NCT01800045

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
103

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Apr 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 13, 2013

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 27, 2013

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2013

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

August 31, 2016

Status Verified

July 1, 2015

Enrollment Period

1.8 years

First QC Date

February 13, 2013

Last Update Submit

August 30, 2016

Conditions

Narcolepsy With CataplexyExcessive Daytime Sleepiness

Keywords

NarcolepsyCataplexySleep disorderExcessive daytime sleepiness

Outcome Measures

Primary Outcomes (1)

  • Measure of anticataplectic efficacy

    Measure of anticataplectic efficacy assessed by the change in the average number of cataplexy attacks per week.

    At week 7

Secondary Outcomes (2)

  • Excessive Daytime Sleepiness assessment

    At week 7

  • Safety assessment

    11 weeks

Study Arms (2)

Pitolisant

EXPERIMENTAL

Pitolisant at 5, 10, 20 or 40mg

Drug: Pitolisant

Placebo

PLACEBO COMPARATOR

Capsules of placebo containing lactose

Drug: Placebo

Interventions

PitolisantDRUG

1 capsule in the morning before breakfast

Also known as: BF2.649
Pitolisant
PlaceboDRUG

1 capsule in the morning before breakfast

Also known as: Capsules of placebo containing lactose
Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Narcoleptic with cataplexy : at least 3 weekly cataplexy attacks
  • ESS \> or = 12
  • ICF signed and dated

You may not qualify if:

  • Other conditions that could generate EDS
  • Psychological and neurological disorders
  • Acute or chronic severe disease
  • Treatment by prohibited medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

State Health Center

Budapest, 1134, Hungary

Location

Related Publications (3)

  • Meskill GJ, Davis CW, Zarycranski D, Doliba M, Schwartz JC, Dayno JM. Clinical Impact of Pitolisant on Excessive Daytime Sleepiness and Cataplexy in Adults With Narcolepsy: An Analysis of Randomized Placebo-Controlled Trials. CNS Drugs. 2022 Jan;36(1):61-69. doi: 10.1007/s40263-021-00886-x. Epub 2021 Dec 21.

    PMID: 34935103DERIVED

  • Watson NF, Davis CW, Zarycranski D, Vaughn B, Dayno JM, Dauvilliers Y, Schwartz JC. Time to Onset of Response to Pitolisant for the Treatment of Excessive Daytime Sleepiness and Cataplexy in Patients With Narcolepsy: An Analysis of Randomized, Placebo-Controlled Trials. CNS Drugs. 2021 Dec;35(12):1303-1315. doi: 10.1007/s40263-021-00866-1. Epub 2021 Nov 25.

    PMID: 34822113DERIVED

  • Szakacs Z, Dauvilliers Y, Mikhaylov V, Poverennova I, Krylov S, Jankovic S, Sonka K, Lehert P, Lecomte I, Lecomte JM, Schwartz JC; HARMONY-CTP study group. Safety and efficacy of pitolisant on cataplexy in patients with narcolepsy: a randomised, double-blind, placebo-controlled trial. Lancet Neurol. 2017 Mar;16(3):200-207. doi: 10.1016/S1474-4422(16)30333-7. Epub 2017 Jan 25.

    PMID: 28129985DERIVED

MeSH Terms

Conditions

NarcolepsyDisorders of Excessive SomnolenceCataplexySleep Wake Disorders

Interventions

pitolisant

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasNervous System DiseasesMental DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Evelyne De Paillette, Dr

    Bioprojet

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 13, 2013

First Posted

February 27, 2013

Study Start

April 1, 2013

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

August 31, 2016

Record last verified: 2015-07

Locations

HU(1)