Clinical Study to Investigate the Efficacy and Safety of NT 201 Compared to Placebo in the Treatment of Chronic Troublesome Drooling Associated With Neurological Disorders and/or Intellectual Disability

PHASE3CompletedINTERVENTIONAL
Enrollment

256

Participants

Timeline

Start Date

February 9, 2015

Primary Completion Date

February 23, 2018

Study Completion Date

May 7, 2019

Conditions
Chronic Troublesome SialorrheaCerebral PalsyStrokeTraumatic Brain InjuryIntellectual Disability
Interventions
DRUG

NT 201 Placebo

NT 201 placebo matching injection.

DRUG

NT 201

NT 201 injection.

Trial Locations (31)

1083

Merz Investigational Site #0360013, Budapest

1125

Merz Investigational Site # 0360014, Budapest

Merz Investigational Site # 0360015, Budapest

1146

Merz Investigational Site #0360018, Budapest

2660

Merz Investigational Site #0360017, Balassagyarmat

6200

Merz Investigational Site #9950003, K'obulet'i

9700

Merz Investigational Site #0360016, Szombathely

11040

Merz Investigational Site #3810001, Belgrade

46020

Merz Investigational Site #3800009, Ternopil

49027

Merz Investigational Site #3800001, Dnipropetrovsk

61068

Merz Investigational Site #3800005, Kharkiv

61153

Merz Investigational Site #3800007, Kharkiv

65012

Merz Investigational site #3800003, Odesa

69063

Merz Investigational Site #3800011, Zaporizhzhya

73010

Merz Investigational Site #3800013, Kherson

76014

Merz Investigational Site #3800012, Ivano-Frankivsk

194100

Merz Investigational # 0070017, Saint Petersburg

214018

Merz Investigational Site #0070013, Smolensk

355029

Merz Investigational Site # 070019, Stavropol

420012

Merz Investigational Site #0070016, Kazan'

620149

Merz Investigational Site #0070301, Yekaterinburg

634052

Merz Investigational Site #0070300, Tomsk

650066

Merz Investigational Site # 0070288, Kemerovo

680038

Merz Investigational Site #0070290, Khabarovsk

0159

Merz Investigational Site #9950001, Tbilisi

Merz Investigational Site #9950002, Tbilisi

15-274

Merz Investigational Site #0480092, Bialystok

80-952

Merz Investigational Site #0480090, Gdansk

40-954

Merz Investigational Site #0480076, Katowice

30-359

Merz Investigational Site #0480059, Krakow

05-462

Merz Investigational Site #0480060, Wiązowna

Sponsors
All Listed Sponsors
lead

Merz Pharmaceuticals GmbH

INDUSTRY

NCT02270736 - Clinical Study to Investigate the Efficacy and Safety of NT 201 Compared to Placebo in the Treatment of Chronic Troublesome Drooling Associated With Neurological Disorders and/or Intellectual Disability | Biotech Hunter | Biotech Hunter