Multiple Sclerosis, Primary Progressive, Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis, Secondary Progressive
Conditions
Brief 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.
Detailed description
Cognitive impairment is common in and devastating to people with MS. MS is a common, chronic, central nervous system (CNS) disease characterized by inflammation, demyelination, and neurodegeneration. One of the most devastating symptoms of this disease is impaired cognitive function, which is common and present in over 60% of individuals with MS. MS-related cognitive impairment is associated with lowered quality of life and reduced functional capacity, including loss of employment, impaired social relationships, compromised driving safety, and poor adherence to treatment. Impaired cognitive functioning has been observed early in the disease, sometimes even before diagnosis, and cognitive function has been shown to decline longitudinally, both over the short- and long-term. Several cognitive domains are impacted in people with MS, including attention, memory, executive functioning, and especially processing speed. To date, multiple pharmacologic interventions have been assessed with disappointing results. There was no significant difference between treatment and placebo for cognition in randomized control trials of donepezil, aminopyridines, gingko biloba, and memantine. Psychostimulants demonstrated some efficacy, but only in secondary outcome measures. Behavioral interventions show promise but are understudied. Furthermore, cognitive rehabilitation is often time consuming, costly, and not universally available. Hence, there is an urgent need to identify or develop novel therapies that can help improve cognitive function in MS. Intranasal insulin is extremely safe and tolerable in other populations, allowing for concentrated delivery to the nervous system. An intranasal delivery system provides a non-invasive way to bypass the blood-brain barrier and allow rapid delivery of a medication to the CNS via the olfactory and trigeminal perivascular channels.The main advantage of the delivery system is reducing systemic side effects via limiting a medication's exposure to peripheral organs and tissues. Insulin administration has been shown to improve memory and learning in healthy people and in those with neurodegenerative diseases. Intranasal insulin has been shown to have neuroprotective and restorative effects in several human clinical trials. Overall, findings suggest that intranasal insulin not only affects cognitive function acutely, but that over time, there may be associated structural changes that lead to a more permanent treatment benefit. Cognitive dysfunction is very common in MS and can be devastating, therefore a treatment intervention (i.e., intranasal insulin) can help both acutely and longitudinally. The primary aim of this study is to assess the safety and tolerability of intranasal insulin in people with MS. The secondary aim is to evaluate if intranasal insulin improves learning and memory in people with MS. The third aim is to evaluate the impact of intranasal insulin on measures of oxidative stress, axonal injury, cellular stress, and energy metabolism in MS.
Interventions
DRUGInsulin
All patients will receive either insulin or placebo using the Vianase III N2B device during the first 24 weeks of the study.
DRUGPlacebo (Sterile diluent)
All patients will receive either insulin or placebo using Vianase III N2B device during the first 24 weeks of the study.
Sponsors
United States Department of Defense
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Meets 2010 criteria for MS * No relapse in past 3 months * At least mild cognitive impairment (based off of SDMT/PST score) * Capacity to learn and self-administer intranasal insulin/placebo, or presence of a caregiver with such capacity who is willing to do it for the duration of the trial * Untreated/on the same MS therapy for at least 6 months, with no anticipated change in the next year * Willing to prevent pregnancy during study if female of childbearing potential
Exclusion criteria
* Current, active major depression * No tricyclic antidepressant or anticonvulsant (except carbamazepine, pregabalin or gabapentin) use within 6 weeks of screening; if on oxybutynin or tolterodine, on stable dose for \> 6 months without plans for changing dose in next year * If taking selective serotonin (± norepinephrine) reuptake inhibitors, pregabalin, gabapentin, sympathomimetic, monoamine oxidase inhibitor, antipsychotic, amantadine, cholinesterase inhibitor, memantine, modafanil, armodafinil, or evening short-acting benzodiazepines, on stable dose for 6 weeks or greater * Pregnant or nursing * THC; illicit drug or alcohol abuse in past 3 months * History of diabetes mellitus or insulin resistance * Active liver disease, stage IV/V kidney disease or severe metabolic derangements * CNS disorder other than MS or headache
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Cognitive Function as Assessed by the Symbol Digit Modalities Test (SDMT) | 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 average change per week in the SDMT. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Cognitive Function as Assessed by the California Verbal Learning Test, Second Edition (CVLT-II) | 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. |
| Change in Cognitive Function as Assessed by the Rao-version of the Paced Auditory Serial Addition Test (PASAT) | 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. |
| Change From Baseline in Cognitive Function as Assessed by the Judgement of Line Orientation Test (JLO) | 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. |
| Change From Baseline in Cognitive Function as Assessed by the Delis-Kaplan Executive Function System Sorting Test | 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. |
| Number of Participants With Adverse Events Leading to Study Discontinuation | 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. |
| Fingerstick Blood Glucose (Subset) | 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. |
| Change From Baseline in Cognitive Function as Assessed by the Controlled Oral Word Association Test (COWAT) | 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 average change per week in the score. |
| Change From Baseline in Cognitive Function as Assessed by the Brief Visuospatial Memory Test - Revised (BVMT-R) Delayed Recall | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of How Overall Sleep Quality Impacts People With MS Using a Sleep Questionnaire (Pittsburgh Sleep Quality Index) | 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. |
| Evaluation of Impact of Study Products on Health Related Quality of Life Using the Functional Assessment of Multiple Sclerosis Questionnaire (FAMS) | 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 baseline to week 24 visit). We then calculated and report the average change per week in the score. |
| Assess Depression Severity, as Measured by the Beck Depression Inventory-II (BDI-II) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intranasal Insulin 20 International Units Subjects will administer 20 I.U. of insulin in the nostrils using a ViaNaseTM controlled particle dispersion nasal device two times/day (BID) for 24 weeks.
Insulin: All patients will receive either insulin or placebo using the Vianase III N2B device during the first 24 weeks of the study. | 37 |
| Intranasal Insulin 10 International Units Subjects will administer 10 I.U. of insulin in the nostrils using a ViaNaseTM controlled particle dispersion nasal device two times/day (BID) for 24 weeks.
Insulin: All patients will receive either insulin or placebo using the Vianase III N2B device during the first 24 weeks of the study. | 33 |
| Placebo Subjects will administer a sterile diluent containing inactive ingredients in the nostrils using a ViaNaseTM controlled particle dispersion nasal device two times/day (BID) for 24 weeks.
Placebo (Sterile diluent): All patients will receive either insulin or placebo using Vianase III N2B device during the first 24 weeks of the study. | 35 |
| Total | 105 |
Baseline characteristics
| Characteristic | Intranasal Insulin 20 International Units | Total | Placebo | Intranasal Insulin 10 International Units |
|---|---|---|---|---|
| Age, Continuous | 53.5 years STANDARD_DEVIATION 10.1 | 52.4 years STANDARD_DEVIATION 9.7 | 49.4 years STANDARD_DEVIATION 9.2 | 54.4 years STANDARD_DEVIATION 9.2 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 12 Participants | 31 Participants | 11 Participants | 8 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 25 Participants | 74 Participants | 24 Participants | 25 Participants |
| Region of Enrollment United States | 37 Participants | 105 Participants | 35 Participants | 33 Participants |
| Sex: Female, Male Female | 20 Participants | 65 Participants | 22 Participants | 23 Participants |
| Sex: Female, Male Male | 17 Participants | 40 Participants | 13 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 37 | 0 / 33 | 0 / 35 |
| other Total, other adverse events | 24 / 37 | 18 / 33 | 18 / 35 |
| serious Total, serious adverse events | 5 / 37 | 3 / 33 | 5 / 35 |
Outcome results
Primary
Change in Cognitive Function as Assessed by the Symbol Digit Modalities Test (SDMT)
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 average change per week in the SDMT.
Time frame: Up to week 24 visit
Population: Individuals with pre-treatment SDMT were included.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intranasal Insulin 20 International Units | Change in Cognitive Function as Assessed by the Symbol Digit Modalities Test (SDMT) | 0.145 score on a scale |
| Intranasal Insulin 10 International Units | Change in Cognitive Function as Assessed by the Symbol Digit Modalities Test (SDMT) | 0.207 score on a scale |
| Placebo | Change in Cognitive Function as Assessed by the Symbol Digit Modalities Test (SDMT) | 0.163 score on a scale |
Secondary
Change From Baseline in Cognitive Function as Assessed by the Brief Visuospatial Memory Test - Revised (BVMT-R) Delayed Recall
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.
Time frame: Up to week 24 visit
Population: Participants who completed a baseline assessment were included.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intranasal Insulin 20 International Units | Change From Baseline in Cognitive Function as Assessed by the Brief Visuospatial Memory Test - Revised (BVMT-R) Delayed Recall | 0.027 score on a scale |
| Intranasal Insulin 10 International Units | Change From Baseline in Cognitive Function as Assessed by the Brief Visuospatial Memory Test - Revised (BVMT-R) Delayed Recall | 0.059 score on a scale |
| Placebo | Change From Baseline in Cognitive Function as Assessed by the Brief Visuospatial Memory Test - Revised (BVMT-R) Delayed Recall | 0.030 score on a scale |
Secondary
Change From Baseline in Cognitive Function as Assessed by the California Verbal Learning Test, Second Edition (CVLT-II)
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.
Time frame: Up to week 24 visit
Population: Participants who completed a baseline assessment were included.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intranasal Insulin 20 International Units | Change From Baseline in Cognitive Function as Assessed by the California Verbal Learning Test, Second Edition (CVLT-II) | 0.082 score on a scale |
| Intranasal Insulin 10 International Units | Change From Baseline in Cognitive Function as Assessed by the California Verbal Learning Test, Second Edition (CVLT-II) | 0.021 score on a scale |
| Placebo | Change From Baseline in Cognitive Function as Assessed by the California Verbal Learning Test, Second Edition (CVLT-II) | 0.020 score on a scale |
Secondary
Change From Baseline in Cognitive Function as Assessed by the Controlled Oral Word Association Test (COWAT)
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 average change per week in the score.
Time frame: Up to week 24 visit
Population: Participants who completed a baseline assessment were included.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intranasal Insulin 20 International Units | Change From Baseline in Cognitive Function as Assessed by the Controlled Oral Word Association Test (COWAT) | 0.090 score on a scale |
| Intranasal Insulin 10 International Units | Change From Baseline in Cognitive Function as Assessed by the Controlled Oral Word Association Test (COWAT) | 0.070 score on a scale |
| Placebo | Change From Baseline in Cognitive Function as Assessed by the Controlled Oral Word Association Test (COWAT) | 0.021 score on a scale |
Secondary
Change From Baseline in Cognitive Function as Assessed by the Delis-Kaplan Executive Function System Sorting Test
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.
Time frame: Up to week 24 visit
Population: Participants who completed a baseline assessment were included.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intranasal Insulin 20 International Units | Change From Baseline in Cognitive Function as Assessed by the Delis-Kaplan Executive Function System Sorting Test | -0.001 score on a scale |
| Intranasal Insulin 10 International Units | Change From Baseline in Cognitive Function as Assessed by the Delis-Kaplan Executive Function System Sorting Test | 0.027 score on a scale |
| Placebo | Change From Baseline in Cognitive Function as Assessed by the Delis-Kaplan Executive Function System Sorting Test | 0.002 score on a scale |
Secondary
Change From Baseline in Cognitive Function as Assessed by the Judgement of Line Orientation Test (JLO)
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.
Time frame: Up to week 24 visit
Population: Participants who completed a baseline assessment were included.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intranasal Insulin 20 International Units | Change From Baseline in Cognitive Function as Assessed by the Judgement of Line Orientation Test (JLO) | -0.031 score on a scale |
| Intranasal Insulin 10 International Units | Change From Baseline in Cognitive Function as Assessed by the Judgement of Line Orientation Test (JLO) | 0.047 score on a scale |
| Placebo | Change From Baseline in Cognitive Function as Assessed by the Judgement of Line Orientation Test (JLO) | -0.005 score on a scale |
Secondary
Change in Cognitive Function as Assessed by the Rao-version of the Paced Auditory Serial Addition Test (PASAT)
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.
Time frame: Up to week 24 visit
Population: Participants who completed a baseline assessment were included.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intranasal Insulin 20 International Units | Change in Cognitive Function as Assessed by the Rao-version of the Paced Auditory Serial Addition Test (PASAT) | 0.372 score on a scale |
| Intranasal Insulin 10 International Units | Change in Cognitive Function as Assessed by the Rao-version of the Paced Auditory Serial Addition Test (PASAT) | 0.363 score on a scale |
| Placebo | Change in Cognitive Function as Assessed by the Rao-version of the Paced Auditory Serial Addition Test (PASAT) | 0.212 score on a scale |
Secondary
Fingerstick Blood Glucose (Subset)
Fingerstick blood glucose levels were monitored twice within the 90 minutes following the first dose administration of study drug for the first 15 participants.
Time frame: At the baseline visit, monitored twice within the 90 minutes following the first dose administration of study drug
Population: The first 15 participants were included in this safety substudy. One placebo participant was missing the second measurement.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intranasal Insulin 20 International Units | Fingerstick Blood Glucose (Subset) | First timepoint | 97.8 mg/dL | Standard Deviation 13.4 |
| Intranasal Insulin 20 International Units | Fingerstick Blood Glucose (Subset) | Second timepoint | 88.4 mg/dL | Standard Deviation 8.8 |
| Intranasal Insulin 10 International Units | Fingerstick Blood Glucose (Subset) | First timepoint | 95.8 mg/dL | Standard Deviation 15.5 |
| Intranasal Insulin 10 International Units | Fingerstick Blood Glucose (Subset) | Second timepoint | 92.2 mg/dL | Standard Deviation 15.5 |
| Placebo | Fingerstick Blood Glucose (Subset) | First timepoint | 90.0 mg/dL | Standard Deviation 18.4 |
| Placebo | Fingerstick Blood Glucose (Subset) | Second timepoint | 87.8 mg/dL | Standard Deviation 11.4 |
Secondary
Number of Participants With Adverse Events Leading to Study Discontinuation
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.
Time frame: Up to week 24 visit
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intranasal Insulin 20 International Units | Number of Participants With Adverse Events Leading to Study Discontinuation | 3 Participants |
| Intranasal Insulin 10 International Units | Number of Participants With Adverse Events Leading to Study Discontinuation | 2 Participants |
| Placebo | Number of Participants With Adverse Events Leading to Study Discontinuation | 1 Participants |
Other Pre-specified
Assess Depression Severity, as Measured by the Beck Depression Inventory-II (BDI-II)
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.
Time frame: Up to week 24 visit
Population: Participants who completed a baseline questionnaire were included.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intranasal Insulin 20 International Units | Assess Depression Severity, as Measured by the Beck Depression Inventory-II (BDI-II) | -0.022 score on a scale |
| Intranasal Insulin 10 International Units | Assess Depression Severity, as Measured by the Beck Depression Inventory-II (BDI-II) | -0.019 score on a scale |
| Placebo | Assess Depression Severity, as Measured by the Beck Depression Inventory-II (BDI-II) | -0.045 score on a scale |
Other Pre-specified
Evaluation of How Overall Sleep Quality Impacts People With MS Using a Sleep Questionnaire (Pittsburgh Sleep Quality Index)
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.
Time frame: Up to week 24 visit
Population: Participants who completed the baseline assessment were eligible for inclusion.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intranasal Insulin 20 International Units | Evaluation of How Overall Sleep Quality Impacts People With MS Using a Sleep Questionnaire (Pittsburgh Sleep Quality Index) | -0.026 score on a scale |
| Intranasal Insulin 10 International Units | Evaluation of How Overall Sleep Quality Impacts People With MS Using a Sleep Questionnaire (Pittsburgh Sleep Quality Index) | 0.035 score on a scale |
| Placebo | Evaluation of How Overall Sleep Quality Impacts People With MS Using a Sleep Questionnaire (Pittsburgh Sleep Quality Index) | -0.045 score on a scale |
Other Pre-specified
Evaluation of Impact of Study Products on Health Related Quality of Life Using the Functional Assessment of Multiple Sclerosis Questionnaire (FAMS)
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 baseline to week 24 visit). We then calculated and report the average change per week in the score.
Time frame: Up to week 24 visit
Population: Participants who completed a baseline questionnaire were included.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intranasal Insulin 20 International Units | Evaluation of Impact of Study Products on Health Related Quality of Life Using the Functional Assessment of Multiple Sclerosis Questionnaire (FAMS) | 0.056 score on a scale |
| Intranasal Insulin 10 International Units | Evaluation of Impact of Study Products on Health Related Quality of Life Using the Functional Assessment of Multiple Sclerosis Questionnaire (FAMS) | 0.051 score on a scale |
| Placebo | Evaluation of Impact of Study Products on Health Related Quality of Life Using the Functional Assessment of Multiple Sclerosis Questionnaire (FAMS) | 0.240 score on a scale |