Parkinson DiseasePhase 3NCT00058838
Study Evaluating Sumanirole for the Treatment of the Signs and Symptoms of Early Parkinson's Disease
A Phase 3 study testing sumanirole in people with Parkinson Disease, run by Pfizer at 134 sites in 14 countries.
Trial summary
The primary purpose of this study is to determine whether sumanirole, at three different dose levels, 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
- How many people
- 854 participants
- Where
- 134 sitesin 14 countries
- Study dates
- Apr 2003to Sep 2004
- 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
- Idiopathic Parkinson's disease < 7 years duration
- Modified Hoehn and Yahr Scale Stages I through III
- Age greater than or equal to 30 years old
- Patients or their partners must use adequate contraceptive methods
- Patients who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures and do not plan on traveling extensively during the study
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
134 sites in 14 countries.
134 sites in 14 countries
United States69 sites
Pfizer Investigational Site
Albany, New York, 12208
Pfizer Investigational Site
Asheville, North Carolina, 28801
Pfizer Investigational Site
Atlanta, Georgia, 30338
Pfizer Investigational Site
Baltimore, Maryland
Pfizer Investigational Site
Bend, Oregon, 97701
Pfizer Investigational Site
Birmingham, Alabama, 35249-7340
Pfizer Investigational Site
Birmingham, Alabama, 35294
Pfizer Investigational Site
Canfield, Ohio, 44406
Pfizer Investigational Site
Charlotte, North Carolina, 28209
Pfizer Investigational Site
Cleveland, Ohio, 44195
Pfizer Investigational Site
Concord, California, 94520
Pfizer Investigational Site
Crestview Hills, Kentucky, 41017
Pfizer Investigational Site
Dayton, Ohio, 45408
Pfizer Investigational Site
Dayton, Ohio, 45415
Pfizer Investigational Site
Decatur, Georgia, 30033
Pfizer Investigational Site
Des Moines, Iowa, 50309
Pfizer Investigational Site
Dubuque, Iowa, 52001
Pfizer Investigational Site
Elkhart, Indiana, 46514
Pfizer Investigational Site
Englewood, Colorado, 80113
Pfizer Investigational Site
Eugene, Oregon, 97401
Pfizer Investigational Site
Fairfield, Connecticut, 06430
Pfizer Investigational Site
Fort Collins, Colorado, 85624
Pfizer Investigational Site
Fort Lauderdale, Florida, 33308
Pfizer Investigational Site
Frederick, Maryland, 21702
Pfizer Investigational Site
Hartford, Connecticut, 06106
Pfizer Investigational Site
Houston, Texas, 77030
Pfizer Investigational Site
Huntsville, Alabama, 35801
Pfizer Investigational Site
Irvine, California, 92618
Pfizer Investigational Site
Jacksonville, Florida, 32216
Pfizer Investigational Site
Kansas City, Kansas, 66160
Pfizer Investigational Site
La Jolla, California, 92037
Pfizer Investigational Site
Las Vegas, Nevada, 89052
Pfizer Investigational Site
Lebanon, New Hampshire, 03766
Pfizer Investigational Site
Lexington, Kentucky, 40503
Pfizer Investigational Site
Little Rock, Arkansas, 72205
Pfizer Investigational Site
Loma Linda, California, 92354
Pfizer Investigational Site
Louisville, Kentucky, 40202
Pfizer Investigational Site
Maitland, Florida, 32751
Pfizer Investigational Site
Marietta, Georgia, 30060
Pfizer Investigational Site
Miami, Florida, 33136
Pfizer Investigational Site
Milwaukee, Wisconsin, 53202
Pfizer Investigational Site
Oceanside, California, 92056
Pfizer Investigational Site
Oxnard, California, 93030
Pfizer Investigational Site
Palm Beach Gardens, Florida, 33410
Pfizer Investigational Site
Portland, Oregon, 97209
Pfizer Investigational Site
Richmond, Virginia, 23294
Pfizer Investigational Site
San Antonio, Texas, 78229
Pfizer Investigational Site
San Francisco, California, 94109
Pfizer Investigational Site
San Francisco, California, 94115
Pfizer Investigational Site
Sarasota, Florida, 34243
Pfizer Investigational Site
Savannah, Georgia, 31405
Pfizer Investigational Site
Scarborough, Maine, 04074
Pfizer Investigational Site
Sellersville, Pennsylvania, 18960
Pfizer Investigational Site
Southfield, Michigan, 48034
Pfizer Investigational Site
Spokane, Washington, 99204
Pfizer Investigational Site
Springfield, Missouri, 65804
Pfizer Investigational Site
Springfield, Missouri, 65807
Pfizer Investigational Site
St. Petersburg, Florida, 33701
Pfizer Investigational Site
St. Petersburg, Florida, 33703-2612
Pfizer Investigational Site
Sunnyvale, California, 94089
Pfizer Investigational Site
Tacoma, Washington, 98405
Pfizer Investigational Site
Tallahasse, Florida, 32308
Pfizer Investigational Site
Tampa, Florida, 33609-4052
Pfizer Investigational Site
Tampa, Florida, 33614
Pfizer Investigational Site
The Bronx, New York, 10461
Pfizer Investigational Site
Upland, Pennsylvania, 19013-3995
Pfizer Investigational Site
Walnut Creek, California, 94598
Pfizer Investigational Site
Wenatchee, Washington, 98801
Pfizer Investigational Site
Winston-Salem, North Carolina, 27103
Spain14 sites
Pfizer Investigational Site
Alcalá de Henares, Madrid, 28805
Pfizer Investigational Site
Ávila, Avila, 05071
Pfizer Investigational Site
Barcelona, Barcelona, 08035
Pfizer Investigational Site
Barcelona, 08003
Pfizer Investigational Site
Barcelona, 08036
Pfizer Investigational Site
Barcelona, 08041
Pfizer Investigational Site
Burgos, 09005
Pfizer Investigational Site
Donostia / San Sebastian, Guipuzcoa, 20012
Pfizer Investigational Site
Madrid, Madrid, 28007
Pfizer Investigational Site
Madrid, Madrid, 28040
Pfizer Investigational Site
Madrid, 28034
Pfizer Investigational Site
Oviedo, Oviedo, 33006
Pfizer Investigational Site
Terrassa, Barcelona, 08221
Pfizer Investigational Site
Zaragoza, 50009
Italy8 sites
Pfizer Investigational Site
Florence, 50139
Pfizer Investigational Site
Grosseto, 58100
Pfizer Investigational Site
Imperia, 18100
Pfizer Investigational Site
Lido di Camaiore, LU, 55043
Pfizer Investigational Site
Milan, 20126
Pfizer Investigational Site
Naples
Pfizer Investigational Site
Pozzilli, 86077
Pfizer Investigational Site
Torino, 10125
Argentina7 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, 1428
Pfizer Investigational Site
Buenos Aires, Buenos Aires, C1221ACI
Pfizer Investigational Site
Buenos Aires, Buenos Aires F.D., 1209
Pfizer Investigational Site
Buenos Aires, Buenos Aires F.D., 1426
Australia5 sites
Pfizer Investigational Site
Adelaide, South Australia, 5000
Pfizer Investigational Site
Herston, Queensland, 4029
Pfizer Investigational Site
Nedlands, Western Australia, 6009
Pfizer Investigational Site
Sydney, New South Wales, 2067
Pfizer Investigational Site
Westmead, New South Wales, 2145
Belgium5 sites
Pfizer Investigational Site
Antwerp, 2020
Pfizer Investigational Site
Edegem, 2650
Pfizer Investigational Site
Ottignies, 1340
Pfizer Investigational Site
Roeselaere, 8800
Pfizer Investigational Site
Tielt, 8700
France5 sites
Pfizer Investigational Site
Aix-en-Provence, 13100
Pfizer Investigational Site
Angers, 49100
Pfizer Investigational Site
Montbelliard, 25200
Pfizer Investigational Site
Nîmes, 30000
Pfizer Investigational Site
Roanne, 42300
Austria4 sites
Pfizer Investigational Site
Innsbruck, A-6020
Pfizer Investigational Site
Linz, A-4020
Pfizer Investigational Site
Sankt Pölten, A-3100
Pfizer Investigational Site
Vienna, 1080
Germany4 sites
Pfizer Investigational Site
Gera, 0755
Pfizer Investigational Site
Hamburg
Pfizer Investigational Site
Straubing, 94315
Pfizer Investigational Site
Wiesbaden
Greece3 sites
Pfizer Investigational Site
Athens, Attica, 115 26
Pfizer Investigational Site
Athens, Attica, 15127
Pfizer Investigational Site
Thessaloniki, Macedonia, 546 36
Mexico3 sites
Pfizer Investigational Site
Mexico City, D.F.
Pfizer Investigational Site
Mexico City, Mexico City, 14269
Pfizer Investigational Site
Zapopan, Jalisco, C.P. 45200
Peru3 sites
Pfizer Investigational Site
Lima, Lima Province, L11
Pfizer Investigational Site
Lima, Lima Province, L13
Pfizer Investigational Site
Lima, Lima Province, L27
Colombia2 sites
Pfizer Investigational Site
Bogotá, D.C., 000
Pfizer Investigational Site
Medellín, Antioquia, 000
Puerto Rico2 sites
Pfizer Investigational Site
Carolina, 00983
Pfizer Investigational Site
Ponce, 00732
About this study
Official title: A Phase III, Double-Blind, Placebo-Controlled, Fixed-Dose Response Study Comparing the Efficacy and Safety of Sumanirole Versus Placebo in Patients With Early Parkinson's Disease.
The primary purpose of this study is to determine whether sumanirole, at three different dose levels, is effective and safe in the treatment of the signs and symptoms of early Parkinson's disease
- Conditions
- Parkinson Disease
- Being tested
- sumanirole
- 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
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 and the benefit of sumanirole in quality of life measures compared to placebo
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2003 (estimated)
- Study startApr 2003
- Study completionSep 2004
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
- 854 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
- NCT00058838
- Sponsor's protocol ID
- DA2APD-0075-031
- Status last verified
- Jun 2006
- First submitted
- 14 Apr 2003
- 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, Fixed-Dose Response Study Comparing the Efficacy and Safety of Sumanirole Versus Placebo in Patients With Early Parkinson's Disease.
- ClinicalTrials.gov ID
- NCT00058838
- Acronym / sponsor ID
- DA2APD-0075-031
- Conditions
- Parkinson Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 854 participants
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Apr 2003
- Study completion
- Sep 2004
- First posted
- 15 Apr 2003 (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, at three different dose levels, 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)
- Idiopathic Parkinson's disease < 7 years duration
- Modified Hoehn and Yahr Scale Stages I through III
- Age greater than or equal to 30 years old
- Patients or their partners must use adequate contraceptive methods
- Patients who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures and do not plan on traveling extensively during the study
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 | – |
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 and the benefit of sumanirole in quality of life measures compared to placebo
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
134 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing sumanirole in people with Parkinson Disease, run by Pfizer at 134 sites in 14 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 134 sites in United States, Spain, Italy, Argentina, Australia and 9 more countries. 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.