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

Sponsor
Nantes University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03302806
Collaborator
(none)
103
1
27.8
3.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Non interventional Study

Study Design

Study Type:
Observational
Actual Enrollment :
103 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
Observational Study to Assess Effect and Safety of High Dose of Biotin (Qizenday®) in Progressive Multiple Sclerosis
Actual Study Start Date :
Jun 29, 2016
Actual Primary Completion Date :
Oct 4, 2017
Actual Study Completion Date :
Oct 24, 2018

Outcome Measures

Primary Outcome Measures

  1. Evolution of post-treatment disability [12 months]

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

Secondary Outcome Measures

  1. CGI-t scale [after 6 months and 12 months]

    Change in Clinical global impression of improvement from both physician and patient assessments

  2. Functional disability : Multiple sclerosis Functional composite [12 months]

    Composite score : Change in test measuring the patient's walking speed over a distance of 25 feet(TW25), Symbol Digit Modalities Test (SDMT), 9-Hole Peg Test Scores (9HPT) from baseline

  3. Ambulation [12 months]

    Change in MSWS-12 score from baseline

  4. Quality of life [12 months]

    Composite score : Change in EQ5D, MusiQuol, TLS coping 10 score from baseline

  5. adverse effect (adverse drug reaction) [12 months]

    number of AE

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Nantes University Hospital Nantes France 44093

Sponsors and Collaborators

  • Nantes University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT03302806
Other Study ID Numbers:
  • RC16_0232
First Posted:
Oct 5, 2017
Last Update Posted:
Sep 21, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Nantes University Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 21, 2021