NCT02807675

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Acorda Therapeutics · Industry
• Sex: All
• Age: 30 Years – 85 Years
• Healthy volunteers: Not accepted

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).

Detailed 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.

Conditions

• Parkinson's Disease

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2016-06-01
• Primary completion: 2016-11-01
• Completion: 2016-11-01
• First posted: 2016-06-21
• Last updated: 2017-01-30

Locations

11 sites across 1 country: United States