NCT01905683 - Long-term Open-label Study of Botulinumtoxin Type A to Treat Spasticity of Leg(s) or Leg(s) and Arm in Cerebral Palsy | Biotech Hunter

Enrollment

370

Participants

Timeline

Start Date

August 31, 2013

Primary Completion Date

January 31, 2017

Study Completion Date

January 31, 2017

Conditions

Lower Limb and Combined Lower Limb and Upper Limb Spasticity Due to Cerebral Palsy

Interventions

DRUG

IncobotulinumtoxinA (16-20 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 dose per injection cycle: up to 500 units; Mode of administration: intramuscular injection into spastic muscles.

Trial Locations (43)

1100

Merz Investigational Site #043036, Vienna

13419

Merz Investigational Site #372001, Tallinn

23119

Merz Investigational Site #090005, Elâzığ

35100

Merz Investigational Site #090003, Izmir

41380

Merz Investigational Site #090002, İzmit

44791

Merz Investigational Site #049328, Bochum

48149

Merz Investigational Site #049329, Münster

49027

Merz Investigational Site #380001, Dnipropetrovsk

51014

Merz Investigational Site #372002, Tartu

61068

Merz Investigational Site #380005, Kharkiv

65012

Merz Investigational Site #380003, Odesa

65691

Merz Investigational Site #420029, Brno

77520

Merz Investigational Site #420028, Olomouc

80337

Merz Investigational Site #049327, Munich

82108

Merz Investigational Site #421008, Bratislava

83569

Merz Investigational Site #049326, Vogtareuth

91240

Merz Investigational Site #972003, Jerusalem

97409

Merz Investigational Site #421003, Banská Bystrica

194100

Merz Investigational Site #007017, Saint Petersburg

214029

Merz Investigational Site #007013, Smolensk

355029

Merz Investigational Site #007019, Stavropol

420097

Merz Investigational Site #007014, Kazan'

630091

Merz Investigational Site #007018, Novosibirsk

680038

Merz Investigational Site #007015, Khabarovsk

700309

Merz Investigational Site #040002, Iași

6423906

Merz Investigational Site #972001, Tel Aviv

Merz Investigational Site #972002, Tel Aviv

15-274

Merz Investigational Site #048089, Bialystok

80-389

Merz Investigational Site #048063, Gdansk

30-539

Merz Investigational Site #048059, Krakow

20-828

Merz Investigational Site #048084, Lublin

62-030

Merz Investigational Site #048072, Luboń

27-600

Merz Investigational Site #048075, Sandomierz

02-315

Merz Investigational Site #048061, Warsaw

041408

Merz Investigational Site #040003, Bucharest

041914

Merz Investigational Site #040001, Bucharest

05342

Merz Investigational Site #421006, Krompachy

05401

Merz Investigational Site #421004, Levoča

410-773

Merz Investigational Site #082019, Goyang

400-711

Merz Investigational Site #082021, Incheon

463-712

Merz Investigational Site #082018, Seongnam-si

135-710

Merz Investigational Site #082020, Seoul

04209

Merz Investigational Site #380002, Kiev