Status:
UNKNOWN
A run-in Study on the Safety and Tolerability of a Fasting Mimicking Diet in Relapsing Remitting Multiple Sclerosis
Lead Sponsor:
Ospedale Policlinico San Martino
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18-50 years
Phase:
EARLY_PHASE1
Brief Summary
This study is an open-label, single-arm, run-in study in patients with RRMS treated with first line therapies (interferon-beta, glatiramer acetate, teriflunomide and dimethyl fumarate), assessing the ...
Detailed Description
The primary objective of the present study is to evaluate the safety and tolerability of 3 cycles of a 7 days FMD as a potential support to the management of patients affected by RRMS treated with fir...
Eligibility Criteria
Inclusion
- Diagnosis of RRMS (Thompson et al. 2018);
- Disease duration 6 months to 10 years (included);
- EDSS 0 to 4, 5;
- Treatment with first line therapies (interferon-beta, glatiramer acetate, teriflunomide and dimethyl fumarate).
Exclusion
- \< 6 months since treatment start with first line therapies (interferon-beta, glatiramer acetate, teriflunomide and dimethyl fumarate);
- Relapse \< 60 days;
- Any active or chronic infection;
- Previous history of a malignancy other than basal cell carcinoma of the skin or carcinoma in situ that has been in remission for more than one year;
- Severely limited life expectancy by another co-morbid illness;
- Nutritional risk screening (NRS 2002) \> or = 3;
- BMI \<= 18.5 kg/m2;
- Bio-impedance phase angle \<5.0°;
- History of previous diagnosis of myelodysplasia or previous hematologic disease or current clinically relevant abnormalities of white blood cell counts;
Key Trial Info
Start Date :
December 16 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 30 2024
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT06039007
Start Date
December 16 2019
End Date
March 30 2024
Last Update
October 4 2023
Active Locations (1)
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1
Ospedale San Martino
Genova, Italy