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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00256204
• Date of registration: 16/11/2005
• Prospective Registration: No
• Primary sponsor: Teva Pharmaceutical Industries
• Public title: A Randomized Placebo Controlled Study to Show That Rasagiline May Slow Disease Progression for Parkinson's Disease ADAGIO
• Scientific 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
• Date of first enrolment: November 2005
• Target sample size: 1174
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00256204
• Study type: Interventional
• Phase: Phase 3

Countries of recruitment

Argentina, Austria, Canada, France, Germany, Hungary, Israel, Italy, Netherlands, Portugal, Romania, Spain, United Kingdom, United States

Contacts

• Name: Yoni Weiss, MD
• Affiliation: Teva Pharmaceutical Industries

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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

- 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



Age minimum: 30 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Parkinson's Disease

Intervention(s)

Drug: Rasagiline Mesylate

Other: Placebo

Primary Outcome(s)

Change in Total Unified Parkinson's Disease Rating Scale (UPDRS) Score From Baseline [Time Frame: 12w, 24w, 36w, 42w, 48w, 54w, 60w, 66w, 72w]

Secondary Outcome(s)

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

Secondary ID(s)

TVP-1012/500 (ADAGIO)

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 21/06/2011
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00256204