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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03302806
Recruitment Status : Completed
First Posted : October 5, 2017
Last Update Posted : September 21, 2021
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital

Study Description
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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
Progressive Multiple Sclerosis Other: Non interventional Study

Study Design
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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 : June 29, 2016
Actual Primary Completion Date : October 4, 2017
Actual Study Completion Date : October 24, 2018

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patients with progressive multiple receiving a daily dose of biotine of 300 mg
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03302806


Locations
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France
Nantes University Hospital
Nantes, France, 44093
Sponsors and Collaborators
Nantes University Hospital
More Information
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Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT03302806    
Other Study ID Numbers: RC16_0232
First Posted: October 5, 2017    Key Record Dates
Last Update Posted: September 21, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nantes University Hospital:
disability
EDSS
Additional relevant MeSH terms:
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Multiple Sclerosis
Multiple Sclerosis, Chronic Progressive
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
 Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Chronic Disease
Disease Attributes