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

Overview

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

Full Title of Study: “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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 2000

Interventions

  • Drug: Pramipexole
  • Drug: Bromocriptine and other dopamine agonists

Arms, Groups and Cohorts

  • Experimental: Pramixpexole
  • Active Comparator: Bromocriptine and other dopamine agonists

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Boehringer Ingelheim
  • Provider of Information About this Clinical Study
    • Sponsor

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