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Safety and Efficacy of THN102 on Sleepiness in Narcoleptic Patients

NCT02821715 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2020-09-04

Study results available
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Summary

This Phase 2 study is a 8-site, double-blind, randomised, placebo-controlled, 3-way cross-over trial, involving 3 treatments with Modafinil 300 mg or the combination drug THN102 (Modafinil/Flecainide 300 /3 mg, Modafinil/Flecainide 300 /27 mg).

Conditions

Interventions

DRUG

Active comparator: Modafinil + placebo

DRUG

THN102 300/3

DRUG

THN102 300/27

Sponsors & Collaborators

  • Theranexus

    lead INDUSTRY

Principal Investigators

  • Yves Dauvilliers, MD, PhD · CHRU Montpellier, France

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2018-12-31
Completion
2019-02-28

Countries

  • Belgium
  • France

Study Locations

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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 NCT02821715 on ClinicalTrials.gov