Term Treatment With Pramipexole Compared to Bromocriptine or Other Dopamine Agonists in Patients With Parkinson's Disease

Phase 4

Completed

• Conditions: Parkinson Disease
• Interventions: Drug: Pramipexole; Drug: Bromocriptine and other dopamine agonists

• Registration Number: NCT02233023
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

Study to assess and compare the safety of long term oral treatment for Parkinson's Disease with pramipexole versus bromocriptine or other dopamine agonists, by measuring cross-sectional the incidence of ophthalmologic disturbances, especially signs of retinal degeneration, in a matched pair design

Detailed Description

Not available

Study Timeline

• Study Start: 1998-06
• Primary Completion: 2000-06
• Status Verified: 2014-09
• Study First Submitted: 2014-09-04
• Study First Submitted QC: 2014-09-04
• Last Update Submitted: 2014-09-04
• Study First Posted: 2014-09-08
• Last Update Posted: 2014-09-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 705

Inclusion Criteria

• Patients with idiopathic Parkinson's Disease
• Patients treated consecutively with either pramipexole or bromocriptine (or other dopamine agonists except ropinirole) for at least two and a half years (i.e. 30 months). Interruptions of ongoing dopamine agonists treatment for less than one month per year duration are acceptable, however, interruptions within the last 6 months are not acceptable. Patients currently participating in ongoing open-label extension trials with pramipexole may be included if they meet the requirement of 30 month treatment
• Written informed consent in accordance with Good Clinical Practice (GCP) and local legislation

Exclusion Criteria

• Patients who have been treated less than two and a half years (i.e. 30 months) with their actual dopamine agonist (regardless of the duration of treatment with a previous dopamine agonist)

• Patient treated with ropinirole

• Patients with any of the following:

  • Patients with a hereditary retinal disease and/or a family history of hereditary retinal disease
  • Patients with a history of drug-induced retinopathies
  • Patients with a history of surgically or laser-treated diabetic retinopathy

• Patients with atypical parkinsonian syndromes due to drugs, metabolic disorders, encephalitis or degenerative diseases (e.g. progressive, supranuclear palsy, multisystem atrophy)

• Dementia or other disorders that could impair the signing of informed consent

• Patients who are participating in other drug studies or who receive other investigational drugs within 30 days prior to the first visit (patients currently participating in ongoing open-label extension trials with pramipexole may be included if they meet the requirement of 30 months treatment duration

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pramixpexole	Pramipexole	-
Bromocriptine and other dopamine agonists	Bromocriptine and other dopamine agonists	-

Primary Outcome Measures

Name	Time	Method
Incidence of drug related signs of retinal degeneration	up to 8 months	based on the evaluation of assessors blind to the treatment allocation

Secondary Outcome Measures

Name	Time	Method
Findings in kinetic perimetry	within 2 month after neurologic visit
Percentage of patients with elevated dark adaptation thresholds	within 2 month after neurologic visit
Number of patients with adverse events	up to 2 month after neurologic visit
Assessment of Parkinson's Disease stage rated of unified Parkinson's Disease Rating Scale (UPDRS) Part IV	within less than 2 months before ophthalmologic visit
Assessment of visual acuity	within 2 month after neurologic visit
Number of abnormal findings in clinical examination in miosis and mydriasis	within 2 month after neurologic visit	including ophthalmoscopy
Assessment of colour vision	within 2 month after neurologic visit	using the Hardy-Rand-Rittler (H-R-R) pseudoisochromatic plates
Findings in standardised electroretinography (ERG)	within 2 monhts after neurologic visit	performed according to International Standardization Committee for the Electrophysiology of Vision (ISCEV) standard
Assessment of ophthalmological history	within 2 month after neurologic visit
Assessment of intraocular pressure (mmHg)	within 2 month after neurologic visit
Assessment of Parkinson's Disease stage rated by modified Hoehn and Yahr Scale	within less than 2 months before ophthalmologic visit