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

NCT00256204 | Completed Phase 3 Results DMC

• 1 other identifier: TVP-1012/500 (ADAGIO)
• Study Type: interventional
• Target: 1,174
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Parkinson's Disease

Keywords

Parkinson's; Rasagiline Mesylate

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  36 weeks

Study Arms (3)

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)

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)

Drug: Rasagiline Mesylate

Placebo

PLACEBO COMPARATOR

Each arm is followed by 36 weeks of placebo

Other: Placebo

Interventions

Rasagiline Mesylate DRUG

tablet, 1mg once daily

1mg rasagiline

Placebo OTHER

Placebo

Placebo

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:
• 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

Sponsors & Collaborators

• Teva Branded Pharmaceutical Products R&D, Inc.: lead

Related Publications (4)

• 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.

  PMID: 27190009 DERIVED

• 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.

  PMID: 25420207 DERIVED

• 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.

  PMID: 21482191 DERIVED

• 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.

  PMID: 19776408 DERIVED

Related Links

• Unified Parkinson's Disease Rating Scale

MeSH Terms

Conditions

Parkinson Disease

Interventions

rasagiline

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Results Point of Contact

• Title: Dennis Ahern, MS, Director
• Organization: Teva Branded Pharmaceutical Products R&D

dennis.ahern@tevausa.com

215-293-6339

Study Officials

• Yoni Weiss, MD

  Teva Branded Pharmaceutical Products R&D, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2005
• First Posted: November 21, 2005
• Study Start: November 1, 2005
• Primary Completion: April 1, 2008
• Study Completion: June 1, 2009
• Last Updated: January 12, 2012
• Results First Posted: June 21, 2011

Record last verified: 2012-01