Study to Assess Effect and Safety of High Dose of Biotin... | NCT03302806

Studies
Study to Assess Effect and Safety of High Dose of Biotin (Qizenday®) in Progressive Multiple Sclerosis

NCT03302806

Sponsor

Nantes University Hospital

Status

Completed

Last Update Posted

Sep 21, 2021Actual

Enrollment

103Actual

Phase

Not provided

Conditions

Progressive Multiple Sclerosis

Interventions

Non interventional Study

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 29, 2016Actual

Primary Completion Date

Oct 4, 2017Actual

Completion Date

Oct 24, 2018Actual

First Submitted Date

Oct 2, 2017

First Submission Date that Met QC Criteria

Oct 4, 2017

First Posted Date

Oct 5, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 20, 2021

Last Update Posted Date

Sep 21, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

103Actual

Name	Type	Description	Arm Group Labels	Other Names
Non interventional Study	Other

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Evolution of post-treatment disability	Change in Expanded Disability Status Scale (EDSS) progression from pretreatment period	12 months

Secondary Outcomes

Measure	Description	Time Frame
CGI-t scale	Change in Clinical global impression of improvement from both physician and patient assessments	after 6 months and 12 months
Functional disability : Multiple sclerosis Functional composite

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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)

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nantes University Hospital		Nantes		44093	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D020528	Multiple Sclerosis, Chronic Progressive

Ancestor Terms

ID	Term
D009103	Multiple Sclerosis
D020278	Demyelinating Autoimmune Diseases, CNS
D020274	Autoimmune Diseases of the Nervous System
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided