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Riluzole Oral Soluble Film Safety and Tolerability in Amyotrophic Lateral Sclerosis

NCT03457753 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2019-05-13

No results posted yet for this study

Summary

The primary objective of this study is to assess the safety and tolerability, with emphasis on the oral cavity, of ROSF (containing riluzole 50mg) in subjects with amyotrophic lateral sclerosis (ALS) administered twice daily for 12 weeks. Secondary objectives include (1) to record the subject's assessment of any difficulty taking riluzole administered as ROSF and any difficulty taking riluzole in the tablet formulation and (2) to record the relative preference, if any, of subjects and caretakers, for riluzole administered as ROSF vs. the riluzole tablet.

Conditions

Interventions

DRUG

Riluzole Oral Soluble Film

Riluzole Oral Soluble Film (ROSF) containing Riluzole 50mg .

Sponsors & Collaborators

  • Inventiv Health

    collaborator UNKNOWN

  • Covance

    collaborator INDUSTRY

  • Aquestive Therapeutics

    lead INDUSTRY

Principal Investigators

  • Emily Plowman, PhD, CCC-SLP · University of Florida

  • James Wymer, MD, PhD · University of Florida

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-01
Primary Completion
2018-03-27
Completion
2018-03-27
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03457753 on ClinicalTrials.gov