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Trial record 1 of 2 for:    CVT-301-005
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Randomized Safety Study of CVT-301 Compared to an Observational Control Group

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ClinicalTrials.gov Identifier: NCT02352363
Recruitment Status : Completed
First Posted : February 2, 2015
Results First Posted : July 10, 2018
Last Update Posted : May 27, 2019
Sponsor:
Information provided by (Responsible Party):
Acorda Therapeutics

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Idiopathic Parkinson's Disease
Interventions Drug: CVT-301
Other: Observational cohort
Enrollment 408
Recruitment Details A total of 408 of the 513 screened were randomly assigned to CVT-301 (278) or observational cohort (130). Of these 408 patients, 398 received at least 1 dose of inhaled CVT-301 CVT-treatment group) or came in for OV1 (observational cohort) and were included in the Safety Population.
Pre-assignment Details  
Arm/Group Title CVT-301 Observational Cohort
Hide Arm/Group Description

Capsules of Levodopa Inhalational Powder (LIP) used up to 5 times per day for OFF episodes, for up to 54 weeks duration.

CVT-301

Standard of care. Patients in both the CVT-301 treatment group and the observational cohort will be managed with their standard PD treatment throughout the study.

Observational cohort

Period Title: Overall Study
Started 278 130
Completed 271 127
Not Completed 7 3
Arm/Group Title CVT-301 Observational Cohort Total
Hide Arm/Group Description

Capsules of Levodopa Inhalational Powder (LIP) used up to 5 times per day for OFF episodes, for up to 54 weeks duration.

CVT-301

Standard of care. Patients in both the CVT-301 treatment group and the observational cohort will be managed with their standard PD treatment throughout the study.

Observational cohort

Total of all reporting groups
Overall Number of Baseline Participants 271 127 398
Hide Baseline Analysis Population Description
A total of 408 of the 513 screened were randomly assigned to CVT-301 (278) or observtional cohort (130). Of these 408 patients, 398 received at least 1 dose of inhaled CVT-301 (CVT-treatment group) or came in for OV1 (observational cohort) and were included in the Safety Population.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 271 participants 127 participants 398 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
137
  50.6%
59
  46.5%
196
  49.2%
>=65 years
134
  49.4%
68
  53.5%
202
  50.8%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 271 participants 127 participants 398 participants
63.6  (8.54) 64.2  (7.88) 63.8  (8.33)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 271 participants 127 participants 398 participants
Female
110
  40.6%
49
  38.6%
159
  39.9%
Male
161
  59.4%
78
  61.4%
239
  60.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 271 participants 127 participants 398 participants
Hispanic or Latino
2
   0.7%
0
   0.0%
2
   0.5%
Not Hispanic or Latino
267
  98.5%
124
  97.6%
391
  98.2%
Unknown or Not Reported
2
   0.7%
3
   2.4%
5
   1.3%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 271 participants 127 participants 398 participants
Romania
55
  20.3%
34
  26.8%
89
  22.4%
Hungary
5
   1.8%
0
   0.0%
5
   1.3%
Czechia
22
   8.1%
16
  12.6%
38
   9.5%
United States
21
   7.7%
6
   4.7%
27
   6.8%
United Kingdom
4
   1.5%
5
   3.9%
9
   2.3%
Spain
28
  10.3%
8
   6.3%
36
   9.0%
Austria
11
   4.1%
1
   0.8%
12
   3.0%
Belgium
4
   1.5%
1
   0.8%
5
   1.3%
Poland
61
  22.5%
32
  25.2%
93
  23.4%
Israel
15
   5.5%
6
   4.7%
21
   5.3%
France
13
   4.8%
7
   5.5%
20
   5.0%
Serbia
11
   4.1%
4
   3.1%
15
   3.8%
Germany
21
   7.7%
7
   5.5%
28
   7.0%
Spirometry FEV1  
Mean (Standard Deviation)
Unit of measure:  Liters
Number Analyzed 271 participants 127 participants 398 participants
2.842  (0.7538) 2.838  (0.853) 2.841  (0.7831)
Spirometry FVC  
Mean (Standard Deviation)
Unit of measure:  Liters
Number Analyzed 271 participants 127 participants 398 participants
3.665  (0.9203) 3.696  (1.0497) 3.675  (0.9622)
Spirometry FEV1/FVC  
Mean (Standard Deviation)
Unit of measure:  Ratio %
Number Analyzed 271 participants 127 participants 398 participants
77.6  (6.23) 76.8  (6.50) 77.3  (6.32)
1.Primary Outcome
Title Pulmonary Safety Assessed by Forced Expiratory Volume in 1 Second [FEV1]
Hide Description To characterize the pulmonary safety, as assessed by spirometry (forced expiratory volume in 1 second [FEV1], over a 12 month period.
Time Frame Month 12 reported
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CVT-301 Observational Cohort
Hide Arm/Group Description:

Capsules of Levodopa Inhalational Powder (LIP) used up to 5 times per day for OFF episodes, for up to 54 weeks duration.

CVT-301

Standard of care. Patients in both the CVT-301 treatment group and the observational cohort will be managed with their standard PD treatment throughout the study.

Observational cohort

Overall Number of Participants Analyzed 271 127
Mean (Standard Deviation)
Unit of Measure: Liters
2.778  (0.7309) 2.767  (0.8419)
2.Primary Outcome
Title Pulmonary Safety Assessed by Forced Vital Capacity [FVC].
Hide Description To characterize the pulmonary safety, as assessed by spirometry (forced vital capacity).
Time Frame Month 12 reported
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CVT-301 Observational Cohort
Hide Arm/Group Description:

Capsules of Levodopa Inhalational Powder (LIP) used up to 5 times per day for OFF episodes, for up to 54 weeks duration.

CVT-301

Standard of care. Patients in both the CVT-301 treatment group and the observational cohort will be managed with their standard PD treatment throughout the study.

Observational cohort

Overall Number of Participants Analyzed 271 127
Mean (Standard Deviation)
Unit of Measure: Liters
3.558  (0.8987) 3.642  (1.0687)
3.Primary Outcome
Title Pulmonary Safety Assessed by Forced Expiratory Volume in 1 Second / Forced Vital Capacity Ratio.
Hide Description To characterize the pulmonary safety, as assessed by spirometry (forced expiratory volume in 1 second / forced vital capacity ratio).
Time Frame Month 12 reported
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CVT-301 Observational Cohort
Hide Arm/Group Description:

Capsules of Levodopa Inhalational Powder (LIP) used up to 5 times per day for OFF episodes, for up to 54 weeks duration.

CVT-301

Standard of care. Patients in both the CVT-301 treatment group and the observational cohort will be managed with their standard PD treatment throughout the study.

Observational cohort

Overall Number of Participants Analyzed 271 127
Mean (Standard Deviation)
Unit of Measure: Ratio (%)
78.1  (6.04) 76.1  (6.4)
4.Secondary Outcome
Title Diffusion Capacity of the Lungs for Carbon Monoxide (DLco).
Hide Description To describe the effects of CVT-301 on diffusion capacity of the lungs for carbon monoxide (DLco) over a 12-month period.
Time Frame Month 12 reported
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CVT-301 Observational Cohort
Hide Arm/Group Description:

Capsules of Levodopa Inhalational Powder (LIP) used up to 5 times per day for OFF episodes, for up to 54 weeks duration.

CVT-301

Standard of care. Patients in both the CVT-301 treatment group and the observational cohort will be managed with their standard PD treatment throughout the study.

Observational cohort

Overall Number of Participants Analyzed 271 127
Mean (Standard Deviation)
Unit of Measure: mL/min/mmHg
23.273  (6.0025) 23.473  (7.0848)
Time Frame 12 Months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title CVT-301 Observational Cohort
Hide Arm/Group Description

Capsules of Levodopa Inhalational Powder (LIP) used up to 5 times per day for OFF episodes, for up to 54 weeks duration.

CVT-301

Standard of care. Patients in both the CVT-301 treatment group and the observational cohort will be managed with their standard PD treatment throughout the study.

Observational cohort

All-Cause Mortality
CVT-301 Observational Cohort
Affected / at Risk (%) Affected / at Risk (%)
Total   1/271 (0.37%)      0/127 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
CVT-301 Observational Cohort
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   42/271 (15.50%)      13/127 (10.24%)    
Blood and lymphatic system disorders     
Anemia   1/271 (0.37%)  1 1/127 (0.79%)  1
Gastrointestinal disorders     
Abdominal pain   0/271 (0.00%)  0 2/127 (1.57%)  2
Inguinal hernia   2/271 (0.74%)  2 0/127 (0.00%)  0
Gastritis   1/271 (0.37%)  1 0/127 (0.00%)  0
Pancreatitis acute   1/271 (0.37%)  1 0/127 (0.00%)  0
General disorders     
Astenia   0/271 (0.00%)  0 1/127 (0.79%)  1
Hepatobiliary disorders     
Bile duct stone   1/271 (0.37%)  1 0/127 (0.00%)  0
Cholecystitis   1/271 (0.37%)  1 0/127 (0.00%)  0
Cholelithiasis   1/271 (0.37%)  1 0/127 (0.00%)  0
Infections and infestations     
Urinary tract infection   4/271 (1.48%)  4 0/127 (0.00%)  0
Bronchitis   0/271 (0.00%)  0 1/127 (0.79%)  1
Cellulitis   0/271 (0.00%)  0 1/127 (0.79%)  1
Escherichia urinary tract   1/271 (0.37%)  1 0/127 (0.00%)  0
Pneumonia   0/271 (0.00%)  0 1/127 (0.79%)  1
Postoperative wound   1/271 (0.37%)  1 0/127 (0.00%)  0
Respiratory tract infection   1/271 (0.37%)  1 0/127 (0.00%)  0
Sepsis   1/271 (0.37%)  1 0/127 (0.00%)  0
Injury, poisoning and procedural complications     
Femoral neck fracture   2/271 (0.74%)  2 0/127 (0.00%)  0
Abdominal wound dehiscence   1/271 (0.37%)  1 0/127 (0.00%)  0
Ankle fracture   1/271 (0.37%)  1 0/127 (0.00%)  0
Hand fracture   1/271 (0.37%)  1 0/127 (0.00%)  0
Head injury   0/271 (0.00%)  0 1/127 (0.79%)  1
Hip fracture   1/271 (0.37%)  1 0/127 (0.00%)  0
Joint dislocation   1/271 (0.37%)  1 0/127 (0.00%)  0
Post procedure haemorrhage   1/271 (0.37%)  1 0/127 (0.00%)  0
Rib fracture   0/271 (0.00%)  0 1/127 (0.79%)  1
Road traffic accident   1/271 (0.37%)  1 0/127 (0.00%)  0
Thoracic vertebral fracture   1/271 (0.37%)  1 0/127 (0.00%)  0
Metabolism and nutrition disorders     
Dehydration   2/271 (0.74%)  2 0/127 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Osteoarthritis   3/271 (1.11%)  3 0/127 (0.00%)  0
Back pain   2/271 (0.74%)  2 0/127 (0.00%)  0
Intervertebral disc protrusion   1/271 (0.37%)  1 1/127 (0.79%)  1
Lumbar spinal stenosis   0/271 (0.00%)  0 1/127 (0.79%)  1
Rhabdomyolysis   1/271 (0.37%)  1 0/127 (0.00%)  0
Spondylitis   1/271 (0.37%)  1 0/127 (0.00%)  0
Vertebral foraminal stenosis   0/271 (0.00%)  0 1/127 (0.79%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Benign ovarian tumor   1/271 (0.37%)  1 0/127 (0.00%)  0
Metastases to central nervous system   1/271 (0.37%)  1 0/127 (0.00%)  0
Prostatic adenoma   1/271 (0.37%)  1 0/127 (0.00%)  0
Nervous system disorders     
Parkinson's disease   2/271 (0.74%)  2 2/127 (1.57%)  2
Cerebrovascular accident   1/271 (0.37%)  1 0/127 (0.00%)  0
Ischaemic stroke   1/271 (0.37%)  1 0/127 (0.00%)  0
Loss of consciousness   0/271 (0.00%)  0 1/127 (0.79%)  1
Occipital neuralgia   1/271 (0.37%)  1 0/127 (0.00%)  0
Syncope   1/271 (0.37%)  1 0/127 (0.00%)  0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
CVT-301 Observational Cohort
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   192/271 (70.85%)      64/127 (50.39%)    
Ear and labyrinth disorders     
Vertigo   8/271 (2.95%)  10 0/127 (0.00%)  0
Gastrointestinal disorders     
Nausea   10/271 (3.69%)  12 1/127 (0.79%)  1
Infections and infestations     
Nasopharyngitis   18/271 (6.64%)  20 7/127 (5.51%)  8
Upper respiratory tract infection   13/271 (4.80%)  16 3/127 (2.36%)  3
Bronchitis   7/271 (2.58%)  7 4/127 (3.15%)  6
Influenza   4/271 (1.48%)  5 4/127 (3.15%)  4
Injury, poisoning and procedural complications     
Fall   22/271 (8.12%)  28 7/127 (5.51%)  8
Investigations     
Blood pressure increased   1/271 (0.37%)  1 4/127 (3.15%)  5
Musculoskeletal and connective tissue disorders     
Back pain   12/271 (4.43%)  19 4/127 (3.15%)  4
Arthralgia   8/271 (2.95%)  8 3/127 (2.36%)  3
Musculoskeletal pain   3/271 (1.11%)  3 4/127 (3.15%)  4
Nervous system disorders     
Dyskinesia   17/271 (6.27%)  18 5/127 (3.94%)  5
Parkinson's disease   8/271 (2.95%)  8 4/127 (3.15%)  4
Psychiatric disorders     
Insomnia   3/271 (1.11%)  3 5/127 (3.94%)  5
Respiratory, thoracic and mediastinal disorders     
Cough   36/271 (13.28%)  43 1/127 (0.79%)  1
Sputum discoloured   9/271 (3.32%)  11 0/127 (0.00%)  0
Throat irritation   9/271 (3.32%)  10 0/127 (0.00%)  0
Vascular disorders     
Hypertension   9/271 (3.32%)  9 4/127 (3.15%)  4
Orthostatic hypotension   7/271 (2.58%)  12 4/127 (3.15%)  4
Indicates events were collected by systematic assessment
Certain Agreements
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: Charles Oh
Organization: Acorda Therapeutics
Phone: 914-326-5455
Responsible Party: Acorda Therapeutics
ClinicalTrials.gov Identifier: NCT02352363     History of Changes
Other Study ID Numbers: CVT-301-005
First Submitted: January 26, 2015
First Posted: February 2, 2015
Results First Submitted: June 4, 2018
Results First Posted: July 10, 2018
Last Update Posted: May 27, 2019