CompletedPhase 3

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

Germany184 participantsStarted 2014-04

Plain-language summary

The objective of this study is to investigate the efficacy and safety of two different dose levels of NT 201 (75 U or 100 U per cycle), compared with placebo, in reducing the salivary flow rate, and the severity and frequency of chronic troublesome sialorrhea that occurs as a result of various neurological conditions in adult subjects.

Who can participate

Age range18 Years – 80 Years

SexALL

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Inclusion criteria

✓. A Drooling Severity and Frequency Scale \[DSFS\] sum score of at least 6 points and
✓. A score of at least 2 points for each item of the DSFS and
✓. A score of at least 3 points on the modified Radboud Oral Motor Inventory for Parkinson's Disease \[mROMP\], Section 'III Drooling', Item A).

What they're measuring

MP: Change From Baseline in Unstimulated Salivary Flow (uSFR) Rate at Week 4

Timeframe: Baseline and Week 4

MP: Participant's Global Impression of Change Scale (GICS) at Week 4

Timeframe: Week 4

Trial details

NCT IDNCT02091739

SponsorMerz Pharmaceuticals GmbH

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2015-08

Results submitted2018-01-15

View on ClinicalTrials.gov More Chronic Troublesome Sialorrhea trials