MedTrace Logo

Intranasal Insulin for Improving Cognitive Function in Multiple Sclerosis

NCT02988401 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2023-03-10

Study results available
· View outcomes & findings →

Summary

This study will evaluate if giving insulin that is administered in the nostrils (intranasal) is safe and tolerable for people with multiple sclerosis (MS). It is also being done to evaluate if intranasal insulin improves cognitive function in people with MS and to evaluate how it might be working.

Conditions

  • Multiple Sclerosis, Relapsing-Remitting
  • Multiple Sclerosis, Secondary Progressive
  • Multiple Sclerosis, Primary Progressive

Interventions

DRUG

Insulin

All patients will receive either insulin or placebo using the Vianase III N2B device during the first 24 weeks of the study.

DRUG

Placebo (Sterile diluent)

All patients will receive either insulin or placebo using Vianase III N2B device during the first 24 weeks of the study.

Sponsors & Collaborators

Principal Investigators

  • Ellen Mowry, MD, MCR · Johns Hopkins University

  • Scott Newsome, DO · Johns Hopkins University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-01
Primary Completion
2021-12-17
Completion
2021-12-17
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

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 NCT02988401 on ClinicalTrials.gov