NCT06025903

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
140

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2021

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 20, 2021

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

August 29, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 6, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2024

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2025

Completed
Last Updated

March 22, 2024

Status Verified

March 1, 2024

Enrollment Period

3 years

First QC Date

August 29, 2023

Last Update Submit

March 21, 2024

Conditions

Multiple Sclerosis

Keywords

multiple sclerosismitochondria

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Primary Progressive multiple sclerosis

patients affected by primary progressive multiple sclerosis

Relapsing Remitting multiple sclerosis

patients affected by primary progressive multiple sclerosis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients will be recruited from primary care clinic

You may qualify if:

  • Patients affected by primary progressive or relapsing remitting multiple sclerosis
  • Patient able to provide informed consent

You may not qualify if:

  • Individuals with \< 18 years
  • Patients not affected by primary progressive or relapsing remitting multiple sclerosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

IRCCS San Raffaele

Milan, MI, 20132, Italy

RECRUITING

ASST della Valle Olona - Ospedale di Gallarate

Gallarate, VA, 21013, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood and cerebrospinal fluid

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Melissa Sorosina

    IRCCS San Raffaele

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Federica Esposito

CONTACT

0226437833esposito.federica@hsr.it

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 29, 2023

First Posted

September 6, 2023

Study Start

September 20, 2021

Primary Completion

September 30, 2024

Study Completion

May 30, 2025

Last Updated

March 22, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

IT(2)