Parkinson's DiseasePhase 3ADAGIONCT00256204

A Randomized Placebo Controlled Study to Show That Rasagiline May Slow Disease Progression for Parkinson's Disease

A Phase 3 study testing Rasagiline Mesylate in people with Parkinson's Disease, run by Teva Branded Pharmaceutical Products R&D, Inc..

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

A 2 phase study to evaluate disease progression in Parkinson's disease patients taking rasagiline Read more about this study

Who is it for?: Ages 30 to 80 years
Conditions the study is for: Parkinson's Disease
What is being tested?: Rasagiline Mesylate
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 1,174 participants
Where: No sites listed yet
Study dates: Nov 2005to Jun 2009
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 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Men and women with idiopathic PD whose diagnosis is confirmed at screening, with at least two cardinal signs without any other known or suspected cause of parkinsonism. If tremor is not present, subjects must have unilateral onset and persistent asymmetry.
Subjects with a diagnosis of early idiopathic PD of less than 1½ years duration from time of documented diagnosis.
Subjects whose clinical condition at the time of enrollment does not require anti-PD treatment and will not require for the next 9 months.
Willing and able to give informed consent.

Who cannot join

Subjects younger than 30 or older than 80 years.
Subjects with loss of postural reflexes.
Subjects with UPDRS Tremor score of 3 or greater in any limb.
Subjects with Hoehn \&Yahr Stage III or greater at screening.
Subjects with freezing while walking.
Subjects with any of the following features that tend to exclude PD as the cause of Parkinsonism:

Show all 33Show fewer

History of repeated strokes with stepwise progression of Parkinsonian features
History of repeated head injury or history of definite encephalitis
Sustained remission
Supranuclear gaze palsy
Cerebellar signs
Early severe autonomic involvement
Babinski's sign
Presence of a cerebral tumour or communicating hydrocephalus
MPTP exposure
Oculogyric crises
Subjects who have had previous use of rasagiline or selegiline
Subjects having used other anti-PD medication basis at any time prior to baseline
Subjects having used other anti-PD medication (including anticholinergics) for less than 3 weeks during the 3 month period prior to baseline. (not including a single L-Dopa dose as part of L-Dopa test)
Subjects having used any other anti-PD medication (including anticholinergics) for less than 3 weeks prior to the 3 month period preceding baseline whose anti-PD medication is intentionally ceased in order for the subject to enter the study.
Subjects who have a clinically significant or unstable medical or surgical condition that may preclude safe and complete participation
Hypertensive subjects whose BP is not well controlled according to the medical record or as observed during the week of home BP recording prior to baseline
Subjects diagnosed with melanoma based on the screening dermatologic examination, or with a history of melanoma. Subjects with suspicious lesions at baseline who do not undergo biopsy
Subjects with significant cognitive impairment as defined by MMSE score < 26
Subjects with clinically significant psychiatric illness, including major depression [Beck Depression Inventory (short form) ≥15
Subjects with a history of alcohol or substance abuse within the past 2 years
Subjects who have taken any experimental medications within 60 days prior to baseline
Subjects who have used coenzyme Q10 (in daily doses > 300 mg) within 120 days prior to baseline
Subjects who have used sympathomimetics (including over-the-counter remedies - nasal or oral), dextromethorphan, pethidine or St. John's Wort within the 7 days prior to baseline
Subjects who have used antidepressants within 42 days prior to baseline
Subjects who have used ciprofloxacin, a potent CYP 1A2 inhibitor within 7 days prior to baseline
Subjects who have used MAO inhibitors including reserpine or methyldopa within the three months prior to baseline, or treatment with an anti-emetic or antipsychotic medication with central dopamine antagonist activity within the six months prior to baseline
Women who are not postmenopausal, surgically sterilized, or using adequate birth control [oral birth control pills, IUD, or a long acting injectable form of contraception; barrier methods alone (i.e., condom) are not sufficient]. Women of childbearing potential without a negative pregnancy test at screening. Nursing women

About this study

Official title: A Multi Center, Double Blind, Randomized Start, Placebo-Controlled, Parallel-Group Study to Assess Rasagiline as a Disease Modifying Therapy in Early Parkinson's Disease Subjects

A 2 phase study to evaluate disease progression in Parkinson's disease patients taking rasagiline

Conditions: Parkinson's Disease
Being tested: Rasagiline Mesylate, Placebo
Keywords: Parkinson's, Rasagiline Mesylate
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
tablet, 1mg once daily
Rasagiline MesylateDrug
tablet, 2mg once daily
PlaceboOther
Placebo

Study groups in NCT00256204
Study group	Role	What they receive
1mg rasagiline	Experimental	1mg early start active treatment arm (72 weeks active)followed by 1mg 36 week delayed start active treatment arm (36 weeks placebo followed by 36 weeks active) Receives: Drug: Rasagiline Mesylate
2mg rasagiline	Experimental	2mg early start active treatment arm (72 weeks active)followed by 2mg 36 week delayed start active treatment arm (36 weeks placebo followed by 36 weeks active) Receives: Drug: Rasagiline Mesylate
Placebo	Placebo comparator	Each arm is followed by 36 weeks of placebo Receives: Other: Placebo

What is being measured

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

Change in Total Unified Parkinson's Disease Rating Scale (UPDRS) Score From Baseline
The primary efficacy endpoint was defined as the change in Total UPDRS from Baseline. Subjects were assessed according to the United Parkinson's Disease Rating Scale (UPDRS,(version 3;) Parts I and II are historical data and are designed to rate mentation, behavior and mood; Part III is done as a motor examination at the time of a visit. The UPDRS measures patient status on a scale 0, which is normal or none, to 4, which is severe or the worst scenario.
Measured: 12w, 24w, 36w, 42w, 48w, 54w, 60w, 66w, 72w

Secondary outcomes (1)

Change in Unified Parkinson's Disease Rating Scale (UPDRS) Score From Baseline to Last Observed Value in the Placebo Phase
Subjects were assessed according to the United Parkinson's Disease Rating Scale UPDRS,(version 3;) Parts I and II are historical data and are designed to rate mentation, behavior and mood; Part III is done as a motor examination at the time of a visit. The UPDRS measures patient status on a scale 0, which is normal or none, to 4, which is severe or the worst scenario.
Measured: 36 weeks

Timeline

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

Nov 2005Jun 2009

First posted21 Nov 2005 (estimated)
Study startNov 2005
Primary completionApr 2008
Study completionJun 2009

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 (5)Papers the sponsor has linked to this study.
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: 1,174 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00256204
Sponsor's protocol ID: TVP-1012/500 (ADAGIO)
Acronym: ADAGIO
Status last verified: Jan 2012
First submitted: 16 Nov 2005
Last updated: 12 Jan 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Kirkham EM, Ishman S, Garetz S, Baldassari CM, Mitchell RB, Liu C, Tapia IE, Elden LM, Hassan F, Ibrahim S, Ross K, Cen M, Wang R, Redline S, Chervin RD. Progression of mild sleep-disordered breathing in children managed with watchful waiting. J Clin Sleep Med. 2026 Jul 7;22(1):106. doi: 10.1007/s44470-026-00082-y.
PubMed 42414790
Masellis M, Collinson S, Freeman N, Tampakeras M, Levy J, Tchelet A, Eyal E, Berkovich E, Eliaz RE, Abler V, Grossman I, Fitzer-Attas C, Tiwari A, Hayden MR, Kennedy JL, Lang AE, Knight J; ADAGIO investigators. Dopamine D2 receptor gene variants and response to rasagiline in early Parkinson's disease: a pharmacogenetic study. Brain. 2016 Jul;139(Pt 7):2050-62. doi: 10.1093/brain/aww109. Epub 2016 May 13.
PubMed 27190009
Smith KM, Eyal E, Weintraub D; ADAGIO Investigators. Combined rasagiline and antidepressant use in Parkinson disease in the ADAGIO study: effects on nonmotor symptoms and tolerability. JAMA Neurol. 2015 Jan;72(1):88-95. doi: 10.1001/jamaneurol.2014.2472.
PubMed 25420207
Rascol O, Fitzer-Attas CJ, Hauser R, Jankovic J, Lang A, Langston JW, Melamed E, Poewe W, Stocchi F, Tolosa E, Eyal E, Weiss YM, Olanow CW. A double-blind, delayed-start trial of rasagiline in Parkinson's disease (the ADAGIO study): prespecified and post-hoc analyses of the need for additional therapies, changes in UPDRS scores, and non-motor outcomes. Lancet Neurol. 2011 May;10(5):415-23. doi: 10.1016/S1474-4422(11)70073-4. Epub 2011 Apr 7.
PubMed 21482191
Olanow CW, Rascol O, Hauser R, Feigin PD, Jankovic J, Lang A, Langston W, Melamed E, Poewe W, Stocchi F, Tolosa E; ADAGIO Study Investigators. A double-blind, delayed-start trial of rasagiline in Parkinson's disease. N Engl J Med. 2009 Sep 24;361(13):1268-78. doi: 10.1056/NEJMoa0809335.
PubMed 19776408

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?

Official record

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All Parkinson's Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multi Center, Double Blind, Randomized Start, Placebo-Controlled, Parallel-Group Study to Assess Rasagiline as a Disease Modifying Therapy in Early Parkinson's Disease Subjects
ClinicalTrials.gov ID: NCT00256204
Acronym / sponsor ID: ADAGIO / TVP-1012/500 (ADAGIO)
Conditions: Parkinson's Disease
Keywords: Parkinson's, Rasagiline Mesylate
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,174 participants (actual)
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.Industry (pharma, biotech, devices)
Study start: Nov 2005
Primary completion: Apr 2008 (actual)
Study completion: Jun 2009 (actual)
First posted: 21 Nov 2005 (estimated)
Results: Posted 21 Jun 2011

Clinical summary

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

A 2 phase study to evaluate disease progression in Parkinson's disease patients taking rasagiline

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
1mg rasagiline	Experimental	Drug: Rasagiline Mesylate1mg early start active treatment arm (72 weeks active)followed by 1mg 36 week delayed start active treatment arm (36 weeks placebo followed by 36 weeks active)
2mg rasagiline	Experimental	Drug: Rasagiline Mesylate2mg early start active treatment arm (72 weeks active)followed by 2mg 36 week delayed start active treatment arm (36 weeks placebo followed by 36 weeks active)
Placebo	Placebo comparator	Other: PlaceboEach arm is followed by 36 weeks of placebo

Who may qualify

Ages: 30 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Men and women with idiopathic PD whose diagnosis is confirmed at screening, with at least two cardinal signs without any other known or suspected cause of parkinsonism. If tremor is not present, subjects must have unilateral onset and persistent asymmetry.
Subjects with a diagnosis of early idiopathic PD of less than 1½ years duration from time of documented diagnosis.
Subjects whose clinical condition at the time of enrollment does not require anti-PD treatment and will not require for the next 9 months.
Willing and able to give informed consent.

Key exclusion criteria (33 listed)

Subjects younger than 30 or older than 80 years.
Subjects with loss of postural reflexes.
Subjects with UPDRS Tremor score of 3 or greater in any limb.
Subjects with Hoehn \&Yahr Stage III or greater at screening.
Subjects with freezing while walking.

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 Mesylatetablet, 1mg once daily	Drug	1mg rasagiline
Rasagiline Mesylatetablet, 2mg once daily	Drug	2mg rasagiline
PlaceboPlacebo	Other	Placebo

Primary outcome

Change in Total Unified Parkinson's Disease Rating Scale (UPDRS) Score From Baseline
Time frame: 12w, 24w, 36w, 42w, 48w, 54w, 60w, 66w, 72w
The primary efficacy endpoint was defined as the change in Total UPDRS from Baseline. Subjects were assessed according to the United Parkinson's Disease Rating Scale (UPDRS,(version 3;) Parts I and II are historical data and are designed to rate mentation, behavior and mood; Part III is done as a motor examination at the time of a visit. The UPDRS measures patient status on a scale 0, which is normal or none, to 4, which is severe or the worst scenario.

1 secondary outcome

Change in Unified Parkinson's Disease Rating Scale (UPDRS) Score From Baseline to Last Observed Value in the Placebo Phase
Time frame: 36 weeks

Results and safety

Results posted to the registry on 21 Jun 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
1mg Delayed Start	298	231
1mg Early Start	288	238
2mg Delayed Start	295	241
2mg Early Start	293	244

Primary outcome: Change in Total Unified Parkinson's Disease Rating Scale (UPDRS) Score From Baseline

Time frame: 12w, 24w, 36w, 42w, 48w, 54w, 60w, 66w, 72w. Mean (Standard Deviation). Unit: Scores on a scale

Measure	1mg Delayed Start n = 298	1mg Early Start n = 288	2mg Early Start n = 293	2mg Delayed Start n = 295
Week 12	0.9 (4.9)	-1.2 (5.6)	-0.7 (4.8)	0.7 (5.6)
Week 24	3.0 (6.5)	-1.1 (5.6)	-0.5 (5.6)	2.2 (6.5)
Week 36	3.7 (7.2)	0.6 (5.9)	0.8 (6.5)	3.0 (6.9)
Week 42	2.4 (7.4)	0.2 (6.7)	0.4 (7.2)	1.7 (6.6)
Week 48	1.9 (6.9)	0.7 (7.0)	0.5 (7.1)	1.4 (6.8)
Week 54	1.9 (7.3)	0.7 (7.1)	0.8 (7.2)	1.1 (7.0)
Week 60	1.9 (7.5)	1.1 (7.3)	1.2 (7.9)	1.6 (7.4)
Week 66	2.5 (8.1)	1.5 (7.7)	1.5 (8.0)	2.0 (8.2)

1mg Delayed Start vs 1mg Early Start vs 2mg Delayed Start: p = 0.0133, Repeated Measures Mixed Linear Model
1mg Delayed Start vs 2mg Early Start vs 2mg Delayed Start: p = 0.0001, Repeated Measures Mixed Linear Model
1mg Delayed Start vs 1mg Early Start: p = 0.0250, Repeated Measures

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 2 years, 6 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo Combined Group	22 of 593 (3.7%)	82 of 593 (13.8%)	Not reported
1mg Active Treatment	37 of 288 (12.8%)	40 of 288 (13.9%)	Not reported
2mg Active Treatment	44 of 293 (15%)	34 of 293 (11.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 42414790Kirkham EM, Ishman S, Garetz S, Baldassari CM, Mitchell RB, Liu C, Tapia IE, Elden LM, Hassan F, Ibrahim S, Ross K, Cen M, Wang R, Redline S, Chervin RD. Progression of mild sleep-disordered breathing in children managed with watchful waiting. J Clin Sleep Med. 2026 Jul 7;22(1):106. doi: 10.1007/s44470-026-00082-y.
Derived from this study: PubMed 27190009Masellis M, Collinson S, Freeman N, Tampakeras M, Levy J, Tchelet A, Eyal E, Berkovich E, Eliaz RE, Abler V, Grossman I, Fitzer-Attas C, Tiwari A, Hayden MR, Kennedy JL, Lang AE, Knight J; ADAGIO investigators. Dopamine D2 receptor gene variants and response to rasagiline in early Parkinson's disease: a pharmacogenetic study. Brain. 2016 Jul;139(Pt 7):2050-62. doi: 10.1093/brain/aww109. Epub 2016 May 13.
Derived from this study: PubMed 25420207Smith KM, Eyal E, Weintraub D; ADAGIO Investigators. Combined rasagiline and antidepressant use in Parkinson disease in the ADAGIO study: effects on nonmotor symptoms and tolerability. JAMA Neurol. 2015 Jan;72(1):88-95. doi: 10.1001/jamaneurol.2014.2472.
Derived from this study: PubMed 21482191Rascol O, Fitzer-Attas CJ, Hauser R, Jankovic J, Lang A, Langston JW, Melamed E, Poewe W, Stocchi F, Tolosa E, Eyal E, Weiss YM, Olanow CW. A double-blind, delayed-start trial of rasagiline in Parkinson's disease (the ADAGIO study): prespecified and post-hoc analyses of the need for additional therapies, changes in UPDRS scores, and non-motor outcomes. Lancet Neurol. 2011 May;10(5):415-23. doi: 10.1016/S1474-4422(11)70073-4. Epub 2011 Apr 7.
Derived from this study: PubMed 19776408Olanow CW, Rascol O, Hauser R, Feigin PD, Jankovic J, Lang A, Langston W, Melamed E, Poewe W, Stocchi F, Tolosa E; ADAGIO Study Investigators. A double-blind, delayed-start trial of rasagiline in Parkinson's disease. N Engl J Med. 2009 Sep 24;361(13):1268-78. doi: 10.1056/NEJMoa0809335.
Unified Parkinsons Disease Ratings ScaleLink provided by the sponsor.
Unified Parkinson's Disease Rating ScaleLink provided by the sponsor.

Related trials for Parkinson's Disease

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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.

Yoni Weiss, MD study director

Teva Branded Pharmaceutical Products R&D, Inc.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Rasagiline Mesylate in people with Parkinson's Disease, run by Teva Branded Pharmaceutical Products R&D, 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 33 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 Jan 2012. 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. 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 21 Jun 2011). 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 in Total Unified Parkinson's Disease Rating Scale (UPDRS) Score From Baseline (time frame: 12w, 24w, 36w, 42w, 48w, 54w, 60w, 66w, 72w). 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 NCT00256204, which also lists 5 linked publications.

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 Jan 2012.