Parkinson´s DiseasePhase 3NCT01736891
Clinical Trial of Rasagiline in Levodopa-Treated Parkinson's Disease Patients With Motor Fluctuations
A Phase 3 study testing Rasagiline in people with Parkinson´s Disease, run by Chongqing Fortune Pharmaceutical Co., Ltd. at 8 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- 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
- 268 participants
- Where
- 8 sitesChina
- Study dates
- Nov 2011to Jun 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
- Patients with severe disabling dyskinesias Other inclusion and exclusion criteria may apply
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
China8 sites
CN002
Chengdu, 610041
CN005
Chenzhou, 423000
CN007
Chongqing, 404000
CN003
Guilin, 541001
CN004
Lanzhou, 730050
CN006
Luzhou, 646000
CN008
Nanjing, 210029
CN001
Xi'an, 710032
About this study
Official title: Evaluation for the Efficacy,Tolerability,and Safety of Rasagiline in Levodopa-treated PD Patients With Motor Fluctuations: A Multicenter, Double Blind, Randomized, Placebo-Controlled Group Study (China)
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.
Read the detailed description
Levodopa has been the mainstay therapy for PD for decades, and it is considered to be one of the most effective medications for relief of the symptoms of PD. However, within few months to few years the majority of levodopa-treated patients notice a decline in the duration of benefit of each dose and develop motor-complications. A major problem is the appearance of fluctuations in mobility, cycles of ON and OFF periods. The administration of rasagiline, a MAO-B inhibitor, can slow the elimination of the endogenous dopamine supplies or the dopamine produced from the exogenous levodopa therapy and may therefore improve ON-OFF fluctuations.
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.
- Conditions
- Parkinson´s Disease
- Being tested
- Rasagiline, Placebo
- Keywords
- Motor fluctuations, Parkinson´s Disease, Rasagiline
- 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
Tablets, qd
PlaceboDrug
Tablets, qd
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 0, 6, 10, 16 weeks
Change from baseline to week 6/14/16 in mean total daily ON time measured by patients' home diaries.
Measured: 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.
Measured: 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.
Measured: 0, 6, 10, 14, 16 weeks
Analysis of the changing rate of the UPDRSⅡ -Ⅵ after treatment of week 6/14/16.
Measured: 0, 6, 14, 16 weeks
The rate of patients whose Levodopa dose is adjusted after 6/14/16 weeks of treatment.
Measured: 0, 2, 6, 14, 16 weeks
BP、 temperature、 breath and heart rate after 5 minutes of stasis.
Measured: -2, 0, 2, 6, 10, 14, 16 weeks
Physical examination.
Measured: -2, 16 weeks
Adverse Events: the occurrence of melanoma.
Measured: 0, 2, 6, 10, 14, 16 weeks
Grade of UPDRS I
Measured: 0, 6, 14, 16 weeks
Blood routine、 urine routine、 ALT、 AST、 TBiL、 γ-GTP、 ALP、 BUN、 Cr、 ECG.
Measured: 0, 6, 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2012 (estimated)
- Study startNov 2011
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson´s DiseaseStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 268 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chongqing Fortune Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Beijing Bionovo Medicine Development Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Gang Zhao, Principal investigator, The First Affiliated Hospital of the Fourth Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01736891
- Sponsor's protocol ID
- RLPDMF2010L03416
- Status last verified
- Nov 2012
- First submitted
- 27 Nov 2012
- Last updated
- 13 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation for the Efficacy,Tolerability,and Safety of Rasagiline in Levodopa-treated PD Patients With Motor Fluctuations: A Multicenter, Double Blind, Randomized, Placebo-Controlled Group Study (China)
- ClinicalTrials.gov ID
- NCT01736891
- Acronym / sponsor ID
- RLPDMF2010L03416
- Conditions
- Parkinson´s Disease
- Keywords
- Motor fluctuations, Parkinson´s Disease, Rasagiline
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 268 participants (actual)
- Lead sponsor
- Chongqing Fortune Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Beijing Bionovo Medicine Development Co., Ltd.
- Study start
- Nov 2011
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 29 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Levodopa has been the mainstay therapy for PD for decades, and it is considered to be one of the most effective medications for relief of the symptoms of PD. However, within few months to few years the majority of levodopa-treated patients notice a decline in the duration of benefit of each dose and develop motor-complications. A major problem is the appearance of fluctuations in mobility, cycles of ON and OFF periods. The administration of rasagiline, a MAO-B inhibitor, can slow the elimination of the endogenous dopamine supplies or the dopamine produced from the exogenous levodopa therapy and may therefore improve ON-OFF fluctuations.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rasagiline | Experimental | Drug: RasagilineRasagiline 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) |
| Placebo | Placebo comparator | Drug: Placeboplacebo 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) |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
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: AzilectTablets, qd | Drug | Rasagiline |
| PlaceboTablets, qd | Drug | Placebo |
Primary outcome
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.
Time frame: 0, 14 weeks
11 secondary outcomes
Change from baseline to week 6/10/16 in mean total daily OFF time measured by patients' home diaries.
Time frame: 0, 6, 10, 16 weeks
Change from baseline to week 6/14/16 in mean total daily ON time measured by patients' home diaries.
Time frame: 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.
Time frame: 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.
Time frame: 0, 6, 10, 14, 16 weeks
Analysis of the changing rate of the UPDRSⅡ -Ⅵ after treatment of week 6/14/16.
Time frame: 0, 6, 14, 16 weeks
The rate of patients whose Levodopa dose is adjusted after 6/14/16 weeks of treatment.
Time frame: 0, 2, 6, 14, 16 weeks
BP、 temperature、 breath and heart rate after 5 minutes of stasis.
Time frame: -2, 0, 2, 6, 10, 14, 16 weeks
Physical examination.
Time frame: -2, 16 weeks
Adverse Events: the occurrence of melanoma.
Time frame: 0, 2, 6, 10, 14, 16 weeks
Grade of UPDRS I
Time frame: 0, 6, 14, 16 weeks
Blood routine、 urine routine、 ALT、 AST、 TBiL、 γ-GTP、 ALP、 BUN、 Cr、 ECG.
Time frame: 0, 6, 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2013.
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.
Gang Zhao principal investigator
The First Affiliated Hospital of the Fourth Military Medical University
8 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 Chongqing Fortune Pharmaceutical Co., Ltd. at 8 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 5 inclusion and 7 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 13 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
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. (time frame: 0, 14 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Sep 2013.