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CompletedNCT03887884Updated Aug 2, 2019

Pharmacokinetic Study of CVT-301 (Levodopa Inhalation Powder)

A Phase 1 interventional study of CVT-301 and Sinemet in Parkinson's Disease, sponsored by Acorda Therapeutics. Completed at 5 sites in United States. Open to participants aged 30 Years to 85 Years. Per ClinicalTrials.gov, last updated 2019-08-02.

Sponsored by Acorda Therapeutics · Phase 1, Interventional, and Other

From the registry’s dates

  • Primary completion was Jun 2019, 7 years 3 months ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
23
Allocation
Randomized
Ages
30 Years to 85 Years
Sex
All
01

Study summary

This study will be an open-label, randomized, multi-center, 2-way crossover Pharmacokinetic PK evaluation of a single inhaled dose of CVT-301 84 mg and a single oral dose of carbidopa/levodopa CD/LD 25 mg/100 mg (Sinemet®) under fed conditions in Parkinson's Disease (PD) patients who regularly take CD/LD.

Read the detailed description

The study duration includes a screening period followed by an overnight stay in the center (4 days, 3 nights) to complete 2 treatments, including a 48-hour interval between the treatments, and a follow-up phone call 1-2 days after discharge from the center.

On each of two treatment days, subjects will consume a standard high fat meal and then receive either (A) a single inhaled dose of CVT-301 or (B) a single dose of oral CD/LD followed by Pharmacokinetic (PK) sampling for 4 hours. A crossover design will be used such that each subject receives both Treatment A and Treatment B over the 2 treatment days, randomized 1:1 to the treatment sequence AB or BA.

02

Conditions studied

  • Parkinson's Disease

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03

In context

Parkinson Disease

4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.

This study's enrollment of 23 is below the median of 40 across 3,294 interventional studies indexed under Parkinson Disease.

Browse Parkinson Disease studies →

Lead sponsor

Acorda Therapeutics is the lead sponsor of 38 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Men and women between the ages of 30 and 85 years, inclusive.
  • 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.
  • Classified as Stage 1 to 3 (in the ON state) on the modified Hoehn and Yahr scale for staging of PD severity.
  • Stable on other non levodopa PD medications for at least 4 weeks prior to the Screening Visit.
  • Subjects must have normal cognition as confirmed by a score of ≥ 25 on the Mini Mental State Examination (MMSE), performed in the ON state.
  • Forced expiratory volume in one second (FEV1) ≥60% of predicted for race, age, sex, and height and FEV1/FVC (forced vital capacity) ratio ≥70%.
  • Body Mass Index (BMI) between 18 - 32 kg/m2, inclusive.

Exclusion criteria

Exclusion Criteria:

  • Any flu-like syndrome or other respiratory infections within 2 weeks prior to the Screening Visit.
  • Chronic obstructive pulmonary disease (COPD), asthma, or other chronic respiratory disease within the last 5 years.
  • History of any cancer in the past 5 years with the exception of successfully treated basal cell carcinoma.
  • Narrow angle glaucoma or a history of peptic ulcer disease less than 1 year prior to screening.
  • Previous surgery for PD (including but not limited to deep brain stimulation or cell transplantation).
  • Current use of nicotine patch or tobacco-containing products including cigarettes, electronic cigarettes, cigars, chewing tobacco, pipe tobacco or snuff or use within 4 weeks prior to the Screening Visit, or expected use during the study.
  • Marijuana smoking within 4 weeks prior to the Screening Visit, or expected smoking/inhalation during the study.
05

Study design

Phase
Phase 1
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
23 participants (actual)

Study arms

  • Experimental
    CVT-301

    Single inhaled dose of CVT-301 84 mg

    Drug: CVT-301

  • Active comparator
    Sinemet

    Single oral dose of Carbidopa/Levodopa 25 mg/100 mg

    Drug: Sinemet

Interventions

  • DrugCVT-301

    Levodopa Inhalation Powder

  • DrugSinemet

    Single oral dose of Carbidopa/Levodopa 25 mg/100 mg

06

What researchers measure

Primary outcomes

  1. Maximum plasma concentration of a single inhaled dose of CVT-301 84 mg and an oral dose of CD/LD 25 mg/100 mg (carbidopa/levodopa) in patients with Parkinson's disease.

    Maximum observed plasma drug concentration (Cmax) of a single inhaled dose of CVT-301 84 mg and an oral dose of CD/LD 25 mg/100 mg in patients with Parkinson's disease (PD) in a fed state.

    Time frame: 4 days, 3 nights

  2. Total plasma concentration of a single inhaled dose of CVT-301 84 mg and an oral dose of CD/LD 25 mg/100 mg (carbidopa/levodopa) in patients with Parkinson's disease.

    Area under the plasma concentration curve from time 0 to the concentration at 4 hours (AUCo-4h) of a single inhaled dose of CVT-301 84 mg and an oral dose of CD/LD 25 mg/100 mg in patients with Parkinson's disease (PD) in a fed state.

    Time frame: 4 days, 3 nights

  3. Terminal half-life of a single inhaled dose of CVT-30184 mg and an oral dose of CD/LD 25 mg/100 mg (carbidopa/levodopa) in patients with Parkinson's disease.

    Terminal half-life (t1/2)of a single inhaled dose of CVT-30184 and an oral dose of CD/LD 25 mg/100 mg in patients with Parkinson's disease (PD) in a fed state.

    Time frame: 4 days, 3 nights

  4. Time to maximum observed plasma drug concentration of a single inhaled dose of CVT-301 84 mg and an oral dose of CD/LD 25 mg/100 mg (carbidopa/levodopa) in patients with Parkinson's disease.

    Time to maximum observed plasma drug concentration (Tmax) of a single inhaled dose of CVT-301 84 mg and an oral dose of CD/LD 25 mg/100 mg in patients with Parkinson's disease (PD) in a fed state.

    Time frame: 4 days, 3 nights

Secondary outcomes

  1. Columbia-Suicide Severity Rating Scale (C-SSRS).

    To evaluate the safety and tolerability of a single inhaled dose of CVT-301 84 mg and an oral dose of CD/LD 25/100 mg) under fed conditions in PD patients using the Columbia-Suicide Severity Rating Scale (C-SSRS). The (C-SSRS) is an assessment tool that evaluates suicidal ideation and behavior. Scale range: Yes or No response to 10 questions, with minimum to maximum range of 0 to 10. Lower score represents better outcomes. Subscales not applicable.

    Time frame: 4 days, 3 nights

  2. Incidence of adverse events.

    To evaluate the safety and tolerability of a single inhaled dose of CVT-301 84 mg and an oral dose of CD/LD 25/100 mg) under fed conditions in PD patients by accessing adverse events.

    Time frame: 4 days, 3 nights

07

Study locations

5 sites
  • Acorda Site #1003
    Long Beach, California 90806, United States
  • Acorda Site #1005
    Hallandale Beach, Florida 33009, United States
  • Acorda Site #1002
    Orlando, Florida 32806, United States
  • Acorda Site #1004
    Atlanta, Georgia 30331, United States
  • Acorda Site #1001
    Farmington Hills, Michigan 48334, United States
08

References and documents

Publications

  • Safirstein BE, Ellenbogen A, Zhao P, Henney HR 3rd, Kegler-Ebo DM, Oh C. Pharmacokinetics of Inhaled Levodopa Administered With Oral Carbidopa in the Fed State in Patients With Parkinson's Disease. Clin Ther. 2020 Jun;42(6):1034-1046. doi: 10.1016/j.clinthera.2020.04.004. Epub 2020 May 29. PubMed 32482490 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 2, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03887884
Lead sponsor
Acorda Therapeutics
Responsible party
Sponsor
First posted
Mar 25, 2019
Start date
Mar 5, 2019
Primary completion
Jun 28, 2019
Completion
Jun 28, 2019
Last update
Aug 2, 2019

Study contacts

Charles Oh, MD
study director · Acorda Therapeutics

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.

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