Efficacy and Safety of BF2.649 in Excessive Daytime Sleepiness (EDS) in Parkinson's Disease (HARPS2)
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ClinicalTrials.gov Identifier: NCT01066442 |
Recruitment Status :
Completed
First Posted : February 10, 2010
Last Update Posted : April 12, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Parkinson's Disease | Drug: BF2.649 (Pitolisant) | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 273 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Randomised, 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 Start Date : | March 2010 |
Actual Primary Completion Date : | August 2012 |
Actual Study Completion Date : | August 2012 |

Arm | Intervention/treatment |
---|---|
Experimental: BF2.649 ( Pitolisant)
BF2.649 (5mg, 10 mg, 20 mg) in capsules
|
Drug: BF2.649 (Pitolisant)
1 capsule of BF2.649 (5mg, 10mg , 20 mg) O.D
Other Name: Pitolisant |
Placebo Comparator: Placebo
Placebo of BF2.649 (5mg, 10mg, 20mg) in capsules
|
Drug: BF2.649 (Pitolisant)
1 capsule of BF2.649 (5mg, 10mg , 20 mg) O.D
Other Name: Pitolisant |
- ESS change (Epworth Sleepiness Scale) versus baseline [ Time Frame: at week 12 / 51 versus baseline ]
- Safety [ Time Frame: 12-week and 52-week ]Any AE observed and reported during the study

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Ages Eligible for Study: | 30 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients with a documented history of Parkinson's disease according to UPDRS,fluctuator and non-fluctuator 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01066442
Germany | |
Klinik für Neurologie Universitätsklinikum | |
Marburg, Germany, 35039 |
Study Director: | Kati Gutierrez, PharmD | Bioprojet |
Responsible Party: | Bioprojet |
ClinicalTrials.gov Identifier: | NCT01066442 |
Other Study ID Numbers: |
P06-11 / BF2.649 2009-013886-24 ( EudraCT Number ) |
First Posted: | February 10, 2010 Key Record Dates |
Last Update Posted: | April 12, 2013 |
Last Verified: | April 2013 |
Excessive Daytime Sleepiness (EDS) Parkinson's Disease |
Parkinson Disease Disorders of Excessive Somnolence Sleepiness Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Movement Disorders Synucleinopathies Neurodegenerative Diseases Sleep Disorders, Intrinsic Dyssomnias Sleep Wake Disorders Mental Disorders |