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A Randomized Placebo Controlled Study to Show That Rasagiline May Slow Disease Progression for Parkinson's Disease (ADAGIO)
This study is ongoing, but not recruiting participants.
Sponsored by: Teva Pharmaceutical Industries
Information provided by: Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier: NCT00256204
  Purpose

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


Condition Intervention Phase
Parkinson's Disease
Drug: Rasagiline Mesylate
Phase III

Genetics Home Reference related topics: familial paroxysmal nonkinesigenic dyskinesia Parkinson disease
MedlinePlus related topics: Parkinson's Disease
Drug Information available for: Rasagiline Rasagiline mesylate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy 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

Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:
  • Change in UPDRS from baseline [ Time Frame: 72 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in UPDRS score from base line to last observed value in the active phase [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]

Enrollment: 1176
Study Start Date: November 2005
Estimated Study Completion Date: June 2008
Estimated Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
1mg early start active treatment arm (72 weeks active)
Drug: Rasagiline Mesylate
tablet, 1 or 2 mg, once daily, 72 weeks
2: Experimental
1mg 36 week delayed start active treatment arm (36 weeks placebo followed by 36 weeks active)
Drug: Rasagiline Mesylate
tablet, placebo for 36 weeks, then 1 or 2 mg, once daily, for additional 36 weeks
3: Experimental
2mg early start active treatment arm (72 weeks active)
Drug: Rasagiline Mesylate
tablet, 1 or 2 mg, once daily, 72 weeks
4: Experimental
2mg 36 week delayed start active treatment arm (36 weeks placebo followed by 36 weeks active)
Drug: Rasagiline Mesylate
tablet, placebo for 36 weeks, then 1 or 2 mg, once daily, for additional 36 weeks

  Eligibility

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Subjects must meet all the inclusion criteria to be eligible:

  1. Men and women with idiopathic Parkinson's disease whose diagnosis is confirmed at screening, by the presence of at least two of the cardinal signs (resting tremor, bradykinesia, rigidity), without any other known or suspected cause of parkinsonism. If tremor is not present, subjects must have unilateral onset and persistent asymmetry.
  2. Subjects with a diagnosis of early idiopathic PD of less than 1½ years duration from time of documented diagnosis.
  3. Subjects whose clinical condition at the time of study enrollment does not require any anti-PD treatment and, to the best of the investigator's judgment, will not require for the next 9 months.
  4. Willing and able to give informed consent.

Exclusion Criteria:

Any of the following will exclude the subject from the study:

  1. Subjects younger than 30 or older than 80 years of age.
  2. Subjects with a loss of postural reflexes.
  3. Subjects with a UPDRS Tremor score (Appendix 8) of 3 or greater in any limb.
  4. Subjects with a Hoehn &Yahr Stage (Appendix 2) of III or greater at screening.
  5. Subjects with freezing while walking.
  6. Subjects with any one 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
    • Oculogyric crises
  7. Subjects who have had any previous use of rasagiline or selegiline.
  8. Subjects having used any other anti-PD medication (including anticholinergics) on a chronic (for more than 3 weeks) basis at any time prior to baseline.
  9. Subjects having used any 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).
  10. 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.
  11. Subjects who, based on the investigator's judgment, have a clinically significant or unstable medical or surgical condition that may preclude safe and complete study participation. Such conditions may include cardiovascular, vascular disease, pulmonary, hepatic impairment (Child-Pugh Score >5 -Appendix 5) renal, or metabolic diseases or malignancies as determined by medical history, physical examination, laboratory tests, chest x-ray, or ECG.
  12. Hypertensive subjects whose BP, in the investigator's opinion, is not well controlled according to the subject's medical record or as observed during the week of home BP recording prior to baseline.
  13. 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.
  14. Subjects with significant cognitive impairment as defined by MMSE score < 26 (Appendix 3).
  15. Subjects with clinically significant psychiatric illness, including major depression [Beck Depression Inventory (short form) ≥15 - (Appendix 4)
  16. Subjects with a history of alcohol or substance abuse within the past 2 years.
  17. Subjects who have taken any experimental medications within 60 days prior to baseline.
  18. Subjects who have used coenzyme Q10 (in daily doses > 300 mg) within 120 days prior to baseline.
  19. 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.
  20. Subjects who have used antidepressants, including selective serotonin reuptake inhibitors, tricyclic and tetracyclic antidepressants (except: amitriptyline ≤ 50 mg/daily, or trazodone ≤ 100 mg/daily, or citalopram ≤ 20 mg/daily, or sertraline ≤ 100 mg/daily or paroxetine ≤ 30 mg/daily, or escitalopram ≤ 10 mg/daily used as single drug therapy) within 42 days prior to baseline.
  21. Subjects who have used ciprofloxacin, a potent CYP 1A2 inhibitor within 7 days prior to baseline.
  22. 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.
  23. 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 (serum beta-HCG) at screening. Nursing women.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00256204

  Show 134 Study Locations
Sponsors and Collaborators
Teva Pharmaceutical Industries
Investigators
Study Director: Weiss Yoni, MD, MBA Teva Pharamaceutical Industries
  More Information

For more information about Teva Neuroscience  This link exits the ClinicalTrials.gov site
For more information about Parkinson's Disease  This link exits the ClinicalTrials.gov site

Responsible Party: Teva Neuroscience ( Siyu Liu, Vice President, North American Innovative Research and Development and Head of Global Clinical Operations )
Study ID Numbers: TVP-1012/500 (ADAGIO)
Study First Received: November 16, 2005
Last Updated: February 27, 2008
ClinicalTrials.gov Identifier: NCT00256204  
Health Authority: United States: Food and Drug Administration;   Canada: Health Canada

Keywords provided by Teva Pharmaceutical Industries:
Parkinson's
Rasagiline Mesylate

Study placed in the following topic categories:
Rasagiline
Ganglion Cysts
Movement Disorders
Parkinson Disease
Basal Ganglia Diseases
Disease Progression
Central Nervous System Diseases
Parkinsonian Disorders
Neurodegenerative Diseases
Brain Diseases

Additional relevant MeSH terms:
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Physiological Effects of Drugs
Nervous System Diseases
Monoamine Oxidase Inhibitors
Enzyme Inhibitors
Central Nervous System Agents
Protective Agents
Neuroprotective Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009