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Parkinson's DiseasePhase 3CHORALNCT01479530

Azilect® (Rasagiline) in Levodopa-treated Parkinson's Patients With Motor Fluctuations in China

A Phase 3 study testing Azilect® in people with Parkinson's Disease, run by H. Lundbeck A/S at 18 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The rationale for conducting this study is to evaluate the efficacy, tolerability, and safety of rasagiline compared to placebo in levodopa-treated Parkinson's Disease (PD) Chinese patients with motor fluctuations. Read more about this study

Who is it for?
Ages 30 years and older
Conditions the study is for
Parkinson's Disease
What is being tested?
Azilect®
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
321 participants
Where
18 sitesChina
Study dates
Dec 2011to Jun 2013
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with idiopathic PD.
  • Patients with motor fluctuations averaging at least 1 hour daily in the "OFF" state during the waking hours.
  • Patients with a Modified Hoehn and Yahr stage ≤3 in the "ON" state.
  • Patients taking optimised levodopa or dopa decarboxylase inhibitor (DDI) therapy; they must be stable for at least 14 days prior to baseline.
  • Patients receiving at least 3 daily doses of levodopa and not more than 8 daily doses of levodopa.
  • Patients who have demonstrated the ability to keep accurate "24-hour" diaries prior to randomisation.

Who cannot join

  • 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 who have undergone a neurosurgical intervention of PD.
  • Patients with severe disabling dyskinesias.
  • 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.

Trial locations and contacts

18 sites in 1 country.

18 sites in 1 country

China18 sites

  • CN015

    Beijing, 100034

  • CN008

    Beijing, 100050

  • CN017

    Beijing, 100050

  • CN001

    Beijing, 100730

  • CN018

    Beijing, 100730

  • CN011

    Chengdu, 610041

  • CN003

    Guangzhou, 510120

  • CN005

    Guangzhou, 510180

  • CN004

    Hangzhou, 310009

  • CN019

    Qingyu Zhou, 510260

  • CN020

    Qingyu Zhou, 510260

  • CN012

    Shanghai, 200025

  • CN007

    Shanghai, 200040

  • CN013

    Shanghai, 200127

  • CN006

    Suzhou, 215004

  • CN009

    Wuhan, 430022

  • CN010

    Xi'an, 710032

  • CN014

    Zi’an, 710061

Other trials in China

About this study

Official title: Randomised, Double-blind, Parallel-group, Placebo-controlled, Fixed-dose Study of [Azilect®] Rasagiline in Levodopa-treated Parkinson's Patients With Motor Fluctuations in China

The rationale for conducting this study is to evaluate the efficacy, tolerability, and safety of rasagiline compared to placebo in levodopa-treated Parkinson's Disease (PD) Chinese patients with motor fluctuations. Azilect® (Rasagiline) is indicated for the treatment of idiopathic PD as monotherapy (without levodopa) or as adjunct therapy (with levodopa) in patients with end of dose fluctuations.

Being tested
Placebo, Azilect®
Keywords
Rasagiline, Azilect, Parkinson´s Disease, Motor fluctuations
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboDrug

    Once daily; tablet; orally; 16 weeks

  • Azilect®Drug

    Also called Rasagiline

    1 mg daily; tablet; orally; 16 weeks

Study groups in NCT01479530
Study groupRoleWhat they receive
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo
Azilect®ExperimentalNot described
Receives: Drug: Azilect®

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline in Mean Total Daily OFF Time Using Parkinson's Disease Patient Diary

    Parkinson's Disease Patient Diary is a self-administered diary designed to assess motor fluctuations throughout the day. It is divided into 30-minute intervals, and the patient selects one of four options for each interval: asleep; off; on with no dyskinesia or without troublesome dyskinesia; or on with troublesome dyskinesia.

    The Change From Baseline in Mean Total Daily OFF time is calculated by taking the difference between the average of the total daily OFF time at Weeks 4, 8, 12, and 16, and the Baseline Total Daily OFF Time.

    Measured: Baseline and Weeks 4, 8, 12, and 16

Secondary outcomes (3)

  1. Clinical Status Using CGI-I Score During ON Time

    Clinical Global Impression - Global Improvement (CGI-I) is a single-item rating scale used to evaluate a patient's condition relative to baseline on a 7-point scale, regardless of whether the improvement is related to the investigational medicinal product (IMP). The scale ranges from 1 (very much improved) to 7 (very much worse).

    Measured: Week 16

  2. Change From Baseline in UPDRS-ADL Score During OFF Time

    Unified Parkinson's Disease Rating Scale (UPDRS) is a 42-item rating scale designed to assess Parkinson's Disease-related disability and impairment using a patient interview and a physical examination. It has 4 parts and 4 subsection scores. A higher score indicates a worse outcome. I: mentation, behaviour and mood symptoms - 0 to 16; II: activities of daily living (ADL) - 0 to 52; III: motor function - 0 to 108; IV: complications of dopaminergic therapy - 0 to 23. Subsection scores for I to III are used to calculate a total score that ranges from 0 (no disability) to 176 (total dependence).

    Measured: Baseline and Week 16

  3. Change From Baseline in UPDRS Motor Score During ON Time

    UPDRS is a 42-item rating scale designed to assess Parkinson's Disease-related disability and impairment using a patient interview and a physical examination. It has 4 parts and 4 subsection scores. A higher score indicates a worse outcome. I: mentation, behaviour and mood symptoms - 0 to 16; II: ADL - 0 to 52; III: motor function - 0 to 108; IV: complications of dopaminergic therapy - 0 to 23. Subsection scores for I to III are used to calculate a total score that ranges from 0 (no disability) to 176 (total dependence).

    Measured: Baseline and Week 16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Nov 2011 (estimated)
  2. Study startDec 2011
  3. Primary completionJun 2013
  4. Study completionJun 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
321 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01479530
Sponsor's protocol ID
13445A
Acronym
CHORAL
Status last verified
Aug 2018
First submitted
22 Nov 2011
Last updated
10 Sep 2018
Data monitoring committee
No

Publications

  • Zhang Z, Shao M, Chen S, Liu C, Peng R, Li Y, Wang J, Zhu S, Qu Q, Zhang X, Chen H, Sun X, Wang Y, Sun S, Zhang B, Li J, Pan X, Zhao G. Adjunct rasagiline to treat Parkinson's disease with motor fluctuations: a randomized, double-blind study in China. Transl Neurodegener. 2018 Jun 30;7:14. doi: 10.1186/s40035-018-0119-7. eCollection 2018.

    PubMed 29988514

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Azilect® in people with Parkinson's Disease, run by H. Lundbeck A/S at 18 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Jun 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Mean Total Daily OFF Time Using Parkinson's Disease Patient Diary (time frame: Baseline and Weeks 4, 8, 12, and 16). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01479530, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2018.

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