Parkinson's DiseasePhase 3NCT00260793
Open Label High Dose Ropinirole (Requip) Study for Patients With Parkinson's Disease
A Phase 3 study testing Ropinirole Hydrochloride in people with Parkinson's Disease, run by Agarwal, Pinky, M.D. at 1 site in United States.
Trial summary
The purpose of this research study is to see if subjects with Parkinson's disease who are experiencing motor fluctuations ("on" and "off" states) and dyskinesias (involuntary excessive movements) would benefit from a higher dose of Requip as compared to the maximum FDA approved dose of dopamine agonist drugs… Read more about this study
- Who is it for?
- Ages 25 years and older
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Ropinirole Hydrochloride
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2005to not given
- Phase
- Phase 3
- 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 25 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must give written informed consent prior to any specific study procedures.
- Males or females; females of childbearing age who are not currently pregnant must agree to use a medically accepted method of contraception throughout the study.
- Age greater than or equal to 25 years.
- Patients must be on a maximum dose of dopamine agonist drug (pergolide 4mg/day, pramipexole 4.5 mg/day or ropinirole 24mg/day).
- Stable dose of all medications for 4 weeks.
Who cannot join
- Current hallucinations.
- History of disabling hallucinations or hallucinations in past requiring treatment.
- Troublesome edema (swelling).
- Unstable depression.
- Female who is pregnant or lactating.
- Use of an investigational drug with in the last 30 days.
- Other inclusion or exclusion criteria to be evaluated by the physician.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Colorado Neurology, P.C.
Englewood, Colorado, 80113
Deborah Judd, RN, CCRC, 303-762-6667, judd@megapathdsl.net
Pinky Agarwal, MD
About this study
Official title: Open Label Prospective Study of High Dose Ropinirole for Motor Fluctuations and Dyskinesias in Advanced Parkinson's Disease
The purpose of this research study is to see if subjects with Parkinson's disease who are experiencing motor fluctuations ("on" and "off" states) and dyskinesias (involuntary excessive movements) would benefit from a higher dose of Requip as compared to the maximum FDA approved dose of dopamine agonist drugs (including Requip, Mirapex, and Permax). Requip as used in this study is investigational, which means it has not been approved by the US Food and Drug Administration (FDA) at this dose level.
- Conditions
- Parkinson's Disease
- Being tested
- Ropinirole Hydrochloride
- Keywords
- Ropinirole, Parkinson's disease, dopamine agonist
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ropinirole HydrochlorideDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2005 (estimated)
- Study startNov 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants
Sponsor and investigators
- Lead sponsor
- Agarwal, Pinky, M.D.
- Collaborators
- Colorado Neurology, GlaxoSmithKline
- Investigators
- Pinky Agarwal, MD, Principal investigator, Colorado Neurology, P.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00260793
- Sponsor's protocol ID
- 103911
- Status last verified
- Nov 2005
- First submitted
- 1 Dec 2005
- Last updated
- 3 Feb 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label Prospective Study of High Dose Ropinirole for Motor Fluctuations and Dyskinesias in Advanced Parkinson's Disease
- ClinicalTrials.gov ID
- NCT00260793
- Acronym / sponsor ID
- 103911
- Conditions
- Parkinson's Disease
- Keywords
- Ropinirole, Parkinson's disease, dopamine agonist
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants
- Lead sponsor
- Agarwal, Pinky, M.D.
- Collaborators
- Colorado Neurology, GlaxoSmithKline
- Study start
- Nov 2005
- First posted
- 2 Dec 2005 (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.
The purpose of this research study is to see if subjects with Parkinson's disease who are experiencing motor fluctuations ("on" and "off" states) and dyskinesias (involuntary excessive movements) would benefit from a higher dose of Requip as compared to the maximum FDA approved dose of dopamine agonist drugs (including Requip, Mirapex, and Permax). Requip as used in this study is investigational, which means it has not been approved by the US Food and Drug Administration (FDA) at this dose level.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients must give written informed consent prior to any specific study procedures.
- Males or females; females of childbearing age who are not currently pregnant must agree to use a medically accepted method of contraception throughout the study.
- Age greater than or equal to 25 years.
- Patients must be on a maximum dose of dopamine agonist drug (pergolide 4mg/day, pramipexole 4.5 mg/day or ropinirole 24mg/day).
- Stable dose of all medications for 4 weeks.
Key exclusion criteria (7 listed)
- Current hallucinations.
- History of disabling hallucinations or hallucinations in past requiring treatment.
- Troublesome edema (swelling).
- Unstable depression.
- Female who is pregnant or lactating.
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 |
|---|---|---|
| Ropinirole Hydrochloride | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2006.
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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.
Pinky Agarwal, MD principal investigator
Colorado Neurology, P.C.
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 Ropinirole Hydrochloride in people with Parkinson's Disease, run by Agarwal, Pinky, M.D. 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 5 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: status not confirmed, as of the sponsor's last update on 3 Feb 2006. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Deborah Judd, RN, CCRC (303-762-6667, judd@megapathdsl.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 3 Feb 2006.