Safety, Pharmacokinetics and Efficacy Study of CVT-301 Inpatients With Parkinson's Disease and "Off" Episodes
This study has been completed.
Sponsor:
Civitas Therapeutics
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: December 21, 2012
Last verified: April 2012
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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
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: | December 21, 2012 |
| 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 May 19, 2013