deltatrials
Terminated PHASE2/PHASE3 INTERVENTIONAL 1-arm NCT01433354

Long-term, Safety and Tolerability Study of AFQ056 in Adolescent Patients With Fragile X Syndrome (Open-label)

An Open-label Study to Evaluate the Long-term Safety and Tolerability of AFQ056 in Adolescent Patients With Fragile X Syndrome

Sponsor: Novartis Pharmaceuticals

Interventions AFQ056
Updated 11 times since 2017 Last updated: Feb 24, 2016 Started: Nov 30, 2011 Primary completion: Sep 30, 2014 Completion: Sep 30, 2014
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

The study treatment failed to demonstrate efficacy in target population in two other clinical studies (CAFQ056B2214 and CAFQ056A2212).

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Listed as NCT01433354, this PHASE2/PHASE3 trial focuses on Fragile X Syndrome and remains terminated or withdrawn. Sponsored by Novartis Pharmaceuticals, it has been updated 11 times since 2011, reflecting substantial change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshotTerminated~Feb 2017 – ~Aug 2017 · 6 months · monthly snapshotTerminated~Aug 2017 – ~May 2018 · 9 months · monthly snapshotTerminated~May 2018 – ~Jun 2018 · 31 days · monthly snapshotTerminated~Jun 2018 – ~Nov 2020 · 29 months · monthly snapshotTerminated~Nov 2020 – ~Jan 2021 · 2 months · monthly snapshotTerminated~Jan 2021 – ~Dec 2021 · 11 months · monthly snapshotTerminated~Dec 2021 – ~Jul 2024 · 31 months · monthly snapshotTerminated~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotTerminated~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshotTerminated~Sep 2025 – present · 11 months · monthly snapshotTerminated

Change History

11 versions recorded
  1. Sep 2025 — Present [monthly]

    Terminated PHASE2/PHASE3

  2. Sep 2024 — Sep 2025 [monthly]

    Terminated PHASE2/PHASE3

  3. Jul 2024 — Sep 2024 [monthly]

    Terminated PHASE2/PHASE3

    Phase: PHASE2_PHASE3PHASE2/PHASE3

  4. Dec 2021 — Jul 2024 [monthly]

    Terminated PHASE2_PHASE3

  5. Jan 2021 — Dec 2021 [monthly]

    Terminated PHASE2_PHASE3

Show 6 earlier versions
  1. Nov 2020 — Jan 2021 [monthly]

    Terminated PHASE2_PHASE3

  2. Jun 2018 — Nov 2020 [monthly]

    Terminated PHASE2_PHASE3

  3. May 2018 — Jun 2018 [monthly]

    Terminated PHASE2_PHASE3

  4. Aug 2017 — May 2018 [monthly]

    Terminated PHASE2_PHASE3

  5. Feb 2017 — Aug 2017 [monthly]

    Terminated PHASE2_PHASE3

  6. Jan 2017 — Feb 2017 [monthly]

    Terminated PHASE2_PHASE3

    First recorded

Nov 2011

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Novartis Pharmaceuticals
Data source: Novartis

For direct contact, visit the study record on ClinicalTrials.gov .