Idiopathic Parkinson's DiseasePhase 2NCT01777555
Efficacy and Safety Study of Inhaled CVT 301 in Parkinson's Disease Patients for Treatment of OFF Episodes
A Phase 2 study testing CVT-301 in people with Idiopathic Parkinson's Disease, run by Acorda Therapeutics at 22 sites in 4 countries.
Trial summary
This randomized, multicenter, placebo-controlled, double-blind study will evaluate the efficacy and safety of inhaled CVT 301 compared with placebo in PD patients experiencing motor response fluctuations (OFF phenomena) as an outpatient (i.e., at home) and in the clinic. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Idiopathic Parkinson's Disease
- What is being tested?
- CVT-301
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 89 participants
- Where
- 22 sitesin 4 countries
- Study dates
- Apr 2013to Jan 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
22 sites in 4 countries.
22 sites in 4 countries
United States13 sites
Civitas Investigational Site 1001
Bingham Farms, Michigan, 48025
Civitas Investigational Site 1004
Boca Raton, Florida, 33427
Civitas Investigational Site 1010
Boston, Massachusetts, 02108
Civitas Investigational Site 1014
Cleveland, Ohio, 44101
Civitas Investigational Site 1007
Kansas City, Kansas, 66101
Civitas Investigational Site 1011
Kingston, New York, 12401
Civitas Investigational Site 1003
Kirkland, Washington, 98033
Civitas Investigational Site 1013
Little Rock, Arkansas, 72201
Civitas Investigational Site 1002
Port Charlotte, Florida, 33948
Civitas Investigational Site 1008
Roseville, Michigan, 48066
Civitas Investigational Site 1009
Saint Louis, Michigan, 48880
Civitas Investigational Site 1015
Tampa, Florida, 33601
Civitas Investigational Site 1005
West Bloomfield, Michigan, 48322
United Kingdom4 sites
Civitas Investigational Site 2004
Cambridge
Civitas Investigational Site 200
Glasgow
Civitas Investigational Site 2001
London
Civitas Investigational Site 2003
Stoke-on-Trent
Italy3 sites
Civitas Investigational Site 4003
Cassino
Civitas Investigational Site 4002
Chieti
Civitas Investigational Site 4001
Rome
Serbia2 sites
Civitas Investigational Site 3001
Belgrade
Civitas Investigational Site 3002
Belgrade
About this study
Official title: A Phase 2b, Randomized, Double-blind, Placebo-controlled Study Investigating the Efficacy and Safety of Inhaled CVT 301 (Levodopa Inhalation Powder) in Parkinson's Disease Patients With Motor Response Fluctuations (OFF Phenomena)
This randomized, multicenter, placebo-controlled, double-blind study will evaluate the efficacy and safety of inhaled CVT 301 compared with placebo in PD patients experiencing motor response fluctuations (OFF phenomena) as an outpatient (i.e., at home) and in the clinic.
- Conditions
- Idiopathic Parkinson's Disease
- Being tested
- CVT-301, Placebo
- Keywords
- Parkinson's Disease, Motor fluctuations, levodopa, inhaled drugs, Off episodes
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CVT-301Drug
Also called Levodopa Inhalation Powder
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| CVT-301 | Experimental | CVT-301 at Dose Level 1 for 1st 14 days of treatment then increased to Dose level 2 for last 14 days of treatment. Receives: Drug: CVT-301 |
| Inhaled Placebo | Placebo comparator | Subjects randomized to receive placebo in a 1:1 randomization scheme Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in average Unified Parkinson's Disease Rating Scale Part III motor score
Measured: pre-dose to 60 minutes following treatment
Secondary outcomes (2)
Time to resolution of OFF episode to an ON state.
Measured: 28 days duration outpatient treatment
To characterize the safety (including pulmonary safety)of CVT-301 when used chronically to provide relief from OFF episodes.
Adverse experiences, ECGs, vital signs, clinical laboratory evaluation, pulmonary function using spirometry
Measured: change from baseline through 28 days outpatient use
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2013 (estimated)
- Study startApr 2013
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Parkinson's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acorda Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Martin Freed, MD, Study chair, Acorda Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01777555
- Sponsor's protocol ID
- CVT-301-003
- Other IDs
- 2012-005822-31
- Status last verified
- May 2015
- First submitted
- 23 Jan 2013
- Last updated
- 8 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2b, Randomized, Double-blind, Placebo-controlled Study Investigating the Efficacy and Safety of Inhaled CVT 301 (Levodopa Inhalation Powder) in Parkinson's Disease Patients With Motor Response Fluctuations (OFF Phenomena)
- ClinicalTrials.gov ID
- NCT01777555
- Acronym / sponsor ID
- CVT-301-003
- Conditions
- Idiopathic Parkinson's Disease
- Keywords
- Parkinson's Disease, Motor fluctuations, levodopa, inhaled drugs, Off episodes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Acorda TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Apr 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 29 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized, multicenter, placebo-controlled, double-blind study will evaluate the efficacy and safety of inhaled CVT 301 compared with placebo in PD patients experiencing motor response fluctuations (OFF phenomena) as an outpatient (i.e., at home) and in the clinic.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CVT-301 | Experimental | Drug: CVT-301CVT-301 at Dose Level 1 for 1st 14 days of treatment then increased to Dose level 2 for last 14 days of treatment. |
| Inhaled Placebo | Placebo comparator | Drug: PlaceboSubjects randomized to receive placebo in a 1:1 randomization scheme |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CVT-301Also: Levodopa Inhalation Powder | Drug | CVT-301 |
| Placebo | Drug | Inhaled Placebo |
Primary outcome
Change in average Unified Parkinson's Disease Rating Scale Part III motor score
Time frame: pre-dose to 60 minutes following treatment
2 secondary outcomes
Time to resolution of OFF episode to an ON state.
Time frame: 28 days duration outpatient treatment
To characterize the safety (including pulmonary safety)of CVT-301 when used chronically to provide relief from OFF episodes.
Time frame: change from baseline through 28 days outpatient use
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2018.
Related trials for Idiopathic Parkinson's Disease
Not yet recruitingObservational study
Longitudinal Observation of Neurodegeneration in Parkinson's Disease Using Molecular Imaging and Blood Biomarkers
Idiopathic Parkinson Disease
Not yet recruiting
Non-invasive Vagus Nerve Stimulation for Parkinson's Disease
Idiopathic Parkinson Disease
RecruitingPhase 2
A Phase 2 Study and Open-Label Extension of NEU-411 in Companion Diagnostic-Positive Participants With Early Parkinson's Disease
Parkinson Disease, Parkinson
Recruiting
MediPD: An Online Mediterranean Diet Program for People Living With Parkinson's Disease
Parkinson Disease, Idiopathic
Recruiting
Ginger-PD: Ginger as a Modifier of Ghrelin Levels and Gut Function in Parkinson's Disease
REM Sleep Behavior Disorder, Parkinson s Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Freed, MD study chair
Acorda Therapeutics
22 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CVT-301 in people with Idiopathic Parkinson's Disease, run by Acorda Therapeutics at 22 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United States, United Kingdom, Italy, Serbia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in average Unified Parkinson's Disease Rating Scale Part III motor score (time frame: pre-dose to 60 minutes following treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2018.