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

NCT03541356 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2020-08-12

Study results available
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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

Conditions

Interventions

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

Sponsors & Collaborators

  • Impel Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Stephen B Shrewsbury, MD · Impel NeuroPharma, Seattle, WA (USA)

  • Terry O'Brien, MD/Prof · The Alfred Hospital, Melbourne, VIC (AUS)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-08
Primary Completion
2019-06-11
Completion
2019-06-11
FDA Drug
Yes
FDA Device
Yes

Countries

  • Australia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03541356 on ClinicalTrials.gov