Parkinson DiseasePhase 3NCT00465452
Impact of Switching to Continuous Release Dopamine Agonists
A Phase 3 study testing Continuous Release Dopamine Agonists in people with Parkinson Disease, run by University of Toledo at 1 site in United States.
Trial summary
The purpose of this proposal is to determine if switching PD patients treated with pramipexole to ropinirole CR reduces the non-motor side effects frequently experienced by these patients. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Continuous Release Dopamine Agonists
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2007to Dec 2011
- Phase
- Phase 3
- 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Each subject must meet all of the following inclusion criteria to qualify for entrance into the study:
- Subjects who are male or female and are aged 55 and older.
- Subjects and/or their legal guardians must be able and willing to give informed consent.
- Subjects must be on stable doses of pramipexole for greater than 4 weeks duration prior to screening.
- Subjects who are female must be non-pregnant and non-nursing. Women of Child-Bearing Potential (WOCBP) must use a reliable method of contraception (e.g., oral contraceptive or long-term injectable or implantable hormonal contraceptive, double-barrier methods, such as condom and diaphragm, condom and foam, condom and sponge or intra-uterine devices) and have a negative serum pregnancy test at screening. Women are considered to not be of child-bearing potential if they have been surgically sterilized (physician-documented hysterectomy or tubal ligation) or if they are post-menopausal.
- Subjects must have a clinical diagnosis of Parkinson's based on the presence of at least 2 of the 3 cardinal criteria - rest tremor, bradykinesia, rigidity - and no obvious history of head trauma, stroke, infectious, structural, or metabolic abnormality consistent with an alternative diagnosis to Parkinson's disease.
- Evidence of one or more of the following symptoms: somnolence (ESS score ≥ 9), cognitive decline (MMSE < 24 ± presence of hallucinations (NPI-Q), peripheral edema (present by objective physical exam with baseline ankle and calf circumference measured in centimeters).
Who cannot join
- A subject who meets any of the following criteria will NOT qualify for the study:
- Subjects must not be receiving any treatments for excess somnolence such as amphetamine derivatives, other stimulants or Provigil.
- Subjects with actively treated malignancies, clinically significant heart disease, kidney, liver, or pulmonary disorders will be excluded.
- Subjects with clinical depression who are not receiving stable doses of antidepressant therapy in excess of 4 weeks duration.
- Subjects with history of orthostatic hypotension (>30mm drop in systolic pressure and/or >20mm drop in diastolic pressure) associated with syncope.
- Subjects started within the last 14 days on any drug known to substantially inhibit CYP1A2 (e.g., cimetidine, fluvoxamine) or induce CYP1A2 (e.g.omeprazole) (Note: Subjects already on these agents may be enrolled but must remain on the stable doses of the agents from 14 days prior to the beginning of the study).
- Subjects who have other medical conditions that are considered clinically unstable or that may compromise the safety of the patient during this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Switching to Continuous Release Dopamine Agonists on Non-Motor Side Effects
The purpose of this proposal is to determine if switching PD patients treated with pramipexole to ropinirole CR reduces the non-motor side effects frequently experienced by these patients. Side effects that we will monitor in particular include somnolence, peripheral edema, cognitive decline with and without hallucinations. PD patients followed in the MUO Neurology Clinic who are being treated with pramipexole and have evidence of at least one of the following symptoms: somnolence, cognitive impairment with or without hallucinations, or peripheral edema will be offered the opportunity to participate in this study.
Read the detailed description
The purpose of this proposal is to determine if switching PD patients treated with pramipexole to ropinirole CR reduces the non-motor side effects frequently experienced by these patients. Side effects that we will monitor in particular include somnolence, peripheral edema, cognitive decline with and without hallucinations. PD patients followed in the MUO Neurology Clinic who are being treated with pramipexole and have evidence of at least one of the following symptoms: somnolence, cognitive impairment with or without hallucinations, or peripheral edema will be offered the opportunity to participate in this study.
Fifteen subjects who are currently receiving pramipexole therapy (monotherapy or adjunctive therapy) who are experiencing one or more of the following symptoms: somnolence, cognitive decline with/without hallucinations, and peripheral edema will be asked if they are willing to participate at the time of their clinic visit at the PDMDP.
The crossover from pramipexole to ropinirole CR will be performed over a 2 week interval. During the first week, the initial drug dose will substitute ½ of the pramipexole with ½ of the target dose of ropinirole CR. If subjects are tolerating the drug change, then 100% of the target dose of ropinirole CR (and no pramipexole) will be started in the second week.
- Conditions
- Parkinson Disease
- Being tested
- Continuous Release 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.
Continuous Release Dopamine AgonistsDrug
Also called ropinirole extended release
Continuous Release Dopamine Agonists
| Study group | Role | What they receive |
|---|---|---|
| Continuous Release Dopamine Agonists | Experimental | Continuous Release Dopamine Agonists Receives: Drug: Continuous Release Dopamine Agonists |
What is being measured
The primary outcome is the main question the study is designed to answer.
Unified Parkinson's Disease Rating Scale (UPDRS), Parts 3 (Motor Performance) and 4 (Disability).
The Unified Parkinson's Disease Rating Scale (UPDRS), parts 3 (motor performance) and 4 (disability) are standardized and validated measures of various symptoms of Parkinson's disease - total scores range from 0 to 148 with lower scores representing better Parkinson symptom control and higher scores representing worse symptoms of Parkinson's.
Measured: initial visit and at end of study 24 weeks
Mini-Mental Status Exam (MMSE), the Clock Drawing Test (CDT), the Patient Health Questionnaire (PHQ-9).
The Mini-Mental Status Exam (MMSE) and the Clock Drawing Test (CDT) are standardized and validated measures of cognitive function. The Patient Health Questionnaire (PHQ-9) is a standardized and validated measure of quality of life. The Mini-Mental Status Exam (MMSE) scale is 0-30 with higher numbers indicating improvement. The Clock Drawing Test (CDT) range is 0-10 with higher numbers indicating improvement. the PHQ scale is 0-27 with lower numbers indicating improved outcome.
Measured: initial visit and at end of study 24 weeks
Peripheral Edema, as Measured by Quantitative Assessment of Ankle Edema
The assessment of ankle edema was considered to be a marker of improvement possibly seen in patients who switched from regular pramipexole to extended release ropinirole. .
Measured: initial visit and at end of study 24 weeks
Patient Satisfaction Questionnaire
The patient satisfaction/preference (Patient Satisfaction Questionnaire - PS) scores vary from 0-10 with higher scores indicating greater satisfaction with the med change.
Measured: initial visit and at end of study 24 weeks
Parkinson's Disease Questionnaire (PDQ-39)
The Improvement in quality of life (Parkinson's Disease Questionnaire - PDQ-39 - is a standardized and validated measure of patient quality of life ranging in score from 0-100 with lower scores indicating improvement versus higher scores indicating worsening of QOL.
Measured: initial visit and at end of study 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2007 (estimated)
- Study startJan 2007
- Primary completionMar 2009
- Study completionDec 2011
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.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Toledo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lawrence Elmer, MD, PhD, University of Toledo
- Investigators
- Lawrence Elmer, MD, PhD, Principal investigator, Medical University of Ohio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00465452
- Sponsor's protocol ID
- MUO-04
- Status last verified
- Apr 2025
- First submitted
- 24 Apr 2007
- Last updated
- 16 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Switching to Continuous Release Dopamine Agonists on Non-Motor Side Effects
- ClinicalTrials.gov ID
- NCT00465452
- Acronym / sponsor ID
- MUO-04
- Conditions
- Parkinson Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of ToledoUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Mar 2009 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 25 Apr 2007 (estimated)
- Results
- Posted 16 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this proposal is to determine if switching PD patients treated with pramipexole to ropinirole CR reduces the non-motor side effects frequently experienced by these patients. Side effects that we will monitor in particular include somnolence, peripheral edema, cognitive decline with and without hallucinations. PD patients followed in the MUO Neurology Clinic who are being treated with pramipexole and have evidence of at least one of the following symptoms: somnolence, cognitive impairment with or without hallucinations, or peripheral edema will be offered the opportunity to participate in this study.
Detailed description
The purpose of this proposal is to determine if switching PD patients treated with pramipexole to ropinirole CR reduces the non-motor side effects frequently experienced by these patients. Side effects that we will monitor in particular include somnolence, peripheral edema, cognitive decline with and without hallucinations. PD patients followed in the MUO Neurology Clinic who are being treated with pramipexole and have evidence of at least one of the following symptoms: somnolence, cognitive impairment with or without hallucinations, or peripheral edema will be offered the opportunity to participate in this study.
Fifteen subjects who are currently receiving pramipexole therapy (monotherapy or adjunctive therapy) who are experiencing one or more of the following symptoms: somnolence, cognitive decline with/without hallucinations, and peripheral edema will be asked if they are willing to participate at the time of their clinic visit at the PDMDP.
The crossover from pramipexole to ropinirole CR will be performed over a 2 week interval. During the first week, the initial drug dose will substitute ½ of the pramipexole with ½ of the target dose of ropinirole CR. If subjects are tolerating the drug change, then 100% of the target dose of ropinirole CR (and no pramipexole) will be started in the second week.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Continuous Release Dopamine Agonists | Experimental | Drug: Continuous Release Dopamine AgonistsContinuous Release Dopamine Agonists |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Each subject must meet all of the following inclusion criteria to qualify for entrance into the study:
- Subjects who are male or female and are aged 55 and older.
- Subjects and/or their legal guardians must be able and willing to give informed consent.
- Subjects must be on stable doses of pramipexole for greater than 4 weeks duration prior to screening.
- Subjects who are female must be non-pregnant and non-nursing. Women of Child-Bearing Potential (WOCBP) must use a reliable method of contraception (e.g., oral contraceptive or long-term injectable or implantable hormonal contraceptive, double-barrier methods, such as condom and diaphragm, condom and foam, condom and sponge or intra-uterine devices) and have a negative serum pregnancy test at screening. Women are considered to not be of child-bearing potential if they have been surgically sterilized (physician-documented hysterectomy or tubal ligation) or if they are post-menopausal.
Key exclusion criteria (7 listed)
- Subjects must not be receiving any treatments for excess somnolence such as amphetamine derivatives, other stimulants or Provigil.
- Subjects with actively treated malignancies, clinically significant heart disease, kidney, liver, or pulmonary disorders will be excluded.
- Subjects with clinical depression who are not receiving stable doses of antidepressant therapy in excess of 4 weeks duration.
- Subjects with history of orthostatic hypotension (>30mm drop in systolic pressure and/or >20mm drop in diastolic pressure) associated with syncope.
- Subjects started within the last 14 days on any drug known to substantially inhibit CYP1A2 (e.g., cimetidine, fluvoxamine) or induce CYP1A2 (e.g.omeprazole) (Note: Subjects already on these agents may be enrolled but must remain on the stable doses of the agents from 14 days prior to the beginning of the study).
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 |
|---|---|---|
| Continuous Release Dopamine AgonistsAlso: ropinirole extended releaseContinuous Release Dopamine Agonists | Drug | Continuous Release Dopamine Agonists |
Primary outcome
Unified Parkinson's Disease Rating Scale (UPDRS), Parts 3 (Motor Performance) and 4 (Disability).
Time frame: initial visit and at end of study 24 weeks
The Unified Parkinson's Disease Rating Scale (UPDRS), parts 3 (motor performance) and 4 (disability) are standardized and validated measures of various symptoms of Parkinson's disease - total scores range from 0 to 148 with lower scores representing better Parkinson symptom control and higher scores representing worse symptoms of Parkinson's.
Mini-Mental Status Exam (MMSE), the Clock Drawing Test (CDT), the Patient Health Questionnaire (PHQ-9).
Time frame: initial visit and at end of study 24 weeks
The Mini-Mental Status Exam (MMSE) and the Clock Drawing Test (CDT) are standardized and validated measures of cognitive function. The Patient Health Questionnaire (PHQ-9) is a standardized and validated measure of quality of life. The Mini-Mental Status Exam (MMSE) scale is 0-30 with higher numbers indicating improvement. The Clock Drawing Test (CDT) range is 0-10 with higher numbers indicating improvement. the PHQ scale is 0-27 with lower numbers indicating improved outcome.
Peripheral Edema, as Measured by Quantitative Assessment of Ankle Edema
Time frame: initial visit and at end of study 24 weeks
The assessment of ankle edema was considered to be a marker of improvement possibly seen in patients who switched from regular pramipexole to extended release ropinirole. .
Patient Satisfaction Questionnaire
Time frame: initial visit and at end of study 24 weeks
The patient satisfaction/preference (Patient Satisfaction Questionnaire - PS) scores vary from 0-10 with higher scores indicating greater satisfaction with the med change.
Parkinson's Disease Questionnaire (PDQ-39)
Time frame: initial visit and at end of study 24 weeks
The Improvement in quality of life (Parkinson's Disease Questionnaire - PDQ-39 - is a standardized and validated measure of patient quality of life ranging in score from 0-100 with lower scores indicating improvement versus higher scores indicating worsening of QOL.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Lawrence Elmer, MD, PhD principal investigator
Medical University of Ohio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Continuous Release Dopamine Agonists in people with Parkinson Disease, run by University of Toledo at 1 site 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 7 inclusion and 7 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 16 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 16 May 2025). 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?
Unified Parkinson's Disease Rating Scale (UPDRS), Parts 3 (Motor Performance) and 4 (Disability). (time frame: initial visit and at end of study 24 weeks). The study lists 5 primary outcomes in all. 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 16 May 2025.