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Multiple SclerosisPhase 3MS-SPINCT02220933

Effect of MD1003 in Spinal Progressive Multiple Sclerosis

A Phase 3 study testing MD1003 100mg capsule in people with Multiple Sclerosis, run by MedDay Pharmaceuticals SA at 17 sites in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Multiple Sclerosis
What is being tested?
MD1003 100mg capsule
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
144 participants
Where
17 sitesFrance
Study dates
Oct 2013to Jan 2018
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis criteria of secondary or primary progressive MS with clinical evidence of spastic paraparesis fulfilling revised McDonald criteria (2010) and Lublin criteria (1996)
  • Progression of the EDSS during the past two years of at least 1 point if EDSS from 4.5 to 5.5 and at least 0.5 point if EDSS from 6 to 7
  • EDSS score from 4.5 to 7 (measured away from a relapse and confirmed at 6 months)
  • Informed consent prior to any study procedure
  • Patient aged 18-75 years

Who cannot join

  • Any general chronic handicapping disease other than MS
  • Intensive physical therapy program within the 3 months prior to inclusion
  • Impossibility to perform the TW25 test
  • New treatment introduced less than 3 months prior to inclusion or less than 1 month for Fampridine
  • Pregnancy or woman with childbearing potential without contraception
  • Evidence of inflammatory activity of the disease defined as "clinical evidence of a relapse during the year before inclusion or evidence of new gadolinium-enhanced lesions on a brain MRI performed the year before inclusion."

Trial locations and contacts

17 sites in 1 country.

17 sites in 1 country

France17 sites

  • Hopital Pellegrin

    Bordeaux, 33000

  • Hopital de la cote de Nacre

    Caen, 14000

  • Hopital Gabriel Montpied

    Clermont-Ferrand, 63000

  • Hopital general du Bocage

    Dijon, 21000

  • Hopital Pierre Wertheimer

    Lyon, 69000

  • Hopital de la Timone

    Marseille, 13000

  • Hopital Gui de Chauliac

    Montpellier, 34000

  • Hopital Central

    Nancy, 54000

  • Hopital Nord Laennec

    Nantes, 44000

  • Hopital Pasteur

    Nice, 06000

  • Groupe hospitalier la Pitié-Salpêtrière

    Paris, 75013

  • Fondation Rothschild

    Paris, 75019

  • Centre hospitalier Intercommunal Poissy/Saint-Germain-en-Laye

    Poissy, 78300

  • Hopital Maison Blanche

    Reims, 51000

  • Hopital Pontchaillou

    Rennes, 35000

  • Hopital Hautepierre

    Strasbourg, 67000

  • Hopital Purpan

    Toulouse, 31000

Other trials in France

About this study

Official title: Effect of MD1003 in Spinal Progressive Multiple Sclerosis: a Pivotal Randomized Double Blind Placebo Controlled Study

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.

Being tested
MD1003 100mg capsule, Placebo
Keywords
Multiple Sclerosis, MS, EDSS
Medical subject headings
Multiple Sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MD1003 100mg capsuleDrug

  • PlaceboDrug

Study groups in NCT02220933
Study groupRoleWhat they receive
MD1003ExperimentalMD1003 100mg capsules, 1 capsule tid for 24 months
Receives: Drug: MD1003 100mg capsule
PlaceboPlacebo comparatorPlacebo capsule, 1 capsule tid for 12 months, then switch to MD1003 100mg capsule, 1 capsule tid for 12 months
Receives: Drug: MD1003 100mg capsule; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Proportions of patients in each treatment arm:

    • with decreased EDSS at M9 confirmed at Month12 (where decreased EDSS is defined as a decrease of at least 0.5 point if initial EDSS from 6 to 7 and a decrease of at least 1 point if initial EDSS from 4.5 to 5.5) or
    • with improved TW25 of at least 20% at Month 9 and Month12 compared to the best EDSS and TW25 scores among screening visit (Month-1) and randomization visit (baseline)

    Measured: up to 24 months

Secondary outcomes (5)

  1. Multiple Sclerosis Walking Scale (MSWS)

    The 12-item multiple sclerosis walking scale (MSWS-12) is a self-report measure of the impact of MS on the individual's walking ability.

    Measured: Baseline, 12 months, 24 months

  2. Clinical Global Impression / Subject Global Impression (CGI / SGI)

    The Clinical Global Impression - Improvement scale (CGI-I) is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention.

    The clinical global impression will be assessed by the patient (subject global impression, SGI) and by the clinician (clinician global impression, CGI).

    Measured: 12 months, 24 months

  3. Unidimensional Fatigue Impact Scale (U-FIS)

    The U-FIS has 22-items measuring the impact of fatigue.

    Measured: Baseline, 12 months, 24 months

  4. Multiple Sclerosis Quality of Life Scale (SEP-59)

    The SEP-59 is a multidimensional health-related quality of life measure that combines 36 generic items and 29 MS-specific items into a single instrument.

    Measured: Baseline, 12 months, 24 months

  5. Hole Peg Test (9-HPT)

    The 9-HPT apparatus comprises a container with nine pegs and an empty pegboard with nine holes, set three by three. The pegs must be picked up one at a time and placed in the holes as quickly as possible until all holes are filled. Then, without pausing, the pegs should be removed one at a time, again as quickly as possible. This should be performed twice for each hand. If a peg falls onto the table, the peg should be picked up with the hand which is being tested. If a peg falls onto the floor, it is picked up by the examiner. The time is recorded in seconds, starting as the patient picks up the first peg and ending when the last peg drops into the container.

    Measured: Baseline, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Aug 2014 (estimated)
  2. Study startOct 2013
  3. Primary completionJan 2016
  4. Study completionJan 2018 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
144 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02220933
Sponsor's protocol ID
MD1003CT2013-02MS-SPI
Other IDs
2013-002113-35
Acronym
MS-SPI
Status last verified
Mar 2017
First submitted
18 Aug 2014
Last updated
27 Mar 2017
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing MD1003 100mg capsule in people with Multiple Sclerosis, run by MedDay Pharmaceuticals SA at 17 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 27 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of patients improved on either Expanded Disability Status Scale (EDSS) or time to walk 25 feet (TW25) (time frame: up to 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02220933.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2017; AzTrials last refreshed its copy on 31 Oct 2026.

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