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

B

Bioprojet

Status and phase

Completed
Phase 3

Conditions

Parkinson's Disease

Treatments

Drug: BF2.649 (pitolisant)

Study type

Interventional

Funder types

Other

Identifiers

NCT01036139
P06-10 / BF 2.649
Eudract number

Details and patient eligibility

About

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.

Full 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.

Enrollment

268 patients

Sex

All

Ages

30 to 80 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

268 participants in 2 patient groups, including a placebo group

BF2.649 (pitolisant)
Experimental group
Description:
BF2.649 (5mg, 10 mg, 20 mg) in capsules
Treatment:
Drug: BF2.649 (pitolisant)
Placebo
Placebo Comparator group
Description:
Placebo of BF2.649 (5mg, 10mg, 20mg) in capsules
Treatment:
Drug: BF2.649 (pitolisant)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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