Phase 3 study comparing masitinib vs placebo in PP-MS and SP-MS V1.0

• Research type

  Research Study

• Full title

  A 96-week, prospective, multicenter, randomised, double-blind, placebo-controlled, 2-parallel groups, Phase 3 study to compare efficacy and safety of masitinib 4.5 mg/kg/day versus placebo in the treatment of patients with primary progressive or relapsefree secondary progressive multiple sclerosis

• IRAS ID

  145943

• Contact name

  David Barnes

• Contact email

  david.barnes@stgeorges.nhs.uk

• Sponsor organisation

  AB Science

• Eudract number

  2010-021219-17

• Clinicaltrials.gov Identifier

  NCT01433497

• Research summary

  Multiple sclerosis (MS) is a progressive disease that causes inflammation in the central nervous system. MS is characterized by a loss of myelin (the insulator around a nerve) leading to progressive nerve dysfunction. Primary-Progressive MS. (PP-MS) is characterized by steadily worsening neurologic function from the beginning. Secondary progressive MS (SP-MS) follows an initial period of relapsing-remitting MS. SP-MS and PP-MS together known as chronic progressive MS (CP-MS), the primary feature of CP-MS is a neurodegeneration (breakdown /damage to the nervous system). There currently is no known drug treatment of PP-MS and only metoxantrone for SP-MS. There is only limited oral treatment available for treating MS and no drugs are currently available to prevent neuronal damage. A drug that could demonstrate efficacy in slowing or preventing neurodegeneration would be beneficial for the treatment of MS.
  This study will compare masitinib (the active drug in tablet form) to placebo (An identical tablet that contains no drug) to determine if masitinib is a safe and effective in treating patients with PP-MS or relapse-free SP-MS. This phase 3 study will include 600 patients from hospitals around the world. Patients will be randomly assigned into one of 4 treatment groups: Group 1a will receive 4.5mg/kg/day masitinib; Group 1b will receive 4.5mg/kg/day masitinib with an increase to 6mg/kg/day masitinib after 3 months; Group 2a will receive placebo; and, Group 2b will receive placebo with an increase after 3 months. Patients will participate for up to 96 weeks and will visit the hospital to undergo MS assessments and safety analysis. Patients will require additional weekly blood samples for the first 8 weeks of treatment for safety evaluation. If at the end of 96 weeks the patient shows benefit from being in the study, the patient may be eligible to enter an extension phase of the study.

• REC name

  North East - Tyne & Wear South Research Ethics Committee

• REC reference

  14/NE/0117

• Date of REC Opinion

  10 Jun 2014

• REC opinion

  Further Information Favourable Opinion