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Pitolisant to Assess Weekly Frequency of Cataplexy Attacks and EDS in Narcoleptic Patients (HARMONY CTP)

NCT01800045 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 103

Last updated 2016-08-31

No results posted yet for this study

Summary

Double blind, randomized, parallel groups study of Pitolisant versus placebo, in narcoleptic patients experiencing EDS, and cataplexy (minimum of 3 complete or partial cataplexy attacks per week).

The patients will be treated during 7 weeks with Pitolisant or placebo.

Conditions

Interventions

DRUG

Pitolisant

1 capsule in the morning before breakfast

DRUG

Placebo

1 capsule in the morning before breakfast

Sponsors & Collaborators

Principal Investigators

  • Evelyne De Paillette, Dr · Bioprojet

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2015-01-31
Completion
2015-01-31

Countries

  • Hungary

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

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 NCT01800045 on ClinicalTrials.gov