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Completed

NCT Number: NCT03302806

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

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.

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Key information

Conditions

Progressive Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Chronic Disease Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Disease Attributes Immune System Diseases Multiple Sclerosis Multiple Sclerosis, Chronic Progressive Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Nantes University Hospital

Nantes, 44093, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Non interventional study

Other

Primary outcomes

  1. Evolution of post-treatment disability

    Time frame: 12 months

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

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study title

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

Acronym: BIOSEP

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Oct 5, 2017
Registry last updated
Sep 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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