Clinical Trial: AZD3241 PET MSA Trial, Phase 2, Randomized,12 Week Safety and Tolerability Trial With PET in MSA Patients

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A 12-Week, Multicenter, Randomized, Parallel-Group Study to Assess the Safety, Tolerability, Pharmacokinetics, Biomarker Effects, Efficacy, and Effect on Microglia Activation, as Measured by Positron

Brief Summary: AZD3241 myeloperoxidase (MPO) inhibitor trial is assessing safety and tolerability, randomized trial, in patients with Multiple System Atrophy.

Detailed Summary:
Sponsor: AstraZeneca

Current Primary Outcome:

  • Assessment of the safety and tolerability of AZD3241 in MSA subjects via Adverse Events [ Time Frame: From Screen up to 3 months ]
    The primary objectives of the study are to assess the safety, tolerability and effect on microglia activation of AZD3241 versus placebo in MSA subjects.
  • Assessment of the safety and tolerability of AZD3241 in MSA subjects via Vital Signs (blood pressure and pulse) as well as body temperature and weight. [ Time Frame: From Screen up to 3 months ]
    The primary objectives of the study are to assess the safety, tolerability and effect on microglia activation of AZD3241 versus placebo in MSA subjects.
  • Assessment of the safety and tolerability of AZD3241 in MSA Subjects via ECG. [ Time Frame: From Screen up to 3 months ]
    The primary objectives of this study are to assess the safety, tolerability and effect on microglia activation of AZD3241 versus placebo in MSA subjects.
  • Assessment of the safety and tolerability of AZD3241 in MSA subjects via clinical laboratory tests (chemistry, hematology and urinalysis) [ Time Frame: From Screen up to 3 months ]
    The primary objectives of the study are to assess the safety, tolerability and effect on microglia activation of AZD3241 versus placebo in MSA Subjects.
  • Assessment of the safety and tolerability of AZD3241 in MSA Subjects via neurological and psychiatric exams. [ Time Frame: From Screen up to 3 months ]
    The primary objectives of the study are to assess the

    Original Primary Outcome:

    • Assessment of the safety and tolerability of AZD3241 in MSA subjects via Adverse Events [ Time Frame: From Screen up to 3 months ]
      The primary objectives of the study are to assess the safety, tolerability and effect on microglia activation of AZD3241 versus placebo in MSA subjects.
    • Assessment of the safety and tolerability of AZD3241 in MSA subjects via Vital Signs (blood pressure and pulse) as well as body temperature and weight. [ Time Frame: From Screen up to 3 months ]
      The primary objectives of the study are to assess the safety, tolerability and effect on microglia activation of AZD3241 versus placebo in MSA subjects.
    • Assessment of the safety and tolerability of AZD3241 in MSA Subjects via ECG. [ Time Frame: From Screen up to 3 months ]
      The primary objectives of this study are to assess the safety, tolerability and effect on microglia activation of AZD3241 versus placebo in MSA subjects.
    • Assessment of the safety and tolerability of AZD3241 in MSA subjects via clinical laboratory tests (chemistry, hematology and urinalysis) [ Time Frame: From Screen up to 3 months ]
      The primary objectives of the study are to assess the safety, tolerability and effect on microglia activation of AZD3241 versus placebo in MSA Subjects.
    • Assessment of the safety and tolerability of AZD3241 in MSA Subjects via neurological and psychiatric exams. [ Time Frame: From Screen up to 3 months ]
      The primary objectives of the study are to assess the

      Current Secondary Outcome: Assessment of the biomarker effects of AZD3241 versus placebo in MSA subjects via assay of myeloperoxidase activity. [ Time Frame: From Screen up to 3 months ]

      A secondary objective is to determine the biomarker effects of AZD3241 in MSA subjects.


      Original Secondary Outcome: Same as current

      Information By: AstraZeneca

      Dates:
      Date Received: March 9, 2015
      Date Started: April 2015
      Date Completion:
      Last Updated: October 25, 2016
      Last Verified: October 2016