Rasagiline in Early Parkinson's Disease Patients Not Treated With Levodopa in China

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT01556165
• Date of registration: 13/03/2012
• Prospective Registration: Yes
• Primary sponsor: H. Lundbeck A/S
• Public title: Rasagiline in Early Parkinson's Disease Patients Not Treated With Levodopa in China
• Scientific 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
• Date of first enrolment: April 2012
• Target sample size: 130
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01556165
• Study type: Interventional
• Phase: Phase 3

Countries of recruitment

China

Contacts

• Name: Email contact via H. Lundbeck A/S
• Affiliation: [e-mail]

Key inclusion & exclusion 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.



Age minimum: 35 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Parkinson's Disease

Intervention(s)

Drug: placebo

Drug: rasagiline

Primary Outcome(s)

Change From Baseline to Week 26 in UPDRS Total Score [Time Frame: Baseline to Week 26]

Secondary Outcome(s)

Change From Baseline to Week 26 in Subscale Scores of the UPDRS (Part II) [Time Frame: Baseline to Week 26]

Change From Baseline to Week 26 in Subscale Scores of the UPDRS (Part I) [Time Frame: Baseline to Week 26]

Time to Onset of Levodopa Therapy [Time Frame: Baseline to Week 26]

Levodopa Administration Within 26 Weeks [Time Frame: Baseline to Week 26]

Change From Baseline to Week 26 in Subscale Scores of the UPDRS (Part III) [Time Frame: Baseline to Week 26]

Secondary ID(s)

13485A

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 23/12/2014
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01556165