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

A Phase 3 study testing rasagiline in people with Parkinson's Disease, run by H. Lundbeck A/S at 15 sites in China.

Completed

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

Trial 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. Read more about this study

Who is it for?: Ages 35 years and older
Conditions the study is for: Parkinson's Disease
What is being tested?: rasagiline
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 130 participants
Where: 15 sitesChina
Study dates: Apr 2012to Dec 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 35 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

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 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

15 sites in 1 country.

City, postcode or hospital

15 sites in 1 country

China15 sites

CN015
Beijing, 100034
CN001
Beijing, 100730
CN011
Chengdu, 610041
CN003
Guangzhou, 510120
CN005
Guangzhou, 510180
CN017
Guangzhou, 510260
CN004
Hangzhou, 310009
CN012
Shanghai, 200025
CN007
Shanghai, 200040
CN013
Shanghai, 200127
CN006
Suzhou, 215004
CN009
Wuhan, 430022
CN016
Wuhan, 430030
CN010
Xi'an, 710032
CN014
Xi'an, 710061

Other trials in China

About this study

Official 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

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.

Conditions: Parkinson's Disease
Being tested: rasagiline, placebo
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.

rasagilineDrug
Also called Azilect
1 mg/day, tablets, once daily, orally
placeboDrug
tablets, once daily, orally

Study groups in NCT01556165
Study group	Role	What they receive
rasagiline	Experimental	Not described Receives: Drug: rasagiline
placebo	Placebo comparator	Not described Receives: Drug: placebo

What is being measured

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

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).
Measured: Baseline to Week 26

Secondary outcomes (5)

Change From Baseline to Week 26 in Subscale Scores of the UPDRS (Part I)
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)
Measured: Baseline to Week 26
Change From Baseline to Week 26 in Subscale Scores of the UPDRS (Part II)
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)
Measured: Baseline to Week 26
Change From Baseline to Week 26 in Subscale Scores of the UPDRS (Part III)
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)
Measured: Baseline to Week 26
Time to Onset of Levodopa Therapy
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.
Measured: Baseline to Week 26
Levodopa Administration Within 26 Weeks
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.
Measured: Baseline to Week 26

Timeline

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

Apr 2012Dec 2013

First posted16 Mar 2012 (estimated)
Study startApr 2012
Primary completionDec 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
More trials run by H. Lundbeck A/SThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: 130 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01556165
Sponsor's protocol ID: 13485A
Status last verified: Dec 2014
First submitted: 13 Mar 2012
Last updated: 23 Dec 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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.
PubMed 30534374

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Parkinson's Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official 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
ClinicalTrials.gov ID: NCT01556165
Acronym / sponsor ID: 13485A
Conditions: Parkinson's Disease
Keywords: Rasagiline, Azilect, Parkinson´s Disease, Motor fluctuations
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 130 participants (actual)
Lead sponsor: H. Lundbeck A/SIndustry (pharma, biotech, devices)
Study start: Apr 2012
Primary completion: Dec 2013 (actual)
First posted: 16 Mar 2012 (estimated)
Results: Posted 23 Dec 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
rasagiline	Experimental	Drug: rasagiline
placebo	Placebo comparator	Drug: placebo

Who may qualify

Ages: 35 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (6 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
rasagilineAlso: Azilect1 mg/day, tablets, once daily, orally	Drug	rasagiline
placebotablets, once daily, orally	Drug	placebo

Primary outcome

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).

5 secondary outcomes

Change From Baseline to Week 26 in Subscale Scores of the UPDRS (Part I)
Time frame: Baseline to Week 26
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 III)
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

Results and safety

Results posted to the registry on 23 Dec 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	65	53
Rasagiline	65	58

Primary outcome: Change From Baseline to Week 26 in UPDRS Total Score

Time frame: Baseline to Week 26. Mean (Standard Error). Unit: units on a scale

Measure	Placebo n = 63	Rasagiline n = 64
Value	-0.18 (0.98)	-3.18 (0.95)

Placebo vs Rasagiline: Mean Difference (Final Values): -3.00 (75% CI -4.53 to -1.47), p = 0.0254, ANCOVA

Population analysed: The full-analysis set (FAS) comprised all patients in the APTS who had a valid baseline assessment and at least one valid post-baseline assessment of the primary efficacy variable.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: 30 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	4 of 65 (6.2%)	6 of 65 (9.2%)	Not reported
Rasagiline	0 of 65 (0%)	8 of 65 (12.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 30534374Zhang 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.

Related trials for Parkinson's Disease

Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
Active, not recruitingPhase 1/2
Clinical Safety and Efficacy of Umbilical Cord Mesenchymal Stromal Cells-derived Exosomes in Patients With Parkinson's Disease
Parkinson Disease (PD)
Active, not recruitingObservational study
Adaptive DBS to Offset STN Dysregulation During Exercise in PD
Parkinson Disease
Not yet recruiting
Compulsive Eating and Brain's Reward System in Different Pathologies
PARKINSON DISEASE (Disorder), Bipolar 1 Disorder
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Email contact via H. Lundbeck A/S principal investigator

LundbeckClinicalTrials@lundbeck.com

15 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing rasagiline in people with Parkinson's Disease, run by H. Lundbeck A/S at 15 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 2 inclusion and 6 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 23 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 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 23 Dec 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 to Week 26 in UPDRS Total Score (time frame: Baseline to Week 26). 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 NCT01556165, 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 23 Dec 2014.