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CompletedNCT03302806BIOSEPUpdated Sep 21, 2021

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

An observational study in Progressive Multiple Sclerosis, sponsored by Nantes University Hospital. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-09-21.

Sponsored by Nantes University Hospital · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
103
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Progressive Multiple Sclerosis

Keywords

  • disability
  • EDSS
03

In context

Multiple Sclerosis, Chronic Progressive

244 studies on the registry are indexed under Multiple Sclerosis, Chronic Progressive; 53 are open to participants now.

This study's enrollment of 103 is below the median of 120 across 47 observational studies indexed under Multiple Sclerosis, Chronic Progressive.

Browse Multiple Sclerosis, Chronic Progressive studies →

Lead sponsor

Nantes University Hospital is the lead sponsor of 839 studies on the registry; 195 are open to participants now.

Browse Nantes University Hospital studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Patient with remittent recurrent multiple sclerosis
  • Pregnant women or women contemplating pregnancy
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
103 participants (actual)
Patient registry
No

Interventions

  • OtherNon interventional Study
06

What researchers measure

Primary outcomes

  1. Evolution of post-treatment disability

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

    Time frame: 12 months

Secondary outcomes

  1. CGI-t scale

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

    Time frame: after 6 months and 12 months

  2. Functional disability : Multiple sclerosis Functional composite

    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

    Time frame: 12 months

  3. Ambulation

    Change in MSWS-12 score from baseline

    Time frame: 12 months

  4. Quality of life

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

    Time frame: 12 months

  5. adverse effect (adverse drug reaction)

    number of AE

    Time frame: 12 months

07

Study locations

1 site
  • Nantes University Hospital
    Nantes, 44093, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jun 2016 to primary completion in Oct 2017, 15 months.

Of 18 observational studies under Multiple Sclerosis, Chronic Progressive, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 34 and three quarters within 87. This study's 15 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 2, 2017
First posted
Oct 5, 2017
StartActual
Jun 29, 2016
Primary completionActual
Oct 4, 2017
CompletionActual
Oct 24, 2018
Last update
Sep 21, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 21, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03302806
Lead sponsor
Nantes University Hospital
Responsible party
Sponsor
First posted
Oct 5, 2017
Start date
Jun 29, 2016
Primary completion
Oct 4, 2017
Completion
Oct 24, 2018
Last update
Sep 21, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.

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Discussion

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