NCT01464307 - Efficacy and Safety Study of Botulinum Toxin Type A Against Placebo to Treat Spasticity in the Leg After a Stroke | Biotech Hunter

Enrollment

290

Participants

Timeline

Start Date

December 31, 2011

Primary Completion Date

August 31, 2014

Study Completion Date

May 31, 2015

Conditions

Post-stroke Spasticity of the Lower 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 (53)

11803

Merz Investigational Site #001207, Plainview

12000

Merz Investigational Site #420030, Prague

14547

Merz Investigational Site #049022, Beelitz-Heilstätten

20246

Merz Investigational Site #049079, Hamburg

24105

Merz Investigational Site #049304, Kiel

27157

Merz Investigational Site #001009, Winston-Salem

28040

Merz Investigational Site #034027, Madrid

28222

Merz Investigational Site #034028, Majadahonda

33172

Investigational site #001188, Doral

35043

Merz Investigational Site #033024, Rennes

37232

Merz Investigational Site #001206, Nashville

40225

Merz Investigational Site #049071, Düsseldorf

41009

Merz Investigational Site #034026, Seville

41013

Merz Investigational Site #034030, Seville

51601

Merz Investigational Site #420047, Rychnov nad Kněžnou

63110

Merz Investigational Site #001210, St Louis

65212

Merz Investigational Site #001209, Columbia

66211

Merz Investigational Site # 001110, Overland Park

70384

Merz Investigational Site #420031, Ostrava-Vitkovice

70852

Merz Investigational Site #420024, Ostrava-Poruba

77030

Merz Investigational Site #001183, Houston

80804

Merz Investigational Site #049072, München

81675

Merz Investigational Site #049148, München

90242

Merz Investigational Site #001184, Downey

90806

Merz Investigational Site #001208, Long Beach

92380

Merz Investigational Site #033018, Garches

93053

Merz Investigational Site #049303, Regensburg

97080

Merz Investigational Site #049302, Würzburg

98125

Merz Investigational Site #039006, Messina

105005

Merz Investigational Site #007011, Moscow

129019

Merz Investigational Site #007009, Saint Petersburg

355000

Merz Investigational Site #007012, Stavropol

660037

Merz Investigational Site #007010, Krasnoyarsk

06824

Merz Investigational Site #001244, Fairfield

08084

Merz Investigational Site #001198, Stratford

B3H 4K4

Merz Investigational Site #001204, Halifax

MB R3A 1M4

Merz Investigational Site #001202, Winnipeg

00168

Merz Investigational Site #039011, Roma

00189

Merz Investigational Site #039012, Roma

80-462

Merz Investigational Site #048057, Gdansk

25-103

Merz Investigational Site #048044, Kielce

30-349

Merz Investigational Site #048080, Krakow

30-510

Merz Investigational Site #048054, Krakow

31-505

Merz Investigational Site #048031, Krakow

90-130

Merz Investigational Site #048022, Lodz

20-022

Merz Investigational Site #048051, Lublin

61-485

Merz Investigational Site #048053, Poznan

61-853

Merz Investigational Site #048081, Poznan

01-697

Merz Investigational Site #048055, Warsaw

02-957

Merz Investigational Site #048023, Warsaw

02097

Merz Investigational Site #048056, Warsaw

04-749

Merz Investigational Site #048033, Warsaw

08221

Merz Investigational Site #034029, Terrassa