A Study of the Safety and Tolerability of a Single Dose Administration of CVT-301 (Levodopa Inhalation Powder)

Parkinson's Disease Clinical Trial

Official title:

A Phase 1 Study of the Safety and Tolerability of a Single Dose Administration of CVT- 301 (Levodopa Inhalation Powder) When Administered for Early Morning OFF Symptoms in Patients With Parkinson's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02807675
• Other study ID #: CVT-301-009
• Status: Completed
• Phase: Phase 1
• First received: June 17, 2016
• Last updated: January 27, 2017
• Start date: June 2016
• Est. completion date: November 2016

Study information

• Verified date: January 2017
• Source: Acorda Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is a double-blind, randomized, placebo-controlled, 2-way crossover study to evaluate the safety of CVT-301 levodopa (l-dopa) when co- administered with the first daily dose of oral levodopa/carbidopa for early morning OFF symptoms in patients with Parkinson's disease (PD).

Description:

An "OFF state" is defined as the time when medication is no longer providing benefit with respect to mobility, slowness, and stiffness. OFF episodes may be heralded by non-motor symptoms (e.g., pain, anxiety) prior to the appearance of motor symptoms.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 85 Years

Eligibility

Inclusion Criteria:

• 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

• diagnosis of Parkinson's disease and motor fluctuations and early morning OFF symptoms

• classified as Stage 1 to 3 on the modified Hoehn and Yahr scale for staging of PD severity (in an ON state)

• subjects who are on a l-dopa-containing therapy, not including Rytary (or equivalent), must be stable on oral l-dopa-containing therapy for at least 2 weeks prior to the Screening Visit with a l-dopa/decarboxylase inhibitor (DDI)-containing regimen

• subjects who are on a l-dopa-containing therapy, when including Rytary (or equivalent), should be on a stable dose for at least 6 weeks prior to the Screening Visit

• the frequency of l-dopa administrations must be at least 3 times during the waking day and a total daily l-dopa dose of = 1600 mg.

• on a stable regimen of their standard PD medications

• on a stable regimen of any blood pressure reducing medications (if applicable) for at least 30 days prior to screening

• forced expiratory volume in one second (FEV1) =60% of predicted for race, age, sex, and height and FEV1/FVC (forced vital capacity) ratio =70%

• no clinically significant abnormalities that would affect ability to complete study as determined by medical history, physical examination, electrocardiogram, clinical laboratory test results

• negative drug and alcohol testing

• negative pregnancy test for all women.

Exclusion Criteria:

• participated in any prior study with CVT-301

• dyskinesia of a severity that would significantly interfere with the subject's ability to participate or perform study procedures (as determined by the UPDRS Part 4)

• any contraindication to performing routine spirometry or who are unable to perform a spirometry maneuver

• have a current history of symptomatic orthostatic hypotension or are treated with medications to treat orthostatic hypotension (for example droxidopa, fludrocortisone), if they have severe dysautonomia

• have chronic obstructive pulmonary disease (COPD), asthma, or another chronic respiratory disease within the last 5 years.

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Drug:
• CVT-301, LIP
All subjects will receive 1 dose of CVT-301 and 1 dose of placebo inhalation powder, to be taken concomitantly with their standard oral medication in 2 dosing periods. The order of treatment will be randomized, with subjects assigned to 1 of 2 sequences CVT-301 (A) administered first, followed by placebo (B), or the reverse order (BA)

Other:
• Placebo
All subjects will receive 1 dose of CVT-301 and 1 dose of placebo inhalation powder, to be taken concomitantly with their standard oral medication in 2 dosing periods. The order of treatment will be randomized, with subjects assigned to 1 of 2 sequences CVT-301 (A) administered first, followed by placebo (B), or the reverse order (BA)

Locations

Country	Name	City	State
United States	Site #9016	Atlanta	Georgia
United States	Site #9002	Boca Raton	Florida
United States	Site #9009	Chicago	Illinois
United States	Site #9003	Farmington Hills	Michigan
United States	Site #9015	Fountain Valley	California
United States	Site #9017	Hallandale	Florida
United States	Site #9007	Nashville	Tennessee
United States	Site #9008	Saint Petersburg	Florida
United States	Site #9018	Sunrise	Florida
United States	Site #9004	Tampa	Florida
United States	Site #9005	West Bloomfield	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Acorda Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with Adverse Events (AEs) including Serious AEs		up to 9 days
Secondary	Examiner rated time to ON comparisons between treatments (CVT-301 and placebo)	An "ON state" is defined as the time when medication is providing benefit with respect to mobility, slowness, and stiffness, and may or may not be providing complete alleviation of all PD symptoms.	day 1 and day 3