NCT01620554

Brief Summary

Prospective, multicenter, double-blind, phase II, randomized, dose-response study in 5 parallel groups (dose-range).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
110

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Oct 2010

Shorter than P25 for phase_2

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

Study Start

First participant enrolled

October 1, 2010

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 8, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 15, 2012

Completed
Last Updated

June 15, 2012

Status Verified

June 1, 2012

Enrollment Period

1.2 years

First QC Date

June 8, 2012

Last Update Submit

June 13, 2012

Conditions

Obstructive Sleep ApnoeaExcessive Daytime Sleepiness

Keywords

Sleep disorderObstructive Sleep ApnoeaExcessive Daytime Sleepiness

Outcome Measures

Primary Outcomes (1)

  • Change in Epworth Sleepiness Scale scores (ESS)

    ESS value compared from baseline (Day 0) and End of treatment period (Day 14)

    change of ESS at 2 weeks

Study Arms (5)

BF2.649 5mg

EXPERIMENTAL
Drug: BF2.649

BF2.649 10mg

EXPERIMENTAL
Drug: BF2.649

BF2.649 20mg

EXPERIMENTAL
Drug: BF2.649

BF2.649 40mg

EXPERIMENTAL
Drug: BF2.649

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

BF2.649DRUG

1 capsule per week during 2 weeks

Also known as: Pitolisant
BF2.649 5mg
PlaceboDRUG

1 capsule per week during 2 weeks

Placebo

Eligibility Criteria

Age21 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient with OSA (treated or not with nCPAP) and still complaining of EDS
  • Epworth Sleepiness Scale score \> or = to 11

You may not qualify if:

  • Patient suffering from chronic severe insomnia in accordance with the International Classification of Sleep Disorders, but without OSA

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Grenoble

Grenoble, 38043, France

Location

MeSH Terms

Conditions

Sleep Apnea, ObstructiveDisorders of Excessive SomnolenceSleep Wake Disorders

Interventions

pitolisant

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasNervous System DiseasesMental DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Evelyne De Paillette, MD

    Bioprojet

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 8, 2012

First Posted

June 15, 2012

Study Start

October 1, 2010

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

June 15, 2012

Record last verified: 2012-06

Locations

FR(1)