A 12 Month, Dose-Level Blinded Study Investigating the Safety and Efficacy of CVT 301 (Levodopa Inhalation Powder) in Parkinsons Disease Patients With Motor Response Fluctuations (OFF Phenomena)
A study for patients with Parkinson's Disease with recurring OFF episodes using a Levodopa inhalation powder
Sponsor: CIVITAS
Enrolling: Male and Female Patients
IRB Number: AAAP4253
U.S. Govt. ID: NCT02242487
Contact: Amber Servi: 212-305-3938 / ads2178@cumc.columbia.edu
Additional Study Information: This study is for patients with Parkinson's disease. For most patients with Parkinsons disease, doctors use levodopa as a treatment to manage their symptoms. Levodopa pills have been used for many years to treat the symptoms of Parkinsons disease patients. However, with long-term treatment, the effectiveness of levodopa pills often lessens and can lead to OFF episodes, which includes slowness, stiffness, and tremors (shaking). There are few treatment options to help combat or manage these OFF episodes. A treatment approach that permits levodopa to be more rapidly and predictably absorbed by the body is needed to help treat the OFF episodes when they occur. CVT-301, the investigational medication under evaluation in this study, is a dry powder form of levodopa. It is inhaled through an inhaler, which allows the body to absorb the medication faster than levodopa pills, which are taken orally.Doctors believe that patients may be better able to find relief from an OFF episode using the inhaled form of levodopa when OFF symptoms start to return. The results of this study will provide more information about whether inhaled levodopa could one day be used to treat OFF episodes in Parkinsons disease patients.
This study is closed
Cheryl Waters, MD
Do You Qualify?
Do you have a medical diagnosis of Parkinson's disease? Yes No
Have you experienced a minimum of 2 hours of OFF episodes per day (excluding early morning OFF time)? Yes No
Are you currently taking oral levodopa at least 4 times during the waking day, and on a stable regimen? Yes No
You may be eligible for this study

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For more information, please contact:
Amber Servi