NCT02091739 - Clinical Study to Investigate the Efficacy and Safety of Two Dose Levels of NT 201 Versus Placebo in Treating Chronic Troublesome Sialorrhea in Various Neurological Conditions | Biotech Hunter

Enrollment

184

Participants

Timeline

Start Date

April 30, 2014

Primary Completion Date

August 31, 2015

Study Completion Date

November 30, 2016

Conditions

Chronic Troublesome SialorrheaParkinson's DiseasePost-strokeTraumatic Brain Injury

Interventions

DRUG

IncobotulinumtoxinA (100 Units)

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).

DRUG

IncobotulinumtoxinA (75 Units)

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).

DRUG

Placebo

Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl).

Trial Locations (31)

51588

Merz Investigational Site #049300, Nümbrecht

53105

Merz investigational site #049172, Bonn

77709

Merz Investigational Site #049333, Wolfach

80804

Merz Investigational Site #049072, Munich

81675

Merz Investigational Site #049148, Munich

83527

Merz Investigational Site #049337, Haag i.OB

89081

Merz Investigational Site #049143, Ulm

93053

Merz Investigational Site #049303, Regensburg

97080

Merz Investigational Site #049302, Würzburg

07551

Merz Investigational Site #049335, Gera

07646

Merz investigational site #049348, Stadtroda

85-015

Merz investigational site #048068, Bydgoszcz

85-080

Merz Investigational Site #048088, Bydgoszcz

80-254

Merz Investigational Site #048029, Gdansk

80-546

Merz investigational site #048074, Gdansk

43-600

Merz investigational site #048078, Jaworzno

40-097

Merz investigational site #048076, Katowice

Merz investigational site #048077, Katowice

25-103

Merz investigational Site #048067, Kielce

30-539

Merz investigational site #048059, Krakow

Merz investigational site #048085, Lublin

31-505

Merz investigational site #048031, Krakow

31-530

Merz Investigational Site #048087, Krakow

90-130

Merz Investigational Site #048022, Lodz

20-718

Merz investigational site #048070, Lublin

62-030

Merz investigational site #048072, Luboń

27-600

Merz Investigational Site #048075, Sandomierz

87-100

Merz Investigational Site #048086, Torun

00-453

Merz investigational site #048065, Warsaw

02-097

Merz investigational site #048056, Warsaw

03-242

Merz investigational site #048064, Warsaw