Parkinson DiseasePhase 3NCT00275275

Pramipexole Conversion to Ropinirole Controlled Release (CR)

A Phase 3 study testing Requip PR and Mirapex in people with Parkinson Disease, run by Rajesh Pahwa, MD at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

A conversion study of Mirapex (pramipexole) to Requip (ropinirole) controlled release (CR) in patients with Parkinson's disease to determine the appropriate conversion ratio and side effects related to the drug. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Parkinson Disease
What is being tested?: Requip PR and Mirapex
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 61 participants
Where: 1 siteUnited States
Study dates: Jan 2006to May 2008
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Diagnosis of Parkinson Disease
Currently taking pramipexole
Never have taken Requip CR

Who cannot join

Can not have significant adverse effects to standard Requip
Can not have atypical PD due to drugs, metabolic disorders, encephalitis or degenerative diseases
Can not have unstable medical conditions
Can not be taking concurrent monoamine oxidase inhibitors except for selegiline (10mg per day or less)
Female patients of childbearing potential must be using an effective method of contraception.
Can not be pregnant or lactating.
This may not be a complete list; there may be additional criteria which may apply.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Kansas Medical Center
Kansas City, Kansas, 66160

Other trials in United States

About this study

Official title: An Open Label Conversion Study of Pramipexole to Ropinirole Controlled Release (CR) in Patients With Parkinson's Disease.

Read the detailed description

Three different arms will be used in this study. Each of the three cohorts will be treated sequentially. Each participant will be taking Mirapex for PD and will be converted to Requip CR by 1 of 3 conversion factors (mg:mg): 1:3, 1:4 and 1:5 from Mirapex to once a day Requip CR. The first five subjects of each cohort will have their initial dose administered in the clinic and be monitored for orthostatic changes. Assessments of motor function before and after conversion will be done.

Conditions: Parkinson Disease
Being tested: Requip PR, Mirapex
Keywords: PD, Parkinson's
Medical subject headings: Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Requip PRDrug
Also called Requip 24-hour prolonged release (PR).
Requip 24-Hour once a day for one month
MirapexDrug
Also called Pramipexole
All subjects started the study on Mirapex. They were all then switched to Requip PR based on a conversion factor of 1:3, 1:4 or 1:5.

Study groups in NCT00275275
Study group	Role	What they receive
1	Experimental	Conversion factor of Mirapex to Requip 24-Hour of 1:3. This was a switch study in which the conversion factor was being investigated to assist in the conversion from Mirapex to Requip PR. In this group, the dose of Requip PR was 3 times the dose of Mirapex. Receives: Drug: Requip PR; Drug: Mirapex
2	Experimental	Conversion factor of Mirapex to Requip 24-Hour of 1:4 Receives: Drug: Requip PR; Drug: Mirapex
3	Experimental	Conversion factor of Mirapex to Requip 24-Hour of 1:5 Receives: Drug: Requip PR; Drug: Mirapex

What is being measured

The primary outcome is the main question the study is designed to answer.

Adverse Effects Experienced
Number of adverse effect experienced by participants in the different conversion ratio groups.
Measured: Week 4

Secondary outcomes (1)

Number of Dose Adjustments
Outcome measures the number of times a dose needed to be adjusted to compensate for adverse effects experienced.
Measured: Week 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2006May 2008

First posted11 Jan 2006 (estimated)
Study startJan 2006
Primary completionMay 2008
Study completionMay 2008

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: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 61 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00275275
Sponsor's protocol ID: 10161
Status last verified: Jul 2012
First submitted: 9 Jan 2006
Last updated: 24 Aug 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Parkinson Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open Label Conversion Study of Pramipexole to Ropinirole Controlled Release (CR) in Patients With Parkinson's Disease.
ClinicalTrials.gov ID: NCT00275275
Acronym / sponsor ID: 10161
Conditions: Parkinson Disease
Keywords: PD, Parkinson's
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 61 participants (actual)
Lead sponsor: Rajesh Pahwa, MDUniversity, hospital or other
Collaborators: GlaxoSmithKline
Study start: Jan 2006
Primary completion: May 2008 (actual)
Study completion: May 2008 (actual)
First posted: 11 Jan 2006 (estimated)
Results: Posted 24 Aug 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
1	Experimental	Drug: Requip PR, Drug: MirapexConversion factor of Mirapex to Requip 24-Hour of 1:3. This was a switch study in which the conversion factor was being investigated to assist in the conversion from Mirapex to Requip PR. In this group, the dose of Requip PR was 3 times the dose of Mirapex.
2	Experimental	Drug: Requip PR, Drug: MirapexConversion factor of Mirapex to Requip 24-Hour of 1:4
3	Experimental	Drug: Requip PR, Drug: MirapexConversion factor of Mirapex to Requip 24-Hour of 1:5

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Diagnosis of Parkinson Disease
Currently taking pramipexole
Never have taken Requip CR

Key exclusion criteria (7 listed)

Can not have significant adverse effects to standard Requip
Can not have atypical PD due to drugs, metabolic disorders, encephalitis or degenerative diseases
Can not have unstable medical conditions
Can not be taking concurrent monoamine oxidase inhibitors except for selegiline (10mg per day or less)
Female patients of childbearing potential must be using an effective method of contraception.

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
Requip PRAlso: Requip 24-hour prolonged release (PR).Requip 24-Hour once a day for one month	Drug	1, 2, 3
MirapexAlso: PramipexoleAll subjects started the study on Mirapex. They were all then switched to Requip PR based on a conversion factor of 1:3, 1:4 or 1:5.	Drug	1, 2, 3

Primary outcome

Adverse Effects Experienced
Time frame: Week 4
Number of adverse effect experienced by participants in the different conversion ratio groups.

1 secondary outcome

Number of Dose Adjustments
Time frame: Week 4

Results and safety

Results posted to the registry on 24 Aug 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Mirapex to Requip 24-Hour of 1:3	20	14
Mirapex to Requip 24-Hour of 1:4	20	18
Mirapex to Requip 24-Hour of 1:5	21	15

Primary outcome: Adverse Effects Experienced

Time frame: Week 4. Number. Unit: number of events

Measure	Preferred Requip PR n = 33	Preferred Mirapex n = 27
Value	29	43

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Preferred Requip PR	0 of 33 (0%)	9 of 33 (27.3%)	Not reported
Preferred Mirapex	0 of 27 (0%)	8 of 27 (29.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Parkinson Disease

RecruitingObservational study
Evaluation and Treatment of Neurosurgical Disorders
Neurologic Disorders
Enrolling by invitation
Efficacy of Repetitive Transcranial Magnetic Stimulation for Improving Depressive Symptoms in Patients With Parkinson's Disease
Parkinson's Disease, Depression
RecruitingPhase 1/2
KEYMAKER-U01 Substudy 01A: Efficacy and Safety Study of Pembrolizumab (MK-3475) With or Without Chemotherapy When Used With Investigational Agents in Treatment-naïve Participants With Stage IV Non-small Cell Lung Cancer (NSCLC) (MK-3475-01A/KEYMAKER-U01A)
Carcinoma, Non-Small-Cell Lung
Active, not recruitingPhase 2
A Pilot Study to Investigate the Safety and Clinical Activity of Avelumab (MSB0010718C) in Thymoma and Thymic Carcinoma After Progression on Platinum-Based Chemotherapy
Thymoma, Thymic Carcinoma
Not yet recruitingObservational study
Twenty-five Years of Advanced RadioTherapy at San Raffaele Hospital
Malignant Tumor, Benign Neoplasm

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.

Rajesh Pahwa, MD principal investigator

University of Kansas Medical Center

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 Requip PR and Mirapex in people with Parkinson Disease, run by Rajesh Pahwa, MD 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 3 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 24 Aug 2012. 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 24 Aug 2012). 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?

Adverse Effects Experienced (time frame: Week 4). 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 NCT00275275.

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 24 Aug 2012.