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

NCT02233023 | Completed Phase 4

• 1 other identifier: 248.342
• Study Type: interventional
• Target: 705
• Locations: 0 countries
• Sites: N/A

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

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

• Incidence of drug related signs of retinal degeneration

  based on the evaluation of assessors blind to the treatment allocation

  up to 8 months

Secondary Outcomes (11)

• 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

• Assessment of intraocular pressure (mmHg)

  within 2 month after neurologic visit

• Assessment of colour vision

  within 2 month after neurologic visit

Study Arms (2)

Pramixpexole

EXPERIMENTAL

Drug: Pramipexole

Bromocriptine and other dopamine agonists

ACTIVE COMPARATOR

Drug: Bromocriptine and other dopamine agonists

Interventions

Pramipexole DRUG

Pramixpexole

Bromocriptine and other dopamine agonists DRUG

Bromocriptine and other dopamine agonists

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Conditions

Parkinson Disease

Interventions

Pramipexole; Bromocriptine

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Benzothiazoles; Thiazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Ergotamines; Ergot Alkaloids; Alkaloids; Ergolines; Heterocyclic Compounds, 4 or More Rings

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2014
• First Posted: September 8, 2014
• Study Start: June 1, 1998
• Primary Completion: June 1, 2000
• Last Updated: September 8, 2014

Record last verified: 2014-09