NCT02002884 - 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 | Biotech Hunter

Enrollment

351

Participants

Timeline

Start Date

March 28, 2014

Primary Completion Date

July 4, 2017

Study Completion Date

August 28, 2018

Conditions

Cerebral PalsySpasticity

Interventions

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)

DRUG

IncobotulinumtoxinA (2 Units per kg body weight)

Trial Locations (32)

20127

Merz Investigational Site #052023, Aguascalientes

31405

Merz Investigational Site #001285, Savannah

32561

Merz Investigational Site #001286, Gulf Breeze

33470

Merz Investigational Site #001284, Loxahatchee Groves

44280

Merz Investigational Site #052003, Guadalajara

45030

Merz Investigational Site #052026, Zapopan

48073

Merz Investigational Site No. #001302, Royal Oak

49000

Merz Investigational Site #380001, Dnipropetrovsk

60611

Merz Investigational Site #001186, Chicago

61068

Merz Investigational Site #380005, Kharkiv

64060

Merz Investigational Site #052027, Monterrey

64710

Merz Investigational Site #052028, Monterrey

65012

Merz Investigational Site #380003, Odesa

65212

Merz Investigational Site #001283, Columbia

192148

Merz Investigational Site #007298, Saint Petersburg

214019

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

M5501

Merz Investigational Site #054010, Godoy Cruz

CP 1428

Merz Investigational Site #054005, Caba

04530

Merz Investigational Site #052024, Mexico City

06700

Merz Investigational Site #052022, Mexico City

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

60-480

Merz Investigational Site #048094, Poznan

27-600

Merz Investigational Site #048075, Sandomierz

05-462

Merz Investigational Site #048060, Wiązowna

04209

Merz Investigational Site #380002, Kyiv