deltatrials
Completed PHASE3 INTERVENTIONAL 1-arm NCT01603459

Efficacy and Safety Dose Titration Study of Botulinum Toxin Type A to Treat Spasticity in the Leg and Arm

Prospective, Open-label, Non-randomized, Single-arm, Multi-center Dose Titration Study to Investigate the Safety and Efficacy of NT 201 in Subjects Deemed to Require Total Body Doses of 800 U of NT 201 During the Course of the Study for the Treatment of Upper and Lower Limb Spasticity of the Same Body Side Due to Cerebral Causes

Sponsor: Merz Pharmaceuticals GmbH

Interventions IncobotulinumtoxinA
Updated 7 times since 2017 Last updated: Mar 27, 2017 Started: May 31, 2012 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.

A PHASE3 clinical study on Spasticity of the Upper and Lower Limb Due to Cerebral Causes, this trial is completed. The trial is conducted by Merz Pharmaceuticals GmbH and has accumulated 7 data snapshots since 2012. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshotCompleted~Feb 2017 – ~Jun 2018 · 16 months · monthly snapshotCompleted~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotCompleted~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshotCompleted~Sep 2025 – present · 10 months · monthly snapshotCompleted

Change History

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

    Completed PHASE3

  2. Sep 2024 — Sep 2025 [monthly]

    Completed PHASE3

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE3

  4. Jan 2021 — Jul 2024 [monthly]

    Completed PHASE3

  5. Jun 2018 — Jan 2021 [monthly]

    Completed PHASE3

Show 2 earlier versions
  1. Feb 2017 — Jun 2018 [monthly]

    Completed PHASE3

  2. Jan 2017 — Feb 2017 [monthly]

    Completed PHASE3

    First recorded

May 2012

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Merz Pharmaceuticals GmbH
Data source: Merz Pharmaceuticals GmbH

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