Parkinson's DiseasePhase 4ANDANTENCT01049984
Rasagiline as Add on to Dopamine Agonists in the Treatment of Parkinson's Disease
A Phase 4 study testing Rasagiline in people with Parkinson's Disease, run by Teva Neuroscience, Inc. at 58 sites in United States.
Trial summary
To assess the efficacy of rasagiline 1 mg as a first add-on treatment to dopamine agonist therapy in early Parkinson Disease (PD) patients, , not optimally controlled on dopamine agonists as compared to placebo. 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
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 328 participants
- Where
- 58 sitesUnited States
- Study dates
- Dec 2009to Oct 2012
- Phase
- Phase 4
- 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
- receiving stable dose of oral ropinirole or pramipexole whose symptoms are not optimally controlled or whose oral dopamine agonist titration regimen was truncated due to intolerability:
- 1) Minimum dose of agonist will be 6 mg/day for ropinirole and 1.0 mg/day for pramipexole
- 2) Stable dopamine agonist treatment must have been ongoing for ≥ 30 days, no longer than 5 years preceding baseline
- Males and females. Women of childbearing potential must agree to practice an acceptable method of birth control.
- Idiopathic Parkinson Disease confirmed at baseline by presence of at least 2 cardinal signs (resting tremor, bradykinesia, rigidity), w/o other known or suspected cause of Parkinsonism
- Hoehn \& Yahr > 1 (symptoms on only one side of the body) with treatment and < 3 (mild to moderate bilateral disease; some postural instability; physically independent).
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- Dopamine agonist dose must be stable for ≥30 days preceding the baseline visit.
- For patients who are receiving amantadine or anticholinergics, the dose must have been stable for ≥30 days prior to screening.
- Medically stable outpatients (Investigator's judgment).
Who cannot join
- receive rasagiline or other monoamine oxidase (MAO) inhibitors 60 days preceding baseline
- receive levodopa > 21 consecutive days within 90 days prior baseline
- moderate to severe motor fluctuations
- hepatic impairment
- investigational medications 30 days preceding baseline
- dopamine agonist use > 5 years prior to baseline
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- major depression as defined by Beck Depression Inventory (BDI) short form score greater than 14
- significant cognitive impairment as defined by Mini-Mental State Exam (MMSE) score less than 26.
- impulse control disorder (ICD) based on the Questionnaire for Impulsive-compulsive Disorders in Parkinson's Disease form (QUIP).
- pregnant or lactating or planning on becoming pregnant in the next 18 weeks
- uncontrolled hypertension. Patients whose hypertension is controlled with medications are eligible.
- Concomitant monoamine oxidase (MAO) inhibitors or medicines contraindicated w/ MAO inhibitors not allowed
Trial locations and contacts
58 sites in 1 country.
58 sites in 1 country
United States58 sites
Teva Investigational Site 05
Asheville, North Carolina
Teva Investigative Site 63
Atlantis, Florida
Teva Investigational Site 30
Boca Raton, Florida
Teva Investigational Site 58
Boise, Idaho
Teva Investigational Site 71
Brownwood, Texas
Teva Investigational Site 31
Charlotte, North Carolina
Teva Investigational Site 35
Cincinnati, Ohio
Teva Investigational Site 68
Cincinnati, Ohio
Teva Investigational Site 13
Clearwater, Florida
Teva Investigational Site 03
Commack, New York
Teva Investigative Site 65
Cordova, Tennessee
Teva Investigational Site 01
Decatur, Georgia
Teva Investigational Site 55
Des Moines, Iowa
Teva Investigational Site 11
Detroit, Michigan
Teva Investigational Site 62
Elkridge, Maryland
Teva Investigational Site 44
Fairfield, Connecticut
Teva Investigational Site 26
Fargo, North Dakota
Teva Investigational Site 15
Fountain Valley, California
Teva Investigational Site 19
Fresno, California
Teva Investigational Site 36
Fresno, California
Teva Investigational Site 49
Glenview, Illinois
Teva Investigational Site 39
Golden Valley, Minnesota
Teva Investigational Site 08
Great Falls, Montana
Teva Investigational Site 47
Indianapolis, Indiana
Teva Investigational Site 67
Indianapolis, Indiana
Teva Investigational Site 76
Indianapolis, Indiana
Teva Investigational Site 04
La Jolla, California
Teva Investigational Site 60
Las Vegas, Nevada
Teva Investigational Site 17
Lexington, Kentucky
Teva Investigational Site 77
Madison, Wisconsin
Teva Investigational Site 07
Manchester, Connecticut
Teva Investigational Site 21
Medford, Oregon
Teva Investigational Site 59
Missoula, Montana
Teva Investigational Site 25
Newark, Delaware
Teva Investigational Site 27
Paducah, Kentucky
Teva Investigational Site 23
Peoria, Illinois
Teva Investigational Site 34
Phoenix, Arizona
Teva Investigational Site 38
Plainview, New York
Teva Investigational Site 40
Portland, Oregon
Teva Investigational Site 28
Raleigh, North Carolina
Teva Investigational Site 29
Reseda, California
Teva Investigational Site 09
Richmond, Virginia
Teva Investigational Site 18
San Antonio, Texas
Teva Investigational Site 69
San Francisco, California
Teva Investigational Site 56
Scarborough, Maine
Teva Investigational Site 14
Somerset, New Jersey
Teva Investigational Site 51
Springfield, Massachusetts
Teva Investigational Site 22
St Louis, Missouri
Teva Investigational Site 42
Sun City, Arizona
Teva Investigational Site 02
Sunnyvale, California
Teva Investigational Site 70
Sunrise, Florida
Teva Investigational Site 41
Tampa, Florida
Teva Investigational Site 32
Temple, Texas
Teva Investigational Site 64
Tulsa, Oklahoma
Teva Investigational Site 43
Ventura, California
Teva Investigational Site 61
Vero Beach, Florida
Teva Investigational Site 46
Virginia Beach, Virginia
Teva Investigational Site 33
West Bloomfield, Michigan
About this study
Official title: A Double-blind, Placebo Controlled, Randomized, Multicenter Study to Assess the Safety and Clinical Benefit of Rasagiline as an Add on Therapy to Stable Dose of Dopamine Agonists in the Treatment of Early Parkinson's Disease
To assess the efficacy of rasagiline 1 mg as a first add-on treatment to dopamine agonist therapy in early Parkinson Disease (PD) patients, , not optimally controlled on dopamine agonists as compared to placebo.
- Conditions
- Parkinson's Disease
- Being tested
- Rasagiline, Placebo
- Keywords
- Parkinson's Disease, UPDRS, Clinical Global Evaluation Illness Severity score, Clinical Global Evaluation Improvement, B-SIT, SCOPA - Sleep Daytime Sleepiness, PDQ -39, SCOPA - Cognition, Levodopa, rasagiline, Dopamine Agonist Therapy, monoamine oxidase type B inhibitor
- 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 TVP-1012, AZILECT®
1mg tablet daily for 18 weeks
PlaceboDrug
one tablet daily for 18 weeks
| Study group | Role | What they receive |
|---|---|---|
| Rasagiline 1 mg | Experimental | Participants took a 1 mg rasagiline tablet orally each day for 18 weeks. Receives: Drug: Rasagiline |
| Placebo | Placebo comparator | Participants took a matching placebo tablet once daily for 18 weeks. 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 18 in the Unified Parkinson's Disease Rating Scale (UPDRS) Total Score for Parts I, II and III
The UPDRS was developed as a comprehensive tool to monitor the impact of Parkinson's Disease and the degree of disability caused. Version 3 of UPDRS contains four parts, three of which are totaled and reported in this outcome. Part I is a clinician's evaluation of mentation (mental activity or state of mind), cognition (ability to acquire knowledge), behaviour and mood. Part II is the participants' evaluation of the disease's impact on normal activities. Part III is a clinician's evaluation of motor function. Parts I, II, and III contain a total of 31 questions, which are each rated on a scale of 0 (normal or no disease effect) to 4 (maximum negative effect), for a total scale of 0-124. Negative change from baseline values indicate improvement.
All site raters (medical doctor [MD], doctor of osteopathy [DO], nurse practitioner, or physician assistant) received training on how to complete the UPDRS. The same site rater completed the UPDRS at all visits.
Measured: Day 0 (baseline), Week 18
Secondary outcomes (5)
Change From Baseline to Week 18 in the Unified Parkinson's Disease Rating Scale (UPDRS) Total Score for Part II - Activities of Daily Living
The UPDRS was developed as a comprehensive tool to monitor the impact of Parkinson's Disease and the degree of disability caused. UPDRS contains four parts, the second of which is reported in this outcome. Part II is the participants' evaluation of the disease's impact on normal activities. Part II contains a total of 13 questions, which are each rated on a scale of 0 (normal or no disease effect) to 4 (maximum negative effect), for a total scale of 0-52. Negative change from baseline values indicate improvement.
Measured: Day 0 (baseline), Week 18
Change From Baseline to Week 18 in the Unified Parkinson's Disease Rating Scale (UPDRS) Total Score for Part III - Motor Function
The UPDRS was developed as a comprehensive tool to monitor the impact of Parkinson's Disease and the degree of disability caused. Version 3 of UPDRS contains four parts, the third of which is reported in this outcome. Part III is a clinician's evaluation of motor function. Part III contains 14 questions, which are each rated on a scale of 0 (normal or no disease effect) to 4 (maximum negative effect), for a total scale of 0-56. Negative change from baseline values indicate improvement.
All site raters (medical doctor [MD], doctor of osteopathy [DO], nurse practitioner, or physician assistant) received training on how to complete the UPDRS. The same site rater completed the UPDRS at all visits
Measured: Day 0 (baseline), Week 18
Clinical Global Improvement (CGI) Score at Week 18 As Assessed by the Site Rater
CGI is used by the site rater to rate participants total improvement during the study whether or not, in the investigators' judgment, it is due entirely to drug treatment. Specifically, site raters are asked to compare the participants condition at the beginning of the study to his/her condition at Week 18, how much has he/she changed? Answers are 0 (not assessed), 1 (very much improved), 2 (much improved), 3 (minimally improved), 4 (no change), 5 (minimally worse), 6 (much worse), 7(very much worse).
Site raters can be the medical doctor [MD], doctor of osteopathy [DO], nurse practitioner, or physician assistant.
Measured: 18 weeks
Clinical Global Improvement (CGI) Score at Week 18 As Assessed by the Participant
CGI is used by the participant to rate his/her total improvement during the study. Specifically, participants are asked to compare their condition at the beginning of the study to his/her condition at Week 18, how much has he/she changed? Answers are 0 (not assessed), 1 (very much improved), 2 (much improved), 3 (minimally improved), 4 (no change), 5 (minimally worse), 6 (much worse), 7(very much worse).
Measured: 18 weeks
Illness Severity Score at Day 0 and Week 18 As Assessed by the Site Rater
Site raters were asked: Considering your total clinical experience with the particular population, how ill is the patient at this time? Answers were based on a 0-7 scale, with 0=not assessed, 1= normal, not at all ill, and 7= among the most extremely ill of patients.
Site raters can be the medical doctor [MD], doctor of osteopathy [DO], nurse practitioner, or physician assistant.
Measured: Day 0 (baseline), Week 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2010 (estimated)
- Study startDec 2009
- Primary completionOct 2012
- Study completionOct 2012
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.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 328 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teva Neuroscience, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- H. Lundbeck A/S
- Responsible party
- Sponsor
- Investigators
- Azhar Choudhry, M.D., Study director, Teva Neuroscience, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01049984
- Sponsor's protocol ID
- TVP-1012/PM103
- Acronym
- ANDANTE
- Status last verified
- Apr 2016
- First submitted
- 13 Jan 2010
- Last updated
- 20 May 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Placebo Controlled, Randomized, Multicenter Study to Assess the Safety and Clinical Benefit of Rasagiline as an Add on Therapy to Stable Dose of Dopamine Agonists in the Treatment of Early Parkinson's Disease
- ClinicalTrials.gov ID
- NCT01049984
- Acronym / sponsor ID
- ANDANTE / TVP-1012/PM103
- Conditions
- Parkinson's Disease
- Keywords
- Parkinson's Disease, UPDRS, Clinical Global Evaluation Illness Severity score, Clinical Global Evaluation Improvement, B-SIT, SCOPA - Sleep Daytime Sleepiness, PDQ -39, SCOPA - Cognition
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 328 participants (actual)
- Lead sponsor
- Teva Neuroscience, Inc.Industry (pharma, biotech, devices)
- Collaborators
- H. Lundbeck A/S
- Study start
- Dec 2009
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 15 Jan 2010 (estimated)
- Results
- Posted 15 Oct 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess the efficacy of rasagiline 1 mg as a first add-on treatment to dopamine agonist therapy in early Parkinson Disease (PD) patients, , not optimally controlled on dopamine agonists as compared to placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rasagiline 1 mg | Experimental | Drug: RasagilineParticipants took a 1 mg rasagiline tablet orally each day for 18 weeks. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants took a matching placebo tablet once daily for 18 weeks. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- receiving stable dose of oral ropinirole or pramipexole whose symptoms are not optimally controlled or whose oral dopamine agonist titration regimen was truncated due to intolerability:
- 1) Minimum dose of agonist will be 6 mg/day for ropinirole and 1.0 mg/day for pramipexole
- 2) Stable dopamine agonist treatment must have been ongoing for ≥ 30 days, no longer than 5 years preceding baseline
- Males and females. Women of childbearing potential must agree to practice an acceptable method of birth control.
- Idiopathic Parkinson Disease confirmed at baseline by presence of at least 2 cardinal signs (resting tremor, bradykinesia, rigidity), w/o other known or suspected cause of Parkinsonism
Key exclusion criteria (12 listed)
- receive rasagiline or other monoamine oxidase (MAO) inhibitors 60 days preceding baseline
- receive levodopa > 21 consecutive days within 90 days prior baseline
- moderate to severe motor fluctuations
- hepatic impairment
- investigational medications 30 days preceding baseline
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: TVP-1012, AZILECT®1mg tablet daily for 18 weeks | Drug | Rasagiline 1 mg |
| Placeboone tablet daily for 18 weeks | Drug | Placebo |
Primary outcome
Change From Baseline to Week 18 in the Unified Parkinson's Disease Rating Scale (UPDRS) Total Score for Parts I, II and III
Time frame: Day 0 (baseline), Week 18
The UPDRS was developed as a comprehensive tool to monitor the impact of Parkinson's Disease and the degree of disability caused. Version 3 of UPDRS contains four parts, three of which are totaled and reported in this outcome. Part I is a clinician's evaluation of mentation (mental activity or state of mind), cognition (ability to acquire knowledge), behaviour and mood. Part II is the participants' evaluation of the disease's impact on normal activities. Part III is a clinician's evaluation of motor function. Parts I, II, and III contain a total of 31 questions, which are each rated on a scale of 0 (normal or no disease effect) to 4 (maximum negative effect), for a total scale of 0-124. Negative change from baseline values indicate improvement. All site raters (medical doctor [MD], doctor of osteopathy [DO], nurse practitioner, or physician assistant) received training on how to complete the UPDRS. The same site rater completed the UPDRS at all visits.
5 secondary outcomes
Change From Baseline to Week 18 in the Unified Parkinson's Disease Rating Scale (UPDRS) Total Score for Part II - Activities of Daily Living
Time frame: Day 0 (baseline), Week 18
Change From Baseline to Week 18 in the Unified Parkinson's Disease Rating Scale (UPDRS) Total Score for Part III - Motor Function
Time frame: Day 0 (baseline), Week 18
Clinical Global Improvement (CGI) Score at Week 18 As Assessed by the Site Rater
Time frame: 18 weeks
Clinical Global Improvement (CGI) Score at Week 18 As Assessed by the Participant
Time frame: 18 weeks
Illness Severity Score at Day 0 and Week 18 As Assessed by the Site Rater
Time frame: Day 0 (baseline), Week 18
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Azhar Choudhry, M.D. study director
Teva Neuroscience, Inc.
58 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rasagiline in people with Parkinson's Disease, run by Teva Neuroscience, Inc. at 58 sites in United States.
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 9 inclusion and 12 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 20 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 58 sites in United States. 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 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?
Yes. Results are posted in the registry (first posted 15 Oct 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 18 in the Unified Parkinson's Disease Rating Scale (UPDRS) Total Score for Parts I, II and III (time frame: Day 0 (baseline), Week 18). 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 20 May 2016.