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Efficacy and Safety of BF2.649 in Excessive Daytime Sleepiness (EDS) in Parkinson's Disease (HARPS1)

Primary Purpose

Parkinson's Disease

Status

Completed

Phase

Phase 3

Locations

France

Study Type

Interventional

Intervention

BF2.649 (pitolisant)

About this trial

This is an interventional treatment trial for Parkinson's Disease focused on measuring EDS in Parkinson's Disease

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients with a documented history of Parkinson's disease according to UPDRS,fluctuating and non-fluctuating patients, Hoehn and Yahr score <5;
stabilized on optimal antiparkinsonian treatments unmodified for 4 weeks prior to study entry;
presenting an Excessive Daytime Sleepiness as indicated by an ESS>or=12

Exclusion Criteria:

Patients with a known diagnosis of other degenerative parkinsonian syndromes (e.g. Progressive supra-nuclear palsy, multisystemic atrophy, corticobasal degenerescence, diffuse Lewy's Body dementia)
Patients who have shift work, chronic or occasional sleep deprivation, circadian rhythm disorders
Patients with a severe depression indicated by (BDI>= 16)or at suicidal risk (BDI item G>0) or depression treated for less than 8 weeks
Patients with a cognitive impairment

Sites / Locations

Pr Arnulf

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

BF2.649 (pitolisant)

Placebo

Arm Description

BF2.649 (5mg, 10 mg, 20 mg) in capsules

Placebo of BF2.649 (5mg, 10mg, 20mg) in capsules

Outcomes

Primary Outcome Measures

ESS change (Epworth Sleepiness Scale)

Secondary Outcome Measures

Safety

Any AE observed and reported during the study

Full Information

NCT ID

NCT01036139

First Posted

December 11, 2009

Last Updated

April 11, 2013

Sponsor

Bioprojet

1. Study Identification

Unique Protocol Identification Number

NCT01036139

Brief Title

Efficacy and Safety of BF2.649 in Excessive Daytime Sleepiness (EDS) in Parkinson's Disease

Acronym

HARPS1

Official Title

A Randomized, Multicenter 12-Week Double-blind Placebo-controlled Study to Assess the Efficacy and Safety of BF2.649 in Excessive Daytime Sleepiness in Parkinson's Disease Followed by a 38-Week Open-label Extension Phase

Study Type

Interventional

2. Study Status

Record Verification Date

April 2013

Overall Recruitment Status

Completed

Study Start Date

December 2009 (undefined)

Primary Completion Date

August 2012 (Actual)

Study Completion Date

August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bioprojet

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

To compare the efficacy of BF2.649 over placebo (12 week Double-Blind Phase) and assess the long term safety and the efficacy maintenance(9 months Open-Label Extension Phase) of BF2.649 in the improvement of excessive daytime sleepiness in patients diagnosed with Parkinson's Disease.

Detailed Description

As measured by the change from baseline in the Epworth Scale Scores (ESS) at Week 12 and at Week 51, in patients diagnosed with EDS in Parkinson's Disease.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Parkinson's Disease

Keywords

EDS in Parkinson's Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

268 (Actual)

8. Arms, Groups, and Interventions

Arm Title

BF2.649 (pitolisant)

Arm Type

Experimental

Arm Description

BF2.649 (5mg, 10 mg, 20 mg) in capsules

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo of BF2.649 (5mg, 10mg, 20mg) in capsules

Intervention Type

Drug

Intervention Name(s)

BF2.649 (pitolisant)

Other Intervention Name(s)

Pitolisant

Intervention Description

1 capsule of BF2.649 (5mg, 10mg , 20 mg) O.D

Primary Outcome Measure Information:

Title

ESS change (Epworth Sleepiness Scale)

Time Frame

at week 12 / 52 versus baseline

Secondary Outcome Measure Information:

Title

Safety

Description

Any AE observed and reported during the study

Time Frame

12-week and 52-week

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients with a documented history of Parkinson's disease according to UPDRS,fluctuating and non-fluctuating patients, Hoehn and Yahr score <5; stabilized on optimal antiparkinsonian treatments unmodified for 4 weeks prior to study entry; presenting an Excessive Daytime Sleepiness as indicated by an ESS>or=12 Exclusion Criteria: Patients with a known diagnosis of other degenerative parkinsonian syndromes (e.g. Progressive supra-nuclear palsy, multisystemic atrophy, corticobasal degenerescence, diffuse Lewy's Body dementia) Patients who have shift work, chronic or occasional sleep deprivation, circadian rhythm disorders Patients with a severe depression indicated by (BDI>= 16)or at suicidal risk (BDI item G>0) or depression treated for less than 8 weeks Patients with a cognitive impairment

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kati Gutierrez, PharmD

Organizational Affiliation

Bioprojet

Official's Role

Study Director

Facility Information:

Facility Name

Pr Arnulf

City

Paris

Country

France

12. IPD Sharing Statement

Learn more about this trial

Efficacy and Safety of BF2.649 in Excessive Daytime Sleepiness (EDS) in Parkinson's Disease

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