Trial Outcomes & Findings for Twelve Month Safety and Efficacy Study of CVT-301 In Parkinson's Disease Patients With OFF Episodes (NCT NCT02242487)
NCT ID: NCT02242487
Last Updated: 2019-08-14
Results Overview
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.
COMPLETED
PHASE3
325 participants
Change from baseline at 52 weeks
2019-08-14
Participant Flow
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.
Participant milestones
| Measure |
CVT-301 Low Dose
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
|
CVT-301 High Dose
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
|
|---|---|---|
|
Overall Study
STARTED
|
161
|
164
|
|
Overall Study
COMPLETED
|
99
|
117
|
|
Overall Study
NOT COMPLETED
|
62
|
47
|
Reasons for withdrawal
| Measure |
CVT-301 Low Dose
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
|
CVT-301 High Dose
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
|
|---|---|---|
|
Overall Study
Adverse Event
|
13
|
15
|
|
Overall Study
Lack of Efficacy
|
4
|
6
|
|
Overall Study
Protocol Violation
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
|
Overall Study
Other - Miscellaneous
|
4
|
6
|
|
Overall Study
Withdrawal by Subject
|
37
|
19
|
Baseline Characteristics
Twelve Month Safety and Efficacy Study of CVT-301 In Parkinson's Disease Patients With OFF Episodes
Baseline characteristics by cohort
| Measure |
CVT-301 Low Dose
n=153 Participants
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
|
CVT-301 High Dose
n=159 Participants
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
n=312 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
71 Participants
n=5 Participants
|
80 Participants
n=7 Participants
|
151 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
82 Participants
n=5 Participants
|
79 Participants
n=7 Participants
|
161 Participants
n=5 Participants
|
|
Age, Continuous
|
63.9 years
STANDARD_DEVIATION 8.76 • n=5 Participants
|
62.9 years
STANDARD_DEVIATION 8.34 • n=7 Participants
|
63.4 years
STANDARD_DEVIATION 8.55 • n=5 Participants
|
|
Sex: Female, Male
Female
|
43 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
83 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
110 Participants
n=5 Participants
|
119 Participants
n=7 Participants
|
229 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
147 Participants
n=5 Participants
|
150 Participants
n=7 Participants
|
297 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
4 participants
n=5 Participants
|
4 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Region of Enrollment
Czechia
|
5 participants
n=5 Participants
|
3 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
39 participants
n=5 Participants
|
45 participants
n=7 Participants
|
84 participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
5 participants
n=5 Participants
|
6 participants
n=7 Participants
|
11 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
100 participants
n=5 Participants
|
101 participants
n=7 Participants
|
201 participants
n=5 Participants
|
|
BMI
|
27.65 kg/m^2
STANDARD_DEVIATION 4.820 • n=5 Participants
|
27.59 kg/m^2
STANDARD_DEVIATION 4.790 • n=7 Participants
|
27.62 kg/m^2
STANDARD_DEVIATION 4.797 • n=5 Participants
|
PRIMARY outcome
Timeframe: Change from baseline at 52 weeksPopulation: 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.
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.
Outcome measures
| Measure |
CVT-301 DL1
n=153 Participants
60 mg (two capsules of 30 mg each) of Levodopa Inhalational Powder (LIP) up to 5 times a day.
|
CVT-301 DL2
n=159 Participants
84 mg (two capsules of 42 mg each) of Levodopa inhalation powder (LIP) up to 5 times a day.
|
|---|---|---|
|
Pulmonary Safety of CVT-301 Change From Baseline for FEV1.
Baseline
|
2.957 Liters
Standard Deviation 0.6995
|
3.117 Liters
Standard Deviation 0.7735
|
|
Pulmonary Safety of CVT-301 Change From Baseline for FEV1.
TV3 (Week 12)
|
-0.059 Liters
Standard Deviation 0.2321
|
-0.078 Liters
Standard Deviation 0.2108
|
|
Pulmonary Safety of CVT-301 Change From Baseline for FEV1.
TV4 (Week 24)
|
-0.057 Liters
Standard Deviation 0.1999
|
-0.058 Liters
Standard Deviation 0.2136
|
|
Pulmonary Safety of CVT-301 Change From Baseline for FEV1.
TV5 (Week 36)
|
-0.076 Liters
Standard Deviation 0.2155
|
-0.052 Liters
Standard Deviation 0.2096
|
|
Pulmonary Safety of CVT-301 Change From Baseline for FEV1.
TV6 (Week 52)
|
-0.086 Liters
Standard Deviation 0.2238
|
-0.097 Liters
Standard Deviation 0.2230
|
PRIMARY outcome
Timeframe: Change from baseline at 52 weeksPopulation: Safety Population - 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.
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.
Outcome measures
| Measure |
CVT-301 DL1
n=153 Participants
60 mg (two capsules of 30 mg each) of Levodopa Inhalational Powder (LIP) up to 5 times a day.
|
CVT-301 DL2
n=159 Participants
84 mg (two capsules of 42 mg each) of Levodopa inhalation powder (LIP) up to 5 times a day.
|
|---|---|---|
|
Pulmonary Safety for CVT-301 Change From Baseline for FVC.
Baseline
|
3.840 Liter
Standard Deviation 0.9047
|
4.045 Liter
Standard Deviation 0.9811
|
|
Pulmonary Safety for CVT-301 Change From Baseline for FVC.
TV3 (Week 12)
|
-0.064 Liter
Standard Deviation 0.2575
|
-0.086 Liter
Standard Deviation 0.2667
|
|
Pulmonary Safety for CVT-301 Change From Baseline for FVC.
TV4 (Week 24)
|
-0.053 Liter
Standard Deviation 0.2710
|
-0.062 Liter
Standard Deviation 0.2688
|
|
Pulmonary Safety for CVT-301 Change From Baseline for FVC.
TV5 (Week 36)
|
-0.089 Liter
Standard Deviation 0.3051
|
-0.050 Liter
Standard Deviation 0.2659
|
|
Pulmonary Safety for CVT-301 Change From Baseline for FVC.
TV6 (Week 52)
|
-0.106 Liter
Standard Deviation 0.2866
|
-0.089 Liter
Standard Deviation 0.2747
|
PRIMARY outcome
Timeframe: Change from baseline at 52 weeksPopulation: Safety Population - 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.
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.
Outcome measures
| Measure |
CVT-301 DL1
n=153 Participants
60 mg (two capsules of 30 mg each) of Levodopa Inhalational Powder (LIP) up to 5 times a day.
|
CVT-301 DL2
n=159 Participants
84 mg (two capsules of 42 mg each) of Levodopa inhalation powder (LIP) up to 5 times a day.
|
|---|---|---|
|
Pulmonary Safety for CVT-301 Change From Baseline for (FEV1/FVC).
Baseline
|
77.2 Ratio %
Standard Deviation 5.24
|
77.2 Ratio %
Standard Deviation 6.00
|
|
Pulmonary Safety for CVT-301 Change From Baseline for (FEV1/FVC).
TV3 (Week 12)
|
-0.2 Ratio %
Standard Deviation 3.35
|
-0.3 Ratio %
Standard Deviation 2.89
|
|
Pulmonary Safety for CVT-301 Change From Baseline for (FEV1/FVC).
TV4 (Week 24)
|
-0.3 Ratio %
Standard Deviation 3.64
|
-0.3 Ratio %
Standard Deviation 2.91
|
|
Pulmonary Safety for CVT-301 Change From Baseline for (FEV1/FVC).
TV5 (Week 36)
|
-0.3 Ratio %
Standard Deviation 2.75
|
-0.3 Ratio %
Standard Deviation 3.02
|
|
Pulmonary Safety for CVT-301 Change From Baseline for (FEV1/FVC).
TV6 (Week 52)
|
-0.2 Ratio %
Standard Deviation 3.36
|
-0.7 Ratio %
Standard Deviation 3.51
|
SECONDARY outcome
Timeframe: At Treatment Visit - TV6 (Week 52)Population: ITT (Intent-to-Treat) Population
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).
Outcome measures
| Measure |
CVT-301 DL1
n=144 Participants
60 mg (two capsules of 30 mg each) of Levodopa Inhalational Powder (LIP) up to 5 times a day.
|
CVT-301 DL2
n=153 Participants
84 mg (two capsules of 42 mg each) of Levodopa inhalation powder (LIP) up to 5 times a day.
|
|---|---|---|
|
Count of Patients Achieving Resolution of an OFF to an ON State Within 60 Minutes.
|
78 Participants
|
92 Participants
|
SECONDARY outcome
Timeframe: Change from baseline through 12 months duration of outpatient usePopulation: ITT - (Intent-to-Treat) Population. Patients who discontinue the study prior to a treatment visit are not included in the analysis for that treatment visit. Therefore, the number of patients decreases with each successive treatment visit.
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.
Outcome measures
| Measure |
CVT-301 DL1
n=144 Participants
60 mg (two capsules of 30 mg each) of Levodopa Inhalational Powder (LIP) up to 5 times a day.
|
CVT-301 DL2
n=153 Participants
84 mg (two capsules of 42 mg each) of Levodopa inhalation powder (LIP) up to 5 times a day.
|
|---|---|---|
|
Change From Baseline in OFF Time.
TV2 (Week 4)
|
-0.33 Hours
Standard Error 0.221
|
-0.55 Hours
Standard Error 0.217
|
|
Change From Baseline in OFF Time.
TV3 (Week 12)
|
-0.23 Hours
Standard Error 0.232
|
-0.38 Hours
Standard Error 0.227
|
|
Change From Baseline in OFF Time.
TV4 (Week 24)
|
-0.65 Hours
Standard Error 0.235
|
-0.73 Hours
Standard Error 0.227
|
|
Change From Baseline in OFF Time.
TV5 (Week 36)
|
-0.49 Hours
Standard Error 0.238
|
-0.92 Hours
Standard Error 0.230
|
|
Change From Baseline in OFF Time.
TV6 (Week 52)
|
-0.70 Hours
Standard Error 0.239
|
-0.88 Hours
Standard Error 0.229
|
Adverse Events
CVT-301 Low Dose
CVT-301 HIgh Dose
Serious adverse events
| Measure |
CVT-301 Low Dose
n=153 participants at risk
60 mg (two capsules of 30 mg each) of Levodopa Inhalational Powder (LIP) up to 5 times a day for OFF episodes for 12 months duration.
|
CVT-301 HIgh Dose
n=159 participants at risk
84 mg (two capsules of 42 mg each) of Levodopa inhalation powder (LIP) up to 5 times a day for OFF episodes for 12 months duration.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Hip fracture
|
1.3%
2/153 • Number of events 2 • 12-month period
|
0.00%
0/159 • 12-month period
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.65%
1/153 • Number of events 1 • 12-month period
|
0.63%
1/159 • Number of events 1 • 12-month period
|
|
Injury, poisoning and procedural complications
Concussion
|
0.65%
1/153 • Number of events 1 • 12-month period
|
0.00%
0/159 • 12-month period
|
|
Injury, poisoning and procedural complications
Fall
|
0.65%
1/153 • Number of events 1 • 12-month period
|
0.00%
0/159 • 12-month period
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/153 • 12-month period
|
0.63%
1/159 • Number of events 1 • 12-month period
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.65%
1/153 • Number of events 1 • 12-month period
|
0.00%
0/159 • 12-month period
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.65%
1/153 • Number of events 1 • 12-month period
|
0.00%
0/159 • 12-month period
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
2.0%
3/153 • Number of events 3 • 12-month period
|
0.00%
0/159 • 12-month period
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.65%
1/153 • Number of events 1 • 12-month period
|
0.63%
1/159 • Number of events 1 • 12-month period
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.00%
0/153 • 12-month period
|
0.63%
1/159 • Number of events 1 • 12-month period
|
|
Musculoskeletal and connective tissue disorders
Osteoporotic fracture
|
0.00%
0/153 • 12-month period
|
0.63%
1/159 • Number of events 1 • 12-month period
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.00%
0/153 • 12-month period
|
0.63%
1/159 • Number of events 1 • 12-month period
|
|
Cardiac disorders
Angina pectoris
|
1.3%
2/153 • Number of events 2 • 12-month period
|
0.00%
0/159 • 12-month period
|
|
Cardiac disorders
Atrial fibrillation
|
0.65%
1/153 • Number of events 1 • 12-month period
|
0.63%
1/159 • Number of events 1 • 12-month period
|
|
Cardiac disorders
Mycardial infarction
|
0.00%
0/153 • 12-month period
|
0.63%
1/159 • Number of events 1 • 12-month period
|
|
Cardiac disorders
Sinus node dysfunction
|
0.65%
1/153 • Number of events 1 • 12-month period
|
0.00%
0/159 • 12-month period
|
|
Gastrointestinal disorders
Dysphagia
|
0.65%
1/153 • Number of events 1 • 12-month period
|
0.00%
0/159 • 12-month period
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.65%
1/153 • Number of events 1 • 12-month period
|
0.00%
0/159 • 12-month period
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.65%
1/153 • Number of events 1 • 12-month period
|
0.00%
0/159 • 12-month period
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/153 • 12-month period
|
0.63%
1/159 • Number of events 1 • 12-month period
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/153 • 12-month period
|
0.63%
1/159 • Number of events 1 • 12-month period
|
|
Gastrointestinal disorders
Megacolon
|
0.00%
0/153 • 12-month period
|
0.63%
1/159 • Number of events 1 • 12-month period
|
|
Gastrointestinal disorders
Naseau
|
0.65%
1/153 • Number of events 1 • 12-month period
|
0.00%
0/159 • 12-month period
|
|
Gastrointestinal disorders
Oesophageal achalasia
|
0.65%
1/153 • Number of events 1 • 12-month period
|
0.00%
0/159 • 12-month period
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/153 • 12-month period
|
0.63%
1/159 • Number of events 1 • 12-month period
|
|
Gastrointestinal disorders
Vomititng
|
0.65%
1/153 • Number of events 1 • 12-month period
|
0.00%
0/159 • 12-month period
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/153 • 12-month period
|
0.63%
1/159 • Number of events 1 • 12-month period
|
|
Infections and infestations
Hepatitis C
|
0.65%
1/153 • Number of events 1 • 12-month period
|
0.00%
0/159 • 12-month period
|
|
Infections and infestations
Necrotising soft tissue infection
|
0.65%
1/153 • Number of events 1 • 12-month period
|
0.00%
0/159 • 12-month period
|
|
Infections and infestations
Pneumonia
|
0.65%
1/153 • Number of events 1 • 12-month period
|
0.00%
0/159 • 12-month period
|
|
Infections and infestations
Urinary tract infection
|
0.65%
1/153 • Number of events 1 • 12-month period
|
0.00%
0/159 • 12-month period
|
|
Nervous system disorders
Central nervous system lesion
|
0.00%
0/153 • 12-month period
|
0.63%
1/159 • Number of events 1 • 12-month period
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.65%
1/153 • Number of events 1 • 12-month period
|
0.00%
0/159 • 12-month period
|
|
Nervous system disorders
Parkinson's disease
|
0.65%
1/153 • Number of events 1 • 12-month period
|
0.00%
0/159 • 12-month period
|
|
Nervous system disorders
Presyncope
|
0.65%
1/153 • Number of events 2 • 12-month period
|
0.00%
0/159 • 12-month period
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.3%
2/153 • Number of events 2 • 12-month period
|
0.00%
0/159 • 12-month period
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.65%
1/153 • Number of events 1 • 12-month period
|
0.00%
0/159 • 12-month period
|
|
General disorders
Chest pain
|
0.00%
0/153 • 12-month period
|
0.63%
1/159 • Number of events 1 • 12-month period
|
|
General disorders
Oedema peripheral
|
0.65%
1/153 • Number of events 1 • 12-month period
|
0.00%
0/159 • 12-month period
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostrate cancer
|
0.65%
1/153 • Number of events 1 • 12-month period
|
0.00%
0/159 • 12-month period
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostrate cancer metastatic
|
0.00%
0/153 • 12-month period
|
0.63%
1/159 • Number of events 1 • 12-month period
|
|
Endocrine disorders
Goitre
|
0.00%
0/153 • 12-month period
|
0.63%
1/159 • Number of events 1 • 12-month period
|
|
Metabolism and nutrition disorders
Dehydration
|
0.65%
1/153 • Number of events 1 • 12-month period
|
0.00%
0/159 • 12-month period
|
|
Product Issues
Device connection tissue
|
0.65%
1/153 • Number of events 1 • 12-month period
|
0.00%
0/159 • 12-month period
|
|
Psychiatric disorders
Impulse-control disorder
|
0.00%
0/153 • 12-month period
|
0.63%
1/159 • Number of events 1 • 12-month period
|
|
Psychiatric disorders
Suicide threat
|
0.00%
0/153 • 12-month period
|
0.63%
1/159 • Number of events 1 • 12-month period
|
|
Surgical and medical procedures
Bone graft
|
0.00%
0/153 • 12-month period
|
0.63%
1/159 • Number of events 1 • 12-month period
|
Other adverse events
| Measure |
CVT-301 Low Dose
n=153 participants at risk
60 mg (two capsules of 30 mg each) of Levodopa Inhalational Powder (LIP) up to 5 times a day for OFF episodes for 12 months duration.
|
CVT-301 HIgh Dose
n=159 participants at risk
84 mg (two capsules of 42 mg each) of Levodopa inhalation powder (LIP) up to 5 times a day for OFF episodes for 12 months duration.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.3%
25/153 • Number of events 28 • 12-month period
|
14.5%
23/159 • Number of events 27 • 12-month period
|
|
Injury, poisoning and procedural complications
Fall
|
15.7%
24/153 • Number of events 26 • 12-month period
|
10.7%
17/159 • Number of events 22 • 12-month period
|
|
Infections and infestations
Upper respiratory tract infection
|
6.5%
10/153 • Number of events 10 • 12-month period
|
7.5%
12/159 • Number of events 13 • 12-month period
|
|
Infections and infestations
Nasopharyngitis
|
5.2%
8/153 • Number of events 8 • 12-month period
|
2.5%
4/159 • Number of events 5 • 12-month period
|
|
Nervous system disorders
Dyskinesia
|
3.9%
6/153 • Number of events 6 • 12-month period
|
6.3%
10/159 • Number of events 11 • 12-month period
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.2%
8/153 • Number of events 9 • 12-month period
|
1.9%
3/159 • Number of events 4 • 12-month period
|
Additional Information
Dr. Charles Oh, Senior Vice President - Clinical Development
Acorda Therapeutics
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER