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Efficacy and Safety of Masitinib Versus Placebo in the Treatment of ALS Patients

StatusRecruiting
PhasePhase 3
SponsorAB Science
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary and study completion dates: Dec 2023 to Dec 2027v13
  2. Study sites: 44 to 56v12
  3. Primary and study completion dates: Dec 2022 to Dec 2023 Start date: Oct 1, 2020 to Feb 2, 2021 · Study sites: 2 to 44 · Secondary endpoints: 4 to 5v11 Show 3 more changesShow less
    • Start date: Oct 1, 2020 to Feb 2, 2021
    • Study sites: 2 to 44
    • Secondary endpoints: 4 to 5

    See this version in full on ClinicalTrials.gov ↗

  4. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Jun 2020 to Oct 1, 2020 · Study sites: 1 to 2 · Primary completion date: Jun 2022 to Dec 2022 · 1 morev10 Show 4 more changesShow less
    • Start date changed from estimate of Jun 2020 to Oct 1, 2020
    • Study sites: 1 to 2
    • Primary completion date: Jun 2022 to Dec 2022
    • Completion date: Sep 2022 to Dec 2022
  5. Primary completion date: Dec 31, 2022 to Jun 2022 Completion date: Dec 31, 2023 to Sep 2022 · Start date: Sep 30, 2020 to Jun 2020v9 Show 2 more changesShow less
    • Completion date: Dec 31, 2023 to Sep 2022
    • Start date: Sep 30, 2020 to Jun 2020
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  1. Primary completion date: Jun 30, 2022 to Dec 31, 2022 Start date: May 2020 to Sep 30, 2020 · Completion date: Jun 30, 2023 to Dec 31, 2023v8 Show 2 more changesShow less
    • Start date: May 2020 to Sep 30, 2020
    • Completion date: Jun 30, 2023 to Dec 31, 2023
  2. Primary completion date: Nov 2021 to Jun 30, 2022 Start date: Mar 2020 to May 2020 · Completion date: Nov 2024 to Jun 30, 2023 · Study site revisedv7 Show 3 more changesShow less
    • Start date: Mar 2020 to May 2020
    • Completion date: Nov 2024 to Jun 30, 2023
    • Study site revised

    See this version in full on ClinicalTrials.gov ↗

  3. Start date: Nov 2019 to Mar 2020 Primary completion date: May 2021 to Nov 2021 · Completion date: May 2024 to Nov 2024v6 Show 2 more changesShow less
    • Primary completion date: May 2021 to Nov 2021
    • Completion date: May 2024 to Nov 2024
  4. Start date: May 2019 to Nov 2019v5
  5. Re-verified, no change to tracked fieldsv4
  6. Study sites: 0 to 1v3
  7. Primary completion date: Sep 1, 2018 to May 2021 Start date: Sep 1, 2017 to May 2019 · Primary endpoint revised · Enrollment target: 406 to 495 · 7 morev2 Show 10 more changesShow less
    • Start date: Sep 1, 2017 to May 2019
    • Primary endpoint revised
    • Enrollment target: 406 to 495
    • Completion date: Sep 1, 2019 to May 2024
    • Interventions: Masitinib Mesylate (Drug), Placebo Oral Tablet (Drug), Riluzole 50Mg Tablet (Drug) to Masitinib (4.5) (Drug), Masitinib (6.0) (Drug), Placebo (Drug), Riluzole (Drug)
    • Eligibility criteria expanded, about 164 words
    • Secondary endpoints: 1 to 4
    • Study description expanded, about 141 words
    • Study title shortened, about 6 words
    • Study arms: 2 to 3

    See this version in full on ClinicalTrials.gov ↗

  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
AB Science
5 trials monitored
See all monitored trials
ALS
387 trials monitored
See 18 trials at risk
The objective is to compare the efficacy and safety of masitinib in combination with riluzole versus matched placebo in combination with riluzole for the treatment of Amyotrophic Lateral Sclerosis (ALS).
Trial Details
NCT Number NCT03127267
Lead Sponsor AB Science
Conditions Amyotrophic Lateral Sclerosis
Enrollment 495 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov