Idiopathic Parkinson's DiseasePhase 2NCT01617135
Safety, Pharmacokinetics and Efficacy Study of CVT-301 Inpatients With Parkinson's Disease and "Off" Episodes
A Phase 2 study testing CVT-301 and Sinemet (carbidopa/levodopa) in people with Idiopathic Parkinson's Disease, run by Acorda Therapeutics at 7 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Idiopathic Parkinson's Disease
- What is being tested?
- CVT-301 and Sinemet (carbidopa/levodopa)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 7 sitesin 3 countries
- Study dates
- May 2012to Dec 2012
- 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 years and older
- 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
7 sites in 3 countries.
7 sites in 3 countries
United Kingdom3 sites
Civitas Clinical Site #1
Glasgow
Civitas Clinical Site #3
Newcastle
Civitas Clinical Site #2
Norwich
Israel2 sites
Civitas Clinical Site #6
Petah Tikva
Civitas Clinical Site #5
Tel Aviv
Serbia2 sites
Civitas Clinical Site #4
Belgrade
Civitas Clinical Site #7
Belgrade
About this study
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")
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.
Read the 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.
- Conditions
- Idiopathic Parkinson's Disease
- Being tested
- CVT-301, Placebo, Sinemet (carbidopa/levodopa)
- Keywords
- Parkinson's disease, Motor fluctuations, levodopa, inhaled drugs, Motor fluctuation ("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
PlaceboDrug
Sinemet (carbidopa/levodopa)Drug
CVT-301Drug
| Study group | Role | What they receive |
|---|---|---|
| CVT-301 Low Dose | Experimental | CVT-Low; levodopa inhalation powder (LIP) Receives: Drug: CVT-301 |
| CVT-301 High Dose | Experimental | CVT-High; levodopa inhalation powder (LIP) Receives: Drug: CVT-301 |
| Inhaled Placebo | Placebo comparator | Inhaled placebo powder Receives: Drug: Placebo |
| Oral Sinemet (carbidopa/levodopa) | Active comparator | Open-label oral carbidopa/levodopa (CD/LD) Receives: Drug: Sinemet (carbidopa/levodopa) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
Adverse experiences, ECGs, clinical laboratory evaluation, pulmonary function
Measured: change from baseline up to 13 weeks
Secondary outcomes (2)
Pharmacodynamics
Time to onset of meaningful "on" and "off" states (patient- and examiner-assessed) UPDRS III motor score Tapping test Dyskinesia
Measured: 3 hours post-dose
Pharmacokinetics
Serial blood draw for determination of plasma concentration-time profile
Measured: 3 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2012 (estimated)
- Study startMay 2012
- Primary completionNov 2012
- Study completionDec 2012
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
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acorda Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Michael J. Fox Foundation for Parkinson's Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01617135
- Sponsor's protocol ID
- CVT-301-002
- Other IDs
- 2012-000181-37
- Status last verified
- Jul 2017
- First submitted
- 7 May 2012
- Last updated
- 27 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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")
- ClinicalTrials.gov ID
- NCT01617135
- Acronym / sponsor ID
- CVT-301-002
- Conditions
- Idiopathic Parkinson's Disease
- Keywords
- Parkinson's disease, Motor fluctuations, levodopa, inhaled drugs, Motor fluctuation ("off episodes")
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Acorda TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- Michael J. Fox Foundation for Parkinson's Research
- Study start
- May 2012
- Primary completion
- Nov 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 12 Jun 2012 (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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| CVT-301 Low Dose | Experimental | Drug: CVT-301CVT-Low; levodopa inhalation powder (LIP) |
| CVT-301 High Dose | Experimental | Drug: CVT-301CVT-High; levodopa inhalation powder (LIP) |
| Inhaled Placebo | Placebo comparator | Drug: PlaceboInhaled placebo powder |
| Oral Sinemet (carbidopa/levodopa) | Active comparator | Drug: Sinemet (carbidopa/levodopa)Open-label oral carbidopa/levodopa (CD/LD) |
Who may qualify
- Ages
- 30 years and older
- 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-301 | Drug | CVT-301 Low Dose |
| Placebo | Drug | Inhaled Placebo |
| Sinemet (carbidopa/levodopa) | Drug | Oral Sinemet (carbidopa/levodopa) |
| CVT-301 | Drug | CVT-301 High Dose |
Primary outcome
Safety
Time frame: change from baseline up to 13 weeks
Adverse experiences, ECGs, clinical laboratory evaluation, pulmonary function
2 secondary outcomes
Pharmacodynamics
Time frame: 3 hours post-dose
Pharmacokinetics
Time frame: 3 hours post-dose
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 27 Jul 2017.
- Related InfoLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CVT-301 and Sinemet (carbidopa/levodopa) in people with Idiopathic Parkinson's Disease, run by Acorda Therapeutics at 7 sites in 3 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 27 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United Kingdom, Israel, 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?
Safety (time frame: change from baseline up to 13 weeks). 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 27 Jul 2017.