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

Parkinson Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02233023
• Other study ID #: 248.342
• Status: Completed
• Phase: Phase 4
• First received: September 4, 2014
• Last updated: September 4, 2014
• Start date: June 1998

Study information

• Verified date: September 2014
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesBelgium: Federal Agency for Medicinal Products and Health ProductsDenmark: Danish Health and Medicines AuthorityAustria: Agency for Health and Food SafetyItaly: The Italian Medicines AgencySpain: Agencia Española de Medicamentos y Productos SanitariosSweden: Medical Products AgencySwitzerland: Federal Office of Public HealthNetherlands: Medicines Evaluation Board (MEB)United Kingdom: Medicines and Healthcare Products Regulatory AgencyIreland: Health Products Regulatory Authority (HPRA)
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 705
• Est. primary completion date: June 2000
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Drug:
• Pramipexole

• Bromocriptine and other dopamine agonists

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of drug related signs of retinal degeneration	based on the evaluation of assessors blind to the treatment allocation	up to 8 months	No
Secondary	Assessment of ophthalmological history		within 2 month after neurologic visit	No
Secondary	Assessment of visual acuity		within 2 month after neurologic visit	No
Secondary	Number of abnormal findings in clinical examination in miosis and mydriasis	including ophthalmoscopy	within 2 month after neurologic visit	No
Secondary	Assessment of intraocular pressure (mmHg)		within 2 month after neurologic visit	No
Secondary	Assessment of colour vision	using the Hardy-Rand-Rittler (H-R-R) pseudoisochromatic plates	within 2 month after neurologic visit	No
Secondary	Findings in kinetic perimetry		within 2 month after neurologic visit	No
Secondary	Percentage of patients with elevated dark adaptation thresholds		within 2 month after neurologic visit	No
Secondary	Assessment of Parkinson's Disease stage rated by modified Hoehn and Yahr Scale		within less than 2 months before ophthalmologic visit	No
Secondary	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	No
Secondary	Number of patients with adverse events		up to 2 month after neurologic visit	No
Secondary	Findings in standardised electroretinography (ERG)	performed according to International Standardization Committee for the Electrophysiology of Vision (ISCEV) standard	within 2 monhts after neurologic visit	No

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