deltatrials
Completed PHASE3 INTERVENTIONAL 2-arm NCT04508621

A Phase 3 Study To Evaluate The Efficacy And Safety Of TNX-102 SL In Patients With Fibromyalgia (RALLY)

A Phase 3, Double-Blind, Randomized, Multicenter, Placebo-Controlled Study To Evaluate The Efficacy And Safety Of TNX-102 SL Taken Daily At Bedtime In Patients With Fibromyalgia

Sponsor: Tonix Pharmaceuticals, Inc.

Conditions Fibromyalgia
Updated 12 times since 2020 Last updated: Dec 13, 2023 Started: Jul 22, 2020 Primary completion: Nov 1, 2021 Completion: Nov 1, 2021
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT04508621, this PHASE3 trial focuses on Fibromyalgia and remains completed. Sponsored by Tonix Pharmaceuticals, Inc., it has been updated 12 times since 2020, reflecting substantial change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Status Flow

~Sep 2020 – ~Oct 2020 · 30 days · monthly snapshotNot Yet Recruiting~Oct 2020 – ~Nov 2020 · 31 days · monthly snapshotRecruiting~Nov 2020 – ~Dec 2020 · 30 days · monthly snapshotRecruiting~Dec 2020 – ~Jan 2021 · 31 days · monthly snapshotRecruiting~Jan 2021 – ~Apr 2021 · 3 months · monthly snapshotRecruiting~Apr 2021 – ~Sep 2021 · 5 months · monthly snapshotRecruiting~Sep 2021 – ~Jan 2022 · 4 months · monthly snapshotActive Not Recruiting~Jan 2022 – ~Jan 2023 · 12 months · monthly snapshotTerminated~Jan 2023 – ~Jan 2024 · 12 months · monthly snapshotTerminated~Jan 2024 – ~Jul 2024 · 6 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – present · 19 months · monthly snapshotCompleted

Change History

12 versions recorded
  1. Sep 2024 — Present [monthly]

    Completed PHASE3

  2. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE3

  3. Jan 2024 — Jul 2024 [monthly]

    Completed PHASE3

    Status: TerminatedCompleted

  4. Jan 2023 — Jan 2024 [monthly]

    Terminated PHASE3

  5. Jan 2022 — Jan 2023 [monthly]

    Terminated PHASE3

    Status: Active Not RecruitingTerminated

Show 7 earlier versions
  1. Sep 2021 — Jan 2022 [monthly]

    Active Not Recruiting PHASE3

    Status: RecruitingActive Not Recruiting

  2. Apr 2021 — Sep 2021 [monthly]

    Recruiting PHASE3

  3. Jan 2021 — Apr 2021 [monthly]

    Recruiting PHASE3

  4. Dec 2020 — Jan 2021 [monthly]

    Recruiting PHASE3

  5. Nov 2020 — Dec 2020 [monthly]

    Recruiting PHASE3

  6. Oct 2020 — Nov 2020 [monthly]

    Recruiting PHASE3

    Status: Not Yet RecruitingRecruiting

  7. Sep 2020 — Oct 2020 [monthly]

    Not Yet Recruiting PHASE3

    First recorded

Jul 2020

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Tonix Pharmaceuticals, Inc.
Data source: Tonix Pharmaceuticals, Inc.

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