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A Phase 3 Study to Examine the Efficacy and Safety of ZX008 in Subjects With CDKL5 Deficiency Disorder.

Study acronym: GEMZ
StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary endpoint(s) modifiedv29 Show 6 more changesShow less
    • Interventions: Matching ZX008 Placebo (Drug), ZX008 (Fenfluramine Hydrochloride) (Drug) to Fenfluramine (Drug), Placebo (Drug)
    • Eligibility criteria expanded, about 21 words
    • Secondary endpoints: 3 to 35
    • Site details revised at 4 of 46 sites
    • Study description shortened, about 1 word
    • Study title expanded, about 2 words
  2. 7 versions Re-verified since Jun 26, 2025, no change to tracked fieldsv22-v28
  3. Primary completion date: Feb 7, 2025 to Nov 8, 2027
    • Study sites: 57 to 46
    • Study completion date: Jun 16, 2026 to Nov 8, 2027
    v21
  4. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 100 to confirmed 87
    • Study sites: 63 to 57
    • Primary completion date: Feb 5, 2025 to Feb 7, 2025
    v20
  5. Study sites: 53 to 63v19
Show 17 earlier versionsHide 17 earlier versions
  1. Study sites: 52 to 53v18
  2. Study sites: 50 to 52v17
  3. Study sites: 49 to 50v16
  4. Site details revised at 2 of 49 sitesv15
  5. Study sites: 46 to 49v14
  6. Study sites: 36 to 46v13
  7. Study sites: 34 to 36v12
  8. Study sites: 31 to 34v11
  9. Study sites: 30 to 31
    • Study completion date: May 29, 2026 to Jun 16, 2026
    • Start date: Jun 1, 2022 to Mar 8, 2022
    v10
  10. Study sites: 28 to 30v9
  11. Study sites: 17 to 28
    • Primary completion date: Nov 13, 2024 to Feb 5, 2025
    • Study completion date: May 13, 2026 to May 29, 2026
    v8
  12. Re-verified, no change to tracked fieldsv7
  13. Primary completion date: May 2023 to Nov 13, 2024
    • Study sites: 3 to 17
    • Study completion date: May 2024 to May 13, 2026
    v6
  14. Re-verified, no change to tracked fieldsv5
  15. Start date changed from estimate of May 2022 to Jun 1, 2022v4
  16. Start date: Oct 2021 to May 2022
    • Study sites: 2 to 3
    v3
  17. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 2
    • Start date: Sep 2021 to Oct 2021
    v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Zogenix, Inc.
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This is a Phase 3 Study to examine the efficacy and safety of ZX008 in children and adults with cyclin-dependent kinase like-5 (CDKL5) deficiency disorder (CDD).
Trial Details
NCT Number NCT05064878
Lead Sponsor Zogenix, Inc.
Conditions
(from sponsor)		 CDKL5 Deficiency Disorder, Generalized Tonic Clonic Seizure, Epileptic Spasm, Refractory Seizures
Related terms CDKL5 deficiency disorder, Epilepsy, Tonic-Clonic, Seizures, Spasms, Infantile
Enrollment 87 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov