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NCT06025903 Clinical Trial

Assessing the Role of Mitochondrial Dysfunction in Primary Progressive Multiple Sclerosis

Multiple Sclerosis Clinical Trial

Official title:
Assessing the Role of Mitochondrial Dysfunction in Primary Progressive Multiple Sclerosis

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06025903
Other study ID # MitoMS_GR-2019-12368672
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 20, 2021
Est. completion date May 30, 2025

Study information
Verified date March 2024
Source IRCCS San Raffaele
Contact Federica Esposito
Phone 0226437833
Email esposito.federica@hsr.it
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this project is to study genetic determinants of mitochondrial impairment in primary progressive multiple sclerosis. Specific aims are: 1) identify mitochondrial-related pathways, inherited and somatic mitochondrial DNA mutations associated to primary progressive multiple sclerosis, 2) functionally assess the identified genetic alterations.

Description:

Multiple Sclerosis is a major cause of neurological disability, with a high socio-economic impact that increases as disability progresses. Effective treatment of primary progressive multiple sclerosis is still an unmet need and the underlying neurodegenerative processes have to be fully investigated. The purpose of this project is to study genetic determinants of mitochondrial impairment in primary progressive multiple sclerosis. Altered mitochondrial pathways will be investigate, as well as inherited and tissue-specific somatic mitochondrial variations associated with primary progressive multiple sclerosis.

Recruitment information / eligibility
Status Recruiting
Enrollment 140
Est. completion date May 30, 2025
Est. primary completion date September 30, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients affected by primary progressive or relapsing remitting multiple sclerosis - Patient able to provide informed consent Exclusion Criteria: - Individuals with < 18 years - Patients not affected by primary progressive or relapsing remitting multiple sclerosis

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Italy ASST della Valle Olona - Ospedale di Gallarate Gallarate VA
Italy IRCCS San Raffaele Milan MI

Sponsors (2)
Lead Sponsor Collaborator
IRCCS San Raffaele Azienda Socio Sanitaria Territoriale della Valle Olona

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary sequencing of mitochondrial DNA the mitochondrial DNA collected from blood and cerebrospinal fluid will be sequenced and analysed, comparing the frequency of variants between the two disease courses 3 years
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