Parkinson DiseasePhase 4NCT00144300
Ophthalmologic Safety Study of Pramipexole Immediate Release (IR) Versus Ropinirole in Early Parkinson's Disease (PD) Patients
A Phase 4 study testing Mirapex and Requip in people with Parkinson Disease, run by Boehringer Ingelheim at 21 sites in United States.
Trial summary
To determine if there is any difference in the presence of retinal deterioration in PD patients treated with pramipexole IR versus ropinirole as monitored by comprehensive ophthalmologic assessments from baseline to the end of study at two years. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Mirapex and Requip
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 246 participants
- Where
- 21 sitesUnited States
- Study dates
- Jan 2005to Sep 2010
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis and main criteria for inclusion. Patients must meet all of the following inclusion criteria to be eligible for enrollment into the study:
- Patients with idiopathic Parkinson's disease of less than 7 years characterized as Stage I-III by the Modified Hoehn and Yahr Scale and with a maximum of 6 months cumulative lifetime exposure to levodopa and/or dopamine agonist. Patients on current dopamine agonist therapy would require 14-day washout.
- Age at least 30 years.
- Women of childbearing potential must have a negative serum beta-HCG pregnancy test at the Screen (Baseline) visit and the patient must use adequate contraceptive methods.
- Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
- Patients who are willing and able to comply with scheduled visits, treatment plan, and other study procedures.
Who cannot join
- Main criteria for exclusion. The presence of any of the following would make a patient ineligible for enrollment into the study:
- Previous history of allergic response or complications with any dopaminergic agonist drug
- Atypical PD syndromes
- History of stereotactic brain surgery
- Positive hepatitis B (surface antigen) or hepatitis C (antibody)
- Surgery within 180 days of randomization which would negatively impact participation
Show all 27Show fewer
- Folstein's Mini Mental State Examination (MMSE) score of 24 or less
- History of active epilepsy (seizure) in the past 1 year
- Third degree AV block or sick sinus syndrome
- Congestive heart failure, Class III or IV
- Unstable heart disease such as unstable angina, dysrhythmia, or myocardial infarction in prior 6 months
- Symptomatic orthostatic hypotension
- Clinically significant liver disease or renal disease
- Malignant melanoma or history of previously treated malignant melanoma.
- Prohibited medications taken (including any drug known to have potential retino-toxic effects taken in the prior 12 months; neuroleptics taken within prior 6 months, MAO inhibitors except rasagiline or selegiline taken within prior 3 months, beta-blockers taken to treat Parkinson's disease in the prior 30 days, and Coenzyme Q10 taken within 14 days)
- Albinism/Albinoidism of any degree, type or syndrome
- History of glaucoma with or without treatment
- Inherited or acquired retinopathy such as age-related macular degeneration with visual loss
- Sarcoidosis
- Diabetes mellitus of any degree even if diet or insulin controlled
- Best corrected visual acuity (BCVA) of less than 20/40 by ETDRS
- Refractive error of greater than minus-6 diopters
- Abnormal electroretinogram (ERG)
- Unable to dilate pupils
- History of severe eye trauma that might affect the outcome of the study
- History of psychosis
- Participation in other investigational drug studies or use of investigational drugs within prior 30 days
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
United States21 sites
248.538.00013 Boehringer Ingelheim Investigational Site
Atlanta, Georgia
248.538.00009 Boehringer Ingelheim Investigational Site
Augusta, Georgia
248.538.00005 Boehringer Ingelheim Investigational Site
Baltimore, Maryland
248.538.00007 Boehringer Ingelheim Investigational Site
Birmingham, Alabama
248.538.00012 Boehringer Ingelheim Investigational Site
Charlotte, North Carolina
248.538.00011 Boehringer Ingelheim Investigational Site
Chicago, Illinois
248.538.00021 Boehringer Ingelheim Investigational Site
Fountain Valley, California
248.538.00003 Boehringer Ingelheim Investigational Site
Houston, Texas
248.538.00008 Boehringer Ingelheim Investigational Site
Little Rock, Arkansas
248.538.00022 Boehringer Ingelheim Investigational Site
Los Angeles, California
248.538.00004 Boehringer Ingelheim Investigational Site
Memphis, Tennessee
248.538.00002 Boehringer Ingelheim Investigational Site
Miami, Florida
248.538.00017 Boehringer Ingelheim Investigational Site
Morgantown, West Virginia
248.538.00001 Boehringer Ingelheim Investigational Site
New Haven, Connecticut
248.538.00010 Boehringer Ingelheim Investigational Site
New York, New York
248.538.00015 Boehringer Ingelheim Investigational Site
New York, New York
248.538.00020 Boehringer Ingelheim Investigational Site
New York, New York
248.538.00006 Boehringer Ingelheim Investigational Site
Philadelphia, Pennsylvania
248.538.00014 Boehringer Ingelheim Investigational Site
Southfield, Michigan
248.538.00016 Boehringer Ingelheim Investigational Site
Tampa, Florida
248.538.00023 Boehringer Ingelheim Investigational Site
Tampa, Florida
About this study
Official title: A Two Year Open Label, Randomized, Parallel Group, Blinded Assessment Ophthalmologic Safety Study of Pramipexole IR Versus Ropinirole in Early Parkinson's Disease Patients
To determine if there is any difference in the presence of retinal deterioration in PD patients treated with pramipexole IR versus ropinirole as monitored by comprehensive ophthalmologic assessments from baseline to the end of study at two years.
- Conditions
- Parkinson Disease
- Being tested
- Mirapex, Requip
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MirapexDrug
Standard marketed product dispensed according to manufacturer's guidelines
RequipDrug
Standard marketed product dispensed according to manufacturer's guidelines
| Study group | Role | What they receive |
|---|---|---|
| Mirapex | Active comparator | Mirapex tablets three times daily (TID) dosing according to manufacturer's guidelines Receives: Drug: Mirapex |
| Requip | Active comparator | Requip tablets three times daily (TID) dosing according to manufacturer's guidelines Receives: Drug: Requip |
What is being measured
The primary outcome is the main question the study is designed to answer.
Expert Panel Overall Assessment Following 2 Years on Drug
Expert panel of ophthalmologists assessed retinal deterioration by a review of the components of the comprehensive ophthalmology assessments
Measured: up to 2 years
Secondary outcomes (20)
Expert Panel Overall Assessment Following 1 Year on Drug
Expert panel of ophthalmologists assessed retinal deterioration by a review of the components of the comprehensive ophthalmology assessments
Measured: up to 1 years
Hoehn and Yahr Scale at Baseline
This scale is an investigator-completed assessment of the degree of complications arising from Parkinson's disease. The scale ranges from 0 (No signs) to 5 (Bedridden)
Measured: Baseline
Hoehn and Yahr Scale at 1 Year
This scale is an investigator-completed assessment of the degree of complications arising from Parkinson's disease. The scale ranges from 0 (No signs) to 5 (Bedridden)
Measured: Up to 1 year
Hoehn and Yahr Scale at 2 Years
This scale is an investigator-completed assessment of the degree of complications arising from Parkinson's disease. The scale ranges from 0 (No signs) to 5 (Bedridden)
Measured: Up to 2 years
Unified Parkinson's Disease Rating Scale (UPDRS), Part II, Total Score at Baseline
Part II of the UPDRS collected retrospective information on patient functioning in various activities of daily living. Individual items scored from 0 (Normal) to 4 (Extreme dysfunction). The total score ranged from 0 to 52.
Measured: Baseline
Unified Parkinson's Disease Rating Scale (UPDRS), Part II, Total Score at 1 Year
Part II of the UPDRS collected retrospective information on patient functioning in various activities of daily living. Individual items scored from 0 (Normal) to 4 (Extreme dysfunction). The total score ranged from 0 to 52.
Measured: 1 year
Unified Parkinson's Disease Rating Scale (UPDRS), Part II, Change From Baseline in Total Score at 1 Year
Part II of the UPDRS collected retrospective information on patient functioning in various activities of daily living. Individual items scored from 0 (Normal) to 4 (Extreme dysfunction). The total score ranged from 0 to 52.
Measured: Baseline, 1 year
Unified Parkinson's Disease Rating Scale (UPDRS), Part II, Total Score at 2 Years
Part II of the UPDRS collected retrospective information on patient functioning in various activities of daily living. Individual items scored from 0 (Normal) to 4 (Extreme dysfunction). The total score ranged from 0 to 52.
Measured: 2 years
Unified Parkinson's Disease Rating Scale (UPDRS), Part II, Change From Baseline in Total Score at 2 Years
Part II of the UPDRS collected retrospective information on patient functioning in various activities of daily living. Individual items scored from 0 (Normal) to 4 (Extreme dysfunction). The total score ranged from 0 to 52.
Measured: Baseline, 2 year
Unified Parkinson's Disease Rating Scale (UPDRS), Part III, Total Score at Baseline
Part III of the UPDRS contained the clinician-scored motor evaluation. Individual items scored from 0 (Normal) to 4 (Extreme dysfunction). The total score ranged from 0 to 56.
Measured: Baseline
Unified Parkinson's Disease Rating Scale (UPDRS), Part III, Total Score at 1 Year
Part III of the UPDRS contained the clinician-scored motor evaluation. Individual items scored from 0 (Normal) to 4 (Extreme dysfunction). The total score ranged from 0 to 56.
Measured: 1 year
Unified Parkinson's Disease Rating Scale (UPDRS), Part III, Change From Baseline in Total Score at 1 Year
Part III of the UPDRS contained the clinician-scored motor evaluation. Individual items scored from 0 (Normal) to 4 (Extreme dysfunction). The total score ranged from 0 to 56.
Measured: Baseline, 1 year
Unified Parkinson's Disease Rating Scale (UPDRS), Part III, Total Score at 2 Years
Part III of the UPDRS contained the clinician-scored motor evaluation. Individual items scored from 0 (Normal) to 4 (Extreme dysfunction). The total score ranged from 0 to 56.
Measured: 2 years
Unified Parkinson's Disease Rating Scale (UPDRS), Part III, Change From Baseline in Total Score at 2 Years
Part III of the UPDRS contained the clinician-scored motor evaluation. Individual items scored from 0 (Normal) to 4 (Extreme dysfunction). The total score ranged from 0 to 56.
Measured: Baseline, 2 year
Unified Parkinson's Disease Rating Scale (UPDRS), Parts II and III, Total Score at Baseline
This is the sum of Part II and Part III of the UPDRS. The total score ranged from 0 (Normal) to 108 (Extreme dysfunction).
Measured: Baseline
Unified Parkinson's Disease Rating Scale (UPDRS), Parts II and III, Total Score at 1 Year
This is the sum of Part II and Part III of the UPDRS. The total score ranged from 0 (Normal) to 108 (Extreme dysfunction).
Measured: 1 year
Unified Parkinson's Disease Rating Scale (UPDRS), Parts II and III, Change From Baseline in Total Score at 1 Year
This is the sum of Part II and Part III of the UPDRS. The total score ranged from 0 (Normal) to 108 (Extreme dysfunction).
Measured: Baseline, 1 year
Unified Parkinson's Disease Rating Scale (UPDRS), Parts II and III, Total Score at 2 Years
This is the sum of Part II and Part III of the UPDRS. The total score ranged from 0 (Normal) to 108 (Extreme dysfunction).
Measured: 2 years
Unified Parkinson's Disease Rating Scale (UPDRS), Parts II and III, Change From Baseline in Total Score at 2 Years
This is the sum of Part II and Part III of the UPDRS. The total score ranged from 0 (Normal) to 108 (Extreme dysfunction).
Measured: Baseline, 2 year
Clinical Abnormal Findings: Clinical Laboratory Evaluations (Biochemistry and Haematology)and Vital Signs
Clinical relevant abnormalities for clinical laboratory evaluations Biochemistry and Haematology) and Vital Signs. New abnormal findings or worsening of baseline conditions were reported.
Measured: Screen (Baseline) and final visit (24 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2005 (estimated)
- Study startJan 2005
- Primary completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 246 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Boehringer Ingelheim, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00144300
- Sponsor's protocol ID
- 248.538
- Status last verified
- Feb 2014
- First submitted
- 2 Sep 2005
- Last updated
- 14 Mar 2014
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Seiple W, Jennings D, Rosen RB, Borchert L, Canale L, Fagan N, Gordon MF. Ophthalmologic Baseline Characteristics and 2-Year Ophthalmologic Safety Profile of Pramipexole IR Compared with Ropinirole IR in Patients with Early Parkinson's Disease. Parkinsons Dis. 2016;2016:8298503. doi: 10.1155/2016/8298503. Epub 2016 Dec 18.
PubMed 28078162
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two Year Open Label, Randomized, Parallel Group, Blinded Assessment Ophthalmologic Safety Study of Pramipexole IR Versus Ropinirole in Early Parkinson's Disease Patients
- ClinicalTrials.gov ID
- NCT00144300
- Acronym / sponsor ID
- 248.538
- Conditions
- Parkinson Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 246 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jan 2005
- Primary completion
- Sep 2010 (actual)
- First posted
- 5 Sep 2005 (estimated)
- Results
- Posted 4 Nov 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine if there is any difference in the presence of retinal deterioration in PD patients treated with pramipexole IR versus ropinirole as monitored by comprehensive ophthalmologic assessments from baseline to the end of study at two years.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mirapex | Active comparator | Drug: MirapexMirapex tablets three times daily (TID) dosing according to manufacturer's guidelines |
| Requip | Active comparator | Drug: RequipRequip tablets three times daily (TID) dosing according to manufacturer's guidelines |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis and main criteria for inclusion. Patients must meet all of the following inclusion criteria to be eligible for enrollment into the study:
- Patients with idiopathic Parkinson's disease of less than 7 years characterized as Stage I-III by the Modified Hoehn and Yahr Scale and with a maximum of 6 months cumulative lifetime exposure to levodopa and/or dopamine agonist. Patients on current dopamine agonist therapy would require 14-day washout.
- Age at least 30 years.
- Women of childbearing potential must have a negative serum beta-HCG pregnancy test at the Screen (Baseline) visit and the patient must use adequate contraceptive methods.
- Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
Key exclusion criteria (27 listed)
- Main criteria for exclusion. The presence of any of the following would make a patient ineligible for enrollment into the study:
- Previous history of allergic response or complications with any dopaminergic agonist drug
- Atypical PD syndromes
- History of stereotactic brain surgery
- Positive hepatitis B (surface antigen) or hepatitis C (antibody)
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 |
|---|---|---|
| MirapexStandard marketed product dispensed according to manufacturer's guidelines | Drug | Mirapex |
| RequipStandard marketed product dispensed according to manufacturer's guidelines | Drug | Requip |
Primary outcome
Expert Panel Overall Assessment Following 2 Years on Drug
Time frame: up to 2 years
Expert panel of ophthalmologists assessed retinal deterioration by a review of the components of the comprehensive ophthalmology assessments
20 secondary outcomes
Expert Panel Overall Assessment Following 1 Year on Drug
Time frame: up to 1 years
Hoehn and Yahr Scale at Baseline
Time frame: Baseline
Hoehn and Yahr Scale at 1 Year
Time frame: Up to 1 year
Hoehn and Yahr Scale at 2 Years
Time frame: Up to 2 years
Unified Parkinson's Disease Rating Scale (UPDRS), Part II, Total Score at Baseline
Time frame: Baseline
Unified Parkinson's Disease Rating Scale (UPDRS), Part II, Total Score at 1 Year
Time frame: 1 year
Unified Parkinson's Disease Rating Scale (UPDRS), Part II, Change From Baseline in Total Score at 1 Year
Time frame: Baseline, 1 year
Unified Parkinson's Disease Rating Scale (UPDRS), Part II, Total Score at 2 Years
Time frame: 2 years
Unified Parkinson's Disease Rating Scale (UPDRS), Part II, Change From Baseline in Total Score at 2 Years
Time frame: Baseline, 2 year
Unified Parkinson's Disease Rating Scale (UPDRS), Part III, Total Score at Baseline
Time frame: Baseline
Unified Parkinson's Disease Rating Scale (UPDRS), Part III, Total Score at 1 Year
Time frame: 1 year
Unified Parkinson's Disease Rating Scale (UPDRS), Part III, Change From Baseline in Total Score at 1 Year
Time frame: Baseline, 1 year
Unified Parkinson's Disease Rating Scale (UPDRS), Part III, Total Score at 2 Years
Time frame: 2 years
Unified Parkinson's Disease Rating Scale (UPDRS), Part III, Change From Baseline in Total Score at 2 Years
Time frame: Baseline, 2 year
Unified Parkinson's Disease Rating Scale (UPDRS), Parts II and III, Total Score at Baseline
Time frame: Baseline
Unified Parkinson's Disease Rating Scale (UPDRS), Parts II and III, Total Score at 1 Year
Time frame: 1 year
Unified Parkinson's Disease Rating Scale (UPDRS), Parts II and III, Change From Baseline in Total Score at 1 Year
Time frame: Baseline, 1 year
Unified Parkinson's Disease Rating Scale (UPDRS), Parts II and III, Total Score at 2 Years
Time frame: 2 years
Unified Parkinson's Disease Rating Scale (UPDRS), Parts II and III, Change From Baseline in Total Score at 2 Years
Time frame: Baseline, 2 year
Clinical Abnormal Findings: Clinical Laboratory Evaluations (Biochemistry and Haematology)and Vital Signs
Time frame: Screen (Baseline) and final visit (24 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28078162Seiple W, Jennings D, Rosen RB, Borchert L, Canale L, Fagan N, Gordon MF. Ophthalmologic Baseline Characteristics and 2-Year Ophthalmologic Safety Profile of Pramipexole IR Compared with Ropinirole IR in Patients with Early Parkinson's Disease. Parkinsons Dis. 2016;2016:8298503. doi: 10.1155/2016/8298503. Epub 2016 Dec 18.
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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.
Boehringer Ingelheim study chair
Boehringer Ingelheim
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Mirapex and Requip in people with Parkinson Disease, run by Boehringer Ingelheim at 21 sites in United States.
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 6 inclusion and 27 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 14 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 4 Nov 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Expert Panel Overall Assessment Following 2 Years on Drug (time frame: up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00144300, which also lists 1 linked publication.
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 14 Mar 2014.