NCT01556165

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P25-P50 for phase_3

Geographic Reach
1 country

15 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 13, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 16, 2012

Completed
16 days until next milestone

Study Start

First participant enrolled

April 1, 2012

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

December 23, 2014

Completed
Last Updated

December 23, 2014

Status Verified

December 1, 2014

Enrollment Period

1.7 years

First QC Date

March 13, 2012

Results QC Date

December 4, 2014

Last Update Submit

December 22, 2014

Conditions

Parkinson's Disease

Keywords

RasagilineAzilectParkinson´s DiseaseMotor fluctuations

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline to Week 26 in UPDRS Total Score

    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).

    Baseline to Week 26

Secondary Outcomes (5)

  • Change From Baseline to Week 26 in Subscale Scores of the UPDRS (Part I)

    Baseline to Week 26

  • Change From Baseline to Week 26 in Subscale Scores of the UPDRS (Part II)

    Baseline to Week 26

  • Change From Baseline to Week 26 in Subscale Scores of the UPDRS (Part III)

    Baseline to Week 26

  • Time to Onset of Levodopa Therapy

    Baseline to Week 26

  • Levodopa Administration Within 26 Weeks

    Baseline to Week 26

Study Arms (2)

rasagiline

EXPERIMENTAL
Drug: rasagiline

placebo

PLACEBO COMPARATOR
Drug: placebo

Interventions

rasagilineDRUG

1 mg/day, tablets, once daily, orally

Also known as: Azilect
rasagiline
placeboDRUG

tablets, once daily, orally

placebo

Eligibility Criteria

Age35 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with idiopathic PD.
  • Patients with a Modified Hoehn and Yahr stage \<3.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

CN015

Beijing, 100034, China

Location

CN001

Beijing, 100730, China

Location

CN011

Chengdu, 610041, China

Location

CN003

Guangzhou, 510120, China

Location

CN005

Guangzhou, 510180, China

Location

CN017

Guangzhou, 510260, China

Location

CN004

Hangzhou, 310009, China

Location

CN012

Shanghai, 200025, China

Location

CN007

Shanghai, 200040, China

Location

CN013

Shanghai, 200127, China

Location

CN006

Suzhou, 215004, China

Location

CN009

Wuhan, 430022, China

Location

CN016

Wuhan, 430030, China

Location

CN010

Xi'an, 710032, China

Location

CN014

Xi'an, 710061, China

Location

Related Publications (1)

  • 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.

    PMID: 30534374DERIVED

MeSH Terms

Conditions

Parkinson Disease

Interventions

rasagiline

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Results Point of Contact

Title
Study director
Organization
Email contact via H. Ludbeck A/S
LundbeckClinicalTrials@lundbeck.com

Study Officials

  • Email contact via H. Lundbeck A/S

    LundbeckClinicalTrials@lundbeck.com

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 13, 2012

First Posted

March 16, 2012

Study Start

April 1, 2012

Primary Completion

December 1, 2013

Last Updated

December 23, 2014

Results First Posted

December 23, 2014

Record last verified: 2014-12

Locations

CN(15)