Efficacy and Safety Study of Inhaled CVT 301 in Parkinson's Disease Patients for Treatment of OFF Episodes
NCT01777555 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 89
Last updated 2018-08-08
Summary
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.
Conditions
- Idiopathic Parkinson's Disease
Interventions
- DRUG
-
CVT-301
- DRUG
Sponsors & Collaborators
-
Acorda Therapeutics
lead INDUSTRY
Principal Investigators
-
Martin Freed, MD · Acorda Therapeutics
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 30 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2013-04-30
- Primary Completion
- 2014-01-31
- Completion
- 2014-01-31
Countries
- United States
- Italy
- Serbia
- United Kingdom
Study Locations
More Related Trials
-
Pharmacokinetic Study of CVT-301 (Levodopa Inhalation Powder)
NCT03887884 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of UCB0022 in Study Participants With Advanced Parkinson's Disease
NCT06055985 ·Status: COMPLETED ·Phase: PHASE2
-
NE3107 Activity and Safety in Patients With Parkinson's Disease Using Levodopa
NCT05083260 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
A Study of the Safety and Pharmacokinetics of Levodopa Following Administration of CVT 301 (Levodopa Inhalation Powder) in Adults With Asthma
NCT02633007 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Compare Two Dose Strengths of CVT-301 (Levodopa Inhalation Powder) With an Oral Dose of Sinemet® (Carbidopa-levodopa) Tablets
NCT02812394 ·Status: COMPLETED ·Phase: PHASE1
-
Efficacy, Safety and Tolerability Study of APL-130277 for the Acute Treatment of OFF Episodes in Patients With Parkinson's Disease
NCT02469090 ·Status: COMPLETED ·Phase: PHASE3
-
Effect of Long-acting Levodopa on Obstructive Sleep Apnea in Parkinson's Disease
NCT03111485 ·Status: COMPLETED ·Phase: PHASE4
-
A Study to Test the Safety, Tolerability, and Pharmacokinetics of UCB0599 in Healthy Study Participants and Patients With Parkinson's Disease (PD)
NCT04875962 ·Status: COMPLETED ·Phase: PHASE1
-
To Evaluate the Efficacy of CVN424 in Parkinson's Disease Participants With Motor Complications
NCT06553027 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
Study to Evaluate DNL201 in Subjects With Parkinson's Disease
NCT03710707 ·Status: COMPLETED ·Phase: PHASE1
-
Safety and Effectiveness of Opicapone Plus Standard of Care in Elderly Patients With Parkinson's Disease
NCT03959540 ·Status: COMPLETED
-
A Study to Assess the Safety and Efficacy of the of the Gastric-retentive AP-CD/LD in Advanced Parkinson's Patients
NCT02605434 ·Status: UNKNOWN ·Phase: PHASE3
-
Study of Efficacy, Safety and Tolerability of Levodopa-Carbidopa Intestinal Gel in Levodopa-Responsive Parkinson's Subjects
NCT00357994 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy Phase IIa Study of CVXL-0107 in Advanced Parkinson's Disease
NCT02641054 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Evaluate the Efficacy and Safety of Intravenous Prasinezumab in Participants With Early Parkinson's Disease
NCT04777331 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Efficacy, Safety, and Pharmacokinetics/Pharmacodynamic Study of L-Dopa/Carbidopa To Treat Parkinson's Disease
NCT00558337 ·Status: COMPLETED ·Phase: PHASE2
-
Study to Evaluate SYN115 in Parkinson's Disease
NCT00605553 ·Status: COMPLETED ·Phase: PHASE2
-
Study of the Symptomatic Effects of Nocturnal Sodium Oxybate in Parkinson's Disease
NCT02111122 ·Status: COMPLETED ·Phase: PHASE2
-
Placebo Controlled Study of Preladenant in Participants With Moderate to Severe Parkinson's Disease (P07037)
NCT01227265 ·Status: COMPLETED ·Phase: PHASE3
-
Study to Evaluate DNL151 in Subjects With Parkinson's Disease
NCT04056689 ·Status: COMPLETED ·Phase: PHASE1
-
Effects of Carbidopa/Levodopa/Entacapone on Motor Function and Quality of Life in Patients With Parkinson's Disease
NCT00219284 ·Status: COMPLETED ·Phase: PHASE4
-
A 18-month Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of Oral UCB0599 in Study Participants With Early-stage Parkinson's Disease
NCT04658186 ·Status: COMPLETED ·Phase: PHASE2
-
Nilotinib in Parkinson's Disease
NCT03205488 ·Status: COMPLETED ·Phase: PHASE2
-
Carbidopa/Levodopa/Entacapone Versus Immediate Release (IR) Carbidopa/Levodopa on Non-motor Symptoms in Patients With Idiopathic Parkinson's Disease and Demonstrating Non-motor Symptoms of Wearing Off
NCT00642356 ·Status: TERMINATED ·Phase: PHASE4
-
AV-101 (L-4-chlorokynurenine) in Parkinson's Disease Subjects With Levodopa-Induced Dyskinesia
NCT04147949 ·Status: UNKNOWN ·Phase: PHASE2