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Trial record 13 of 49 for:    Acorda

Randomized Safety Study of CVT-301 Compared to an Observational Control Group

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Acorda Therapeutics
ClinicalTrials.gov Identifier:
NCT02352363
First received: January 26, 2015
Last updated: December 5, 2016
Last verified: December 2016
  Purpose
This study is a 12-month, open-label, randomized, multicenter study which will evaluate the safety and efficacy of CVT-301 for the treatment of up to 5 OFF episodes per day in Parkinson's Disease (PD) patients experiencing motor fluctuations (OFF episodes) and will include a concurrent observational cohort of PD patients managed using the usual standards of care.

Condition Intervention Phase
Idiopathic Parkinson's Disease
Drug: CVT-301
Other: Observational cohort
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized Study Investigating the Safety of CVT-301 (Levodopa Inhalation Powder) in Parkinson's Disease (PD) Patients With Motor Response Fluctuations (OFF Phenomena) Compared to an Observational Cohort Control

Resource links provided by NLM:


Further study details as provided by Acorda Therapeutics:

Primary Outcome Measures:
  • Pulmonary safety within the CVT-301 treated patients, assessed by spirometry (forced expiratory volume in 1 second [FEV1], forced vital capacity [FVC] and FEV1/FVC ratio) [ Time Frame: Over a 12-month period ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pulmonary safety within the observational (standard of care) cohort, assessed by spirometry FEV1, FVC and FEV1/FVC ratio. [ Time Frame: Over a 12-month period ] [ Designated as safety issue: Yes ]
  • Difference between the CVT-301-treated patients and the observational cohort on measures of pulmonary safety [ Time Frame: Over a 12-month period ] [ Designated as safety issue: Yes ]
  • Safety of CVT-301 measured by the number of patients with Adverse Events (AEs) [ Time Frame: Over a 12-month period ] [ Designated as safety issue: Yes ]
  • Effect of CVT-301 on mean change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part 4 measures of motor fluctuations (dyskinesias and wearing off) [ Time Frame: Pre-dose, at 6 and 12 months ] [ Designated as safety issue: Yes ]
  • Occurrence and severity of examiner-rated dyskinesia following CVT-301 treatment of patients experiencing an OFF episode in the clinic [ Time Frame: Over a 12-month period ] [ Designated as safety issue: Yes ]
  • Effect of CVT-301 on carbon monoxide diffusing capacity (DLco) [ Time Frame: Over a 12-month period ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 365
Study Start Date: March 2015
Estimated Study Completion Date: February 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CVT-301
Capsules of Levodopa Inhalational Powder (LIP) used up to 5 times per day for OFF episodes, for up to 54 weeks duration.
Drug: CVT-301
Other Name: Inhaled levodopa
Observational Cohort
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.
Other: Observational cohort

  Eligibility

Ages Eligible for Study:   30 Years to 85 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Has signed and dated an Internal Review Board/Independent Ethics Committee (IRB/IEC)-approved informed consent form before any protocol-specific screening procedures are performed.
  • Women of child-bearing potential must use protocol-defined contraceptive measures and must have a negative serum human chorionic gonadotropin (hCG) test at screening. These patients must be willing to remain on their current form of contraception for the duration of the study.
  • Patients who have idiopathic PD (i.e., not induced by drugs or other diseases) as defined by fulfilling Steps 1 and 2 of the United Kingdom (UK) Brain Bank criteria, diagnosed after the age of 30 years.
  • Patients who are classified as Stage 1 to 3 (in the ON state) on the modified Hoehn and Yahr scale for staging of PD severity.
  • Patients who have experienced motor fluctuations for a minimum of 2 hours of average daily OFF time per waking day (excluding early morning OFF time) by self-report and confirmed by the PD Diary (on 3 consecutive days) during the screening period.

Exclusion Criteria:

  • Patients who have dyskinesia of a severity that would significantly interfere with their ability to participate or perform study procedures.
  • Pregnant or lactating females or females wishing to become pregnant.
  • Patients who have any known contraindication to the use of levodopa (LD), including a history of malignant melanoma or a history of narrow-angle glaucoma.
  • Patients who have had previous surgery for PD (including but not limited to deep brain stimulation [DBS] or cell transplantation).
  • Patients with a history of psychotic symptoms requiring treatment, or suicide ideation or attempt within the prior 12 months.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02352363

  Show 76 Study Locations
Sponsors and Collaborators
Acorda Therapeutics
Investigators
Study Director: Charles Oh, MD Acorda Therapeutics
  More Information

Additional Information:
Responsible Party: Acorda Therapeutics
ClinicalTrials.gov Identifier: NCT02352363     History of Changes
Other Study ID Numbers: CVT-301-005 
Study First Received: January 26, 2015
Last Updated: December 5, 2016
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
European Union: European Medicines Agency
United States: Food and Drug Administration

Keywords provided by Acorda Therapeutics:
Parkinson's Disease
Motor fluctuations
levodopa
inhaled drugs
OFF episodes

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Levodopa
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on December 07, 2016