Trials / Completed
CompletedNCT01893411
Dose-response Study of Efficacy and Safety of Botulinum Toxin Type A to Treat Spasticity of the Leg(s) in Cerebral Palsy
Prospective, Multicenter, Randomized, Double-blind, Parallel-group, Dose-response Study of Three Doses Xeomin® (incobotulinumtoxinA, NT 201) for the Treatment of Lower Limb Spasticity in Children and Adolescents (Age 2 - 17 Years) With Cerebral Palsy
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 311 (actual)
- Sponsor
- Merz Pharmaceuticals GmbH · Industry
- Sex
- All
- Age
- 2 Years – 17 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to determine whether injections of Botulinum toxin type A into muscles of the leg(s) are effective in treating children/adolescents (age 2-17 years) with increased muscle tension/uncontrollable muscle stiffness (spasticity) due to cerebral palsy.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | IncobotulinumtoxinA (16 Units per kg body weight) | Active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins. Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl); Total volume 8.0 mL; 400 units; Mode of administration: intramuscular injection into spastic muscles. |
| DRUG | IncobotulinumtoxinA (12 Units per kg body weight) | Active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins. Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl); Total volume 8.0 mL; 300 units; Mode of administration: intramuscular injection into spastic muscles. |
| DRUG | IncobotulinumtoxinA (4 Units per kg body weight) | Active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins. Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl); Total volume 8.0 mL; 100 units; Mode of administration: intramuscular injection into spastic muscles. |
Timeline
- Start date
- 2013-06-01
- Primary completion
- 2015-08-01
- Completion
- 2016-05-01
- First posted
- 2013-07-09
- Last updated
- 2021-08-05
- Results posted
- 2017-05-12
Locations
53 sites across 14 countries: Austria, Czechia, Estonia, France, Germany, Israel, Poland, Romania, Russia, Slovakia, South Korea, Spain, Turkey (Türkiye), Ukraine
Source: ClinicalTrials.gov record NCT01893411. Inclusion in this directory is not an endorsement.