Adults 18 to 70, any sex, with Multiple Sclerosis, Relapsing-Remitting or Multiple Sclerosis, Secondary Progressive. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change in Cognitive Function as Assessed by the Symbol Digit Modalities Test (SDMT)Primary· Up to week 24 visit
This task will be performed at five study visits. The SDMT is one of the most commonly used tests to assess processing speed in the MS population and is included in the Minimal Assessment of Cognitive Function in MS (MACFIMS). Higher scores reflect a better outcome (range 0 to 110). In order to account for all contributed data (even for those who did not complete the study but contributed some post-randomization data in the active study phase), the primary analyses include the SDMTs acquired within the active treatment phase (from baseline to week 24 visit). We then calculated and report the a
Group
Value
95% CI
Intranasal Insulin 20 International Units
0.145
0.000 – 0.290
Intranasal Insulin 10 International Units
0.207
0.033 – 0.381
Placebo
0.163
0.029 – 0.297
Number of Participants With Adverse Events Leading to Study DiscontinuationSecondary· Up to week 24 visit
An adverse event will be defined as any occurrence or worsening of an undesirable or unintended sign, symptom (or abnormal laboratory test), or disease temporally associated with the use of a medicinal product or intervention, whether or not it is considered related to the product/intervention. We report overall adverse events in the relevant section. Here, we report adverse events that led to study discontinuation.
Group
Value
95% CI
Intranasal Insulin 20 International Units
3
Intranasal Insulin 10 International Units
2
Placebo
1
Fingerstick Blood Glucose (Subset)Secondary· At the baseline visit, monitored twice within the 90 minutes following the first dose administration of study drug
Fingerstick blood glucose levels were monitored twice within the 90 minutes following the first dose administration of study drug for the first 15 participants.
First timepoint
Group
Value
95% CI
Intranasal Insulin 20 International Units
97.8
± 13.4
Intranasal Insulin 10 International Units
95.8
± 15.5
Placebo
90.0
± 18.4
Second timepoint
Group
Value
95% CI
Intranasal Insulin 20 International Units
88.4
± 8.8
Intranasal Insulin 10 International Units
92.2
± 15.5
Placebo
87.8
± 11.4
Change From Baseline in Cognitive Function as Assessed by the Controlled Oral Word Association Test (COWAT)Secondary· Up to week 24 visit
This test measures phonemic fluency. The test scores the number of words a participant can provide that begin with a specified letter within one minute, such that scores range from zero (worst) to an infinite number (better). Total score is sum of three 60-second trials. In order to account for all contributed data (even for those who did not complete the study but contributed some post-randomization data in the active study phase), the primary analyses include the COWAT scores acquired within the active treatment phase (from baseline to week 24 visit). We then calculated and report the averag
Group
Value
95% CI
Intranasal Insulin 20 International Units
0.090
-0.112 – 0.292
Intranasal Insulin 10 International Units
0.070
-0.162 – 0.303
Placebo
0.021
-0.174 – 0.216
Change From Baseline in Cognitive Function as Assessed by the California Verbal Learning Test, Second Edition (CVLT-II)Secondary· Up to week 24 visit
This is a verbal learning and memory test. Scores range from zero to 16; a higher number is better. In order to account for all contributed data (even for those who did not complete the study but contributed some post-randomization data in the active study phase), the primary analyses include the CVLT-II scores acquired within the active treatment phase (from baseline to week 24 visit). We then calculated and report the average change per week in the score.
Group
Value
95% CI
Intranasal Insulin 20 International Units
0.082
0.015 – 0.149
Intranasal Insulin 10 International Units
0.021
-0.057 – 0.100
Placebo
0.020
-0.043 – 0.082
Change From Baseline in Cognitive Function as Assessed by the Brief Visuospatial Memory Test - Revised (BVMT-R) Delayed RecallSecondary· Up to week 24 visit
This is a visual, nonverbal test of learning and memory. Scores range from zero to 12; higher is better. In order to account for all contributed data (even for those who did not complete the study but contributed some post-randomization data in the active study phase), the analyses include the BVMT-R delayed recall scores acquired within the active treatment phase (from baseline to week 24 visit). We then calculated and report the average change per week in the score.
Group
Value
95% CI
Intranasal Insulin 20 International Units
0.027
-0.020 – 0.074
Intranasal Insulin 10 International Units
0.059
0.006 – 0.113
Placebo
0.030
-0.015 – 0.075
Change in Cognitive Function as Assessed by the Rao-version of the Paced Auditory Serial Addition Test (PASAT)Secondary· Up to week 24 visit
The Rao-version of the PASAT evaluates processing speed, working memory, and basic addition skills. Scores range from zero to 60; higher is better. Herein we present 3-second PASAT results ("PASAT-3"). In order to account for all contributed data (even for those who did not complete the study but contributed some post-randomization data in the active study phase), the analyses include PASAT-3 scores acquired within the active treatment phase (from baseline to week 24 visit). We then calculated and report the average change per week in the SDMT.
Group
Value
95% CI
Intranasal Insulin 20 International Units
0.372
0.180 – 0.563
Intranasal Insulin 10 International Units
0.363
0.136 – 0.591
Placebo
0.212
0.027 – 0.398
Change From Baseline in Cognitive Function as Assessed by the Judgement of Line Orientation Test (JLO)Secondary· Up to week 24 visit
Judgment of Line Orientation Test measures a person's ability to match the angle and orientation of lines in space. Scores range from zero to 30; higher is better. In order to account for all contributed data (even for those who did not complete the study but contributed some post-randomization data in the active study phase), the analyses include JLO data acquired within the active treatment phase (from baseline to week 24 visit). We then calculated and report the average change per week in the score.
Group
Value
95% CI
Intranasal Insulin 20 International Units
-0.031
-0.109 – 0.046
Intranasal Insulin 10 International Units
0.047
-0.044 – 0.139
Placebo
-0.005
-0.079 – 0.069
Change From Baseline in Cognitive Function as Assessed by the Delis-Kaplan Executive Function System Sorting TestSecondary· Up to week 24 visit
This test measures executive functioning, concept formation, and cognitive flexibility. Scores range from zero to 16; higher is better. In order to account for all contributed data (even for those who did not complete the study but contributed some post-randomization data in the active study phase), the analyses include DKEFS correct sort scores acquired within the active treatment phase (from baseline to week 24 visit). We then calculated and report the average change per week in the score.
Group
Value
95% CI
Intranasal Insulin 20 International Units
-0.001
-0.112 – 0.111
Intranasal Insulin 10 International Units
0.027
-0.104 – 0.159
Placebo
0.002
-0.114 – 0.118
Assess Depression Severity, as Measured by the Beck Depression Inventory-II (BDI-II)Secondary· Up to week 24 visit
The BDI-II is a 21-question multiple-choice self-report inventory test for measuring the severity of depression. Scores range from zero to 63; higher scores indicate greater depression. In order to account for all contributed data (even for those who did not complete the study but contributed some post-randomization data in the active study phase), the analyses include the BDI-II scores acquired within the active treatment phase (from baseline to week 24 visit). We then calculated and report the average change per week in the scores.
Group
Value
95% CI
Intranasal Insulin 20 International Units
-0.022
-0.152 – 0.108
Intranasal Insulin 10 International Units
-0.019
-0.179 – 0.140
Placebo
-0.045
-0.183 – 0.094
Evaluation of Impact of Study Products on Health Related Quality of Life Using the Functional Assessment of Multiple Sclerosis Questionnaire (FAMS)Secondary· Up to week 24 visit
FAMS is a self-reported health-related quality-of-life instrument for people with multiple sclerosis. Subjects rate six quality-of-life domains: Mobility, Symptoms, Emotional well-being, General contentment, Thinking/fatigue, and Family/social well-being. Scores range from zero to 176; higher scores indicate better health-related quality of life. In order to account for all contributed data (even for those who did not complete the study but contributed some post-randomization data in the active study phase), the analyses include the FAMS scores acquired within the active treatment phase (from
Group
Value
95% CI
Intranasal Insulin 20 International Units
0.056
-0.277 – 0.389
Intranasal Insulin 10 International Units
0.051
-0.357 – 0.459
Placebo
0.240
-0.087 – 0.567
Evaluation of How Overall Sleep Quality Impacts People With MS Using a Sleep Questionnaire (Pittsburgh Sleep Quality Index)Secondary· Up to week 24 visit
The sleep questionnaire asks subjects to report various aspects related to their sleep routine. Scores range from zero to 21; higher score indicates worse sleep quality. In order to account for all contributed data (even for those who did not complete the study but contributed some post-randomization data in the active study phase), the analyses include the PSQIs acquired within the active treatment phase (from baseline to week 24 visit). We then calculated and report the average change per week in the score.
Group
Value
95% CI
Intranasal Insulin 20 International Units
-0.026
-0.091 – 0.039
Intranasal Insulin 10 International Units
0.035
-0.035 – 0.105
Placebo
-0.045
-0.110 – 0.021
Adverse events — posted to ClinicalTrials.gov
Time frame: AEs and SAEs were collected from the point of randomization until a participant terminated from the study. Unresolved AEs, as well as SAEs, were followed for an added 30 days after study completion. Up to 48 weeks overall..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
6 peer-reviewed publications reference this trial (live from Europe PMC):
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· not yet recruiting
NCT06762314 — Efficacy and Safety of Empagliflozin or Semaglutide in Overweight/Obese Patients With Type 1 Diabetes
· Phase 2
· recruiting
NCT06781775 — GDM: Insulin with or Without Metformin?
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· recruiting
NCT06391853 — Investigating Brain Insulin Resistance in Alzheimer Disease with IntraNasal Insulin : a Multimodal Neuroimaging Study
· NA
· withdrawn
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Johns Hopkins University
Last refreshed: 10 March 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02988401.