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

Sponsor

Boehringer Ingelheim (Industry)

Overall Status

Completed

CT.gov ID

NCT02233023

Collaborator

(none)

705

Enrollment

Arms

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Parkinson Disease	Drug: Pramipexole Drug: Bromocriptine and other dopamine agonists	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

705 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Jun 1, 1998

Actual Primary Completion Date :

Jun 1, 2000

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Pramixpexole

Drug: Pramipexole

Active Comparator: Bromocriptine and other dopamine agonists

Drug: Bromocriptine and other dopamine agonists

Outcome Measures

Primary Outcome Measures

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

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 [within 2 month after neurologic visit]
including ophthalmoscopy
Assessment of intraocular pressure (mmHg) [within 2 month after neurologic visit]
Assessment of colour vision [within 2 month after neurologic visit]
using the Hardy-Rand-Rittler (H-R-R) pseudoisochromatic plates
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) [within 2 monhts after neurologic visit]
performed according to International Standardization Committee for the Electrophysiology of Vision (ISCEV) standard

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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