Rasagiline in Early Parkinson's Disease Patients Not Treated With Levodopa in China
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:
NCT01556165
First received: March 13, 2012
Last updated: April 10, 2013
Last verified: April 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
Rasagiline has been developed for the treatment of Parkinson's Disease (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.
The rationale for conducting this study is to evaluate the efficacy, tolerability, and safety of rasagiline compared to placebo in Chinese PD patients not treated with levodopa.
| 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 Early Parkinson's Disease Patients Not Treated With Levodopa in China |
Resource links provided by NLM:
Further study details as provided by H. Lundbeck A/S:
Primary Outcome Measures:
- Change from baseline to 26 weeks in Unified Parkinson's Disease Rating Scale (UPDRS) total score in patients with early PD not treated with levodopa [ Time Frame: baseline to 26 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Change from baseline to 26 weeks in sub-scale scores of the UPDRS (part I, II, and III) [ Time Frame: baseline to 26 weeks ] [ Designated as safety issue: No ]
- Time to onset of levodopa therapy [ Time Frame: baseline to 26 weeks ] [ Designated as safety issue: No ]
- Levodopa administration within 26 weeks [ Time Frame: baseline to 26 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 130 |
| Study Start Date: | April 2012 |
| Estimated Primary Completion Date: | November 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: rasagiline |
Drug: rasagiline
1 mg/day, tablets, once daily, orally
Other Name: Azilect
|
| Placebo Comparator: placebo |
Drug: placebo
tablets, once daily, orally
|
Eligibility| Ages Eligible for Study: | 35 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients with idiopathic PD.
- Patients with a Modified Hoehn and Yahr stage <3.
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 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: NCT01556165
Contacts
| Contact: Email contact via H. Lundbeck A/S | LundbeckClinicalTrials@lundbeck.com |
Locations
| China | |
| CN015 | Recruiting |
| Beijing, China, 100034 | |
| CN001 | Recruiting |
| Beijing, China, 100730 | |
| CN011 | Recruiting |
| Chengdu, China, 610041 | |
| 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 | |
| CN016 | Recruiting |
| Wuhan, China, 430030 | |
| 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: | NCT01556165 History of Changes |
| Other Study ID Numbers: | 13485A |
| Study First Received: | March 13, 2012 |
| 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 22, 2013