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MAO-B inhibitor

Rasagiline for Parkinson's Disease

Phase 2
Waitlist Available
Led By David E Vaillancourt, PhD.
Research Sponsored by University of Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
96 patients with clinically diagnosed PD. For the PD diagnosis, we will use the University of Kentucky PD brain bank diagnostic criteria implemented by a movement disorders trained neurologist. Only early stage PD within 5 years of diagnosis who have never taken rasagiline will be included. 5 years since diagnosis was chosen to focus on early stages of PD, where MAO-B inhibitors have shown the most promise. PD are eligible to participate if they are age 40-77, Hoehn and Yahr stage < or equal to 2 when on medication, and able and willing to sign informed consent to be randomized to the placebo or active drug arm.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up changes from baseline to 1 year
Awards & highlights

Study Summary

This study is evaluating whether a drug that slows the progression of the brain in people with Parkinson's disease can be detected in the brain using MRI and fMRI.

Eligible Conditions
  • Parkinson's Disease

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and one-year
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and one-year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Blood Oxygen Level-dependent(BOLD) Signal in the Posterior Putamen, M1, and Supplementary Motor Area(SMA).
Change in Free-water Accumulation in the Substantia Nigra
Secondary outcome measures
Changes Between the Groups on fMRI
Changes in Parkinson's Disease Motor Symptoms and Bradykinesia

Side effects data

From 2015 Phase 4 trial • 170 Patients • NCT01723228
8%
Fall
8%
Dizziness
6%
Arthralgia
6%
Headache
6%
Orthostatic hypotension
1%
Transient ischaemic attack
100%
80%
60%
40%
20%
0%
Study treatment Arm
Rasagiline 1.0 mg/Day
Placebo

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: RasagilineExperimental Treatment4 Interventions
This group will receive a 1 mg rasagiline tablet to be taken once daily for one year. In addition, the following test will be performed: a Magnetic Resonance Imaging (MRI), functional Magnetic Resonance Imaging (fMRI), the Montreal Cognitive Assessment, Stroop, Digit Span, Hopkins Verbal Learning Test, Brief Test of Attention, Beck Depression Index, Hamilton Anxiety and Depression Rating Scales, Physical Function Performance Test, and Epworth Sleepiness Scale.
Group II: PlaceboPlacebo Group4 Interventions
This group will receive a placebo tablet in the same forum as the rasagiline tablet to be taken once daily for one year. In addition, the following test will be performed: a Magnetic Resonance Imaging (MRI), functional Magnetic Resonance Imaging (fMRI), the Montreal Cognitive Assessment, Stroop, Digit Span, Hopkins Verbal Learning Test, Brief Test of Attention, Beck Depression Index, Hamilton Anxiety and Depression Rating Scales, Physical Function Performance Test, and Epworth Sleepiness Scale.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rasagiline
2015
Completed Phase 4
~2680
Magnetic Resonance Imaging
2017
Completed Phase 3
~1190
functional Magnetic Resonance Imaging
2016
Completed Phase 2
~100

Find a Location

Who is running the clinical trial?

University of FloridaLead Sponsor
1,340 Previous Clinical Trials
715,609 Total Patients Enrolled
National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,339 Previous Clinical Trials
649,210 Total Patients Enrolled
David E Vaillancourt, PhD.Principal InvestigatorUniversity of Florida

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Image Parkinson's Disease Progression Study
2016. "Image Parkinson's Disease Progression Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02789020.
~12 spots leftby Apr 2025
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