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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.
Patients who successfully complete this study will be eligible to enroll into a 12 month treatment extension (CVT-301-004E) study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CVT-301 Low Dose | Experimental | Capsules of levodopa inhalational powder used up to 5 times/day for OFF episodes for 3 months duration |
|
| CVT-301 High Dose | Experimental | Capsules of levodopa inhalational powder used up to 5 times/day for OFF episodes for 3 months duration |
|
| Placebo | Placebo Comparator | Capsules of inhalation-grade lactose used up to 5 times/day for OFF episodes for 3 months duration. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CVT-301 Low Dose | Drug |
|
| |
| CVT-301 High Dose |
| Measure | Description | Time Frame |
|---|---|---|
| Unified Parkinson's Disease Rating Scale (UPDRS) Part III | Primary Efficacy Analysis: Change from Predose in the Unified Parkinson's Disease Rating Scale (UPDRS) Part III Score at 30 Minutes post-dose at Week 12 for CVT-301 High Dose versus Placebo (ITT Population). UPDRS Part III ranges from 0 minimum to 86 maximum, with lower scores indicating better movement. Units on a scale. | 30 minutes post-dose at week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Patients Achieving Resolution of an OFF to an ON State Within 60 Minutes. | Examiner-assessed observation - Subject Achieving Resolution of an OFF to and ON state within 60 Minutes at TV4 - Observed | at week 12 |
| UPDRS Part III Motor Score at 20 Minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Charles Oh, MD | Acorda Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Acorda Site #5020 | Scottsdale | Arizona | 85259 | United States | ||
| Acorda Site #5042 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30663606 | Derived | LeWitt PA, Hauser RA, Pahwa R, Isaacson SH, Fernandez HH, Lew M, Saint-Hilaire M, Pourcher E, Lopez-Manzanares L, Waters C, Rudzinska M, Sedkov A, Batycky R, Oh C; SPAN-PD Study Investigators. Safety and efficacy of CVT-301 (levodopa inhalation powder) on motor function during off periods in patients with Parkinson's disease: a randomised, double-blind, placebo-controlled phase 3 trial. Lancet Neurol. 2019 Feb;18(2):145-154. doi: 10.1016/S1474-4422(18)30405-8. |
| Label | URL |
|---|---|
| Click here for more information about this study: CVT-301-004 | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | CVT-301 Low Dose | Capsules of levodopa inhalational powder used up to 5 times/day for OFF episodes for 3 months duration CVT-301 |
| FG001 | CVT-301 High Dose | Capsules of levodopa inhalational powder used up to 5 times/day for OFF episodes for 3 months duration CVT-301 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Drug |
|
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| Placebo | Other |
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|
Change from Predose in the Unified Parkinson's Disease Rating Scale (UPDRS) Part III Score at 20 Minutes post-dose at Week 12 for CVT-301 High Dose versus Placebo (ITT Population) and CVT 301 Low Dose versus Placebo. UPDRS Part III ranges from 0 minimum to 86 maximum, with lower scores indicating better movement. Units on a scale. |
| at week 12 |
| Proportion of Subjects Who Improved PGIC With CVT-301 vs. Placebo at Week 12 | Patient Global impression of change at treatment visit 4 (week 12) by improvement category. Seven point Likert scale ranging from 1= much worse to 7= much better. | week 12 |
| UPDRS Part III at 10 Min. | Change from Predose in the Unified Parkinson's Disease Rating Scale (UPDRS) Part III Score at 10 Minutes post-dose at Week 12 for CVT-301 High Dose versus Placebo (ITT Population). UPDRS Part III ranges from 0 minimum to 86 maximum, with lower scores indicating better movement. Units on a scale. | week 12 |
| PD Patient Diary | Change in total daily OFF times for 3 consecutive days prior to week 12 visit compared to 3 consecutive days prior to baseline visit. Participants recorded On or Off state in 30 minute intervals during waking hours. | post week 12 |
| Fresno |
| California |
| 93710 |
| United States |
| Acorda Site #5064 | Fullerton | California | 92835 | United States |
| Acorda Site #5035 | Loma Linda | California | 92354 | United States |
| Acorda Site #5027 | Long Beach | California | 90806 | United States |
| Acorda Site #5037 | Los Angeles | California | 90033 | United States |
| Acorda Site #5070 | Pasadena | California | 91105 | United States |
| Acorda Site #5047 | Reseda | California | 91335 | United States |
| Acorda Site #5068 | Santa Ana | California | 92705 | United States |
| Acorda Site #5069 | Torrance | California | 90505 | United States |
| Acorda Site #5052 | Washington D.C. | District of Columbia | 20007 | United States |
| Acorda Site #5046 | Atlantis | Florida | 33462 | United States |
| Acorda Site #5053 | Aventura | Florida | 33180 | United States |
| Acorda Site #5013 | Boca Raton | Florida | 33486 | United States |
| Acorda Site #5016 | Jacksonville | Florida | 32209 | United States |
| Acorda Site #5071 | Maitland | Florida | 32751 | United States |
| Acorda Site #5044 | Orlando | Florida | 32806 | United States |
| Acorda Site #5060 | Palm Beach Gardens | Florida | 33410 | United States |
| Acorda Site #5001 | Port Charlotte | Florida | 33952 | United States |
| Acorda Site #5065 | St. Petersburg | Florida | 33713 | United States |
| Acorda Site #5012 | Tampa | Florida | 33613 | United States |
| Acorda Site #5040 | Atlanta | Georgia | 30329 | United States |
| Acorda Site #5025 | Chicago | Illinois | 60611 | United States |
| Acorda Site #5030 | Chicago | Illinois | 60612 | United States |
| Acorda Site #5011 | Elk Grove Village | Illinois | 60007 | United States |
| Acorda Site #5003 | Kansas City | Kansas | 66160 | United States |
| Acorda Site #5067 | Baton Rouge | Louisiana | 70810 | United States |
| Acorda Site #5057 | Baltimore | Maryland | 21201 | United States |
| Acorda Site #5056 | Boston | Massachusetts | 02114 | United States |
| Acorda Site #5018 | Boston | Massachusetts | 02118 | United States |
| Acorda Site #5002 | Bingham Farms | Michigan | 48025 | United States |
| Acorda Site #5014 | West Bloomfield | Michigan | 48322 | United States |
| Acorda Site #5041 | Golden Valley | Minnesota | 55427 | United States |
| Acorda Site #5006 | St Louis | Missouri | 63110 | United States |
| Acorda Site #5023 | Las Vegas | Nevada | 89102 | United States |
| Acorda Site #5028 | Albany | New York | 12208 | United States |
| Acorda Site #5039 | Brooklyn | New York | 11203 | United States |
| Acorda Site #5031 | New York | New York | 10016 | United States |
| Acorda Site #5032 | New York | New York | 10029 | United States |
| Acorda Site #5004 | New York | New York | 10032 | United States |
| Acorda Site #5038 | Syracuse | New York | 13210 | United States |
| Acorda Site #5048 | Charlotte | North Carolina | 28204 | United States |
| Acorda Site #5005 | Cleveland | Ohio | 44195 | United States |
| Acorda Site #5050 | Norwood | Ohio | 45212 | United States |
| Acorda Site #5062 | Portland | Oregon | 97239 | United States |
| Acorda Site #5036 | Allentown | Pennsylvania | 18103 | United States |
| Acorda Site #5010 | Philadelphia | Pennsylvania | 19107 | United States |
| Acorda Site #5058 | Willow Grove | Pennsylvania | 19090 | United States |
| Acorda Site #5022 | Charleston | South Carolina | 29425 | United States |
| Acorda Site #5029 | Nashville | Tennessee | 372322551 | United States |
| Acorda Site #5019 | Houston | Texas | 77030 | United States |
| Acorda Site #5045 | Houston | Texas | 77030 | United States |
| Acorda Site #5049 | Henrico | Virginia | 23226 | United States |
| Acorda Site #5059 | Virginia Beach | Virginia | 23456 | United States |
| Acorda Site #5051 | Kirkland | Washington | 98034 | United States |
| Acorda Site #5103 | London | Ontario | N6A5A5 | Canada |
| Acorda Site #5104 | Ottawa | Ontario | K1Y4E9 | Canada |
| Acorda Site #5105 | Toronto | Ontario | M5T2S8 | Canada |
| Acorda Site #5201 | Prague | 10000 | Czechia |
| Acorda Site #5203 | Prague | 14000 | Czechia |
| Acorda Site #5304 | Katowice | 40588 | Poland |
| Acorda Site #5306 | Krakow | 30349 | Poland |
| Acorda Site #5303 | Krakow | 30510 | Poland |
| Acorda Site #5307 | Krakow | 31505 | Poland |
| Acorda Site #5302 | Lodz | 90130 | Poland |
| Acorda Site #5308 | Warsaw | 00453 | Poland |
| Acorda Site #5301 | Warsaw | 01868 | Poland |
| Acorda Site #5305 | Zaspa | 80462 | Poland |
| Acorda Site #5407 | Pamplona | Navarre | 31008 | Spain |
| Acorda Site #5404 | Barcelona | 08026 | Spain |
| Acorda Site #5406 | Barcelona | 08035 | Spain |
| Acorda Site #5405 | Madrid | 28006 | Spain |
| Acorda Site #5403 | San Sebastián | 20009 | Spain |
| Acorda Site #5401 | Sant Cugat del Vallès | 08190 | Spain |
| FG002 | Placebo | Capsules of inhalation-grade lactose used up to 5 times/day for OFF episodes for 3 months duration. CVT-301 |
| COMPLETED |
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| NOT COMPLETED |
|
12 participants were randomized but withdrew before receiving any study drug (4 placebo, 2 CVT-301 low-dose, 6 CVT-301 high-dose.
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| ID | Title | Description |
|---|---|---|
| BG000 | CVT-301 Low Dose | Capsules of levodopa inhalational powder used up to 5 times/day for OFF episodes for 3 months duration CVT-301 |
| BG001 | CVT-301 High Dose | Capsules of levodopa inhalational powder used up to 5 times/day for OFF episodes for 3 months duration CVT-301 |
| BG002 | Placebo | Capsules of inhalation-grade lactose used up to 5 times/day for OFF episodes for 3 months duration. CVT-301 |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Unified Parkinson's Disease Rating Scale (UPDRS) Part III | Primary Efficacy Analysis: Change from Predose in the Unified Parkinson's Disease Rating Scale (UPDRS) Part III Score at 30 Minutes post-dose at Week 12 for CVT-301 High Dose versus Placebo (ITT Population). UPDRS Part III ranges from 0 minimum to 86 maximum, with lower scores indicating better movement. Units on a scale. | 12 participants were randomized but withdrew before receiving any study drug (4 placebo, 2 CVT-301 low-dose, 6 CVT-301 high-dose). | Posted | Least Squares Mean | Standard Error | units on a scale | 30 minutes post-dose at week 12 |
|
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| ||||||||||||||||||||||||||||
| Secondary | Proportion of Patients Achieving Resolution of an OFF to an ON State Within 60 Minutes. | Examiner-assessed observation - Subject Achieving Resolution of an OFF to and ON state within 60 Minutes at TV4 - Observed | 12 participants were randomized but withdrew before receiving any study drug (4 placebo, 2 CVT-301 low-dose, 6 CVT-301 high-dose). | Posted | Count of Participants | Participants | No | at week 12 |
|
| |||||||||||||||||||||||||||||
| Secondary | UPDRS Part III Motor Score at 20 Minutes | Change from Predose in the Unified Parkinson's Disease Rating Scale (UPDRS) Part III Score at 20 Minutes post-dose at Week 12 for CVT-301 High Dose versus Placebo (ITT Population) and CVT 301 Low Dose versus Placebo. UPDRS Part III ranges from 0 minimum to 86 maximum, with lower scores indicating better movement. Units on a scale. | 12 participants were randomized but withdrew before receiving any study drug (4 placebo, 2 CVT-301 low-dose, 6 CVT-301 high-dose). | Posted | Least Squares Mean | 97.5% Confidence Interval | units on a scale | at week 12 |
| ||||||||||||||||||||||||||||||
| Secondary | Proportion of Subjects Who Improved PGIC With CVT-301 vs. Placebo at Week 12 | Patient Global impression of change at treatment visit 4 (week 12) by improvement category. Seven point Likert scale ranging from 1= much worse to 7= much better. | 12 participants were randomized but withdrew before receiving any study drug (4 placebo, 2 CVT-301 low-dose, 6 CVT-301 high-dose). | Posted | Count of Participants | Participants | week 12 |
|
| ||||||||||||||||||||||||||||||
| Secondary | UPDRS Part III at 10 Min. | Change from Predose in the Unified Parkinson's Disease Rating Scale (UPDRS) Part III Score at 10 Minutes post-dose at Week 12 for CVT-301 High Dose versus Placebo (ITT Population). UPDRS Part III ranges from 0 minimum to 86 maximum, with lower scores indicating better movement. Units on a scale. | 12 participants were randomized but withdrew before receiving any study drug (4 placebo, 2 CVT-301 low-dose, 6 CVT-301 high-dose). | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | week 12 |
| ||||||||||||||||||||||||||||||
| Secondary | PD Patient Diary | Change in total daily OFF times for 3 consecutive days prior to week 12 visit compared to 3 consecutive days prior to baseline visit. Participants recorded On or Off state in 30 minute intervals during waking hours. | 12 participants were randomized but withdrew before receiving any study drug (4 placebo, 2 CVT-301 low-dose, 6 CVT-301 high-dose). | Posted | Least Squares Mean | 95% Confidence Interval | hours | post week 12 |
|
|
12 Week Study
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CVT-301 Low Dose | Capsules of levodopa inhalational powder used up to 5 times/day for OFF episodes for 3 months duration CVT-301 | 0 | 113 | 6 | 113 | 37 | 113 |
| EG001 | CVT-301 High Dose | Capsules of levodopa inhalational powder used up to 5 times/day for OFF episodes for 3 months duration CVT-301 | 0 | 114 | 2 | 114 | 44 | 114 |
| EG002 | Placebo | Capsules of inhalation-grade lactose used up to 5 times/day for OFF episodes for 3 months duration. CVT-301 | 0 | 112 | 3 | 112 | 10 | 112 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pericarditis | Cardiac disorders | Systematic Assessment |
| ||
| Atrial fibrillation | Cardiac disorders | Systematic Assessment |
| ||
| Bradycardia | Cardiac disorders | Systematic Assessment |
| ||
| Chest pain | General disorders | Systematic Assessment |
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| Syncope | Nervous system disorders | Systematic Assessment |
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| Coronary artery disease | Cardiac disorders | Systematic Assessment |
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| Pancreatitis acute | Gastrointestinal disorders | Systematic Assessment |
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| Lumbar spinal stinosis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Throat Irritation | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Sputum discoloured | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Upper respiratory tract | Infections and infestations | Systematic Assessment |
| ||
| Dyskinesia | Nervous system disorders | Systematic Assessment |
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| Dizziness | Nervous system disorders | Systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Fall | Injury, poisoning and procedural complications | Systematic Assessment |
|
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding the study results for a period up to 30 days from the date the communication is submitted to the sponsor. The sponsor shall have the right to defer proposed publication an additional 60 days from the end of the review period. The sponsor cannot require changes to the communication and cannot unilaterally extend the embargo.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Charles Oh | Acorda Therapeutics | 914-326-5455 | coh@acorda.com |
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
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| Between 18 and 65 years |
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| >=65 years |
|
| Male |
|
| United States |
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| Poland |
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| Spain |
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