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Effect of MD1003 in Progressive Multiple Sclerosis (SPI2) (SPI2)

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ClinicalTrials.gov Identifier: NCT02936037
Recruitment Status : Recruiting
First Posted : October 18, 2016
Last Update Posted : October 9, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to demonstrate the superiority of MD1003 over placebo in the disability of patients suffering from progressive multiple sclerosis and especially those with gait impairment.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Drug: MD1003 100mg capsule Drug: PLACEBO Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Randomized double blind placebo-controlled for at least 15 months, followed by an open label extension phase of up to 12 months.

The placebo-controlled phase, will end when the last patient randomized will perform his 15 months evaluation (visit 7). Then all patients will be treated with the active drug during an open-label extension phase for a total study duration of 27 months.

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of MD1003 in Progressive Multiple Sclerosis: a Randomized Double Blind Placebo Controlled Study
Actual Study Start Date : December 2016
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Placebo Comparator: GROUP 1
Placebo capsule, 1 capsule tid (morning,noon and evening) for 15 months at least, then switch to MD1003 100mg capsule, 1 capsule tid for up to 12 months
Drug: MD1003 100mg capsule
Other Name: high dose biotin
Drug: PLACEBO
an inactive substance
Experimental: GROUP 2
MD1003 capsule, 1 capsule tid (morning,noon and evening) for 15 months at least (double blind period) and then for all patients in open label extension for up to 12 months
Drug: MD1003 100mg capsule
Other Name: high dose biotin


Outcome Measures

Primary Outcome Measures :
  1. Proportion of patients improved on either Expanded Disability Status Scale (EDSS) or time to walk 25 feet (TW25) [ Time Frame: 15 months ]

    Proportion of patients improved on either Expanded Disability Status Scale (EDSS) or time to walk 25 feet (TW25) :

    - with decreased EDSS at M12 confirmed at M15 (where decreased EDSS is defined as a decrease of at least 1 point if initial EDSS from 3.5 to 5.5 and of at least 0.5 point if initial EDSS from 6 to 6.5)

    or

    - with improved TW25 of at least 20% at Month 12 and Month15

    compared to the lowest of the two EDSS and TW25* scores among inclusion and randomization visits.

    *The lowest TW25 value recorded among the four values obtained during the inclusion and randomization visits will be considered as the baseline TW25 value.



Secondary Outcome Measures :
  1. Time to EDSS progression confirmed at 12 weeks [ Time Frame: 15 months ]
  2. CGI-I score (clinical global impression of change - improvement), evaluated both by the patient (SGI) and by the evaluating physician (CGI) [ Time Frame: 15 months ]
  3. Mean change in TW25 between M0 and M15 [ Time Frame: 15 months ]

Other Outcome Measures:
  1. Brain MRI changes between M0 and M15 [ Time Frame: 15 months ]
  2. Remote monitoring of ambulation [ Time Frame: 15 months ]
  3. (MSQOL54) & (CAREQOL-MS) subscores and composite scores [ Time Frame: 15 months ]
  4. Subscores of the Kurtzke functional score [ Time Frame: 15 months ]
  5. Symbol digit modalities test (SDMT) [ Time Frame: 15 months ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient aged 18-65 years old
  • Signed and dated written informed consent form in accordance with local regulations: having freely given their written informed consent to participate in the study
  • Diagnosis of primary or secondary progressive MS fulfilling revised McDonald criteria (2010) and Lublin criteria (2014)
  • Documented evidence of clinical disability progression within the 2 years prior to inclusion, i.e. a) progression of EDSS during the past two years of at least 1 point sustained for at least 6 months if inclusion EDSS is from 3.5 to 5.5 or at least 0.5 point increase sustained for at least 6 months if inclusion EDSS is from 6 to 6.5 or b) increase of TW25 by at least 20% in the last two years sustained for at least 6 months or c) other well-documented objective worsening validated by the Adjudication Committee
  • EDSS at inclusion from 3.5 to 6.5
  • TW25 < 40 seconds
  • Kurtzke pyramidal functional subscore ≥2 defined as "minimal disability: patient complains of motor-fatigability or reduced performance in strenuous motor tasks (motor performance grade 1) and/or BMRC grade 4 in one or two muscle groups"

Exclusion Criteria:

  • Clinical evidence of a relapse in 24 months prior to inclusion
  • Treatment with any product containing biotin as single ingredient within six months prior to inclusion (multivitamin supplementation authorized if biotin < 1mg per day)
  • Concomitant treatment with fampridine at inclusion or in the 30 days prior to inclusion
  • New immunosuppressive/immunomodulatory drug initiated less than 90 days prior to inclusion
  • Treatment with botulinium toxin (except for cosmetic purpose) initiated within 6 months prior to inclusion
  • In-patient rehabilitation program within the 3 months prior to inclusion
  • Pregnancy, breastfeeding or women with childbearing potential without acceptable form of contraception
  • Men unwilling to use an acceptable form of contraception
  • Any general chronic handicapping/incapacitating disease other than MS
  • Any serious disease necessitating biological follow-up with biological tests using biotinylated antibodies or substrates
  • Past history of rhabdomyolysis/metabolic myopathy
  • Known fatty acids beta oxidation defect
  • Known hypersensitivity or intolerance to biotin, analogues or excipients, patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption
  • Patients with hypersensitivity or any contra-indication to Gadolinium
  • Patients with uncontrolled hepatic disorder, renal or cardiovascular disease, or cancer
  • Laboratory tests out of normal ranges considered by the investigator as clinically significant with regards to the study continuation
  • Patients with history or presence of alcohol abuse or drug addiction
  • Untreated or uncontrolled psychiatric disorders, especially suicidal risk assessed by Columbia-Suicide Severity Rating Scale (C-SSRS)
  • Participation in another research study involving an investigational product (IP) in the 90 days prior to inclusion, or planned use during the study duration
  • Patients likely to be non-compliant to the study procedures or for whom a long-term follow-up seems to be difficult to achieve
  • Relapse that occurs between inclusion and randomization visit
Contacts and Locations

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): NCT02936037


Contacts
Contact: abdelkarim Bendarraz clinical.trials@medday-pharma.com

  Show 81 Study Locations
Sponsors and Collaborators
MedDay Pharmaceuticals SA
Investigators
Principal Investigator: Bruce Cree, MD, PHD University of California, San Francisco
Study Director: Frederic Sedel, MD, PHD Medday Pharmaceuticals
More Information

Additional Information:
Responsible Party: MedDay Pharmaceuticals SA
ClinicalTrials.gov Identifier: NCT02936037     History of Changes
Other Study ID Numbers: MD1003CT2016-01MS-SPI2
First Posted: October 18, 2016    Key Record Dates
Last Update Posted: October 9, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by MedDay Pharmaceuticals SA:
progressive multiple sclerosis
MS
EDSS
TW25
multiple sclerosis

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases