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):
Civitas Therapeutics
ClinicalTrials.gov Identifier:
NCT01617135
First received: May 7, 2012
Last updated: June 12, 2013
Last verified: June 2013
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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")

Resource links provided by NLM:


Further study details as provided by Civitas Therapeutics:

Primary Outcome Measures:
  • Safety [ Time Frame: change from baseline up to 13 weeks ] [ Designated as safety issue: Yes ]
    Adverse experiences, ECGs, clinical laboratory evaluation, pulmonary function


Secondary Outcome Measures:
  • 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


Enrollment: 25
Study Start Date: May 2012
Study Completion Date: December 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CVT-301 Low Dose Drug: CVT-301
Experimental: CVT-301 High Dose Drug: CVT-301
Placebo Comparator: Inhaled Placebo Drug: Placebo
Active Comparator: Oral Sinemet (carbidopa/levodopa) Drug: Sinemet (carbidopa/levodopa)

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.

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01617135

Locations
Israel
Civitas Clinical Site #6
Petach-Tikva, Israel
Civitas Clinical Site #5
Tel Aviv, Israel
Serbia
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
Civitas Therapeutics
Michael J. Fox Foundation for Parkinson's Research
  More Information

Additional Information:
No publications provided

Responsible Party: Civitas Therapeutics
ClinicalTrials.gov Identifier: NCT01617135     History of Changes
Other Study ID Numbers: CVT-301-002, 2012-000181-37
Study First Received: May 7, 2012
Last Updated: June 12, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
Israel: Ministry of Health
Serbia and Montenegro: Agency for Drugs and Medicinal Devices

Keywords provided by Civitas Therapeutics:
Parkinson's disease
Motor fluctuations
levodopa
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
Carbidopa, levodopa drug combination
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Dopamine Agonists
Adjuvants, Immunologic
Immunologic Factors

ClinicalTrials.gov processed this record on July 28, 2014