Trials / Completed
CompletedNCT01603628
BOTOX® Treatment in Pediatric Lower Limb Spasticity
BOTOX® Treatment in Pediatric Lower Limb Spasticity: Double-blind Study
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 384 (actual)
- Sponsor
- Allergan · Industry
- Sex
- All
- Age
- 2 Years – 16 Years
- Healthy volunteers
- Not accepted
Summary
This study will evaluate the safety and efficacy of BOTOX® (botulinum toxin Type A) in pediatric patients with lower limb spasticity.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | botulinum toxin Type A | Participants received intramuscular injections of botulinum toxin Type A into specified muscles of the lower limb on Day 1. |
| DRUG | Normal Saline (Placebo) | Participants received intramuscular injections of normal saline (placebo) into specified muscles of the lower limb on Day 1. |
Timeline
- Start date
- 2012-09-11
- Primary completion
- 2017-06-28
- Completion
- 2017-06-28
- First posted
- 2012-05-22
- Last updated
- 2018-08-14
- Results posted
- 2018-08-14
Locations
53 sites across 9 countries: United States, Hungary, Italy, Philippines, Poland, Russia, South Korea, Thailand, Turkey (Türkiye)
Source: ClinicalTrials.gov record NCT01603628. Inclusion in this directory is not an endorsement.