Rasagiline in Levodopa-treated Parkinson's Patients With Motor Fluctuations in China (CHORAL)
This study is currently recruiting participants.
Verified April 2013 by H. Lundbeck A/S
Sponsor:
H. Lundbeck A/S
Information provided by (Responsible Party):
H. Lundbeck A/S
ClinicalTrials.gov Identifier:
NCT01479530
First received: November 22, 2011
Last updated: April 10, 2013
Last verified: April 2013
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Purpose
The rationale for conducting this study is to evaluate the efficacy, tolerability, and safety of rasagiline compared to placebo in levodopa-treated Parkinson's Disease (PD) Chinese patients with motor fluctuations. Rasagiline has been developed for the treatment of PD, as monotherapy in early PD patients not treated with levodopa and as adjunct therapy to levodopa in levodopa-treated 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 China |
Resource links provided by NLM:
Further study details as provided by H. Lundbeck A/S:
Primary Outcome Measures:
- 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 16 weeks of treatment in levodopa-treated PD patients with motor fluctuations. [ Time Frame: baseline to 16 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Change from baseline after 16 weeks of treatment on Clinical Global Impression - Improvement (CGI-I) score during "ON" time [ Time Frame: baseline to 16 weeks ] [ Designated as safety issue: No ]
- Change from baseline after 16 weeks of treatment on Unified Parkinson's Disease Rating Scale (UPDRS) Activities of Daily Living (ADL) score during "OFF" time [ Time Frame: baseline to 16 weeks ] [ Designated as safety issue: No ]
- Change from baseline after 16 weeks of treatment on UPDRS Motor score during "ON" time [ Time Frame: baseline to 16 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 320 |
| Study Start Date: | December 2011 |
| Estimated Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: rasagiline |
Drug: rasagiline
1 mg/day, once daily, tablets, orally
Other Name: Azilect
|
| Placebo Comparator: placebo |
Drug: placebo
once daily, tablets, orally
|
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 ≤3 in the "ON" state.
- Patients taking optimised levodopa or dopa decarboxylase inhibitor (DDI) therapy; they must be stable 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.
- Patients 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 with a clinically significant or unstable vascular disease.
- Patients who have undergone a neurosurgical intervention of PD.
- Patients with severe disabling dyskinesias.
- 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.
Other inclusion and exclusion criteria may apply.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01479530
Contacts
| Contact: Email contact via H. Lundbeck A/S | LundbeckClinicalTrials@lundbeck.com |
Locations
| China | |
| CN015 | Recruiting |
| Beijing, China, 100034 | |
| CN017 | Recruiting |
| Beijing, China, 100050 | |
| CN018 | Recruiting |
| Beijing, China, 100730 | |
| CN001 | Recruiting |
| Beijing, China, 100730 | |
| CN008 | Recruiting |
| Beijing, China, 100050 | |
| CN011 | Recruiting |
| Chengdu, China, 610041 | |
| CN019 | Recruiting |
| Guang Zhou, China, 510260 | |
| CN020 | Recruiting |
| Guang Zhou, China, 510260 | |
| CN003 | Recruiting |
| Guangzhou, China, 510120 | |
| CN005 | Recruiting |
| Guangzhou, China, 510180 | |
| CN004 | Recruiting |
| Hangzhou, China, 310009 | |
| CN013 | Recruiting |
| Shanghai, China, 200127 | |
| CN012 | Recruiting |
| Shanghai, China, 200025 | |
| CN007 | Recruiting |
| Shanghai, China, 200040 | |
| CN006 | Recruiting |
| Suzhou, China, 215004 | |
| CN009 | Recruiting |
| Wuhan, China, 430022 | |
| CN010 | Recruiting |
| Xi'an, China, 710032 | |
| CN014 | Recruiting |
| Zi'an, China, 710061 | |
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: | NCT01479530 History of Changes |
| Other Study ID Numbers: | 13445A |
| Study First Received: | November 22, 2011 |
| Last Updated: | April 10, 2013 |
| Health Authority: | China: Food and Drug Administration |
Keywords provided by H. Lundbeck A/S:
|
Rasagiline Azilect Parkinson´s Disease Motor fluctuations |
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 16, 2013