NCT01392300 - Efficacy and Safety Study of Botulinum Toxin Type A Against Placebo to Treat Spasticity in the Arm After a Stroke | Biotech Hunter

Enrollment

317

Participants

Timeline

Start Date

September 30, 2011

Primary Completion Date

March 31, 2013

Study Completion Date

February 28, 2014

Conditions

Post-stroke Spasticity of the Upper Limb

Interventions

DRUG

IncobotulinumtoxinA (400 Units)

Main period: One injection session of solution, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), 400 units, total volume 8.0 mL; Mode of administration: intramuscular injection

DRUG

Placebo Comparator

Main period: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl, corresponding total placebo volume 8.0 mL; Mode of administration: intramuscular injection

Trial Locations (47)

1121

Merz Investigational Site #036004, Budapest

1204

Merz Investigational Site # 036009, Budapest

4400

Merz Investigational Site #036005, Nyíregyháza

6725

Merz Investigational Site #036008, Szeged

12000

Merz Investigational Site #420030, Prague

15006

Merz Investigational Site #420045, Prague

15213

Merz Investigational Site #001211, Pittsburgh

18147

Merz Investigational Site #049134, Rostock

19140

Merz Investigational Site #001241, Philadelphia

27157

Merz Investigational Site #001009, Winston-Salem

27599

Merz Investigational Site #001240, Chapel Hill

30912

Merz Investigational Site #001037, Augusta

33172

Merz Investigational Site #001188, Miami

37403

Merz Investigational Site #001245, Chattanooga

51601

Merz Investigational Site #420047, Rychnov nad Kněžnou

53203

Merz Investigational Site #420025, Pardubice

60611

Merz Investigational Site #001186, Chicago

62500

Merz Investigational Site #420046, Brno

65691

Merz Investigational Site #420029, Brno

66211

Merz Investigational Site # 001110, Overland Park

70852

Merz Investigational Site #420024, Ostrava-Poruba

77030

Merz Investigational Site #001226, Houston

77520

Merz Investigational Site #420028, Olomouc

90242

Merz Investigational Site #001184, Downey

92728

Merz Investigational Site #001017, Fountain Valley

105005

Merz Investigational Site #007011, Moscow

110065

Merz Investigational Site #091004, New Delhi

129019

Merz Investigational Site #007009, Saint Petersburg

226003

Merz Investigational Site #091001, Lucknow

355000

Merz Investigational Site #007005, Stavropol

560054

Merz Investigational Site #091006, Bangalore

600116

Merz Investigational Site #091003, Porur

Merz Investigational Site #091007, Chennai

641014

Merz Investigational Site #091008, Coimbatore

660037

Merz Investigational Site #007010, Krasnoyarsk

695011

Merz Investigational Site #091002, Trivandrum

08084

Merz Investigational Site #001198, Stratford

80-254

Merz Investigational Site # 048029, Gdansk

25-103

Merz Investigational Site #048044, Kielce

31-505

Merz Investigational Site #048031, Krakow

90-130

Merz Investigational Site #048050, Lodz

20-022

Merz Investigational Site #048051, Lublin

10-561

Merz Investigational Site #048032, Olsztyn

61-485

Merz Investigational Site #048053, Poznan

02-957

Merz Investigational Site #048023, Warsaw

04-141

Merz Investigational Site #048052, Warsaw

04-749

Merz Investigational Site #048033, Warsaw