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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 : Unknown
Verified October 2017 by Nantes University Hospital.
Recruitment status was:  Recruiting
First Posted : October 5, 2017
Last Update Posted : October 5, 2017
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital

Tracking Information
First Submitted Date October 2, 2017
First Posted Date October 5, 2017
Last Update Posted Date October 5, 2017
Actual Study Start Date November 1, 2016
Estimated Primary Completion Date November 1, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 4, 2017)
Evolution of post-treatment disability [ Time Frame: 12 months ]
Change in Expanded Disability Status Scale (EDSS) progression from pretreatment period
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: October 4, 2017)
  • CGI-t scale [ Time Frame: after 6 months and 12 months ]
    Change in Clinical global impression of improvement from both physician and patient assessments
  • 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
  • Ambulation [ Time Frame: 12 months ]
    Change in MSWS-12 score from baseline
  • Quality of life [ Time Frame: 12 months ]
    Composite score : Change in EQ5D, MusiQuol, TLS coping 10 score from baseline
  • adverse effect (adverse drug reaction) [ Time Frame: 12 months ]
    number of AE
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Study to Assess Effect and Safety of High Dose of Biotin (Qizenday®) in Progressive Multiple Sclerosis
Official Title Observational Study to Assess Effect and Safety of High Dose of Biotin (Qizenday®) in Progressive Multiple Sclerosis
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
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population patients with progressive multiple receiving a daily dose of biotine of 300 mg
Condition Progressive Multiple Sclerosis
Intervention Other: Non interventional Study
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: October 4, 2017)
100
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 1, 2018
Estimated Primary Completion Date November 1, 2017   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03302806
Other Study ID Numbers RC16_0232
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Nantes University Hospital
Study Sponsor Nantes University Hospital
Collaborators Not Provided
Investigators Not Provided
PRS Account Nantes University Hospital
Verification Date October 2017