CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 32 enrolled
Drug / intervention
Placebo +4 morecombination
Likely dose
L-dopa 35 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03541356
NCT03541356Phase 2Completed
CompareCT.gov

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

Impel Pharmaceuticals·interventional·Posted May 30, 2018·Updated Aug 12, 2020

In Brief

A Phase 2 clinical trial evaluating Placebo, L-dopa 35 mg, and 3 other interventions for Parkinson's Disease. Completed, enrolled 32 participants across 5 sites.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsParkinson's Disease
CountriesAustralia
Collaborators--

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedMay 30, 2018
Enrollment StartMay 8, 2018
Primary CompletionJun 11, 2019
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 8.1 years ago

Interventions

Placebocombination

Delivered via the I231 POD (Precision Olfactory Delivery) device

L-dopa 35 mgcombination

Delivered via the I231 POD (Precision Olfactory Delivery) device via one puff to one nostril

L-dopa 70mgcombination

Delivered via the I231 POD (Precision Olfactory Delivery) device with two puffs, one to each nostril

L-dopa 140 mgcombination

Delivered via the I231 POD (Precision Olfactory Delivery) device with four puffs, two to each nostril

L-dopa 70mg/carbidopa 7mgcombination

Delivered via the I231 POD (Precision Olfactory Delivery) device with two puffs, one to each nostril