Parkinson's DiseasePhase 4NCT00399477
A Non-Blinded Study Demonstrating the Effectiveness and Safety of Azilect Alone or in Combination Therapy in Parkinson's Disease
A Phase 4 study testing rasagiline mesylate, Rasagiline mesylate plus Mirapex and Rasagiline mesylate with Levodopa in people with Parkinson's Disease, run by Teva Neuroscience, Inc..
Trial summary
Patients with Parkinson's Disease (PD) will be divided into 2 groups at each study center at their first visit based on the drugs they are taking for their PD: Group 1 Patients using Azilect and no other therapy. Group 2 Azilect in combination with other medications like Levodopa, Mirapex, or Requip. 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?
- rasagiline mesylate, Rasagiline mesylate plus Mirapex and Rasagiline mesylate with Levodopa
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Oct 2006to Jul 2007
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Idiopathic Parkinson's disease. Diagnosis previously confirmed by the presence of bradykinesia and by at least one additional cardinal sign (i.e., resting tremor, rigidity), without other known or suspected cause of parkinsonism.
- Requiring therapy for PD symptom control
- Azilect monotherapy.
- Azilect as adjunct therapy..
Who cannot join
- Patients previously exposed to Azilect
- Patients with pheochromocytoma
- Concomitant MAO inhibitors or medications contraindicated for use with MAO inhibitors are not allowed.
About this study
Official title: Open-label, Multicenter, Effectiveness and Safety Study of Once Daily AZILECT® as Mono- or Adjunct Therapy in Patients With Idiopathic Parkinson's Disease (PD)
Patients with Parkinson's Disease (PD) will be divided into 2 groups at each study center at their first visit based on the drugs they are taking for their PD:
- Group 1 Patients using Azilect and no other therapy.
- Group 2 Azilect in combination with other medications like Levodopa, Mirapex, or Requip.
- Conditions
- Parkinson's Disease
- Being tested
- rasagiline mesylate, Rasagiline mesylate plus Mirapex, Rasagiline mesylate with Levodopa, Rasagiline mesylate with Requip
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rasagiline mesylateDrug
Azilect®
Rasagiline mesylate plus MirapexDrug
Mirapex, Azilect®
Rasagiline mesylate with LevodopaDrug
Azilect®, Levodopa
Rasagiline mesylate with RequipDrug
Azilect®, Requip
| Study group | Role | What they receive |
|---|---|---|
| Rasagiline mesylate | Active comparator | Not described Receives: Drug: rasagiline mesylate |
| Rasagiline mesylate plus adjunct therapy | Experimental | Rasagiline mesylate with one of three adjunct therapies Receives: Drug: Rasagiline mesylate plus Mirapex; Drug: Rasagiline mesylate with Levodopa; Drug: Rasagiline mesylate with Requip |
What is being measured
The primary outcome is the main question the study is designed to answer.
To identify the earliest scheduled visit of symptomatic effect
Measured: 8 months
Secondary outcomes (1)
To characterize the effectiveness of Azilect in a usual community neurological
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2006 (estimated)
- Study startOct 2006
- Primary completionJul 2007
- Study completionJul 2007
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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teva Neuroscience, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- MerriKay Oleen-Burkey, PhD, Study director, Teva Neuroscience, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00399477
- Sponsor's protocol ID
- TVP-1012/PM101
- Status last verified
- Apr 2011
- First submitted
- 10 Nov 2006
- Last updated
- 12 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label, Multicenter, Effectiveness and Safety Study of Once Daily AZILECT® as Mono- or Adjunct Therapy in Patients With Idiopathic Parkinson's Disease (PD)
- ClinicalTrials.gov ID
- NCT00399477
- Acronym / sponsor ID
- TVP-1012/PM101
- Conditions
- Parkinson's Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Teva Neuroscience, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2006
- Primary completion
- Jul 2007 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 14 Nov 2006 (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.
Patients with Parkinson's Disease (PD) will be divided into 2 groups at each study center at their first visit based on the drugs they are taking for their PD:
- Group 1 Patients using Azilect and no other therapy.
- Group 2 Azilect in combination with other medications like Levodopa, Mirapex, or Requip.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rasagiline mesylate | Active comparator | Drug: rasagiline mesylate |
| Rasagiline mesylate plus adjunct therapy | Experimental | Drug: Rasagiline mesylate plus Mirapex, Drug: Rasagiline mesylate with Levodopa, Drug: Rasagiline mesylate with RequipRasagiline mesylate with one of three adjunct therapies |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Idiopathic Parkinson's disease. Diagnosis previously confirmed by the presence of bradykinesia and by at least one additional cardinal sign (i.e., resting tremor, rigidity), without other known or suspected cause of parkinsonism.
- Requiring therapy for PD symptom control
Key exclusion criteria (3 listed)
- Patients previously exposed to Azilect
- Patients with pheochromocytoma
- Concomitant MAO inhibitors or medications contraindicated for use with MAO inhibitors are not allowed.
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 |
|---|---|---|
| rasagiline mesylateAzilect® | Drug | Rasagiline mesylate |
| Rasagiline mesylate plus MirapexMirapex, Azilect® | Drug | Rasagiline mesylate plus adjunct therapy |
| Rasagiline mesylate with LevodopaAzilect®, Levodopa | Drug | Rasagiline mesylate plus adjunct therapy |
| Rasagiline mesylate with RequipAzilect®, Requip | Drug | Rasagiline mesylate plus adjunct therapy |
Primary outcome
To identify the earliest scheduled visit of symptomatic effect
Time frame: 8 months
1 secondary outcome
To characterize the effectiveness of Azilect in a usual community neurological
Time frame: 8 months
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 12 Apr 2011.
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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.
MerriKay Oleen-Burkey, PhD study director
Teva Neuroscience, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing rasagiline mesylate, Rasagiline mesylate plus Mirapex and Rasagiline mesylate with Levodopa in people with Parkinson's Disease, run by Teva Neuroscience, Inc..
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 4 inclusion and 3 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 12 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
To identify the earliest scheduled visit of symptomatic effect (time frame: 8 months). 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 12 Apr 2011.