Study Evaluating Sumanirole for the Treatment of the Signs and Symptoms of Early Parkinson's Disease.
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Parkinson Disease |
Drug: sumanirole Drug: ropinirole |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| 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. |
- Change from baseline in UPDRS (Unified Parkinson's Disease Rating Scale) II + III total scores at end of maintenance, for sumanirole compared to placebo
- 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
| Estimated Enrollment: | 600 |
| Study Start Date: | December 2001 |
| Estimated Study Completion Date: | April 2003 |
Eligibility| Ages Eligible for Study: | 30 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Participation in clinical trial within the previous 30 days.
Malignant melanoma or history of melanoma
Significant medical or pshychiatric condition.
Contacts and Locations
Show 102 Study Locations| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00036218 History of Changes |
| Other Study ID Numbers: | 666E-CNS-0075-021 |
| Study First Received: | May 8, 2002 |
| Last Updated: | June 6, 2006 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Parkinson Disease Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Movement Disorders Neurodegenerative Diseases Ropinirole Antiparkinson Agents |
Anti-Dyskinesia Agents Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Dopamine Agonists Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 23, 2013