Safety, Pharmacokinetics and Efficacy Study of CVT-301 Inpatients With Parkinson's Disease and "Off" Episodes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01617135
Recruitment Status : Completed
First Posted : June 12, 2012
Last Update Posted : July 27, 2017
Michael J. Fox Foundation for Parkinson's Research
Information provided by (Responsible Party):
Acorda Therapeutics

May 7, 2012
June 12, 2012
July 27, 2017
May 2012
November 2012   (Final data collection date for primary outcome measure)
Safety [ Time Frame: change from baseline up to 13 weeks ]
Adverse experiences, ECGs, clinical laboratory evaluation, pulmonary function
Same as current
Complete list of historical versions of study NCT01617135 on Archive Site
  • Pharmacodynamics [ Time Frame: 3 hours post-dose ]
    Time to onset of meaningful "on" and "off" states (patient- and examiner-assessed) UPDRS III motor score Tapping test Dyskinesia
  • Pharmacokinetics [ Time Frame: 3 hours post-dose ]
    Serial blood draw for determination of plasma concentration-time profile
Same as current
Not Provided
Not Provided
Safety, Pharmacokinetics and Efficacy Study of CVT-301 Inpatients With Parkinson's Disease and "Off" Episodes
A Randomized, Placebo-Controlled, Phase 2 Study of the Safety, Pharmacokinetics and Pharmacodynamics of CVT-310 (Levodopa Inhalation Powder) in Patients With Parkinson's Disease and Motor Response Fluctuations ("Off Episodes")
The purpose of this study is to determine the safety, efficacy and pharmacokinetics following administration of CVT-301 in treatment of "off" episodes in Parkinson's Disease patients.
Treatment options for patients with motor response fluctuations are limited. Most commonly, "off" episodes are managed by adjusting the dose interval of their standard oral medications or by self-administration of unscheduled doses of oral Parkinson's medication. Due to the variability in levodopa absorption following oral dosing, resumption of motor function is unreliable and may be delayed for an hour or more. CVT-301 delivers levodopa using a simple inhaler, resulting in rapid increases in levodopa blood levels and is expected to result in rapid restoration in motor function for patients experiencing "off" episodes.
Phase 2
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Idiopathic Parkinson's Disease
  • Drug: CVT-301
  • Drug: Placebo
  • Drug: Sinemet (carbidopa/levodopa)
  • Experimental: CVT-301 Low Dose
    CVT-Low; levodopa inhalation powder (LIP)
    Intervention: Drug: CVT-301
  • Experimental: CVT-301 High Dose
    CVT-High; levodopa inhalation powder (LIP)
    Intervention: Drug: CVT-301
  • Placebo Comparator: Inhaled Placebo
    Inhaled placebo powder
    Intervention: Drug: Placebo
  • Active Comparator: Oral Sinemet (carbidopa/levodopa)
    Open-label oral carbidopa/levodopa (CD/LD)
    Intervention: Drug: Sinemet (carbidopa/levodopa)
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
December 2012
November 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Idiopathic Parkinson's Disease (PD) diagnosed between the ages of 30 and 80 years;
  • Hoehn and Yahr Stage 1-3 in an "on" state;
  • Require levodopa-containing medication regimen at least 4 times during the waking day;
  • Experience motor fluctuations with a minimum of 2 hours of average daily "off" time per waking day (excluding early morning "off" time) and demonstrate levodopa responsiveness;
  • Are on stable PD medication regimen.

Exclusion Criteria:

  • Pregnant or lactating females;
  • Previous surgery for PD or plan to have stereotactic surgery during the study period;
  • History of psychotic symptoms requiring treatment, or suicide ideation or attempt within last year;
  • Adequate lung function as measured by spirometry;
  • Any significant condition, severe concurrent disease, abnormality or finding that would make patients unsuitable or may compromise patient safety.
Sexes Eligible for Study: All
30 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Israel,   Serbia,   United Kingdom
2012-000181-37 ( EudraCT Number )
Not Provided
Not Provided
Acorda Therapeutics
Acorda Therapeutics
Michael J. Fox Foundation for Parkinson's Research
Not Provided
Acorda Therapeutics
July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP