NCT03302806

Brief Summary

The purpose of this observational study is to collect efficacy and safety data in real life condition within the first year of treatment in patients with progressive multiple receiving a daily dose of biotine of 300 mg.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
103

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

June 29, 2016

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

October 2, 2017

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 4, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 5, 2017

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 24, 2018

Completed
Last Updated

September 21, 2021

Status Verified

September 1, 2021

Enrollment Period

1.3 years

First QC Date

October 2, 2017

Last Update Submit

September 20, 2021

Conditions

Progressive Multiple Sclerosis

Keywords

disabilityEDSS

Outcome Measures

Primary Outcomes (1)

  • Evolution of post-treatment disability

    Change in Expanded Disability Status Scale (EDSS) progression from pretreatment period

    12 months

Secondary Outcomes (5)

  • CGI-t scale

    after 6 months and 12 months

  • Functional disability : Multiple sclerosis Functional composite

    12 months

  • Ambulation

    12 months

  • Quality of life

    12 months

  • adverse effect (adverse drug reaction)

    12 months

Interventions

Non interventional StudyOTHER

Eligibility Criteria

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

patients with progressive multiple receiving a daily dose of biotine of 300 mg

You may qualify if:

  • Progressive multiple sclerosis patients with an EDSS score ≤ 7 who have been prescribed high dose of biotin (temporary use administration) at Nantes university hospital (France)

You may not qualify if:

  • Patient with remittent recurrent multiple sclerosis
  • Pregnant women or women contemplating pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nantes University Hospital

Nantes, 44093, France

Location

MeSH Terms

Conditions

Multiple Sclerosis, Chronic Progressive

Condition Hierarchy (Ancestors)

Multiple SclerosisDemyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 2, 2017

First Posted

October 5, 2017

Study Start

June 29, 2016

Primary Completion

October 4, 2017

Study Completion

October 24, 2018

Last Updated

September 21, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)