Intranasal Insulin for Improving Cognitive Function in Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis, Secondary Progressive, Multiple Sclerosis, Primary Progressive
About this trial
This is an interventional treatment trial for Multiple Sclerosis, Relapsing-Remitting
Eligibility Criteria
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
Sites / Locations
- Johns Hopkins University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Placebo Comparator
Intranasal insulin 20 international units
Intranasal insulin 10 international units
Intranasal saline
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.
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.
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.