Trials / Completed

CompletedNCT03541356

Therapeutic Potential for Intranasal Levodopa in Parkinson's Disease -Off Reversal

A Phase IIa, Randomized, Double Blind, Placebo Controlled, Single Ascending Dose, Safety and Pharmacokinetic/Pharmacodynamic Study of INP103 (POD L-dopa) Administered in the Presence of DCI to L-dopa Responsive Parkinson's Disease Patients

Status: Completed
Phase: Phase 2
Study type: Interventional
Enrollment: 32 (actual)

Sponsor: Impel Pharmaceuticals · Industry
Sex: All
Age: 40 Years – 80 Years
Healthy volunteers: Not accepted

Summary

A Phase IIa, Randomized, Double Blind, Placebo Controlled, Single Dose, Safety and Pharmacokinetic/Pharmacodynamic Study of INP103 (POD L-dopa) Administered in the Presence of Decarboxylase Inhibitor to L-dopa Responsive Parkinson's Disease Patients

Detailed description

This is a Phase IIa randomized, double-blind, placebo-controlled, single dose study to compare the safety, tolerability and PK/PDyn of intranasal L-dopa following administration of INP103 in the presence of L-dopa decarboxylase inhibitor (DCI) during an OFF episode.

Conditions

Parkinson's Disease

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Placebo	Delivered via the I231 POD (Precision Olfactory Delivery) device
COMBINATION_PRODUCT	L-dopa 35 mg	Delivered via the I231 POD (Precision Olfactory Delivery) device via one puff to one nostril
COMBINATION_PRODUCT	L-dopa 70mg	Delivered via the I231 POD (Precision Olfactory Delivery) device with two puffs, one to each nostril
COMBINATION_PRODUCT	L-dopa 140 mg	Delivered via the I231 POD (Precision Olfactory Delivery) device with four puffs, two to each nostril
COMBINATION_PRODUCT	L-dopa 70mg/carbidopa 7mg	Delivered via the I231 POD (Precision Olfactory Delivery) device with two puffs, one to each nostril

Timeline

Start date: 2018-05-08
Primary completion: 2019-06-11
Completion: 2019-06-11
First posted: 2018-05-30
Last updated: 2020-08-12
Results posted: 2020-08-12

Locations

5 sites across 1 country: Australia

Regulatory

FDA-regulated drug study
FDA-regulated device study

Source: ClinicalTrials.gov record NCT03541356. Inclusion in this directory is not an endorsement.