Multiple SclerosisCARMUSNCT03995810
Oral Carnosine for Neuromuscular Performance in Multiple Sclerosis
A study testing Carnosine, capsulle, 2 g/day, 8 weeks in people with Multiple Sclerosis, run by University of Novi Sad, Faculty of Sport and Physical Education at 1 site in Serbia.
Trial summary
Low levels of tissue carnosine and mitochondrial dysfunction appears to accompany multiple sclerosis (MS), with oral carnosine might be applicable to tackle impaired bioenergetics and oxidative stress in MS, and perhaps win back neuromuscular function. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Carnosine, capsulle, 2 g/day, 8 weeks
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteSerbia
- Study dates
- 15 Jun 2019to 1 Dec 2019
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Body mass index 19 - 30 kg/m2
- Free of major chronic diseases or acute disorders besides MS
- Fulfilled 2017 McDonald Criteria for the diagnosis of MS
Who cannot join
- Pregnancy
- Psychiatric comorbidity
- Use of dietary supplements within 4 weeks before study commences
- Unwillingness to return for follow-up analysis
- Abnormal values for lab clinical chemistry (> 2 SD)
- Immunotherapy for the past 6 months
- Treated with systemic corticosteroids during the 30 days before study commences
Trial locations and contacts
1 site in 1 country.
Serbia1 site
Applied Bioenergetics Lab at Faculty of Sport and PE
Novi Sad, Vojvodina, 21000
About this study
Official title: Oral Carnosine for Neuromuscular Performance, Brain Biomarkers of Carnosine Metabolism and Health-related Quality of Life in Multiple Sclerosis
Low levels of tissue carnosine and mitochondrial dysfunction appears to accompany multiple sclerosis (MS), with oral carnosine might be applicable to tackle impaired bioenergetics and oxidative stress in MS, and perhaps win back neuromuscular function. However, several formulations of carnosine have shown limited applicability due to restraints in brain delivery or tissue performance. No human studies so far evaluated the impact of innovative carnosine formulation (Karnozin EXTRA) in MS. Here, we will evaluate the impact of supplemental carnosine on neuromuscular performance, brain biomarkers of carnosine metabolism, and health-related quality of life in a case series of patients with MS.
Read the detailed description
Multiple sclerosis (MS) is a complex autoimmune disorder that affects millions of people around the world, negatively interfering with different aspects of health and everyday life. Being the most frequently seen demyelinating disease, MS prevalence varies considerably, from high levels in North America and Europe (> 100/100,000 inhabitants) to low rates in Eastern Asia and sub-Saharan Africa (2/100,000 population). Due to its rather high prevalence in developed countries, the development of effective and applicable strategies to prevent or manage MS becomes a must for the medical community. Among other factors, it appears that low levels of tissue carnosine and mitochondrial dysfunction accompany MS, with oral carnosine might be applicable to tackle impaired bioenergetics and oxidative stress in MS, and perhaps win back neuromuscular function. However, several formulations of carnosine have shown limited applicability due to restraints in brain delivery or tissue performance thus pushing both industry and researchers to find bioavailable and effective formulation of carnosine. No human studies so far evaluated the impact of innovative carnosine formulation (Karnozin EXTRA) in MS. Here, we will evaluate the impact of supplemental carnosine on neuromuscular performance, brain biomarkers of carnosine metabolism, and health-related quality of life in a case series of patients with MS.
- Conditions
- Multiple Sclerosis
- Being tested
- Carnosine, capsulle, 2 g/day, 8 weeks
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carnosine, capsulle, 2 g/day, 8 weeksDietary supplement
We will administer supplemental carnosine (2 grams per day) for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Carnosine | Experimental | Carnosine, capsulle, 2 g/day, 8 weeks Receives: Dietary Supplement: Carnosine, capsulle, 2 g/day, 8 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain carnosine change
Monitor change in brain carnosine levels
Measured: Baseline vs. eight weeks
Secondary outcomes (4)
Health-related quality of life with SF36 Questionnaire change
Monitor change in health-related quality of life with SF36 Questionnaire
Measured: Baseline vs. eight weeks
Change in neuromuscular performance for autonomic dysfunction (Ewing)
Monitor change in neuromuscular performance for autonomic dysfunction (Ewing)
Measured: Baseline vs. eight weeks
Change in multidimensional fatigue
Monitor change in multidimensional Multidimensional Fatigue Inventory (MFI) 20-item questionnaire
Measured: Baseline vs. eight weeks
Change in blood clinical chemistry panel
Lactic acid change in mmol/L
Measured: Baseline vs. eight weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2019
- Study start15 Jun 2019
- Primary completion1 Nov 2019
- Study completion1 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Novi Sad, Faculty of Sport and Physical Education
- Sponsor type
- University, hospital or other
- Collaborators
- CarnoMed
- Responsible party
- Principal investigator, Sergej Ostojic, University of Novi Sad, Faculty of Sport and Physical Education
- Investigators
- Sergej Ostojic, MD, PhD, Principal investigator, University of Novi Sad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03995810
- Sponsor's protocol ID
- CM-03CS/2019
- Acronym
- CARMUS
- Status last verified
- Mar 2020
- First submitted
- 18 Jun 2019
- Last updated
- 24 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be available after request to PI
Publications
Keytsman C, Blancquaert L, Wens I, Missine M, Noten PV, Vandenabeele F, Derave W, Eijnde BO. Muscle carnosine in experimental autoimmune encephalomyelitis and multiple sclerosis. Mult Scler Relat Disord. 2018 Apr;21:24-29. doi: 10.1016/j.msard.2018.02.013. Epub 2018 Feb 11.
PubMed 29454153Sariev AK, Abaimov DA, Tankevich MV, Pantyukhova EY, Prokhorov DI, Fedorova TN, Lopachev AV, Stvolinskii SL, Konovalova EV, Seifulla RD. [Experimental study of the basic pharmacokinetic characteristics of dipeptide carnosine and its efficiency of penetration into brain tissues]. Eksp Klin Farmakol. 2015;78(3):30-5. Russian.
PubMed 26036009
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Carnosine for Neuromuscular Performance, Brain Biomarkers of Carnosine Metabolism and Health-related Quality of Life in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT03995810
- Acronym / sponsor ID
- CARMUS / CM-03CS/2019
- Conditions
- Multiple Sclerosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University of Novi Sad, Faculty of Sport and Physical EducationUniversity, hospital or other
- Collaborators
- CarnoMed
- Study start
- 15 Jun 2019 (actual)
- Primary completion
- 1 Nov 2019 (actual)
- Study completion
- 1 Dec 2019 (actual)
- First posted
- 24 Jun 2019 (actual)
- 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.
Low levels of tissue carnosine and mitochondrial dysfunction appears to accompany multiple sclerosis (MS), with oral carnosine might be applicable to tackle impaired bioenergetics and oxidative stress in MS, and perhaps win back neuromuscular function. However, several formulations of carnosine have shown limited applicability due to restraints in brain delivery or tissue performance. No human studies so far evaluated the impact of innovative carnosine formulation (Karnozin EXTRA) in MS. Here, we will evaluate the impact of supplemental carnosine on neuromuscular performance, brain biomarkers of carnosine metabolism, and health-related quality of life in a case series of patients with MS.
Detailed description
Multiple sclerosis (MS) is a complex autoimmune disorder that affects millions of people around the world, negatively interfering with different aspects of health and everyday life. Being the most frequently seen demyelinating disease, MS prevalence varies considerably, from high levels in North America and Europe (> 100/100,000 inhabitants) to low rates in Eastern Asia and sub-Saharan Africa (2/100,000 population). Due to its rather high prevalence in developed countries, the development of effective and applicable strategies to prevent or manage MS becomes a must for the medical community. Among other factors, it appears that low levels of tissue carnosine and mitochondrial dysfunction accompany MS, with oral carnosine might be applicable to tackle impaired bioenergetics and oxidative stress in MS, and perhaps win back neuromuscular function. However, several formulations of carnosine have shown limited applicability due to restraints in brain delivery or tissue performance thus pushing both industry and researchers to find bioavailable and effective formulation of carnosine. No human studies so far evaluated the impact of innovative carnosine formulation (Karnozin EXTRA) in MS. Here, we will evaluate the impact of supplemental carnosine on neuromuscular performance, brain biomarkers of carnosine metabolism, and health-related quality of life in a case series of patients with MS.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Carnosine | Experimental | Dietary Supplement: Carnosine, capsulle, 2 g/day, 8 weeksCarnosine, capsulle, 2 g/day, 8 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years
- Body mass index 19 - 30 kg/m2
- Free of major chronic diseases or acute disorders besides MS
- Fulfilled 2017 McDonald Criteria for the diagnosis of MS
Key exclusion criteria (7 listed)
- Pregnancy
- Psychiatric comorbidity
- Use of dietary supplements within 4 weeks before study commences
- Unwillingness to return for follow-up analysis
- Abnormal values for lab clinical chemistry (> 2 SD)
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 |
|---|---|---|
| Carnosine, capsulle, 2 g/day, 8 weeksWe will administer supplemental carnosine (2 grams per day) for 8 weeks | Dietary supplement | Carnosine |
Primary outcome
Brain carnosine change
Time frame: Baseline vs. eight weeks
Monitor change in brain carnosine levels
4 secondary outcomes
Health-related quality of life with SF36 Questionnaire change
Time frame: Baseline vs. eight weeks
Change in neuromuscular performance for autonomic dysfunction (Ewing)
Time frame: Baseline vs. eight weeks
Change in multidimensional fatigue
Time frame: Baseline vs. eight weeks
Change in blood clinical chemistry panel
Time frame: Baseline vs. eight weeks
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 24 Mar 2020.
- Background: PubMed 29454153Keytsman C, Blancquaert L, Wens I, Missine M, Noten PV, Vandenabeele F, Derave W, Eijnde BO. Muscle carnosine in experimental autoimmune encephalomyelitis and multiple sclerosis. Mult Scler Relat Disord. 2018 Apr;21:24-29. doi: 10.1016/j.msard.2018.02.013. Epub 2018 Feb 11.
- Background: PubMed 26036009Sariev AK, Abaimov DA, Tankevich MV, Pantyukhova EY, Prokhorov DI, Fedorova TN, Lopachev AV, Stvolinskii SL, Konovalova EV, Seifulla RD. [Experimental study of the basic pharmacokinetic characteristics of dipeptide carnosine and its efficiency of penetration into brain tissues]. Eksp Klin Farmakol. 2015;78(3):30-5. Russian.
- Individual participant dataSharing planned: Yes. Data will be available after request to PI
Related trials for Multiple Sclerosis
Active, not recruitingPhase 3
An Extension Study of Ublituximab in Participants With Relapsing Multiple Sclerosis
Relapsing Multiple Sclerosis (RMS)
RecruitingObservational study
A Study Evaluating the Real World Experience of Participants Treated With BRIUMVI® (Ublituximab-xiiy) for Relapsing Multiple Sclerosis (RMS)
Relapsing Multiple Sclerosis, Multiple Sclerosis
RecruitingObservational study
Non-interventional Study of Subcutaneous Ocrelizumab in Persons With Relapsing-Remitting Multiple Sclerosis
Relapsing-Remitting Multiple Sclerosis
RecruitingPhase 2
A Phase 2a Study of SUN-627 in Participants With Non-Active Secondary Progressive and Primary Progressive Multiple Sclerosis (SPMS/PPMS)
Primary Progressive Multiple Sclerosis, Primary Progressive MS
RecruitingPhase 4
A Study of Ocrelizumab Administered Subcutaneously in Participants With Multiple Sclerosis Who Switch From an Approved Anti-CD20 Therapy
Multiple Sclerosis
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.
Sergej Ostojic, MD, PhD principal investigator
University of Novi Sad
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Carnosine, capsulle, 2 g/day, 8 weeks in people with Multiple Sclerosis, run by University of Novi Sad, Faculty of Sport and Physical Education at 1 site in Serbia.
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 4 inclusion and 7 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 24 Mar 2020. 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 Serbia. 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. 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?
Brain carnosine change (time frame: Baseline vs. eight weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03995810, which also lists 2 linked publications.
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 24 Mar 2020.