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

Condition(s) targeted: Parkinson Disease

Intervention: Pramipexole (Drug); Bromocriptine and other dopamine agonists (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Boehringer Ingelheim

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

Official 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

Study design: Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Incidence of drug related signs of retinal degeneration

Secondary outcome:

Assessment of ophthalmological history

Assessment of visual acuity

Number of abnormal findings in clinical examination in miosis and mydriasis

Assessment of intraocular pressure (mmHg)

Assessment of colour vision

Findings in kinetic perimetry

Percentage of patients with elevated dark adaptation thresholds

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

Assessment of Parkinson's Disease stage rated of unified Parkinson's Disease Rating Scale (UPDRS) Part IV

Number of patients with adverse events

Findings in standardised electroretinography (ERG)

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Starting date: June 1998
Last updated: September 4, 2014