Parkinson DiseasePhase 4NCT02233023
Ophthalmologic Safety of Long Term Treatment With Pramipexole Compared to Bromocriptine or Other Dopamine Agonists in Patients With Parkinson's Disease
A Phase 4 study testing Pramipexole and Bromocriptine and other dopamine agonists in people with Parkinson Disease, run by Boehringer Ingelheim.
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 Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Pramipexole and Bromocriptine and other dopamine agonists
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 705 participants
- Where
- No sites listed yet
- Study dates
- Jun 1998to Jun 2000
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
About this study
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 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
- Being tested
- Pramipexole, Bromocriptine and other dopamine agonists
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PramipexoleDrug
Bromocriptine and other dopamine agonistsDrug
| Study group | Role | What they receive |
|---|---|---|
| Pramixpexole | Experimental | Not described Receives: Drug: Pramipexole |
| Bromocriptine and other dopamine agonists | Active comparator | Not described Receives: Drug: Bromocriptine and other dopamine agonists |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of drug related signs of retinal degeneration
based on the evaluation of assessors blind to the treatment allocation
Measured: up to 8 months
Secondary outcomes (11)
Assessment of ophthalmological history
Measured: within 2 month after neurologic visit
Assessment of visual acuity
Measured: within 2 month after neurologic visit
Number of abnormal findings in clinical examination in miosis and mydriasis
including ophthalmoscopy
Measured: within 2 month after neurologic visit
Assessment of intraocular pressure (mmHg)
Measured: within 2 month after neurologic visit
Assessment of colour vision
using the Hardy-Rand-Rittler (H-R-R) pseudoisochromatic plates
Measured: within 2 month after neurologic visit
Findings in kinetic perimetry
Measured: within 2 month after neurologic visit
Percentage of patients with elevated dark adaptation thresholds
Measured: within 2 month after neurologic visit
Assessment of Parkinson's Disease stage rated by modified Hoehn and Yahr Scale
Measured: 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
Measured: within less than 2 months before ophthalmologic visit
Number of patients with adverse events
Measured: up to 2 month after neurologic visit
Findings in standardised electroretinography (ERG)
performed according to International Standardization Committee for the Electrophysiology of Vision (ISCEV) standard
Measured: within 2 monhts after neurologic visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2014 (estimated)
- Study startJun 1998
- Primary completionJun 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 705 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02233023
- Sponsor's protocol ID
- 248.342
- Status last verified
- Sep 2014
- First submitted
- 4 Sep 2014
- Last updated
- 8 Sep 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02233023
- Acronym / sponsor ID
- 248.342
- Conditions
- Parkinson Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 705 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jun 1998
- Primary completion
- Jun 2000 (actual)
- First posted
- 8 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pramixpexole | Experimental | Drug: Pramipexole |
| Bromocriptine and other dopamine agonists | Active comparator | Drug: Bromocriptine and other dopamine agonists |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- 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 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pramipexole | Drug | Pramixpexole |
| Bromocriptine and other dopamine agonists | Drug | Bromocriptine and other dopamine agonists |
Primary outcome
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
11 secondary outcomes
Assessment of ophthalmological history
Time frame: within 2 month after neurologic visit
Assessment of visual acuity
Time frame: within 2 month after neurologic visit
Number of abnormal findings in clinical examination in miosis and mydriasis
Time frame: within 2 month after neurologic visit
Assessment of intraocular pressure (mmHg)
Time frame: within 2 month after neurologic visit
Assessment of colour vision
Time frame: within 2 month after neurologic visit
Findings in kinetic perimetry
Time frame: within 2 month after neurologic visit
Percentage of patients with elevated dark adaptation thresholds
Time frame: within 2 month after neurologic visit
Assessment of Parkinson's Disease stage rated by modified Hoehn and Yahr Scale
Time frame: 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
Time frame: within less than 2 months before ophthalmologic visit
Number of patients with adverse events
Time frame: up to 2 month after neurologic visit
Findings in standardised electroretinography (ERG)
Time frame: within 2 monhts after neurologic visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pramipexole and Bromocriptine and other dopamine agonists in people with Parkinson Disease, run by Boehringer Ingelheim.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of drug related signs of retinal degeneration (time frame: up to 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2014.