Completed PHASE3 INTERVENTIONAL 3-arm NCT01603628

BOTOX® Treatment in Pediatric Lower Limb Spasticity

BOTOX® Treatment in Pediatric Lower Limb Spasticity: Double-blind Study

Sponsor: Allergan

Conditions Cerebral Palsy Muscle Spasticity Pediatrics

Interventions Normal Saline (Placebo) botulinum toxin Type A

Updated 9 times since 2017 Last updated: Jul 16, 2018 Started: Sep 11, 2012 Primary completion: Jun 28, 2017 Completion: Jun 28, 2017

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT01603628, this PHASE3 trial focuses on Cerebral Palsy and Muscle Spasticity and remains completed. Sponsored by Allergan, it has been updated 9 times since 2012, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Status Flow

Change History

9 versions recorded

Sep 2025 — Present [monthly]

Completed PHASE3
Sep 2024 — Sep 2025 [monthly]

Completed PHASE3
Jul 2024 — Sep 2024 [monthly]

Completed PHASE3
Jan 2021 — Jul 2024 [monthly]

Completed PHASE3
Sep 2018 — Jan 2021 [monthly]

Completed PHASE3

▶ Show 4 earlier versions

Jun 2018 — Sep 2018 [monthly]

Completed PHASE3
Oct 2017 — Jun 2018 [monthly]

Completed PHASE3

Status: Recruiting → Completed
Feb 2017 — Oct 2017 [monthly]

Recruiting PHASE3
Jan 2017 — Feb 2017 [monthly]

Recruiting PHASE3

First recorded

Sep 2012

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Allergan

Data source: Allergan

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

Study Locations

Ankara, Turkey (Türkiye) , Atlanta, United States , Aurora, United States , Bialystok, Poland , Budapest, Hungary , Charlotte, United States , Chiang Mai, Thailand , Chicago, United States , Daegu, South Korea , Dallas, United States and 33 more locations