NCT01736891

Brief Summary

The objective of this study is to evaluate the efficacy, tolerability, and safety of rasagiline compared to placebo in PD patients with motor fluctuations on levodopa therapy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
268

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Nov 2011

Geographic Reach
1 country

8 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

Study Start

First participant enrolled

November 1, 2011

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

November 27, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 29, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

September 13, 2013

Status Verified

November 1, 2012

Enrollment Period

1.6 years

First QC Date

November 27, 2012

Last Update Submit

September 12, 2013

Conditions

Parkinson´s Disease

Keywords

Motor fluctuationsParkinson´s DiseaseRasagiline

Outcome Measures

Primary Outcomes (1)

  • Efficacy of rasagiline vs placebo as assessed by the change from baseline to week 14 in mean total daily OFF time measured by patients' home diaries in levodopa-treated PD patients with motor fluctuations.

    0, 14 weeks

Secondary Outcomes (11)

  • Change from baseline to week 6/10/16 in mean total daily OFF time measured by patients' home diaries.

    0, 6, 10, 16 weeks

  • Change from baseline to week 6/14/16 in mean total daily ON time measured by patients' home diaries.

    0, 6, 14, 16 weeks

  • Change from baseline to week 6/14/16 on Unified Parkinson's Disease Rating Scale (UPDRS) Ⅱ- Ⅵ Activities of Daily Living.

    0, 6, 14, 16 weeks

  • Change from baseline to week 6/10/14/16 in mean total daily ON time measured by patients' home diaries.

    0, 6, 10, 14, 16 weeks

  • Analysis of the changing rate of the UPDRSⅡ -Ⅵ after treatment of week 6/14/16.

    0, 6, 14, 16 weeks

  • +6 more secondary outcomes

Study Arms (2)

Rasagiline

EXPERIMENTAL

Rasagiline 0.5 mg by mouth every day for 2 weeks, then 1 mg by mouth every day for 12 weeks, then switch to 0.5mg by mouth every day for remainder of the study (approximately 16 weeks total)

Drug: Rasagiline

Placebo

PLACEBO COMPARATOR

placebo 0.5 mg by mouth every day for two weeks, then 1 mg by mouth every day for 12 weeks, then switch to 0.5mg by mouth every day for remainder of the study (approximately 16 weeks total)

Drug: Placebo

Interventions

RasagilineDRUG

Tablets, qd

Also known as: Azilect
Rasagiline
PlaceboDRUG

Tablets, qd

Placebo

Eligibility Criteria

Age30 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with idiopathic PD
  • Patients receiving at least 300 mg daily doses of levodopa and not less than 8 daily doses of levodopa with the stable dose
  • Patient with a Modified Hoehn and Yahr stage between 2 to 4 in the OFF state
  • Patient with motor fluctuations averaging at least 2 hour daily in the OFF state
  • Patients who have demonstrated the ability to keep accurate 24-hour diaries

You may not qualify if:

  • Patients with Parkinsonian syndrome induced by medicine, metabolic disease, Encephalitis and central nervous system degenerative diseases or Disease of basal ganglia
  • Patients with severe cognitive impairment judged by a Mini Mental State Examination
  • Patients with a clinically significant psychiatric illness
  • Patients with Hamilton Depression Rating Scale (HAMD): total score ≤10
  • Patients with a clinically significant or unstable medical or surgical condition which would preclude safe and complete study participation
  • Patients with a clinically significant or unstable vascular disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

CN002

Chengdu, 610041, China

Location

CN005

Chenzhou, 423000, China

Location

CN007

Chongqing, 404000, China

Location

CN003

Guilin, 541001, China

Location

CN004

Lanzhou, 730050, China

Location

CN006

Luzhou, 646000, China

Location

CN008

Nanjing, 210029, China

Location

CN001

Xi'an, 710032, China

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

rasagiline

Condition Hierarchy (Ancestors)

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

Study Officials

  • Gang Zhao

    The First Affiliated Hospital of the Fourth Military Medical University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

November 27, 2012

First Posted

November 29, 2012

Study Start

November 1, 2011

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

September 13, 2013

Record last verified: 2012-11

Locations

CN(8)