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

Primary Purpose

Parkinson Disease

Status

Completed

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

Pramipexole

Bromocriptine and other dopamine agonists

About this trial

This is an interventional treatment trial for Parkinson Disease

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Pramixpexole

Bromocriptine and other dopamine agonists

Arm Description

Outcomes

Primary Outcome Measures

Incidence of drug related signs of retinal degeneration

based on the evaluation of assessors blind to the treatment allocation

Secondary Outcome Measures

Assessment of ophthalmological history

Assessment of visual acuity

Number of abnormal findings in clinical examination in miosis and mydriasis

including ophthalmoscopy

Assessment of intraocular pressure (mmHg)

Assessment of colour vision

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

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)

performed according to International Standardization Committee for the Electrophysiology of Vision (ISCEV) standard

Full Information

NCT ID

NCT02233023

First Posted

September 4, 2014

Last Updated

September 4, 2014

Sponsor

Boehringer Ingelheim

1. Study Identification

Unique Protocol Identification Number

NCT02233023

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

September 2014

Overall Recruitment Status

Completed

Study Start Date

June 1998 (undefined)

Primary Completion Date

June 2000 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Boehringer Ingelheim

4. Oversight

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Parkinson Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

705 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Pramixpexole

Arm Type

Experimental

Arm Title

Bromocriptine and other dopamine agonists

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Pramipexole

Intervention Type

Drug

Intervention Name(s)

Bromocriptine and other dopamine agonists

Primary Outcome Measure Information:

Title

Incidence of drug related signs of retinal degeneration

Description

based on the evaluation of assessors blind to the treatment allocation

Time Frame

up to 8 months

Secondary Outcome Measure Information:

Title

Assessment of ophthalmological history

Time Frame