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 (SIPEXI)
Prospective, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study With an Open-label Extension Period to Investigate the Efficacy and Safety of NT 201 in the Treatment of Children and Adolescents (2-17 Years) With Chronic Troublesome Sialorrhea Associated With Neurological Disorders, and/or Intellectual Disability
Sponsor: Merz Pharmaceuticals GmbH
This PHASE3 trial investigates Cerebral Palsy and Chronic Troublesome Sialorrhea and is currently completed. Merz Pharmaceuticals GmbH leads this study, which shows 24 recorded versions since 2015 — indicating substantial longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.
Status Flow
Change History
24 versions recorded-
Sep 2025 — Present [monthly]
Completed PHASE3
-
Sep 2024 — Sep 2025 [monthly]
Completed PHASE3
-
Jul 2024 — Sep 2024 [monthly]
Completed PHASE3
-
Sep 2021 — Jul 2024 [monthly]
Completed PHASE3
-
Feb 2021 — Sep 2021 [monthly]
Completed PHASE3
▶ Show 19 earlier versions
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Jan 2021 — Feb 2021 [monthly]
Completed PHASE3
-
Aug 2019 — Jan 2021 [monthly]
Completed PHASE3
-
Jul 2019 — Aug 2019 [monthly]
Completed PHASE3
Status: Active Not Recruiting → Completed
-
Jun 2019 — Jul 2019 [monthly]
Active Not Recruiting PHASE3
-
May 2019 — Jun 2019 [monthly]
Active Not Recruiting PHASE3
-
Mar 2019 — May 2019 [monthly]
Active Not Recruiting PHASE3
-
Jan 2019 — Mar 2019 [monthly]
Active Not Recruiting PHASE3
-
Dec 2018 — Jan 2019 [monthly]
Active Not Recruiting PHASE3
-
Nov 2018 — Dec 2018 [monthly]
Active Not Recruiting PHASE3
-
Oct 2018 — Nov 2018 [monthly]
Active Not Recruiting PHASE3
-
Sep 2018 — Oct 2018 [monthly]
Active Not Recruiting PHASE3
-
Jul 2018 — Sep 2018 [monthly]
Active Not Recruiting PHASE3
-
Jun 2018 — Jul 2018 [monthly]
Active Not Recruiting PHASE3
-
Apr 2018 — Jun 2018 [monthly]
Active Not Recruiting PHASE3
Status: Recruiting → Active Not Recruiting
-
Oct 2017 — Apr 2018 [monthly]
Recruiting PHASE3
-
Sep 2017 — Oct 2017 [monthly]
Recruiting PHASE3
-
Aug 2017 — Sep 2017 [monthly]
Recruiting PHASE3
-
Feb 2017 — Aug 2017 [monthly]
Recruiting PHASE3
-
Jan 2017 — Feb 2017 [monthly]
Recruiting PHASE3
First recorded
Feb 2015
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Merz Pharmaceuticals GmbH
For direct contact, visit the study record on ClinicalTrials.gov .
Study Locations
Balassagyarmat, Hungary , Belgrade, Serbia , Bialystok, Poland , Budapest, Hungary , Dnipropetrovsk, Ukraine , Gdansk, Poland , Ivano-Frankivsk, Ukraine , K'obulet'i, Georgia , Katowice, Poland , Kazan', Russia and 16 more locations