Skip to main content
Advertisement
  • Neurology.org
  • Journals
    • Neurology
    • Clinical Practice
    • Education
    • Genetics
    • Neuroimmunology & Neuroinflammation
  • Online Sections
    • Neurology Video Journal Club
    • Diversity, Equity, & Inclusion (DEI)
    • Neurology: Clinical Practice Accelerator
    • Practice Buzz
    • Practice Current
    • Residents & Fellows
    • Without Borders
  • Collections
    • COVID-19
    • Disputes & Debates
    • Health Disparities
    • Infographics
    • Neurology Future Forecasting Series
    • Null Hypothesis
    • Patient Pages
    • Topics A-Z
    • Translations
  • Podcast
  • CME
  • About
    • About the Journals
    • Contact Us
    • Editorial Board
  • Authors
    • Submit New Manuscript
    • Submit Revised Manuscript
    • Author Center

Advanced Search

Main menu

  • Neurology.org
  • Journals
    • Neurology
    • Clinical Practice
    • Education
    • Genetics
    • Neuroimmunology & Neuroinflammation
  • Online Sections
    • Neurology Video Journal Club
    • Diversity, Equity, & Inclusion (DEI)
    • Neurology: Clinical Practice Accelerator
    • Practice Buzz
    • Practice Current
    • Residents & Fellows
    • Without Borders
  • Collections
    • COVID-19
    • Disputes & Debates
    • Health Disparities
    • Infographics
    • Neurology Future Forecasting Series
    • Null Hypothesis
    • Patient Pages
    • Topics A-Z
    • Translations
  • Podcast
  • CME
  • About
    • About the Journals
    • Contact Us
    • Editorial Board
  • Authors
    • Submit New Manuscript
    • Submit Revised Manuscript
    • Author Center
  • Home
  • Latest Articles
  • Current Issue
  • Past Issues
  • Neurology Video Journal Club
  • Residents & Fellows

User menu

  • Subscribe
  • My Alerts
  • Log in

Search

  • Advanced search
Neurology
Home
The most widely read and highly cited peer-reviewed neurology journal
  • Subscribe
  • My Alerts
  • Log in
Site Logo
  • Home
  • Latest Articles
  • Current Issue
  • Past Issues
  • Neurology Video Journal Club
  • Residents & Fellows

Share

April 09, 2019; 92 (15 Supplement) May 6, 2019

Efficacy results of a 12-month, dose-level blinded study of CVT-301 (levodopa inhalation powder) in patients with Parkinson’s disease (P2.8-048)

Eric S. Farbman, Mark Lew, Cheryl Hawthorne Waters, Robert A. Hauser, Michael Klingler, Charles Oh
First published April 16, 2019,
Eric S. Farbman
1University of Nevada Las Vegas School of Medicine Las Vegas NV United States
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Mark Lew
2Keck/University of Southern California School of Medicine Los Angeles CA United States
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Cheryl Hawthorne Waters
3Columbia University Medical Center New York NY United States
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Robert A. Hauser
4Parkinson’s Disease and Movement Disorders Center, Parkinson Foundation Center of Excellence Tampa FL United States
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Michael Klingler
5Acorda Therapeutics, Inc Ardsley NY United States
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Charles Oh
5Acorda Therapeutics, Inc Ardsley NY United States
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Citation
Efficacy results of a 12-month, dose-level blinded study of CVT-301 (levodopa inhalation powder) in patients with Parkinson’s disease (P2.8-048)
Eric S. Farbman, Mark Lew, Cheryl Hawthorne Waters, Robert A. Hauser, Michael Klingler, Charles Oh
Neurology Apr 2019, 92 (15 Supplement) P2.8-048;

Citation Manager Formats

  • BibTeX
  • Bookends
  • EasyBib
  • EndNote (tagged)
  • EndNote 8 (xml)
  • Medlars
  • Mendeley
  • Papers
  • RefWorks Tagged
  • Ref Manager
  • RIS
  • Zotero
Permissions

Make Comment

See Comments

Downloads
0

Share

  • Article
  • Info & Disclosures
Loading

Abstract

Objective: To present the efficacy results from a 12-month safety and efficacy extension of a phase 3 study of CVT-301, a levodopa inhalation powder in development for the treatment of OFF symptoms.

Background: In the initial 12-week, double-blind, placebo-controlled study (SPAN-PD) of patients experiencing OFF periods, CVT-301 84mg significantly improved motor function, and, in addition, 57.7% of patients on CVT-301 84mg turned ON within 60 minutes after treatment vs 36.1% on placebo at 12 weeks. This abstract describes an extension study that investigates efficacy over 12 months.

Design/Methods: Patients from the SPAN-PD study and eligible CVT-301-naïve patients were enrolled. Patients maintained their usual oral carbidopa/levodopa regimen. All patients were on CVT-301 treatment for OFF periods, but were blinded to dose (60mg/84mg). Efficacy assessments included in-clinic assessment for occurrence of an ON state during the 60-minute postdose period, and, via a PD home diary, change in total daily OFF time and change in daily ON time without dyskinesia.

Results: Patients were randomized: CVT-301 60mg (n=161) or CVT-301 84mg(n=164). At 12 months, during in-clinic evaluations, 68.4% of patients on CVT-301 60mg and 73.0% of those on 84mg achieved an ON state within 60 minutes of treatment. Percentages were not significantly different from 1-month values. Home diaries demonstrated that mean changes from baseline in total daily OFF time improved from 1-month values of −0.33 and −0.55 hours, to −0.70 and −0.88 hours at 12 months (60-mg and 84-mg doses, respectively). Change from baseline in daily ON time without dyskinesia improved from +0.23 and +0.18 hours at month 1 to +0.32 and +0.40 hours at month 12 (60mg and 84mg, respectively).

Conclusions: This extension study shows that CVT-301 maintained its efficacy in achieving an ON state in patients experiencing OFF periods, and showed improved efficacy in decreasing daily OFF time and increasing ON time without dyskinesia over 12 months.

Disclosure: Dr. Farbman has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Dr. Farbman has received honoraria for advisory board participation from Teva Pharmaceuticals and UCB. Dr. Lew has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Teva, US World Meds, UCB, Lundbeck, AbbVie, Adamas Pharmaceuticals, Cynapsus, Revance, Acadia Pharmaceuticals, Neurocrine Biosciences, and Acorda Therapeutics. Dr. Lew has received research support from Parkinson’s Study Group, Michael J. Fox Foundation, Biotie, Neuroderm, Enterin Inc., Pharm2B Fellowship Grants, Allergan, and Medtronic. Dr. Waters has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Sunovion, US WorldMeds, Acadia, Impax, Acadia, Lundbeck, Adamas, and US WorldMeds. Dr. Waters has received research support from Sanofi, Sunovion, and Roche. Dr. Hauser has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with AbbVie Inc., Acorda Therapeutics, Academy for Continued Healthcare Learning, Acadia Pharmaceuticals, Inc., Adamas Pharmaceuticals, AstraZeneca, ApoPharma, Back Bay Life Science, Biotie Therapies, Bracket, Cerecor, Inc., ClearView Healthcare Partners, ClinicalMind Medical and Therapeutic Communications, CNS Ratings, LLC., Cowen and Company, Cynapsus Therapeutics, DDB Health LLC, Decision Resources Group (DRG), Eli Lilly & Company, eResearch Technology, Inc., Expert Connect, Extera Partners, GE Healthcare, Health Advances, HealthLogix, Health and Wellness Partners, Huron Consulting Group, Impax Laboratories, Impel Neuropharma, Intec Pharma Ltd., Jazz Pharmaceuticals, Kashiv Pharma LLC, Kyowa Kirin Pharmaceutical Development, Ltd., LCN Consulting, LifeMax, Life Sciences, Lundbeck LLC, The Lockwood Group, MEDACorp, Medscape, Medtronic, Michael J. Fox Foundation, Mitsubishi Tanabe Pharmaceuticals, Movement Disorder Society, National Institutes of Health (NIH), Neurocea LLC, Neurocrine Biosciences, Neuroderm, Neuropore Therapies, Orbes Medical Group, Outcomes Insights, Parkinson Study Group, Peerview Press, Pennside Partners, Pfizer, Inc., Pharma Two B, Ltd, Phase Five Communications, Prescott Medical Group, Prexton Therapeutics, Prilenia Development Ltd., Projects in Knowledge, Putnam Associates, Quintiles, RMEI Medical Education for Better Outcomes, SAI Med Partners LLC, Sarepta Therapeutics, Schlesinger Associates, Scion Neurostim, LLC, Seagrove Partners, LLC, Slingshot Insights, Sunovion Pharmaceuticals, Inc., Sun Pharma, Teva Pharmaceutical Industries, US WorldMeds, Vista Research, WebMD, Windrose Consulting Group. Dr. Hauser has received royalty, license fees, or contractual rights payments from the University of South Florida. Dr. Hauser has received research support from AbbVie Inc., Acorda Therapeutics, AstraZeneca, Axovant Sciences , Biogen Inc., Cavion, Enterin Inc., Impax Laboratories, LLC., Intec Pharma Ltd, Jazz Pharmaceuticals, NeuroDerm Ltd., Lundbeck, Michael J Fox Foundation for Parkinson’s Research, F. Hoffman-La Roche, Dart NeuroScience LLC, Prexton Therapeutics, Revance Therapeutics Inc., Sunovion Pharmaceuticals. Dr. Klingler has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Acorda Therapeutics, Inc.. Dr. Oh has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Acorda Therapeutics, Inc. Dr. Oh is an employee and stockholder of Acorda Therapeutics, Inc.

Letters: Rapid online correspondence

No comments have been published for this article.
Comment

REQUIREMENTS

You must ensure that your Disclosures have been updated within the previous six months. Please go to our Submission Site to add or update your Disclosure information.

Your co-authors must send a completed Publishing Agreement Form to Neurology Staff (not necessary for the lead/corresponding author as the form below will suffice) before you upload your comment.

If you are responding to a comment that was written about an article you originally authored:
You (and co-authors) do not need to fill out forms or check disclosures as author forms are still valid
and apply to letter.

Submission specifications:

  • Submissions must be < 200 words with < 5 references. Reference 1 must be the article on which you are commenting.
  • Submissions should not have more than 5 authors. (Exception: original author replies can include all original authors of the article)
  • Submit only on articles published within 6 months of issue date.
  • Do not be redundant. Read any comments already posted on the article prior to submission.
  • Submitted comments are subject to editing and editor review prior to posting.

More guidelines and information on Disputes & Debates

Compose Comment

More information about text formats

Plain text

  • No HTML tags allowed.
  • Web page addresses and e-mail addresses turn into links automatically.
  • Lines and paragraphs break automatically.
Author Information
NOTE: The first author must also be the corresponding author of the comment.
First or given name, e.g. 'Peter'.
Your last, or family, name, e.g. 'MacMoody'.
Your email address, e.g. higgs-boson@gmail.com
Your role and/or occupation, e.g. 'Orthopedic Surgeon'.
Your organization or institution (if applicable), e.g. 'Royal Free Hospital'.
Publishing Agreement
NOTE: All authors, besides the first/corresponding author, must complete a separate Publishing Agreement Form and provide via email to the editorial office before comments can be posted.
CAPTCHA
This question is for testing whether or not you are a human visitor and to prevent automated spam submissions.

Vertical Tabs

You May Also be Interested in

Back to top
  • Article
  • Info & Disclosures
Advertisement

Safety and Efficacy of Tenecteplase and Alteplase in Patients With Tandem Lesion Stroke: A Post Hoc Analysis of the EXTEND-IA TNK Trials

Dr. Nicole Sur and Dr. Mausaminben Hathidara

► Watch

Related Articles

  • No related articles found.

Alert Me

  • Alert me when eletters are published
Neurology: 100 (22)

Articles

  • Ahead of Print
  • Current Issue
  • Past Issues
  • Popular Articles
  • Translations

About

  • About the Journals
  • Ethics Policies
  • Editors & Editorial Board
  • Contact Us
  • Advertise

Submit

  • Author Center
  • Submit a Manuscript
  • Information for Reviewers
  • AAN Guidelines
  • Permissions

Subscribers

  • Subscribe
  • Activate a Subscription
  • Sign up for eAlerts
  • RSS Feed
Site Logo
  • Visit neurology Template on Facebook
  • Follow neurology Template on Twitter
  • Visit Neurology on YouTube
  • Neurology
  • Neurology: Clinical Practice
  • Neurology: Education
  • Neurology: Genetics
  • Neurology: Neuroimmunology & Neuroinflammation
  • AAN.com
  • AANnews
  • Continuum
  • Brain & Life
  • Neurology Today

Wolters Kluwer Logo

Neurology | Print ISSN:0028-3878
Online ISSN:1526-632X

© 2023 American Academy of Neurology

  • Privacy Policy
  • Feedback
  • Advertise