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

Matched Pair, Assessor Blinded, Open Label Clinical Trial to Assess the Ophthalmologic Safety of Long Term Oral Treatment With Pramipexole Compared to Bromocriptine or Other Dopamine Agonists in Patients With Parkinson's Disease

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

Study Overview

• Status: Completed
• Conditions: Parkinson Disease
• Intervention / Treatment: Drug: Pramipexole; Drug: Bromocriptine and other dopamine agonists

• Study Type: Interventional
• Enrollment (Actual): 705
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pramixpexole	Drug: Pramipexole
Active Comparator: Bromocriptine and other dopamine agonists	Drug: Bromocriptine and other dopamine agonists

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of drug related signs of retinal degeneration	based on the evaluation of assessors blind to the treatment allocation	up to 8 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of ophthalmological history		within 2 month after neurologic visit
Assessment of visual acuity		within 2 month after neurologic visit
Number of abnormal findings in clinical examination in miosis and mydriasis	including ophthalmoscopy	within 2 month after neurologic visit
Assessment of intraocular pressure (mmHg)		within 2 month after neurologic visit
Assessment of colour vision	using the Hardy-Rand-Rittler (H-R-R) pseudoisochromatic plates	within 2 month after neurologic visit
Findings in kinetic perimetry		within 2 month after neurologic visit
Percentage of patients with elevated dark adaptation thresholds		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
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
Number of patients with adverse events		up to 2 month after neurologic visit
Findings in standardised electroretinography (ERG)	performed according to International Standardization Committee for the Electrophysiology of Vision (ISCEV) standard	within 2 monhts after neurologic visit

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: June 1, 1998
• Primary Completion (Actual): June 1, 2000

Study Registration Dates

• First Submitted: September 4, 2014
• First Submitted That Met QC Criteria: September 4, 2014
• First Posted (Estimate): September 8, 2014

Study Record Updates

• Last Update Posted (Estimate): September 8, 2014
• Last Update Submitted That Met QC Criteria: September 4, 2014
• Last Verified: September 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Hormones, Hormone Substitutes, and Hormone Antagonists; Protective Agents; Cardiotonic Agents; Dopamine Agents; Hormone Antagonists; Antioxidants; Sympathomimetics; Antiparkinson Agents; Anti-Dyskinesia Agents; Dopamine; Pramipexole; Bromocriptine; Dopamine Agonists
• Other Study ID Numbers: 248.342