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

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: NCT02936037
Recruitment Status : Active, not recruiting
First Posted : October 18, 2016
Last Update Posted : May 9, 2019
Sponsor:
Information provided by (Responsible Party):
MedDay Pharmaceuticals SA

Tracking Information
First Submitted Date  ICMJE October 14, 2016
First Posted Date  ICMJE October 18, 2016
Last Update Posted Date May 9, 2019
Actual Study Start Date  ICMJE December 2016
Estimated Primary Completion Date August 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 14, 2016)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02936037 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 7, 2019)
  • Time to 12-Weeks Confirmed EDSS progression [ Time Frame: 3 to 27 months ]
    12-weeks EDSS progression is defined by an increase of at least 1 point for baseline EDSS 3.5 to 5.5 and of at least 0.5 point for baseline EDSS 6 to 6.5 with respective confirmation 12 weeks later. Date of 12-weeks confirmed EDSS progression will be the first date of an EDSS progression (as defined above) that is confirmed 12 weeks later.
  • 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 ]
  • Mean change in TW25 between M0 and M15 [ Time Frame: 15 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 14, 2016)
  • Time to EDSS progression confirmed at 12 weeks [ Time Frame: 15 months ]
  • 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 ]
  • Mean change in TW25 between M0 and M15 [ Time Frame: 15 months ]
Current Other Pre-specified Outcome Measures
 (submitted: May 7, 2019)
  • Brain MRI changes between M0 and M15 [ Time Frame: 15 months ]
  • Remote monitoring of ambulation [ Time Frame: 27 months ]
  • (MSQOL54) & (CAREQOL-MS) subscores and composite scores [ Time Frame: 15 months ]
  • Subscores of the Kurtzke functional score [ Time Frame: 15 months ]
  • Symbol digit modalities test (SDMT) [ Time Frame: 15 months ]
Original Other Pre-specified Outcome Measures
 (submitted: October 14, 2016)
  • Brain MRI changes between M0 and M15 [ Time Frame: 15 months ]
  • Remote monitoring of ambulation [ Time Frame: 15 months ]
  • (MSQOL54) & (CAREQOL-MS) subscores and composite scores [ Time Frame: 15 months ]
  • Subscores of the Kurtzke functional score [ Time Frame: 15 months ]
  • Symbol digit modalities test (SDMT) [ Time Frame: 15 months ]
 
Descriptive Information
Brief Title  ICMJE Effect of MD1003 in Progressive Multiple Sclerosis (SPI2)
Official Title  ICMJE Effect of MD1003 in Progressive Multiple Sclerosis: a Randomized Double Blind Placebo Controlled Study
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

PART 1:

Total duration of Part 1 is 27 months. The randomized double-blind placebo-controlled period ranges from 15 to 27 months depending upon the randomization date of an individual patient.

Once the last month 15 evaluation of the study has been completed, patients will switch to the active drug at the next planned visit. Participants and study personnel will remain blinded as to the original treatment assignment.

Maximum duration of double-blind period per patient will be no longer than 27 months.

PART 2:

At the last evaluation of Part 1 (Visit 11/Month 27) all participants will be offered active treatment in an open label extension for 39 additional months (From V11/M27 to V18/M66).

The purpose of the active drug extension is to further define the safety of MD1003.

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Multiple Sclerosis
Intervention  ICMJE
  • Drug: MD1003 100mg capsule
    Other Name: high dose biotin
  • Drug: PLACEBO
    an inactive substance
Study Arms  ICMJE
  • Placebo Comparator: GROUP 1
    Placebo capsule, 1 capsule tid (morning,noon and evening) for 15 months and up to 27 months.
    Intervention: Drug: PLACEBO
  • Experimental: GROUP 2
    MD1003 capsule, 1 capsule tid (morning,noon and evening) for 15 months and up to 27 months.
    Intervention: Drug: MD1003 100mg capsule
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  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: May 7, 2019)
642
Original Estimated Enrollment  ICMJE
 (submitted: October 14, 2016)
300
Estimated Study Completion Date  ICMJE June 2023
Estimated Primary Completion Date August 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 at inclusion visit
  • 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 botulinum 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Belgium,   Canada,   Czechia,   Germany,   Hungary,   Italy,   Poland,   Spain,   Sweden,   Turkey,   United Kingdom,   United States
Removed Location Countries Czech Republic,   Netherlands
 
Administrative Information
NCT Number  ICMJE NCT02936037
Other Study ID Numbers  ICMJE MD1003CT2016-01MS-SPI2
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party MedDay Pharmaceuticals SA
Study Sponsor  ICMJE MedDay Pharmaceuticals SA
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Bruce Cree, MD, PHD University of California, San Francisco
Study Director: Frederic Sedel, MD, PHD Medday Pharmaceuticals
PRS Account MedDay Pharmaceuticals SA
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP