Relapsing Remitting MSNCT01848327
Caprylic Triglyceride for Treatment of Cognitive Impairments in Multiple Sclerosis
A study testing Caprylic Triglyceride in people with Relapsing Remitting MS and Secondary Progressive MS, run by University of Miami at 1 site in United States.
Trial 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-related cognitive impairment. Glucose (a type of sugar) is used to fuel the cells of the healthy brain. Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- Relapsing Remitting MS, Secondary Progressive MS, Primary Progressive MS
- What is being tested?
- Caprylic Triglyceride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 124 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2013to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Miami Miller School of Medicine
Miami, Florida, 33136
About this study
Official title: A Randomized Double-Blind Placebo-Controlled Study of Caprylic Triglyceride for Cognitive Impairment in Subjects With Multiple Sclerosis.
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-related cognitive impairment. Glucose (a type of sugar) is used to fuel the cells of the healthy brain. For people with neurological conditions such as MS, glucose is not converted into energy as efficiently as it would be in a healthy brain, which can lead to a decrease in cognitive function. Caprylic Triglyceride may work to bypass this problem by providing an alternative energy source that is metabolized in the liver and used by the brain.
Objective: To evaluate the therapeutic effects of 90 days of caprylic triglyceride on cognitive impairment in multiple sclerosis.
Read more
Design: Randomized, double blinded, placebo controlled trial of 158 subjects.
Outcome: Change in Total Learning (Trials 1-5) on the California Verbal Learning Test-2nd Edition-(CVLT-II) AND Change in Symbol Digit Modalities Test (SDMT) (at day 90
Read the 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 initiating treatment and again after 90 days of treatment, to determine whether Caprylic Triglyceride demonstrates a benefit over placebo.
Dosage: 40 gram packet orally once a day Duration of Treatment: 90 days
Analyses: Interim analyses will be conducted after 72 subjects have completed the trial and objective STOP criteria for efficacy and futility have been defined in the protocol. Final analyses will be an intent-to-treat (ITT) analysis to evaluate each of the primary aims.
- Being tested
- Caprylic Triglyceride, Placebo
- Keywords
- Cognition, Neuropsychology, Multiple Sclerosis
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caprylic TriglycerideDietary supplement
Also called Axona
Caprylic Triglyceride is a medical food that is used for the dietary management of the metabolic processes associated with mild to moderate Alzheimer's disease.
PlaceboDietary supplement
Placebo (40 gram packet orally once a day for 90 days)
| Study group | Role | What they receive |
|---|---|---|
| Caprylic Triglyceride | Experimental | Caprylic Triglyceride (40 gram packet orally once a day for 90 days) Receives: Dietary Supplement: Caprylic Triglyceride |
| Placebo | Placebo comparator | Placebo (40 gram packet orally once a day for 90 days) Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Total Learning (Trials 1-5) on the California Verbal Learning Test-2nd Edition (CVLT-II) (range from 0 to 80)
measure of verbal learning and memory
Measured: Baseline and 90 days
Change in Symbol Digit Modalities Test (SDMT) (range from 0-110)
measure of processing speed and attention
Measured: Baseline and 90 days
Number of participants reporting adverse events
The number of participants experiencing adverse events in the active treatment and placebo group will be examined.
Measured: Baseline and 90 days
Secondary outcomes (4)
Change in EDSS
measure of disease severity
Measured: Baseline and 90 days
Change in Beck Depression Inventory -2nd edition (BDI-II)
Self-report depression scale
Measured: Baseline and 90 days
Change in Multiple Sclerosis Quality of Life Inventory (MSQOL-54)
Quality of life inventory
Measured: Baseline and 90 days
Change in Modified Fatigue Impact Scale (MFIS)
Self-report Fatigue scale
Measured: Baseline and 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2013 (estimated)
- Study startFeb 2013
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsing Remitting MSStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- National Multiple Sclerosis Society, Cerecin
- Responsible party
- Principal investigator, Leticia Tornes, University of Miami
- Investigators
- Leticia Tornes, M.D., Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01848327
- Sponsor's protocol ID
- 20120415
- Other IDs
- 5559072
- Status last verified
- Jan 2018
- First submitted
- 16 Apr 2013
- Last updated
- 25 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Via Publications
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Double-Blind Placebo-Controlled Study of Caprylic Triglyceride for Cognitive Impairment in Subjects With Multiple Sclerosis.
- ClinicalTrials.gov ID
- NCT01848327
- Acronym / sponsor ID
- 20120415
- Keywords
- Cognition, Neuropsychology, Multiple Sclerosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- National Multiple Sclerosis Society, Cerecin
- Study start
- Feb 2013 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 7 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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-related cognitive impairment. Glucose (a type of sugar) is used to fuel the cells of the healthy brain. For people with neurological conditions such as MS, glucose is not converted into energy as efficiently as it would be in a healthy brain, which can lead to a decrease in cognitive function. Caprylic Triglyceride may work to bypass this problem by providing an alternative energy source that is metabolized in the liver and used by the brain.
Objective: To evaluate the therapeutic effects of 90 days of caprylic triglyceride on cognitive impairment in multiple sclerosis.
Design: Randomized, double blinded, placebo controlled trial of 158 subjects.
Outcome: Change in Total Learning (Trials 1-5) on the California Verbal Learning Test-2nd Edition-(CVLT-II) AND Change in Symbol Digit Modalities Test (SDMT) (at day 90
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 initiating treatment and again after 90 days of treatment, to determine whether Caprylic Triglyceride demonstrates a benefit over placebo.
Dosage: 40 gram packet orally once a day Duration of Treatment: 90 days
Analyses: Interim analyses will be conducted after 72 subjects have completed the trial and objective STOP criteria for efficacy and futility have been defined in the protocol. Final analyses will be an intent-to-treat (ITT) analysis to evaluate each of the primary aims.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Caprylic Triglyceride | Experimental | Dietary Supplement: Caprylic TriglycerideCaprylic Triglyceride (40 gram packet orally once a day for 90 days) |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo (40 gram packet orally once a day for 90 days) |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (28 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Caprylic TriglycerideAlso: AxonaCaprylic Triglyceride is a medical food that is used for the dietary management of the metabolic processes associated with mild to moderate Alzheimer's disease. | Dietary supplement | Caprylic Triglyceride |
| PlaceboPlacebo (40 gram packet orally once a day for 90 days) | Dietary supplement | Placebo |
Primary outcome
Change in Total Learning (Trials 1-5) on the California Verbal Learning Test-2nd Edition (CVLT-II) (range from 0 to 80)
Time frame: Baseline and 90 days
measure of verbal learning and memory
Change in Symbol Digit Modalities Test (SDMT) (range from 0-110)
Time frame: Baseline and 90 days
measure of processing speed and attention
Number of participants reporting adverse events
Time frame: Baseline and 90 days
The number of participants experiencing adverse events in the active treatment and placebo group will be examined.
4 secondary outcomes
Change in EDSS
Time frame: Baseline and 90 days
Change in Beck Depression Inventory -2nd edition (BDI-II)
Time frame: Baseline and 90 days
Change in Multiple Sclerosis Quality of Life Inventory (MSQOL-54)
Time frame: Baseline and 90 days
Change in Modified Fatigue Impact Scale (MFIS)
Time frame: Baseline and 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2018.
- Individual participant dataSharing planned: Yes. Via Publications
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leticia Tornes, M.D. principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Caprylic Triglyceride in people with Relapsing Remitting MS and Secondary Progressive MS, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Total Learning (Trials 1-5) on the California Verbal Learning Test-2nd Edition (CVLT-II) (range from 0 to 80) (time frame: Baseline and 90 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2018.