Phase 3
Completed N=408
Randomized Safety Study of CVT-301 Compared to an Observational Control Group
Source: ClinicalTrials.gov NCT02352363 ↗Enrolled (actual)
408
Serious AEs
13.8%
Results posted
Jul 2018
Primary outcomePrimary: Pulmonary Safety Assessed by Forced Expiratory Volume in 1 Second [FEV1] — 2.778; 2.767 Liters
◆ Published Evidence
Emerging
13citations · ~3 / year
Natural history of lung function over one year in patients with Parkinson's disease.
Summary
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.
Linked Publications
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Natural history of lung function over one year in patients with Parkinson's disease.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pulmonary Safety Assessed by Forced Expiratory Volume in 1 Second [FEV1] |
2.778; 2.767 | — |
| PRIMARY Pulmonary Safety Assessed by Forced Vital Capacity [FVC]. |
3.558; 3.642 | — |
| PRIMARY Pulmonary Safety Assessed by Forced Expiratory Volume in 1 Second / Forced Vital Capacity Ratio. |
78.1; 76.1 | — |
| SECONDARY Diffusion Capacity of the Lungs for Carbon Monoxide (DLco). |
23.273; 23.473 | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT02352363) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.