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

This study has been completed.
Sponsor:
Collaborator:
Michael J. Fox Foundation for Parkinson's Research
Information provided by (Responsible Party):
Acorda Therapeutics
ClinicalTrials.gov Identifier:
NCT01617135
First received: May 7, 2012
Last updated: June 12, 2013
Last verified: June 2013

May 7, 2012
June 12, 2013
May 2012
November 2012   (final data collection date for primary outcome measure)
Safety [ Time Frame: change from baseline up to 13 weeks ] [ Designated as safety issue: Yes ]
Adverse experiences, ECGs, clinical laboratory evaluation, pulmonary function
Same as current
Complete list of historical versions of study NCT01617135 on ClinicalTrials.gov Archive Site
  • Pharmacodynamics [ Time Frame: 3 hours post-dose ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Idiopathic Parkinson's Disease
  • Drug: CVT-301
  • Drug: Placebo
  • Drug: Sinemet (carbidopa/levodopa)
  • Experimental: CVT-301 Low Dose
    Intervention: Drug: CVT-301
  • Experimental: CVT-301 High Dose
    Intervention: Drug: CVT-301
  • Placebo Comparator: Inhaled Placebo
    Intervention: Drug: Placebo
  • Active Comparator: Oral Sinemet (carbidopa/levodopa)
    Intervention: Drug: Sinemet (carbidopa/levodopa)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
25
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.
Both
30 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Israel,   Serbia,   United Kingdom
 
NCT01617135
CVT-301-002, 2012-000181-37
No
Acorda Therapeutics
Acorda Therapeutics
Michael J. Fox Foundation for Parkinson's Research
Not Provided
Acorda Therapeutics
June 2013

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