Status:
COMPLETED
Caprylic Triglyceride for Treatment of Cognitive Impairments in Multiple Sclerosis
Lead Sponsor:
University of Miami
Collaborating Sponsors:
National Multiple Sclerosis Society
Cerecin
Conditions:
Relapsing Remitting MS
Secondary Progressive MS
Eligibility:
All Genders
18-59 years
Phase:
NA
Brief Summary
Background/Rationale: Cognitive problems are a common symptom in individuals with Multiple Sclerosis (MS). Treatment options are limited, and there is a pressing need for new interventions to treat MS...
Detailed Description
Patients with all types of MS (Relapsing Remitting, Secondary Progressive, or Primary Progressive) are eligible to participate. Participants will undergo detailed cognitive assessment before initiatin...
Eligibility Criteria
Inclusion
- Institutional Review Board (IRB)-approved Informed Consent Form signed by patient
- A diagnosis of MS as defined by the Revised McDonald criteria.
- All subtypes of MS, relapsing and progressive, are eligible.
- Males and females age 18 to 59 years old.
- Complaints of difficulties with memory or other aspects of cognition.
- Mini-Mental Status Exam (MMSE) score \>=24 for determination of ability to provide informed consent.
- 8th grade English reading proficiency as determined by Wide Range Achievement Test-4th edition-reading .
- Females of childbearing potential must have a negative pregnancy test prior to entry into treatment phase and must simultaneously use two forms of effective contraception during the treatment and for one month or one menstrual cycle after discontinuation of the study medication.
- All concomitant medication doses must be stable for at least 30 days prior to randomization and remain stable for the study duration.
- An Expanded Disability Status Scale (EDSS) score of at least a 2.0 with a Functional System Score of at least a 2 in the Cerebral section due to decreased mentation.
- Stable neurologic function with no multiple sclerosis relapses for at least 30 days prior to study entry.
- No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during Screen.
- Documented memory deficit as defined by a score at least 0.5 standard deviations (SD) below age- and gender-based normative values on the Total Learning Score of the CVLT-II OR a documented processing speed deficit as defined by a score of at least 1.0 SD below normative values on the SDMT.
Exclusion
- Any condition that would render the patient or the caregiver unsuitable for the study, or place them at substantial risk of adverse outcome.
- Unwillingness/inability of the patient to fulfill the study requirements.
- Evidence of major depression or a score on the BDI-II \> or = 30 OR a score \< 30 on BDI-II but with endorsed suicidal ideation.
- Hypothyroidism
- B12 deficiency
- Diabetes (Type 1 or 2).
- Positive rapid plasma reagin.
- Fasting triglyceride level\>2 times upper limit of normal value w/in 3 months of Study Visit 1.
- History of malignancy of any organ system (other than localized squamous and basal cell carcinoma of the skin), treated or untreated, within the past 2 years.
- Clinically significant renal disease or insufficiency.
- Clinically significant hepatic disease or insufficiency.
- Ethanol consumption greater than an equivalent of 2 oz/20 g/2 units of spirits per day OR 14 oz/140 g/14 units of spirits per week. One oz/10 g/1 unit of spirits = 6 oz/15 g/1 unit of wine = 12 oz/12 g/1 unit of beer.
- History of current alcohol or substance abuse.
- Known HIV infection.
- History of head injury with loss of consciousness \> 30 minutes.
- History of inflammatory bowel syndrome.
- History of severe irritable bowel disease.
- History of severe gastroesophageal reflux disease.
- History of diverticular disease.
- Use of any investigational compound within 30 days prior to screening.
- Prior or current use of medium chain triglycerides for medical purposes.
- Known allergies to dairy products or soy.
- Use of anticholinergic medication within 30 days prior to Study Visit 1.
- Use of acetylcholinesterase inhibitors within 30 days prior to Study Visit 1.
- Use of memantine within 30 days prior to Study Visit 1.
- Use of stimulants within 30 days prior to Study Visit 1
- Use of modafinil, amantadine, and dalfampridine within 30 days prior to Study Visit 1, unless the dose has been stable for 90 days prior to Study Visit 1
- Use of orlistat within 30 days prior to Study Visit 1.
Key Trial Info
Start Date :
February 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2017
Estimated Enrollment :
124 Patients enrolled
Trial Details
Trial ID
NCT01848327
Start Date
February 1 2013
End Date
December 1 2017
Last Update
January 25 2018
Active Locations (1)
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1
University of Miami Miller School of Medicine
Miami, Florida, United States, 33136