Trials / Completed
CompletedNCT01603641
BOTOX® Open-Label Treatment in Pediatric Lower Limb Spasticity
BOTOX® Treatment in Pediatric Lower Limb Spasticity: Open-label Study
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 370 (actual)
- Sponsor
- Allergan · Industry
- Sex
- All
- Age
- 2 Years – 17 Years
- Healthy volunteers
- Not accepted
Summary
This study will evaluate the long-term safety of BOTOX® (botulinum toxin Type A) for the treatment of pediatric lower limb spasticity.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Botulinum Toxin Type A | Participants received intramuscular injections of botulinum toxin Type A into the lower limb muscles and/or upper limb muscles at a minimum of 12 weeks apart for a maximum of 5 treatments. |
Timeline
- Start date
- 2012-11-05
- Primary completion
- 2018-08-25
- Completion
- 2018-08-25
- First posted
- 2012-05-22
- Last updated
- 2019-08-21
- Results posted
- 2019-08-21
Locations
56 sites across 9 countries: United States, Hungary, Italy, Philippines, Poland, Russia, South Korea, Thailand, Turkey (Türkiye)
Source: ClinicalTrials.gov record NCT01603641. Inclusion in this directory is not an endorsement.