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Idiopathic Parkinson's DiseasePhase 3NCT02242487

Twelve Month Safety and Efficacy Study of CVT-301 In Parkinson's Disease Patients With OFF Episodes

A Phase 3 study testing CVT-301 in people with Idiopathic Parkinson's Disease, run by Acorda Therapeutics at 74 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This study is a 12-month, dose-level blinded, multicenter study of 2 inhaled dose levels of CVT-301 for the treatment of up to 5 OFF episodes per day in PD patients experiencing motor fluctuations (OFF episodes). All patients will receive active treatment, but patients will be blinded to dose level. Read more about this study

Who is it for?
Ages 30 to 86 years
Conditions the study is for
Idiopathic Parkinson's Disease
What is being tested?
CVT-301
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
325 participants
Where
74 sitesin 5 countries
Study dates
Mar 2015to May 2018
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 86 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 3 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;
  • Total daily levodopa (LD) dose <1600 mg/day;
  • Able to perform a spirometry maneuver in the ON and OFF states
  • Normal cognition confirmed by Mini Mental State Examination (MMSE) score ≥25 ;

Who cannot join

  • Pregnant or lactating females;
  • Previous surgery for PD or plan to have stereotactic surgery during the study period. Patients who have had deep brain stimulation [DBS] will also be excluded unless the procedure was performed more than 6 months prior to study enrollment.
  • History of psychotic symptoms requiring treatment, or suicide ideation or attempt within last year;
  • Known contraindication to the use of levodopa;
  • Any significant condition, severe concurrent disease, abnormality or finding that would make patients unsuitable or may compromise patient safety;
  • Any any contraindication to performing routine spirometry.

Trial locations and contacts

74 sites in 5 countries.

74 sites in 5 countries

United States55 sites

  • Acorda Site #5028

    Albany, New York, 12208

  • Acorda Site #5036

    Allentown, Pennsylvania, 18103

  • Acorda Site #5040

    Atlanta, Georgia, 30329

  • Acorda Site #5046

    Atlantis, Florida, 33462

  • Acorda Site #5053

    Aventura, Florida, 33180

  • Acorda Site #5057

    Baltimore, Maryland, 21201

  • Acorda Site #5067

    Baton Rouge, Louisiana, 70810

  • Acorda Site #5002

    Bingham Farms, Michigan, 48025

  • Acorda Site #5013

    Boca Raton, Florida, 33486

  • Acorda Site #5056

    Boston, Massachusetts, 02114

  • Acorda Site #5018

    Boston, Massachusetts, 02118

  • Acorda Site #5039

    Brooklyn, New York, 11203

  • Acorda Site #5022

    Charleston, South Carolina, 29425

  • Acorda Site #5048

    Charlotte, North Carolina, 28204

  • Acorda Site #5025

    Chicago, Illinois, 60611

  • Acorda Site #5030

    Chicago, Illinois, 60612

  • Acorda Site #5005

    Cleveland, Ohio, 44195

  • Acorda Site #5011

    Elk Grove Village, Illinois, 60007

  • Acorda Site #5042

    Fresno, California, 93710

  • Acorda Site #5064

    Fullerton, California, 92835

  • Acorda Site #5041

    Golden Valley, Minnesota, 55427

  • Acorda Site #5049

    Henrico, Virginia, 23226

  • Acorda Site #5019

    Houston, Texas, 77030

  • Acorda Site #5045

    Houston, Texas, 77030

  • Acorda Site #5016

    Jacksonville, Florida, 32209

  • Acorda Site #5003

    Kansas City, Kansas, 66160

  • Acorda Site #5051

    Kirkland, Washington, 98034

  • Acorda Site #5023

    Las Vegas, Nevada, 89102

  • Acorda Site #5035

    Loma Linda, California, 92354

  • Acorda Site #5027

    Long Beach, California, 90806

  • Acorda Site #5037

    Los Angeles, California, 90033

  • Acorda Site #5071

    Maitland, Florida, 32751

  • Acorda Site #5029

    Nashville, Tennessee, 372322551

  • Acorda Site #5031

    New York, New York, 10016

  • Acorda Site #5032

    New York, New York, 10029

  • Acorda Site #5004

    New York, New York, 10032

  • Acorda Site #5050

    Norwood, Ohio, 45212

  • Acorda Site #5044

    Orlando, Florida, 32806

  • Acorda Site #5060

    Palm Beach Gardens, Florida, 33410

  • Acorda Site #5070

    Pasadena, California, 91105

  • Acorda Site #5010

    Philadelphia, Pennsylvania, 19107

  • Acorda Site #5001

    Port Charlotte, Florida, 33952

  • Acorda Site #5062

    Portland, Oregon, 97239

  • Acorda Site #5047

    Reseda, California, 91335

  • Acorda Site #5068

    Santa Ana, California, 92705

  • Acorda Site #5020

    Scottsdale, Arizona, 85259

  • Acorda Site #5006

    St Louis, Missouri, 63110

  • Acorda Site #5065

    St. Petersburg, Florida, 33713

  • Acorda Site #5038

    Syracuse, New York, 13210

  • Acorda Site #5012

    Tampa, Florida, 33613

  • Acorda Site #5069

    Torrance, California, 90505

  • Acorda Site #5059

    Virginia Beach, Virginia, 23456

  • Acorda Site #5052

    Washington D.C., District of Columbia, 20007

  • Acorda Site #5014

    West Bloomfield, Michigan, 48322

  • Acorda Site #5058

    Willow Grove, Pennsylvania, 19090

Other trials in United States

Poland8 sites

  • Acorda Site #5305

    Gdansk, Zappa, 80462

  • Acorda Site #5304

    Katowice, 40588

  • Acorda Site #5306

    Krakow, 30349

  • Acorda Site #5303

    Krakow, 30510

  • Acorda Site #5307

    Krakow, 31505

  • Acorda Site #5302

    Lodz, 90130

  • Acorda Site #5308

    Warsaw, 00453

  • Acorda Site #5301

    Warsaw, 01868

Other trials in Poland

Spain6 sites

  • Acorda Site #5404

    Barcelona, 08026

  • Acorda Site #5406

    Barcelona, 08035

  • Acorda Site #5405

    Madrid, 28006

  • Acorda Site #5407

    Pamplona, Navarre, 31008

  • Acorda Site #5403

    San Sebastián, 20009

  • Acorda Site #5401

    Sant Cugat del Vallès, 08190

Other trials in Spain

Canada3 sites

  • Acorda Site #5103

    London, Ontario, N6A5A5

  • Acorda Site #5104

    Ottawa, Ontario, K1Y4E9

  • Acorda Site #5105

    Toronto, Ontario, M5T2S8

Other trials in Canada

Czechia2 sites

  • Acorda Site #5201

    Prague, 10000

  • Acorda Site #5203

    Prague, 14000

Other trials in Czechia

About this study

Official title: A 12 Month, Dose-Level Blinded Study Investigating the Safety and Efficacy of CVT 301 (Levodopa Inhalation Powder) in Parkinson's Disease Patients With Motor Response Fluctuations (OFF Phenomena)

This study is a 12-month, dose-level blinded, multicenter study of 2 inhaled dose levels of CVT-301 for the treatment of up to 5 OFF episodes per day in PD patients experiencing motor fluctuations (OFF episodes). All patients will receive active treatment, but patients will be blinded to dose level. This will serve as an extension to the CVT-301-004 (NCT02240030) study for those patients who participated in that study and remain eligible for this study. In addition, patients who previously completed the CVT-301-003 (NCT01777555), CVT-301-009 (NCT02807675) and CVT-301-005 (NCT02352363) (observational arm completers), as well as CVT-301 naïve patients may be enrolled if they meet the CVT-301-004E eligibility criteria.

Being tested
CVT-301
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 Inhaled levodopa

Study groups in NCT02242487
Study groupRoleWhat they receive
CVT-301 Low DoseExperimentalCapsules of levodopa inhalational powder used up to 5 times/day for OFF episodes for 12 months duration
Receives: Drug: CVT-301
CVT-301 High DoseExperimentalCapsules of levodopa inhalational powder used up to 5 times/day for OFF episodes for 12 months duration
Receives: Drug: CVT-301

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pulmonary Safety of CVT-301 Change From Baseline for FEV1.

    To characterize the effects of CVT-301 on pulmonary safety, as assessed by spirometry FEV1 (forced expiratory volume in 1 second) by treatment group and Treatment Visit (TV). This study was a 12-month, dose-level blinded, multi-center study of 2 inhaled dose levels of CVT-301 for the treatment of up to 5 OFF periods per day in PD (Parkinson's Disease) patients experiencing motor fluctuations (OFF periods). Baseline is defined as the last non-missing assessment before the first dose of CVT-301 in CVT-301-004 study and as the last non-missing assessment before the first dose of CVT-301 in CVT-301-004E study for the rest of the patients.

    Measured: Change from baseline at 52 weeks

  2. Pulmonary Safety for CVT-301 Change From Baseline for FVC.

    To characterize the effects of CVT-301 on pulmonary safety, as assessed by spirometry FVC, (forced vital capacity) by treatment group and Treatment Visit (TV). This study was a 12-month, dose-level blinded, multi-center study of 2 inhaled dose levels of CVT-301 for the treatment of up to 5 OFF periods per day in PD patients experiencing motor fluctuations (OFF periods). Baseline is defined as the last non-missing assessment before the first dose of CVT-301 in CVT-301-004 study and as the last non-missing assessment before the first dose of CVT-301 in CVT-301-004E study for the rest of the patients.

    Measured: Change from baseline at 52 weeks

  3. Pulmonary Safety for CVT-301 Change From Baseline for (FEV1/FVC).

    To characterize the effects of CVT-301 on pulmonary safety, as assessed by spirometry FEV1/FVC (FEV1-forced expiratory volume in 1 second and (FVC) forced vital capacity ratio) by treatment group and Treatment Visit (TV). This study was a 12-month, dose-level blinded, multi-center study of 2 inhaled dose levels of CVT-301 for the treatment of up to 5 OFF periods per day in PD (Parkinson's Disease) patients experiencing motor fluctuations (OFF periods). Baseline is defined as the last non-missing assessment before the first dose of CVT-301 in CVT-301-004 study and as the last non-missing assessment before the first dose of CVT-301 in CVT-301-004E study for the rest of the patients.

    Measured: Change from baseline at 52 weeks

Secondary outcomes (2)

  1. Count of Patients Achieving Resolution of an OFF to an ON State Within 60 Minutes.

    Count of patients achieving resolution of an OFF to an ON state within 60 minutes after study drug is administered in the clinic, and maintaining the ON state at 60 minutes after study drug administration (per the examiner's subjective assessment).

    Measured: At Treatment Visit - TV6 (Week 52)

  2. Change From Baseline in OFF Time.

    Patient reported total daily OFF time and was assessed by the patient and recorded in the patient Diary. An "OFF state" is defined as the time when medication is not providing benefit with respect to mobility, slowness, and stiffness. OFF episodes may be heralded by non-motor symptoms (e.g., pain, anxiety) prior to the appearance of motor symptoms. Patients will record their ON and OFF states in their diaries at home.

    Measured: Change from baseline through 12 months duration of outpatient use

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Sep 2014 (estimated)
  2. Study startMar 2015
  3. Primary completionMay 2018
  4. Study completionMay 2018

Resources

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 3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
325 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02242487
Sponsor's protocol ID
CVT-301-004E
Status last verified
Jul 2019
First submitted
15 Sep 2014
Last updated
14 Aug 2019
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing CVT-301 in people with Idiopathic Parkinson's Disease, run by Acorda Therapeutics at 74 sites in 5 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 8 inclusion and 6 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 14 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 74 sites in United States, Poland, Spain, Canada, Czechia. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Pulmonary Safety of CVT-301 Change From Baseline for FEV1. (time frame: Change from baseline at 52 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02242487.

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 14 Aug 2019.

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