Study of Rasagiline in Levodopa-treated PD Patients With Motor Fluctuations
This study has been completed.
Sponsor:
H. Lundbeck A/S
Information provided by (Responsible Party):
H. Lundbeck A/S
ClinicalTrials.gov Identifier:
NCT01268891
First received: December 30, 2010
Last updated: June 29, 2012
Last verified: June 2012
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Purpose
To evaluate the efficacy of a fixed dose of rasagiline (1 mg/day) vs placebo as assessed by the change from baseline in mean total daily OFF time during 18 weeks of treatment in levodopa-treated Parkinson's Disease (PD) patients with motor fluctuations.
| Condition | Intervention | Phase |
|---|---|---|
|
Parkinson's Disease |
Drug: Rasagiline Drug: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | Randomised, Double-blind, Parallel-group, Placebo-controlled, Fixed-dose Study of Rasagiline in Levodopa-treated Parkinson's Patients With Motor Fluctuations in Korea |
Resource links provided by NLM:
Further study details as provided by H. Lundbeck A/S:
Primary Outcome Measures:
- Efficacy of rasagiline (1 mg/day) vs placebo as assessed by the change from baseline in mean total daily OFF time during 18 weeks of treatment in levodopa-treated PD patients with motor fluctuations [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Change from baseline to week 18 on Clinical Global Impression (CGI-I) during ON time [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
- Change from baseline to week 18 on Unified Parkinson's Disease Rating Scale (UPDRS) Activities of Daily Living during OFF time [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
- Change from baseline to week 18 on UPDRS Motor score during ON time [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 132 |
| Study Start Date: | January 2011 |
| Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Rasagiline |
Drug: Rasagiline
1 mg daily; orally; 18 weeks
Other Name: Azilect®
|
| Placebo Comparator: Placebo |
Drug: Placebo
Once daily; orally; 18 weeks
|
Detailed Description:
Levodopa has been the mainstay therapy for PD for decades, and it is considered to be one of the most effective medications for relief of the symptoms of PD. However, within few months to few years the majority of levodopa-treated patients notice a decline in the duration of benefit of each dose and develop motor-complications. A major problem is the appearance of fluctuations in mobility, cycles of ON and OFF periods. The administration of rasagiline, a MAO-B inhibitor, can slow the elimination of the endogenous dopamine supplies or the dopamine produced from the exogenous levodopa therapy and may therefore improve ON-OFF fluctuations.
The objective of this study is to evaluate the efficacy, tolerability, and safety of rasagiline compared to placebo in Korean PD patients with motor fluctuations on levodopa therapy.
Eligibility| Ages Eligible for Study: | 30 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients with idiopathic PD
- Patients with motor fluctuations averaging at least 1 hour daily in the OFF state during the waking hours
- Patients with a Modified Hoehn and Yahr stage <5 in the OFF state
- Patients taking optimised levodopa/DOPA decarboxylase inhibitor (DDI) therapy for at least 14 days prior to baseline
- Patients receiving at least 3 daily doses of levodopa and not more than 8 daily doses of levodopa
- Patient who have demonstrated the ability to keep accurate 24-hour diaries prior to randomisation
Exclusion Criteria:
- Patients with a clinically significant or unstable medical or surgical condition that would preclude his/her safe and complete study participation
- Patients taking any disallowed medication according to the Azilect® approved label
- Patients taking MAO inhibitors within 3 months prior to baseline visit
- Patients with a known serious adverse reaction to selegiline
- Patients with a clinically significant psychiatric illness, including a major depression, which compromises their ability to provide consent or participate fully in the study
- Patients with a Mini Mental State Examination (MMSE) score <=24
- Patients with a diagnosis of melanoma or a history of melanoma, or a suspicious lesion
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01268891
Locations
| Korea, Republic of | |
| KR003 | |
| Busan, Korea, Republic of | |
| KR007 | |
| Busan, Korea, Republic of, 614-735 | |
| KR012 | |
| Daegu, Korea, Republic of, 702-210 | |
| KR011 | |
| Kwangju, Korea, Republic of, 501-757 | |
| KR004 | |
| Seongnam, Korea, Republic of, 463-707 | |
| KR008 | |
| Seoul, Korea, Republic of, 135-710 | |
| KR009 | |
| Seoul, Korea, Republic of, 156-707 | |
| KR002 | |
| Seoul, Korea, Republic of, 138-736 | |
| KR005 | |
| Seoul, Korea, Republic of, 120-752 | |
| KR010 | |
| Seoul, Korea, Republic of, 130-702 | |
| KR006 | |
| Seoul, Korea, Republic of, 133-792 | |
| KR001 | |
| Seoul, Korea, Republic of, 110-744 | |
Sponsors and Collaborators
H. Lundbeck A/S
Investigators
| Study Director: | Email contact via H. Lundbeck A/S | LundbeckClinicalTrials@lundbeck.com |
More Information
No publications provided
| Responsible Party: | H. Lundbeck A/S |
| ClinicalTrials.gov Identifier: | NCT01268891 History of Changes |
| Other Study ID Numbers: | 13484A |
| Study First Received: | December 30, 2010 |
| Last Updated: | June 29, 2012 |
| Health Authority: | South Korea: Korea Food and Drug Administration (KFDA) |
Keywords provided by H. Lundbeck A/S:
|
Azilect Motor fluctuations Parkinson´s Disease Rasagiline |
Additional relevant MeSH terms:
|
Parkinson Disease Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Movement Disorders Neurodegenerative Diseases Levodopa Rasagiline Antiparkinson Agents Anti-Dyskinesia Agents |
Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Monoamine Oxidase Inhibitors Enzyme Inhibitors Neuroprotective Agents Protective Agents |
ClinicalTrials.gov processed this record on May 23, 2013