WHO ICTRP trial
Long-term open-label study of botulinumtoxin type A to treat spasticity of…
EUCTR2012-005055-17-AT · EU Clinical Trials Register · Not Recruiting
Key facts
| Trial ID | EUCTR2012-005055-17-AT |
|---|---|
| Public title | Long-term open-label study of botulinumtoxin type A to treat spasticity of leg(s) or leg(s) and arm in cerebral palsy |
| Scientific title | Open-label, non-controlled, multicenter long-term study to investigate the safety and efficacy of Xeomin® (incobotulinumtoxin A, NT 201) for the treatment of spasticity of the lower limb(s) or of combined spasticity of upper and lower limb in children and adolescents (age 2 - 17 years) with cerebral… |
| Primary sponsor | Merz Pharmaceuticals GmbH |
| Registry | EU Clinical Trials Register |
| Recruitment status | Not Recruiting |
| Study type | Interventional clinical trial of medicinal product |
| Phase | Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no |
| Countries | Estonia;Slovakia;Spain;Ukraine;Turkey;Austria;Russian Federation;Israel;Czech Republic;Poland;Romania;Australia;Germany;New Zealand;Korea, Republic of |
| Conditions | Lower limb and combined lower limb and upper limb spasticity due to cerebral palsy MedDRA version: 18.0 Level: LLT Classification code 10058977 Term: Spastic paresis System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous… |
| Interventions | Trade Name: Xeomin Product Name: NT 201 Product Code: NT 201 Pharmaceutical Form: Powder for solution for injection INN or Proposed INN: n.a Current Sponsor code: NT 101 Other descriptive name: CLOSTRIDIUM BOTULINUM NEUROTOXIN TYPE A… |
| Registration date | Mar 26, 2013 |
| Target size | 360 |
| Secondary IDs | MRZ60201_3071_1 |
| Registry page | clinicaltrialsregister.eu |
At a glance
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About WHO ICTRP trial registrations
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: