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OpenTrials
Completed

NCT Number: NCT02233023

Ophthalmologic Safety of Long Term 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

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pramipexole

Drug

Bromocriptine and other dopamine agonists

Drug

Primary outcomes

  1. 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 outcomes

  1. Assessment of ophthalmological history

    Time frame: within 2 month after neurologic visit

  2. Assessment of visual acuity

    Time frame: within 2 month after neurologic visit

  3. Number of abnormal findings in clinical examination in miosis and mydriasis

    Time frame: within 2 month after neurologic visit

    including ophthalmoscopy

  4. Assessment of intraocular pressure (mmHg)

    Time frame: within 2 month after neurologic visit

  5. Assessment of colour vision

    Time frame: within 2 month after neurologic visit

    using the Hardy-Rand-Rittler (H-R-R) pseudoisochromatic plates

  6. Findings in kinetic perimetry

    Time frame: within 2 month after neurologic visit

  7. Percentage of patients with elevated dark adaptation thresholds

    Time frame: within 2 month after neurologic visit

  8. Assessment of Parkinson's Disease stage rated by modified Hoehn and Yahr Scale

    Time frame: within less than 2 months before ophthalmologic visit

  9. 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

  10. Number of patients with adverse events

    Time frame: up to 2 month after neurologic visit

  11. 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

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

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

Important dates

Study start
1998
Primary completion
2000
First posted
Sep 8, 2014
Registry last updated
Sep 8, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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