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NCT01994109 · ClinicalTrials.gov registry record · Phase 3

Efficacy and Safety Study of MYOBLOC® Followed by Open-Label Multiple-Treatment With MYOBLOC® in the Treatment of Troublesome Sialorrhea in Adult Subjects

A Phase 3 study of Sialorrhea, sponsored by Supernus Pharmaceuticals.

Completed
Registry status
Phase 3
Development phase
187
Enrollment target
20
Study locations

NCT01994109 is a Phase 3 study of Sialorrhea that has completed, run by Supernus Pharmaceuticals. The registered enrollment target is 187 participants. The trial reports 20 study locations across 15 states.

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The verdict

NCT01994109, a Phase 3 study of Sialorrhea, has completed, sponsored by Supernus Pharmaceuticals.

COMPLETED
Registry status
Phase 3
Development phase
187 participants
Enrollment target
20
Study locations

Study Summary

This study will evaluate the efficacy and safety of MYOBLOC in the treatment of Sialorrhea (drooling), which can be a symptom of many disease conditions. MYOBLOC will be injected directly into the salivary glands. MYOBLOC has been shown in previous trials to safely decrease saliva production, thereby demonstrating its potential as a safe and effective treatment for troublesome sialorrhea.

Conditions Studied

Interventions

  • DRUG MYOBLOC
  • OTHER PLACEBO

Study Locations (20)

California

  • - Loma Linda
  • - Los Angeles
  • - National City

Florida

  • - Boca Raton
  • - Port Charlotte

Maryland

  • - Baltimore
  • - Elkridge

New York

  • - Albany
  • - New York

Colorado

  • - Aurora

District of Columbia

  • - Washington D.C.

Indiana

  • - Carmel

Michigan

  • - Detroit

Trial Details

FieldValue
Enrollment Target 187 participants
Start Date 2013-11
Est. Completion 2017-01
Phase Phase 3

Sponsor

Supernus Pharmaceuticals

57 total trials

What the Registry Record Tells You About NCT01994109

The ClinicalTrials.gov registry entry for NCT01994109 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 187 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Supernus Pharmaceuticals, which has 57 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Sialorrhea appearing as the primary indexed condition, and to 2 interventions - of which MYOBLOC is the first listed.

NCT01994109 reports 20 study locations spanning 15 distinct geographic areas - top geographies include California, Florida, Maryland.

Frequently Asked Questions

What is clinical trial NCT01994109 about?

NCT01994109 is a clinical study titled "Efficacy and Safety Study of MYOBLOC® Followed by Open-Label Multiple-Treatment With MYOBLOC® in the Treatment of Troublesome Sialorrhea in Adult Subjects". This study will evaluate the efficacy and safety of MYOBLOC in the treatment of Sialorrhea (drooling), which can be a symptom of many disease conditions. MYOBLOC will be injected directly into the salivary glands. MYOBLOC has been shown in previous trials to safely decrease saliva production, thereb...

What is the current status of trial NCT01994109?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 187 participants. The study started on 2013-11. Estimated completion is 2017-01.

What conditions does trial NCT01994109 study?

This clinical trial studies the following conditions: Sialorrhea.

What interventions are being tested in trial NCT01994109?

The interventions under investigation include: MYOBLOC (DRUG), PLACEBO (OTHER).

Who is sponsoring clinical trial NCT01994109?

This trial is sponsored by Supernus Pharmaceuticals, which has 57 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01994109 being conducted?

This trial has 20 study locations across California, Colorado, District of Columbia, Florida, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.