Parkinson DiseasePhase 3NCT00036218
Study Evaluating Sumanirole for the Treatment of the Signs and Symptoms of Early Parkinson's Disease.
A Phase 3 study testing sumanirole and ropinirole in people with Parkinson Disease, run by Pfizer at 102 sites in 4 countries.
Trial summary
The primary purpose of this study is to determine whether sumanirole is effective and safe in the treatment of the signs and symptoms of early Parkinson's disease. 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?
- sumanirole and ropinirole
- How many people
- 600 participants
- Where
- 102 sitesin 4 countries
- Study dates
- Dec 2001to Apr 2003
- 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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Parkinson's disease of less than 7 years duration
- Modified Hoehn and Yahr Scale Stages 1 through 3.
- Age greater than or equal to 30 years old.
- Men or women (women of childbearing potential must have a negative pregnancy test at screen) and both must use adequate contraceptive methods.
- Patients who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
Who cannot join
- Atypical Parkinson's disease syndromes due to drugs, metabolic disorders, encephalitis, or degenerative diseases.
- Levodopa received for 1-year accumulated interval in the last two years.
- Dopamine agonist medications or catechol-o-methyl transferase inhibitors in the 30 days prior to baseline.
- Unstable dose regimes of hypnotics, anxiolytics or antidepressants
- Dementia
- History of stereotaxic brain surgery, psychosis or active epilepsy within past year.
Show all 9Show fewer
- Participation in clinical trial within the previous 30 days.
- Malignant melanoma or history of melanoma
- Significant medical or pshychiatric condition.
Trial locations and contacts
102 sites in 4 countries.
102 sites in 4 countries
United States93 sites
Pfizer Investigational Site
Ann Arbor, Michigan, 48104
Pfizer Investigational Site
Asheville, North Carolina, 28803
Pfizer Investigational Site
Atlanta, Georgia, 30303
Pfizer Investigational Site
Austin, Texas, 78756
Pfizer Investigational Site
Baltimore, Maryland, 21201
Pfizer Investigational Site
Bellevue, Washington, 98004
Pfizer Investigational Site
Boca Raton, Florida, 33486
Pfizer Investigational Site
Boston, Massachusetts, 02115
Pfizer Investigational Site
Boston, Massachusetts, 02118
Pfizer Investigational Site
Burlington, Vermont, 05401
Pfizer Investigational Site
Carmichael, California, 95608
Pfizer Investigational Site
Chicago, Illinois, 60610
Pfizer Investigational Site
Chicago, Illinois, 60612
Pfizer Investigational Site
Clearwater, Florida, 33761
Pfizer Investigational Site
Columbia, Maryland, 21044
Pfizer Investigational Site
Conyers, Georgia, 30013
Pfizer Investigational Site
Dallas, Texas, 75390
Pfizer Investigational Site
Decatur, Georgia, 30033
Pfizer Investigational Site
Denver, Colorado, 80218
Pfizer Investigational Site
East Lansing, Michigan, 48848
Pfizer Investigational Site
Fairfield, Connecticut, 06824
Pfizer Investigational Site
Fort Lauderdale, Florida, 33308
Pfizer Investigational Site
Frederick, Maryland, 21702
Pfizer Investigational Site
Fresno, California, 93710
Pfizer Investigational Site
Glenbrook, Illinois, 60025
Pfizer Investigational Site
Golden Valley, Minnesota, 55422
Pfizer Investigational Site
Grand Rapids, Michigan, 49525
Pfizer Investigational Site
Henderson, Nevada, 89052
Pfizer Investigational Site
Hot Springs, Arkansas, 71913
Pfizer Investigational Site
Houston, Texas, 77030
Pfizer Investigational Site
Irvine, California, 92618
Pfizer Investigational Site
Jacksonville, Florida, 32209
Pfizer Investigational Site
Jacksonville, Florida, 32216
Pfizer Investigational Site
Kansas City, Kansas, 66160
Pfizer Investigational Site
Kansas City, Missouri, 64108
Pfizer Investigational Site
Knoxville, Tennessee, 37916
Pfizer Investigational Site
La Jolla, California, 92037
Pfizer Investigational Site
Lake Charles, Louisiana, 70601
Pfizer Investigational Site
Lebanon, New Hampshire, 03766
Pfizer Investigational Site
Little Rock, Arkansas, 72205
Pfizer Investigational Site
Loma Linda, California, 92354
Pfizer Investigational Site
Los Angeles, California, 90033
Pfizer Investigational Site
Maitland, Florida, 32751
Pfizer Investigational Site
Manhasset, New York, 11030
Pfizer Investigational Site
Memphis, Tennessee, 38163
Pfizer Investigational Site
Miami, Florida, 33136
Pfizer Investigational Site
Milwaukee, Wisconsin, 53201
Pfizer Investigational Site
Mineola, New York, 11501
Pfizer Investigational Site
Minneapolis, Minnesota, 55455
Pfizer Investigational Site
Morristown, New Jersey, 07960
Pfizer Investigational Site
Mount Vernon, New York, 10550
Pfizer Investigational Site
Naples, Florida, 34102
Pfizer Investigational Site
Nashville, Tennessee, 37212-3375
Pfizer Investigational Site
New Brunswick, New Jersey, 08901
Pfizer Investigational Site
New Haven, Connecticut, 06510
Pfizer Investigational Site
New York, New York, 10010
Pfizer Investigational Site
New York, New York, 10029-6501
Pfizer Investigational Site
New York, New York, 10032
Pfizer Investigational Site
Norristown, Pennsylvania, 19401-3434
Pfizer Investigational Site
Oceanside, California, 92056
Pfizer Investigational Site
Oklahoma City, Oklahoma, 73104
Pfizer Investigational Site
Oklahoma City, Oklahoma, 73118
Pfizer Investigational Site
Omaha, Nebraska, 68105
Pfizer Investigational Site
Omaha, Nebraska, 68131-2197
Pfizer Investigational Site
Orlando, Florida, 32806
Pfizer Investigational Site
Palm Beach Gardens, Florida, 33410
Pfizer Investigational Site
Plantation, Florida, 33324
Pfizer Investigational Site
Raleigh, North Carolina, 27607-6520
Pfizer Investigational Site
Richmond, Virginia, 23294
Pfizer Investigational Site
Ridgewood, New Jersey, 07450
Pfizer Investigational Site
Rockville, Maryland, 20850
Pfizer Investigational Site
Saint Cloud, Minnesota, 56303
Pfizer Investigational Site
Salt Lake City, Utah, 84107
Pfizer Investigational Site
San Antonio, Texas, 78229
Pfizer Investigational Site
San Francisco, California, 94109
Pfizer Investigational Site
San Francisco, California, 94143
Pfizer Investigational Site
San Luis Obiapo, California, 93401
Pfizer Investigational Site
Savannah, Georgia, 31416
Pfizer Investigational Site
Sellersville, Pennsylvania, 18960
Pfizer Investigational Site
Shreveport, Louisiana, 71135
Pfizer Investigational Site
Southfield, Michigan, 48034
Pfizer Investigational Site
Spokane, Washington, 99204
Pfizer Investigational Site
Springfield, Missouri, 65807
Pfizer Investigational Site
St. Petersburg, Florida, 33703
Pfizer Investigational Site
Syracuse, New York, 13210
Pfizer Investigational Site
Tallahassee, Florida, 32308
Pfizer Investigational Site
Tampa, Florida, 33614
Pfizer Investigational Site
Traverse City, Michigan, 49684
Pfizer Investigational Site
Upland, Pennsylvania, 19013-3995
Pfizer Investigational Site
Walnut Creek, California, 94596
Pfizer Investigational Site
Walnut Creek, California, 94598
Pfizer Investigational Site
Wenatchee, Washington, 98801
Pfizer Investigational Site
Wilmington, Delaware, 19806
Argentina6 sites
Pfizer Investigational Site
Buenos Aires, Buenos Aires, 1117
Pfizer Investigational Site
Buenos Aires, Buenos Aires, 1221
Pfizer Investigational Site
Buenos Aires, Buenos Aires, 1419
Pfizer Investigational Site
Buenos Aires, Buenos Aires F.D., 1209
Pfizer Investigational Site
Buenos Aires, Buenos Aires F.D., 1426
Pfizer Investigational Site
Mar del Plata, Buenos Aires, 7600
Mexico2 sites
Pfizer Investigational Site
Mexico City, Mexico City, 07760
Pfizer Investigational Site
Monterrey, Nuevo León, 64000
About this study
Official title: A Phase III, Double-Blind, Placebo-Controlled, Randomized Study Comparing the Efficacy, Safety, and Tolerability of Sumanirole Versus Placebo or Ropinirole in Patients With Early Parkinson's Disease.
The primary purpose of this study is to determine whether sumanirole is effective and safe in the treatment of the signs and symptoms of early Parkinson's disease.
- Conditions
- Parkinson Disease
- Being tested
- sumanirole, ropinirole
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sumaniroleDrug
ropiniroleDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in UPDRS (Unified Parkinson's Disease Rating Scale) II + III total scores at end of maintenance, for sumanirole compared to placebo
Secondary outcomes (1)
To assess the safety profile of sumanirole; the benefit of sumanirole in quality of life measures, and change from baseline in UPDRS II + III total scores at end of maintenance, for sumanirole compared to ropinirole
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2002 (estimated)
- Study startDec 2001
- Study completionApr 2003
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 PfizerThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 600 participants
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00036218
- Sponsor's protocol ID
- 666E-CNS-0075-021
- Status last verified
- Jun 2006
- First submitted
- 8 May 2002
- Last updated
- 7 Jun 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Double-Blind, Placebo-Controlled, Randomized Study Comparing the Efficacy, Safety, and Tolerability of Sumanirole Versus Placebo or Ropinirole in Patients With Early Parkinson's Disease.
- ClinicalTrials.gov ID
- NCT00036218
- Acronym / sponsor ID
- 666E-CNS-0075-021
- Conditions
- Parkinson Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Dec 2001
- Study completion
- Apr 2003
- First posted
- 9 May 2002 (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 primary purpose of this study is to determine whether sumanirole is effective and safe in the treatment of the signs and symptoms of early Parkinson's disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Parkinson's disease of less than 7 years duration
- Modified Hoehn and Yahr Scale Stages 1 through 3.
- Age greater than or equal to 30 years old.
- Men or women (women of childbearing potential must have a negative pregnancy test at screen) and both must use adequate contraceptive methods.
- Patients who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
Key exclusion criteria (9 listed)
- Atypical Parkinson's disease syndromes due to drugs, metabolic disorders, encephalitis, or degenerative diseases.
- Levodopa received for 1-year accumulated interval in the last two years.
- Dopamine agonist medications or catechol-o-methyl transferase inhibitors in the 30 days prior to baseline.
- Unstable dose regimes of hypnotics, anxiolytics or antidepressants
- Dementia
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 |
|---|---|---|
| sumanirole | Drug | – |
| ropinirole | Drug | – |
Primary outcome
Change from baseline in UPDRS (Unified Parkinson's Disease Rating Scale) II + III total scores at end of maintenance, for sumanirole compared to placebo
1 secondary outcome
To assess the safety profile of sumanirole; the benefit of sumanirole in quality of life measures, and change from baseline in UPDRS II + III total scores at end of maintenance, for sumanirole compared to ropinirole
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 7 Jun 2006.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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.
Pfizer CT.gov Call Center study director
Pfizer
102 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing sumanirole and ropinirole in people with Parkinson Disease, run by Pfizer at 102 sites in 4 countries.
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 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 7 Jun 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 102 sites in United States, Argentina, Mexico, Puerto Rico. 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?
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?
Change from baseline in UPDRS (Unified Parkinson's Disease Rating Scale) II + III total scores at end of maintenance, for sumanirole compared to placebo. 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 7 Jun 2006.