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History of Changes for Study: NCT03302806
Study to Assess Effect and Safety of High Dose of Biotin (Qizenday®) in Progressive Multiple Sclerosis (BIOSEP)
Latest version (submitted September 20, 2021) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 October 4, 2017 None (earliest Version on record)
2 September 20, 2021 Recruitment Status, Study Status, Contacts/Locations and Study Design
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Study NCT03302806
Submitted Date:  October 4, 2017 (v1)

Open or close this module Study Identification
Unique Protocol ID: RC16_0232
Brief Title: Study to Assess Effect and Safety of High Dose of Biotin (Qizenday®) in Progressive Multiple Sclerosis (BIOSEP)
Official Title: Observational Study to Assess Effect and Safety of High Dose of Biotin (Qizenday®) in Progressive Multiple Sclerosis
Secondary IDs:
Open or close this module Study Status
Record Verification: October 2017
Overall Status: Recruiting
Study Start: November 1, 2016
Primary Completion: November 1, 2017 [Anticipated]
Study Completion: March 1, 2018 [Anticipated]
First Submitted: October 2, 2017
First Submitted that
Met QC Criteria:
October 4, 2017
First Posted: October 5, 2017 [Actual]
Last Update Submitted that
Met QC Criteria:
October 4, 2017
Last Update Posted: October 5, 2017 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Nantes University Hospital
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module 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.
Detailed Description:
Open or close this module Conditions
Conditions: Progressive Multiple Sclerosis
Keywords: disability
EDSS
Open or close this module Study Design
Study Type: Observational
Observational Study Model: Other
Time Perspective: Prospective
Biospecimen Retention:
Biospecimen Description:
Enrollment: 100 [Anticipated]
Number of Groups/Cohorts 0
Open or close this module Groups and Interventions
Intervention Details:
Non interventional Study
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Evolution of post-treatment disability
[ Time Frame: 12 months ]

Change in Expanded Disability Status Scale (EDSS) progression from pretreatment period
Secondary Outcome Measures:
1. CGI-t scale
[ Time Frame: 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
[ Time Frame: 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
[ Time Frame: 12 months ]

Change in MSWS-12 score from baseline
4. Quality of life
[ Time Frame: 12 months ]

Composite score : Change in EQ5D, MusiQuol, TLS coping 10 score from baseline
5. adverse effect (adverse drug reaction)
[ Time Frame: 12 months ]

number of AE
Open or close this module Eligibility
Study Population: patients with progressive multiple receiving a daily dose of biotine of 300 mg
Sampling Method: Probability Sample
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
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
Open or close this module Contacts/Locations
Central Contact Person: David Laplaud, Pr
Telephone: (0)2.40165.200 Ext. +33
Email: david.laplaud@chu-nantes.fr
Central Contact Backup: Laetitia Barbin
Email: laetitia.barbin@ch-nantes.fr
Locations: France
Nantes University Hospital
[Recruiting]
Nantes, France, 44093
Contact:Contact: David Laplaud, Pr david.laplaud@chu-nantes.fr
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Citations:
Links:
Available IPD/Information:

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