---
title: "Efficacy and Safety of BF2.649 in Excessive Daytime Sleepiness (EDS) in Parkinson's Disease"
nct_id: NCT01036139
overall_status: COMPLETED
phase: PHASE3
sponsor: Bioprojet
study_type: INTERVENTIONAL
primary_condition: "Parkinson's Disease"
countries: France
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01036139.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01036139"
ct_last_update_post_date: 2013-04-12
last_seen_at: "2026-05-12T06:27:45.785Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Efficacy and Safety of BF2.649 in Excessive Daytime Sleepiness (EDS) in Parkinson's Disease

**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

**NCT ID:** [NCT01036139](https://clinicaltrials.gov/study/NCT01036139)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE3
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 268
- **Lead Sponsor:** Bioprojet
- **Conditions:** Parkinson's Disease
- **Start Date:** 2009-12
- **Completion Date:** 2012-08
- **CT.gov Last Update:** 2013-04-12

## 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.

## Eligibility

- **Minimum age:** 30 Years
- **Maximum age:** 80 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Arms

- **BF2.649 (pitolisant)** (EXPERIMENTAL) — BF2.649 (5mg, 10 mg, 20 mg) in capsules
- **Placebo** (PLACEBO_COMPARATOR) — Placebo of BF2.649 (5mg, 10mg, 20mg) in capsules

## Interventions

- **BF2.649 (pitolisant)** (DRUG) — 1 capsule of BF2.649 (5mg, 10mg , 20 mg) O.D

## Primary Outcomes

- **ESS change (Epworth Sleepiness Scale)** _(time frame: at week 12 / 52 versus baseline)_

## Secondary Outcomes

- **Safety** _(time frame: 12-week and 52-week)_

## Locations (1)

- Pr Arnulf, Paris, France

## Recent Field Changes (last 30 days)

- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.pr arnulf|paris||france` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT01036139.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT01036139*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*