CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 90 enrolled
Drug / intervention
Nuedexta +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01806857
NCT01806857Phase 2Completed
CompareCT.gov

The Experimental Treatment of Bulbar Dysfunction in Amyotrophic Lateral Sclerosis (ALS)

Center for Neurologic Study, La Jolla, California,·interventional·Posted Mar 7, 2013·Updated Mar 24, 2017

In Brief

A Phase 2 clinical trial evaluating Nuedexta and Matching Placebo for Amyotrophic Lateral Sclerosis (ALS). Completed, enrolled 90 participants across 7 sites.

Detailed Summary

The purpose of this study is to determine whether Nuedexta is effective in the treatment of symptoms (impaired speech, swallowing, and saliva control)associated with Amyotrophic Lateral Sclerosis (ALS).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAmyotrophic Lateral Sclerosis (ALS)
CountriesUnited States
CollaboratorsALS Association, State University of New York - Upstate Medical University

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedMar 7, 2013
Enrollment StartApr 1, 2013
Primary CompletionMar 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 13.3 years ago

Interventions

Nuedextadrug

Nuedexta PO (by mouth) for 28 ± 3 days

Matching Placebodrug

matching placebo PO (by mouth) for 28 ± 3 days