Twelve Month Safety and Efficacy Study of CVT-301 In Parkinson's Disease Patients With OFF Episodes
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| ClinicalTrials.gov Identifier: NCT02242487 |
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Recruitment Status :
Completed
First Posted : September 17, 2014
Results First Posted : July 30, 2019
Last Update Posted : August 14, 2019
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Sponsor:
Acorda Therapeutics
Information provided by (Responsible Party):
Acorda Therapeutics
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| Study Type | Interventional |
|---|---|
| Study Design | Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
| Condition |
Idiopathic Parkinson's Disease |
| Intervention |
Drug: CVT-301 |
| Enrollment | 325 |
Participant Flow
| Recruitment Details | |
| Pre-assignment Details | Safety population - Altogether, 325 patients were randomized and 312 patients received at least 1 dose of study drug and were included in the Safety Population. Thirteen patients were randomized but did not receive study drug. |
| Arm/Group Title | CVT-301 Low Dose | CVT-301 High Dose |
|---|---|---|
 Arm/Group Description |
Two capsules of 30 mg each (60 mg total) of levodopa inhalational powder orally inhaled up to 5 times/day for OFF episodes for 12 months duration CVT-301 |
Two capsules of 42 mg each (84 mg total) of levodopa inhalational powder orally inhaled up to 5 times/day for OFF episodes for 12 months duration CVT-301 |
| Period Title: Overall Study | ||
| Started | 161 | 164 |
| Completed | 99 | 117 |
| Not Completed | 62 | 47 |
| Reason Not Completed | ||
| Adverse Event | 13 | 15 |
| Lack of Efficacy | 4 | 6 |
| Protocol Violation | 2 | 0 |
| Lost to Follow-up | 2 | 1 |
| Other - Miscellaneous | 4 | 6 |
| Withdrawal by Subject | 37 | 19 |
Baseline Characteristics
| Arm/Group Title | CVT-301 Low Dose | CVT-301 High Dose | Total | |
|---|---|---|---|---|
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Arm/Group Description |
60 mg (two capsules of 30 mg) of levodopa inhalational powder used up to 5 times/day for OFF episodes for 12 months duration CVT-301 |
84 mg (two capsules of 42 mg) of levodopa inhalational powder used up to 5 times/day for OFF episodes for 12 months duration CVT-301 |
Total of all reporting groups | |
| Overall Number of Baseline Participants | 153 | 159 | 312 | |
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Baseline Analysis Population Description |
Baseline Characteristics of 312 is based on the Safety Population of 325 participants randomized less 13 who were randomized and Not Dosed.
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 153 participants | 159 participants | 312 participants | |
| <=18 years |
0 0.0%
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0 0.0%
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0 0.0%
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| Between 18 and 65 years |
71 46.4%
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80 50.3%
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151 48.4%
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| >=65 years |
82 53.6%
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79 49.7%
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161 51.6%
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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| Number Analyzed | 153 participants | 159 participants | 312 participants | |
| 63.9 (8.76) | 62.9 (8.34) | 63.4 (8.55) | ||
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 153 participants | 159 participants | 312 participants | |
| Female |
43 28.1%
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40 25.2%
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83 26.6%
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| Male |
110 71.9%
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119 74.8%
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229 73.4%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 153 participants | 159 participants | 312 participants | |
| American Indian or Alaska Native |
0 0.0%
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1 0.6%
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1 0.3%
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| Asian |
1 0.7%
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5 3.1%
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6 1.9%
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| Native Hawaiian or Other Pacific Islander |
1 0.7%
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0 0.0%
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1 0.3%
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| Black or African American |
3 2.0%
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3 1.9%
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6 1.9%
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| White |
147 96.1%
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150 94.3%
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297 95.2%
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| More than one race |
1 0.7%
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0 0.0%
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1 0.3%
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| Unknown or Not Reported |
0 0.0%
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0 0.0%
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0 0.0%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 153 participants | 159 participants | 312 participants |
| Canada | 4 | 4 | 8 | |
| Czechia | 5 | 3 | 8 | |
| Poland | 39 | 45 | 84 | |
| Spain | 5 | 6 | 11 | |
| United States | 100 | 101 | 201 | |
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BMI
Mean (Standard Deviation) Unit of measure: Kg/m^2 |
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| Number Analyzed | 153 participants | 159 participants | 312 participants | |
| 27.65 (4.820) | 27.59 (4.790) | 27.62 (4.797) | ||
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
| Name/Title: | Dr. Charles Oh, Senior Vice President - Clinical Development |
| Organization: | Acorda Therapeutics |
| Phone: | 914-326-5455 |
| EMail: | coh@acorda.com |
| Responsible Party: | Acorda Therapeutics |
| ClinicalTrials.gov Identifier: | NCT02242487 |
| Other Study ID Numbers: |
CVT-301-004E |
| First Submitted: | September 15, 2014 |
| First Posted: | September 17, 2014 |
| Results First Submitted: | June 12, 2019 |
| Results First Posted: | July 30, 2019 |
| Last Update Posted: | August 14, 2019 |