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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

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ClinicalTrials.gov Identifier: NCT02233023
Recruitment Status : Completed
First Posted : September 8, 2014
Last Update Posted : September 8, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

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

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Study Type : Interventional  (Clinical Trial)
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 : June 1998
Actual Primary Completion Date : June 2000


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



Primary Outcome Measures :
  1. Incidence of drug related signs of retinal degeneration [ Time Frame: up to 8 months ]
    based on the evaluation of assessors blind to the treatment allocation


Secondary Outcome Measures :
  1. Assessment of ophthalmological history [ Time Frame: within 2 month after neurologic visit ]
  2. Assessment of visual acuity [ Time Frame: within 2 month after neurologic visit ]
  3. Number of abnormal findings in clinical examination in miosis and mydriasis [ Time Frame: within 2 month after neurologic visit ]
    including ophthalmoscopy

  4. Assessment of intraocular pressure (mmHg) [ Time Frame: within 2 month after neurologic visit ]
  5. Assessment of colour vision [ Time Frame: within 2 month after neurologic visit ]
    using the Hardy-Rand-Rittler (H-R-R) pseudoisochromatic plates

  6. Findings in kinetic perimetry [ Time Frame: within 2 month after neurologic visit ]
  7. Percentage of patients with elevated dark adaptation thresholds [ Time Frame: within 2 month after neurologic visit ]
  8. Assessment of Parkinson's Disease stage rated by modified Hoehn and Yahr Scale [ Time Frame: within less than 2 months before ophthalmologic visit ]
  9. Assessment of Parkinson's Disease stage rated of unified Parkinson's Disease Rating Scale (UPDRS) Part IV [ Time Frame: within less than 2 months before ophthalmologic visit ]
  10. Number of patients with adverse events [ Time Frame: up to 2 month after neurologic visit ]
  11. Findings in standardised electroretinography (ERG) [ Time Frame: within 2 monhts after neurologic visit ]
    performed according to International Standardization Committee for the Electrophysiology of Vision (ISCEV) standard



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Additional Information:
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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02233023    
Other Study ID Numbers: 248.342
First Posted: September 8, 2014    Key Record Dates
Last Update Posted: September 8, 2014
Last Verified: September 2014
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases
Dopamine
Pramipexole
Bromocriptine
Dopamine Agonists
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Cardiotonic Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists