Trials / Completed
CompletedNCT02002884
Dose-response Study of Efficacy and Safety of Botulinum Toxin Type A to Treat Spasticity of the Arm(s) or of Arm(s) and 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 Upper Limb Spasticity Alone or Combined Upper and Lower Limb Spasticity in Children and Adolescents (Age 2 - 17 Years) With Cerebral Palsy
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 351 (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 one or both arms alone or in combination with injections into one or both legs are effective and safe 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 (8 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); Mode of administration: intramuscular injection into spastic muscles. |
| DRUG | IncobotulinumtoxinA (6 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); Mode of administration: intramuscular injection into spastic muscles. |
| DRUG | IncobotulinumtoxinA (2 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); Mode of administration: intramuscular injection into spastic muscles. |
Timeline
- Start date
- 2014-03-28
- Primary completion
- 2017-07-04
- Completion
- 2018-08-28
- First posted
- 2013-12-06
- Last updated
- 2021-08-05
- Results posted
- 2020-08-03
Locations
32 sites across 6 countries: United States, Argentina, Mexico, Poland, Russia, Ukraine
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02002884. Inclusion in this directory is not an endorsement.