Open Label Sumanirole Study of Safety, Tolerability, and Therapeutic Response In Patients With Parkinson's Disease

A Phase 3 study testing sumanirole in people with Parkinson Disease, run by Pfizer at 110 sites in 4 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial summary

The primary objective is to assess the long term safety and tolerability of sumanirole as measured by safety labs, ECG monitoring, vital signs, and adverse event reports in subjects with Parkinson's Disease who participated in previous sumanirole studies. 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: 984 participants
Where: 110 sitesin 4 countries
Study dates: Aug 2000to Dec 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
Modified Hoehn and Yahr Scale Stages 1-4
Age over 30 years
Previous participation in prior sumanirole studies

Who cannot join

Use of dopamine agonist medications and other medications in defined timeframe
Unstable dose of CNS active therapies (eg, hypnotics, antidepressants, anxiolytics) within the last 30 days
Atypical Parkinson's syndromes due to drugs, metabolic disorders, encephalitis, or degenerative diseases
Dementia
History of active epilepsy within the past year
Significant liver disease with defined laboratory criteria

Show all 15Show fewer

Significant renal disease with defined laboratory criteria
Certain cardiac conditions
Electroconvulsive therapy in the previous 90 days
Subjects participating in other drug studies or receiving other investigational drugs within previous 30 days
Positive pregnancy test at Screen
Unwillingness to use adequate contraceptive methods
Lactating women
History of stereotaxic brain surgery
Malignant melanoma or history of treated melanoma

Trial locations and contacts

110 sites in 4 countries.

Country

City, postcode or hospital

110 sites in 4 countries

United States103 sites

Pfizer Investigational Site
Asheville, North Carolina
Pfizer Investigational Site
Atlanta, Georgia
Pfizer Investigational Site
Austin, Texas
Pfizer Investigational Site
Baltimore, Maryland
Pfizer Investigational Site
Bellevue, Washington
Pfizer Investigational Site
Bingham Farms, Michigan
Pfizer Investigational Site
Birmingham, Alabama
Pfizer Investigational Site
Boca Raton, Florida
Pfizer Investigational Site
Boston, Massachusetts
Pfizer Investigational Site
Burlington, Vermont
Pfizer Investigational Site
Canfield, Ohio
Pfizer Investigational Site
Charlotte, North Carolina
Pfizer Investigational Site
Charlottesville, Virginia
Pfizer Investigational Site
Chicago, Illinois
Pfizer Investigational Site
Clearwater, Florida
Pfizer Investigational Site
Concord, California
Pfizer Investigational Site
Covington, Louisiana
Pfizer Investigational Site
Crestview Hills, Kentucky
Pfizer Investigational Site
Dallas, Texas
Pfizer Investigational Site
Dayton, Ohio
Pfizer Investigational Site
Decatur, Georgia
Pfizer Investigational Site
Denver, Colorado
Pfizer Investigational Site
Des Moines, Iowa
Pfizer Investigational Site
Dubuque, Iowa
Pfizer Investigational Site
Elkhart, Indiana
Pfizer Investigational Site
Elkridge, Maryland
Pfizer Investigational Site
Englewood, Colorado
Pfizer Investigational Site
Eugene, Oregon
Pfizer Investigational Site
Fairfield, Connecticut
Pfizer Investigational Site
Farmington Hills, Michigan
Pfizer Investigational Site
Fort Lauderdale, Florida
Pfizer Investigational Site
Frederick, Maryland
Pfizer Investigational Site
Fresno, California
Pfizer Investigational Site
Fridley, Minnesota
Pfizer Investigational Site
Golden Valley, Minnesota
Pfizer Investigational Site
Grand Rapids, Michigan
Pfizer Investigational Site
Hartford, Connecticut
Pfizer Investigational Site
Houston, Texas
Pfizer Investigational Site
Irvine, California
Pfizer Investigational Site
Jacksonville, Florida
Pfizer Investigational Site
Kansas City, Kansas
Pfizer Investigational Site
Knoxville, Tennessee
Pfizer Investigational Site
La Jolla, California
Pfizer Investigational Site
Lake Charles, Louisiana
Pfizer Investigational Site
Las Vegas, Nevada
Pfizer Investigational Site
Lebanon, New Hampshire
Pfizer Investigational Site
Lee's Summit, Missouri
Pfizer Investigational Site
Lenexa, Kansas
Pfizer Investigational Site
Little Rock, Arkansas
Pfizer Investigational Site
Loma Linda, California
Pfizer Investigational Site
Los Angeles, California
Pfizer Investigational Site
Maitland, Florida
Pfizer Investigational Site
Manhasset, New York
Pfizer Investigational Site
Marietta, Georgia
Pfizer Investigational Site
Marshfield, Wisconsin
Pfizer Investigational Site
Memphis, Tennessee
Pfizer Investigational Site
Miami, Florida
Pfizer Investigational Site
Milwaukee, Wisconsin
Pfizer Investigational Site
Mineola, New York
Pfizer Investigational Site
Minneapolis, Minnesota
Pfizer Investigational Site
Morristown, New Jersey
Pfizer Investigational Site
Mount Vernon, New York
Pfizer Investigational Site
Naples, Florida
Pfizer Investigational Site
New Brunswick, New Jersey
Pfizer Investigational Site
New Haven, Connecticut
Pfizer Investigational Site
New York, New York
Pfizer Investigational Site
Norristown, Pennsylvania
Pfizer Investigational Site
Oceanside, California
Pfizer Investigational Site
Oklahoma City, Oklahoma
Pfizer Investigational Site
Omaha, Nebraska
Pfizer Investigational Site
Orlando, Florida
Pfizer Investigational Site
Palm Beach Gardens, Florida
Pfizer Investigational Site
Peoria, Arizona
Pfizer Investigational Site
Plantation, Florida
Pfizer Investigational Site
Raleigh, North Carolina
Pfizer Investigational Site
Richmond, Virginia
Pfizer Investigational Site
Rochester, New York
Pfizer Investigational Site
Royal Oak, Michigan
Pfizer Investigational Site
Saint Cloud, Minnesota
Pfizer Investigational Site
Salisbury, Missouri
Pfizer Investigational Site
Salt Lake City, Utah
Pfizer Investigational Site
San Antonio, Texas
Pfizer Investigational Site
San Diego, California
Pfizer Investigational Site
San Francisco, California
Pfizer Investigational Site
San Luis Obiapo, California
Pfizer Investigational Site
Sarasota, Florida
Pfizer Investigational Site
Savannah, Georgia
Pfizer Investigational Site
Scarborough, Maine
Pfizer Investigational Site
Sellersville, Pennsylvania
Pfizer Investigational Site
Springfield, Missouri
Pfizer Investigational Site
St. Petersburg, Florida
Pfizer Investigational Site
Sunnyvale, California
Pfizer Investigational Site
Syracuse, New York
Pfizer Investigational Site
Tallahassee, Florida
Pfizer Investigational Site
Tampa, Florida
Pfizer Investigational Site
Traverse City, Michigan
Pfizer Investigational Site
Trumbull, Connecticut
Pfizer Investigational Site
Tucson, Arizona
Pfizer Investigational Site
Upland, Pennsylvania
Pfizer Investigational Site
Walnut Creek, California
Pfizer Investigational Site
Wenatchee, Washington
Pfizer Investigational Site
Wilmington, Delaware
Pfizer Investigational Site
Winston-Salem, North Carolina

Other trials in United States

Argentina4 sites

Pfizer Investigational Site
Buenos Aires, Barcelona
Pfizer Investigational Site
Buenos Aires, Buenos Aires
Pfizer Investigational Site
Buenos Aires, Buenos Aires F.D.
Pfizer Investigational Site
Mar del Plata, Buenos Aires

Other trials in Argentina

Colombia2 sites

Pfizer Investigational Site
Bogotá, D.C.
Pfizer Investigational Site
Medellín, Antioquia

Other trials in Colombia

Puerto Rico1 site

Pfizer Investigational Site
Carolina

Other trials in Puerto Rico

About this study

Official title: Open-Label, Long Term, Flexible Dose Study Of Safety, Tolerability, And Therapeutic Response In Patients With 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.

The primary objective is to assess the long term safety and tolerability of sumanirole by measuring Safety labs, ECG monitoring, vital signs and adverse events, over a period of up to 4 years.

Secondary outcomes (4)

Pharmacoeconomics, quality of life, and the long term therapeutic response associated with sumanirole by using Parts II and III of the UPDRS (Unified Parkinson's Disease Rating Scale).
Part II -- Activities of Daily Living, will be collected in order to record the patient's level of function between visits.
Part III will be used to evaluate motor function.
Three quality of life instruments will be employed: a general scale--the Functional Status Questionnaire, a disease specific scale--the Parkinson's Disease Questionnaire, and a utility scale--the EuroQol.

Timeline

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

Aug 2000Dec 2004

First posted9 May 2002 (estimated)
Study startAug 2000
Study completionDec 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: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 984 participants

IDs, dates and publications

ClinicalTrials.gov ID: NCT00036205
Sponsor's protocol ID: M27600011
Status last verified: Jan 2007
First submitted: 8 May 2002
Last updated: 18 Jan 2007
Results posted: 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

Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
RecruitingPhase 3
A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) as First-line Maintenance Treatment of Cervical Cancer (MK-2870-036/TroFuse-036/GOG-3123/ENGOT-cx22)
Cervical Cancer
Active, not recruitingPhase 1/2
Clinical Safety and Efficacy of Umbilical Cord Mesenchymal Stromal Cells-derived Exosomes in Patients With Parkinson's Disease
Parkinson Disease (PD)
Active, not recruitingObservational study
Adaptive DBS to Offset STN Dysregulation During Exercise in PD
Parkinson Disease

All Parkinson Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Jan 2007. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Open-Label, Long Term, Flexible Dose Study Of Safety, Tolerability, And Therapeutic Response In Patients With Parkinson's Disease.
ClinicalTrials.gov ID: NCT00036205
Acronym / sponsor ID: M27600011
Conditions: Parkinson Disease
Phase: Phase 3
Study type: Interventional
Recruitment status: Terminated
Enrolment: 984 participants
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Aug 2000
Study completion: Dec 2004
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.

Study design

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

Who may qualify

Ages: 30 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Idiopathic Parkinson's disease
Modified Hoehn and Yahr Scale Stages 1-4
Age over 30 years
Previous participation in prior sumanirole studies

Key exclusion criteria (15 listed)

Use of dopamine agonist medications and other medications in defined timeframe
Unstable dose of CNS active therapies (eg, hypnotics, antidepressants, anxiolytics) within the last 30 days
Atypical Parkinson's syndromes due to drugs, metabolic disorders, encephalitis, or degenerative diseases
Dementia
History of active epilepsy within the past year

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

The primary objective is to assess the long term safety and tolerability of sumanirole by measuring Safety labs, ECG monitoring, vital signs and adverse events, over a period of up to 4 years.

4 secondary outcomes

Pharmacoeconomics, quality of life, and the long term therapeutic response associated with sumanirole by using Parts II and III of the UPDRS (Unified Parkinson's Disease Rating Scale).
Part II -- Activities of Daily Living, will be collected in order to record the patient's level of function between visits.
Part III will be used to evaluate motor function.
Three quality of life instruments will be employed: a general scale--the Functional Status Questionnaire, a disease specific scale--the Parkinson's Disease Questionnaire, and a utility scale--the EuroQol.

Results and safety

The study was stopped early. Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2007.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

Related trials for Parkinson Disease

Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
RecruitingPhase 3
A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) as First-line Maintenance Treatment of Cervical Cancer (MK-2870-036/TroFuse-036/GOG-3123/ENGOT-cx22)
Cervical Cancer
Active, not recruitingPhase 1/2
Clinical Safety and Efficacy of Umbilical Cord Mesenchymal Stromal Cells-derived Exosomes in Patients With Parkinson's Disease
Parkinson Disease (PD)
Active, not recruitingObservational study
Adaptive DBS to Offset STN Dysregulation During Exercise in PD
Parkinson Disease

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

110 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 in people with Parkinson Disease, run by Pfizer at 110 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 4 inclusion and 15 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: stopped early, as of the sponsor's last update on 18 Jan 2007. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 110 sites in United States, Argentina, Colombia, 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 was stopped early. Results are not available in the source record.

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?

The primary objective is to assess the long term safety and tolerability of sumanirole by measuring Safety labs, ECG monitoring, vital signs and adverse events, over a period of up to 4 years.. 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 NCT00036205.

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 18 Jan 2007.