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

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ClinicalTrials.gov 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

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Idiopathic Parkinson's Disease Drug: CVT-301 Drug: Placebo Drug: Sinemet (carbidopa/levodopa) Phase 2

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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")
Study Start Date : May 2012
Primary Completion Date : November 2012
Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Levodopa
U.S. FDA Resources

Arm Intervention/treatment
Experimental: CVT-301 Low Dose
CVT-Low; levodopa inhalation powder (LIP)
Drug: CVT-301
Experimental: CVT-301 High Dose
CVT-High; levodopa inhalation powder (LIP)
Drug: CVT-301
Placebo Comparator: Inhaled Placebo
Inhaled placebo powder
Drug: Placebo
Active Comparator: Oral Sinemet (carbidopa/levodopa)
Open-label oral carbidopa/levodopa (CD/LD)
Drug: Sinemet (carbidopa/levodopa)

Primary Outcome Measures :
  1. Safety [ Time Frame: change from baseline up to 13 weeks ]
    Adverse experiences, ECGs, clinical laboratory evaluation, pulmonary function

Secondary Outcome Measures :
  1. 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

  2. Pharmacokinetics [ Time Frame: 3 hours post-dose ]
    Serial blood draw for determination of plasma concentration-time profile

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01617135

Civitas Clinical Site #6
Petach-Tikva, Israel
Civitas Clinical Site #5
Tel Aviv, Israel
Civitas Clinical Site #4
Belgrade, Serbia
Civitas Clinical Site #7
Belgrade, Serbia
United Kingdom
Civitas Clinical Site #1
Glasgow, United Kingdom
Civitas Clinical Site #3
Newcastle, United Kingdom
Civitas Clinical Site #2
Norwich, United Kingdom
Sponsors and Collaborators
Acorda Therapeutics
Michael J. Fox Foundation for Parkinson's Research

Additional Information:
Responsible Party: Acorda Therapeutics
ClinicalTrials.gov Identifier: NCT01617135     History of Changes
Other Study ID Numbers: CVT-301-002
2012-000181-37 ( EudraCT Number )
First Posted: June 12, 2012    Key Record Dates
Last Update Posted: July 27, 2017
Last Verified: July 2017

Keywords provided by Acorda Therapeutics:
Parkinson's disease
Motor fluctuations
inhaled drugs
Motor fluctuation ("off episodes")

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Carbidopa, levodopa drug combination
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Aromatic Amino Acid Decarboxylase Inhibitors
Enzyme Inhibitors
Adjuvants, Immunologic
Immunologic Factors
Dopamine Agonists