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

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ClinicalTrials.gov Identifier: NCT01556165
Recruitment Status : Completed
First Posted : March 16, 2012
Results First Posted : December 23, 2014
Last Update Posted : December 23, 2014
Sponsor:
Information provided by (Responsible Party):
H. Lundbeck A/S

Tracking Information
First Submitted Date  ICMJE March 13, 2012
First Posted Date  ICMJE March 16, 2012
Results First Submitted Date  ICMJE December 4, 2014
Results First Posted Date  ICMJE December 23, 2014
Last Update Posted Date December 23, 2014
Study Start Date  ICMJE April 2012
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 22, 2014)
Change From Baseline to Week 26 in UPDRS Total Score [ Time Frame: Baseline to Week 26 ]
The Unified Parkinson's Disease Rating Scale (UPDRS) is a 42-item rating scale designed to assess Parkinson's disease-related disability and impairment. The scale comprises four parts: Part I evaluates mentation, behaviour, and mood symptoms; Part II evaluates activities of daily living (ADL); Part III evaluates motor function; and Part IV evaluates complications of dopaminergic therapy. The total score is the sum of the subscale scores for Parts I to III and ranges from 0 (no disability) to 176 (total dependence).
Original Primary Outcome Measures  ICMJE
 (submitted: March 15, 2012)
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 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 22, 2014)
  • Change From Baseline to Week 26 in Subscale Scores of the UPDRS (Part I) [ Time Frame: Baseline to Week 26 ]
    The Unified Parkinson's Disease Rating Scale (UPDRS) Part I evaluates mentation, behaviour and mood symptoms, it comprises 4 parts and the score ranges from 0 (normal) to 16 (severe impairement)
  • Change From Baseline to Week 26 in Subscale Scores of the UPDRS (Part II) [ Time Frame: Baseline to Week 26 ]
    The Unified Parkinson's Disease Rating Scale (UPDRS) Part II evaluates activities of daily living, it comprises 13 parts and the score ranges from 0 (normal) to 52 (severe impairement and disability)
  • Change From Baseline to Week 26 in Subscale Scores of the UPDRS (Part III) [ Time Frame: Baseline to Week 26 ]
    The Unified Parkinson's Disease Rating Scale (UPDRS) Part III evaluates motor function, it comprises 14 parts and the score ranges from 0 (normal) to 108 (severe impairement and disability)
  • Time to Onset of Levodopa Therapy [ Time Frame: Baseline to Week 26 ]
    It was stated in the statistical analysis plan (SAP) that if >10% of FAS patients were considered to have taken levodopa during the treatment period, the endpoint, time to onset of levodopa treatment was to be analysed. However, since only one patient (in the placebo group) had levodopa administered during the treatment period, this endpoint was not analysed, as had been defined a priori in the SAP.
  • Levodopa Administration Within 26 Weeks [ Time Frame: Baseline to Week 26 ]
    It was stated in the statistical analysis plan (SAP) that if >10% of FAS patients were considered to have taken levodopa during the treatment period, the endpoint, levodopa administration within 26 Weeks was to be analysed. However, since only one patient (in the placebo group) had levodopa administered during the treatment period, this endpoint was not analysed, as had been defined a priori in the SAP.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 15, 2012)
  • Change from baseline to 26 weeks in sub-scale scores of the UPDRS (part I, II, and III) [ Time Frame: baseline to 26 weeks ]
  • Time to onset of levodopa therapy [ Time Frame: baseline to 26 weeks ]
  • Levodopa administration within 26 weeks [ Time Frame: baseline to 26 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Rasagiline in Early Parkinson's Disease Patients Not Treated With Levodopa in China
Official Title  ICMJE Randomised, Double-blind, Parallel-group, Placebo-controlled, Fixed-dose Study of Rasagiline in Early Parkinson's Disease Patients Not Treated With Levodopa in China
Brief Summary

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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Parkinson's Disease
Intervention  ICMJE
  • Drug: rasagiline
    1 mg/day, tablets, once daily, orally
    Other Name: Azilect
  • Drug: placebo
    tablets, once daily, orally
Study Arms  ICMJE
  • Experimental: rasagiline
    Intervention: Drug: rasagiline
  • Placebo Comparator: placebo
    Intervention: Drug: placebo
Publications * Zhang Z, Wang J, Chen S, Liu C, Zhang B, Peng R, Sun S, Sun X, Zhao G, Qu Q, Li Y, Zhu S, Pan X, Shao M, Wang Y. Efficacy and safety of rasagiline in Chinese patients with early Parkinson's disease: a randomized, double-blind, parallel, placebo-controlled, fixed-dose study. Transl Neurodegener. 2018 Dec 6;7:32. doi: 10.1186/s40035-018-0137-5. eCollection 2018.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 15, 2012)
130
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 35 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01556165
Other Study ID Numbers  ICMJE 13485A
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party H. Lundbeck A/S
Study Sponsor  ICMJE H. Lundbeck A/S
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Email contact via H. Lundbeck A/S LundbeckClinicalTrials@lundbeck.com
PRS Account H. Lundbeck A/S
Verification Date December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP