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

January 10, 2012 updated by: Teva Branded Pharmaceutical Products R&D, Inc.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1174

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1mg rasagiline
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
tablet, 1mg once daily
Drug: Rasagiline Mesylate
tablet, 2mg once daily
Experimental: 2mg rasagiline
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
tablet, 1mg once daily
Drug: Rasagiline Mesylate
tablet, 2mg once daily
Placebo Comparator: Placebo
Each arm is followed by 36 weeks of placebo
Other: Placebo
Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12w, 24w, 36w, 42w, 48w, 54w, 60w, 66w, 72w

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Teva Branded Pharmaceutical Products R&D, Inc.

Investigators

  • Study Director: Yoni Weiss, MD, Teva Branded Pharmaceutical Products R&D, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2005

Primary Completion (Actual)

April 1, 2008

Study Completion (Actual)

June 1, 2009

Study Registration Dates

First Submitted

November 16, 2005

First Submitted That Met QC Criteria

November 18, 2005

First Posted (Estimate)

November 21, 2005

Study Record Updates

Last Update Posted (Estimate)

January 12, 2012

Last Update Submitted That Met QC Criteria

January 10, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TVP-1012/500 (ADAGIO)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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