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

Sponsor

Pfizer (Industry)

Overall Status

Terminated

CT.gov ID

NCT00036205

Collaborator

(none)

984

Enrollment

110

Locations

Duration (Months)

8.9

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Parkinson Disease	Drug: sumanirole	Phase 3

Study Design

Study Type:

Interventional

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Open-Label, Long Term, Flexible Dose Study Of Safety, Tolerability, And Therapeutic Response In Patients With Parkinson's Disease.

Study Start Date :

Aug 1, 2000

Study Completion Date :

Dec 1, 2004

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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
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

Contacts and Locations

Locations

	Site	City	State	Country
1	Pfizer Investigational Site	Birmingham	Alabama	United States
2	Pfizer Investigational Site	Peoria	Arizona	United States
3	Pfizer Investigational Site	Tucson	Arizona	United States
4	Pfizer Investigational Site	Little Rock	Arkansas	United States
5	Pfizer Investigational Site	Concord	California	United States
6	Pfizer Investigational Site	Fresno	California	United States
7	Pfizer Investigational Site	Irvine	California	United States
8	Pfizer Investigational Site	La Jolla	California	United States
9	Pfizer Investigational Site	Loma Linda	California	United States
10	Pfizer Investigational Site	Los Angeles	California	United States
11	Pfizer Investigational Site	Oceanside	California	United States
12	Pfizer Investigational Site	San Diego	California	United States
13	Pfizer Investigational Site	San Francisco	California	United States
14	Pfizer Investigational Site	San Luis Obiapo	California	United States
15	Pfizer Investigational Site	Sunnyvale	California	United States
16	Pfizer Investigational Site	Walnut Creek	California	United States
17	Pfizer Investigational Site	Denver	Colorado	United States
18	Pfizer Investigational Site	Englewood	Colorado	United States
19	Pfizer Investigational Site	Fairfield	Connecticut	United States
20	Pfizer Investigational Site	Hartford	Connecticut	United States
21	Pfizer Investigational Site	New Haven	Connecticut	United States
22	Pfizer Investigational Site	Trumbull	Connecticut	United States
23	Pfizer Investigational Site	Wilmington	Delaware	United States
24	Pfizer Investigational Site	Boca Raton	Florida	United States
25	Pfizer Investigational Site	Clearwater	Florida	United States
26	Pfizer Investigational Site	Fort Lauderdale	Florida	United States
27	Pfizer Investigational Site	Jacksonville	Florida	United States
28	Pfizer Investigational Site	Maitland	Florida	United States
29	Pfizer Investigational Site	Miami	Florida	United States
30	Pfizer Investigational Site	Naples	Florida	United States
31	Pfizer Investigational Site	Orlando	Florida	United States
32	Pfizer Investigational Site	Palm Beach Gardens	Florida	United States
33	Pfizer Investigational Site	Plantation	Florida	United States
34	Pfizer Investigational Site	Sarasota	Florida	United States
35	Pfizer Investigational Site	St Petersburg	Florida	United States
36	Pfizer Investigational Site	Tallahassee	Florida	United States
37	Pfizer Investigational Site	Tampa	Florida	United States
38	Pfizer Investigational Site	Atlanta	Georgia	United States
39	Pfizer Investigational Site	Decatur	Georgia	United States
40	Pfizer Investigational Site	Marietta	Georgia	United States
41	Pfizer Investigational Site	Savannah	Georgia	United States
42	Pfizer Investigational Site	Chicago	Illinois	United States
43	Pfizer Investigational Site	Elkhart	Indiana	United States
44	Pfizer Investigational Site	Des Moines	Iowa	United States
45	Pfizer Investigational Site	Dubuque	Iowa	United States
46	Pfizer Investigational Site	Kansas City	Kansas	United States
47	Pfizer Investigational Site	Lenexa	Kansas	United States
48	Pfizer Investigational Site	Crestview Hills	Kentucky	United States
49	Pfizer Investigational Site	Covington	Louisiana	United States
50	Pfizer Investigational Site	Lake Charles	Louisiana	United States
51	Pfizer Investigational Site	Scarborough	Maine	United States
52	Pfizer Investigational Site	Baltimore	Maryland	United States
53	Pfizer Investigational Site	Elkridge	Maryland	United States
54	Pfizer Investigational Site	Frederick	Maryland	United States
55	Pfizer Investigational Site	Boston	Massachusetts	United States
56	Pfizer Investigational Site	Bingham Farms	Michigan	United States
57	Pfizer Investigational Site	Farmington Hills	Michigan	United States
58	Pfizer Investigational Site	Grand Rapids	Michigan	United States
59	Pfizer Investigational Site	Royal Oak	Michigan	United States
60	Pfizer Investigational Site	Traverse City	Michigan	United States
61	Pfizer Investigational Site	Fridley	Minnesota	United States
62	Pfizer Investigational Site	Golden Valley	Minnesota	United States
63	Pfizer Investigational Site	Minneapolis	Minnesota	United States
64	Pfizer Investigational Site	St. Cloud	Minnesota	United States
65	Pfizer Investigational Site	Lee's Summit	Missouri	United States
66	Pfizer Investigational Site	Salisbury	Missouri	United States
67	Pfizer Investigational Site	Springfield	Missouri	United States
68	Pfizer Investigational Site	Omaha	Nebraska	United States
69	Pfizer Investigational Site	Las Vegas	Nevada	United States
70	Pfizer Investigational Site	Lebanon	New Hampshire	United States
71	Pfizer Investigational Site	Morristown	New Jersey	United States
72	Pfizer Investigational Site	New Brunswick	New Jersey	United States
73	Pfizer Investigational Site	Manhasset	New York	United States
74	Pfizer Investigational Site	Mineola	New York	United States
75	Pfizer Investigational Site	Mount Vernon	New York	United States
76	Pfizer Investigational Site	New York	New York	United States
77	Pfizer Investigational Site	Rochester	New York	United States
78	Pfizer Investigational Site	Syracuse	New York	United States
79	Pfizer Investigational Site	Asheville	North Carolina	United States
80	Pfizer Investigational Site	Charlotte	North Carolina	United States
81	Pfizer Investigational Site	Raleigh	North Carolina	United States
82	Pfizer Investigational Site	Winston-Salem	North Carolina	United States
83	Pfizer Investigational Site	Canfield	Ohio	United States
84	Pfizer Investigational Site	Dayton	Ohio	United States
85	Pfizer Investigational Site	Oklahoma City	Oklahoma	United States
86	Pfizer Investigational Site	Eugene	Oregon	United States
87	Pfizer Investigational Site	Norristown	Pennsylvania	United States
88	Pfizer Investigational Site	Sellersville	Pennsylvania	United States
89	Pfizer Investigational Site	Upland	Pennsylvania	United States
90	Pfizer Investigational Site	Knoxville	Tennessee	United States
91	Pfizer Investigational Site	Memphis	Tennessee	United States
92	Pfizer Investigational Site	Austin	Texas	United States
93	Pfizer Investigational Site	Dallas	Texas	United States
94	Pfizer Investigational Site	Houston	Texas	United States
95	Pfizer Investigational Site	San Antonio	Texas	United States
96	Pfizer Investigational Site	Salt Lake City	Utah	United States
97	Pfizer Investigational Site	Burlington	Vermont	United States
98	Pfizer Investigational Site	Charlottesville	Virginia	United States
99	Pfizer Investigational Site	Richmond	Virginia	United States
100	Pfizer Investigational Site	Bellevue	Washington	United States
101	Pfizer Investigational Site	Wenatchee	Washington	United States
102	Pfizer Investigational Site	Marshfield	Wisconsin	United States
103	Pfizer Investigational Site	Milwaukee	Wisconsin	United States
104	Pfizer Investigational Site	Buenos Aires	Barcelona	Argentina
105	Pfizer Investigational Site	Mar Del Plata	Buenos Aires	Argentina
106	Pfizer Investigational Site	Buenos Aires	Capital Federal	Argentina
107	Pfizer Investigational Site	Buenos Aires		Argentina
108	Pfizer Investigational Site	Medellin	Antioquia	Colombia
109	Pfizer Investigational Site	Bogota	D.c.	Colombia
110	Pfizer Investigational Site	Carolina		Puerto Rico

Sponsors and Collaborators

Pfizer

Investigators

Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

To obtain contact information for a study center near you, click here.

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00036205

Other Study ID Numbers:

M27600011

First Posted:

May 9, 2002

Last Update Posted:

Jan 18, 2007

Last Verified:

Jan 1, 2007

Additional relevant MeSH terms:

Parkinson Disease

Study Results

No Results Posted as of Jan 18, 2007