NCT01603459 - Efficacy and Safety Dose Titration Study of Botulinum Toxin Type A to Treat Spasticity in the Leg and Arm | Biotech Hunter

Enrollment

155

Participants

Timeline

Start Date

May 31, 2012

Primary Completion Date

September 30, 2014

Study Completion Date

September 30, 2014

Conditions

Spasticity of the Upper and Lower Limb Due to Cerebral Causes

Interventions

DRUG

IncobotulinumtoxinA

"Subjects to receive up to 3 injection cycle, with the dose titrated from 400 units to up to 800 units.~For each injection session: solution prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), 400-800 units, volume 2.0 mL per 100 units; Mode of administration: intramuscular injection."

Trial Locations (33)

5053

Merz Investigational Site #047001, Bergen

10029

Merz Investigational Site # 001191, New York

10178

Merz Investigational Site #049298, Berlin

14547

Merz Investigational Site #049022, Beelitz-Heilstätten

20122

Merz Investigational Site # 039010, Milan

20157

Merz Investigational Site # 039015, Milan

23845

Merz Investigational Site # 039005, Lecco

28046

Merz Investigational Site #034007, Madrid

28100

Merz Investigational Site # 039017, Novara

28203

Merz Investigational Site #001238, Charlotte

29009

Merz Investigational Site #034025, Málaga

30029

Merz Investigational Site # 033050, Nîmes

33172

Merz Investigational Site # 001197, Doral

34295

Merz Investigational Site #033049, Montpellier

35385

Merz Investigational Site # 049153, Giessen

37075

Merz Investigational Site #049295, Göttingen

37134

Merz Investigational Site #039014, Verona

39008

Merz Investigational Site #034024, Santander

44195

Merz Investigational Site # 001232, Cleveland

46202

Merz Investigational Site # 001235, Indianapolis

51588

Merz Investigational Site #049300, Nümbrecht

52074

Merz Investigational Site #049191, Aachen

53226

Merz Investigational Site #001237, Milwaukee

71013

Merz Investigational Site #039016, San Giovanni Rotondo

72076

Merz Investigational Site #049296, Tübingen

83043

Merz Investigational Site #049297, Bad Aibling

92380

Merz Investigational Site # 033018, Garches

T2N 2T9

Merz Investigational Site # 001203, Calgary, AB

T5G 0B7

Merz Investigational site #001195, Edmonton, AB

06065

Merz Investigational Site #039013, Passignano sul Trasimeno

1150-199

Merz Investigational Site # 351003, Lisbon

1649-028

Merz Investigational Site # 351001, Lisbon

08242

Merz Investigational Site #034022, Manresa