22 completed, 3 terminated, 2 recruiting, 2 withdrawn. 13 Phase 3, 12 Phase 2, 5 Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 13 | Completed 12, Withdrawn 1 |
| Phase 2 | 12 | Completed 6, Recruiting 2, Terminated 2, Active not recruiting 1, Withdrawn 1 |
| Phase 1 | 5 | Completed 4, Terminated 1 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Proof of Concept Study on BP1.4979 Effect on Essential Tremor BP1.4979, Placebo - Essential Tremor | Phase 2 | Recruiting | Bioprojet | 50 | 2025-09-17 | 2025-12-16 |
| Proof of Concept Study on BP1.4979 Effect on Primary Premature Ejaculation BP1.4979, Placebo - Premature (Early) Ejaculation | Phase 2 | Recruiting | Bioprojet | 60 | 2025-09-15 | 2025-10-06 |
| Proof of Concept Study on Pitolisant Effect on Autism Spectrum Disorders in Children and Adolescents Pitolisant, Placebo - Autism Spectrum Disorder | Phase 2 | Active not recruiting | Bioprojet | 62 | 2023-12-20 | 2025-10-02 |
| Proof of Concept Study Evaluating BP1.3656 in Patients With Fatigue Following Ischemic Stroke BP1.3656 - Fatigue | Phase 2 | Terminated | Bioprojet | 5 | 2023-01-20 | 2024-08-09 |
| Pilot Study on BP1.4979 Effect on Binge Eating Disorders BP1.4979 active drug, Placebo - Binge-Eating Disorder | Phase 2 | Completed | Bioprojet | 67 | 2022-03-07 | 2025-11-25 |
| Clinical Trial Assessing the Efficacy and Safety of BP1.4979 in Restless Legs Syndrome BP 1.4979, Placebo - Restless Legs Syndrome | Phase 2 | Terminated | Bioprojet | 29 | 2018-02-06 | 2020-07-30 |
| Randomized Clinical Trial Evaluating BP1.3656 Versus Placebo For Alcohol Use Disorder Treatment BP1.3656 low dose, BP1.3656 intermediate dose, Placebo - Alcohol Use Disorder | Phase 2 | Completed | Bioprojet | 210 | 2018-01-09 | 2022-01-21 |
| Determination the Abuse Potential of Pitolisant in Healthy, Non-Dependent Recreational Stimulant Users Pitolisant, Placebos, Phentermine - Healthy, Drug Abuse | Phase 1 | Completed | Bioprojet | 43 | 2017-03-15 | 2017-11-13 |
| A Trial Evaluating Pitolisant (BF2.649) in Alcohol Use Disorder Treatment Pitolisant (BF2.649), Placebo - Alcohol Abuse, Nervous System | Phase 2 | Withdrawn | Bioprojet | 2016-10-01 | 2017-01-12 | |
| Study to Assess the Absorption, Distribution, Metabolism and Excretion (ADME) of [14C]-Pitolisant in Healthy Male Volunteers Pitolisant, [14C]-Pitolisant - Healthy Volunteers | Phase 1 | Completed | Bioprojet | 8 | 2016-07-01 | 2016-10-11 |
| Efficacy and Safety of Pitolisant in Pediatric Narcoleptic Patients With or Without Cataplexy, Double-blind Study Followed by a Prolonged Open-label Period pitolisant, Placebo - Narcolepsy With Cataplexy, Narcolepsy Without Cataplexy | Phase 3 | Completed | Bioprojet | 110 | 2016-06-06 | 2025-06-26 |
| Pitolisant (BF2.649) in the Treatment of EDS in Patients With OSA Pitolisant (BF2.649), Placebo - Excessive Daytime Sleepiness, Obstructive Sleep Apnea | Phase 3 | Completed | Bioprojet | 389 | 2016-04-01 | 2020-07-08 |
| First-time-in-man, to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BP1.5375 BP1.5375 suspension, Diphenhydramine, Placebo - Healthy Male Volunteers | Phase 1 | Terminated | Bioprojet | 48 | 2014-10-01 | 2015-01-21 |
| Racecadotril Suspension Linearity Study & Comparative Bioavailability Versus Granules Racecadotril suspension, Racecadotril granules - Healthy Male Volunteers | Phase 1 | Completed | Bioprojet | 53 | 2013-09-01 | 2014-02-25 |
| Pitolisant to Assess Weekly Frequency of Cataplexy Attacks and EDS in Narcoleptic Patients (HARMONY CTP) Pitolisant, Placebo - Narcolepsy With Cataplexy, Excessive Daytime Sleepiness | Phase 3 | Completed | Bioprojet | 103 | 2013-04-01 | 2016-08-31 |
| Efficacy and Safety of BP1.4979 in Smoking Cessation BP1.4979, Placebo - Tobacco Addiction | Phase 2 | Completed | Bioprojet | 219 | 2013-02-01 | 2015-01-21 |
| Patient Narcoleptic Treated With BF2.649 (Pitolisant) in add-on to Sodium Oxybate (HARMONY IV) BF2.649 - Narcolepsy | Phase 3 | Completed | Bioprojet | 51 | 2012-09-01 | 2015-11-18 |
| BF2.649 in Patients With OSA, Still Complaining of EDS and Refusing to be Treated by CPAP. BF2.649, Placebo - Obstructive Sleep Apnea, Excessive Daytime Sleepiness | Phase 3 | Completed | Bioprojet | 268 | 2011-10-01 | 2015-01-21 |
| BF2.649 in Patients With OSA and Treated by CPAP But Still Complaining of EDS BF2.649, Placebo - Obstructive Sleep Apnea, Excessive Daytime Sleepiness | Phase 3 | Completed | Bioprojet | 244 | 2011-08-01 | 2015-01-21 |
| Pharmacokinetics of BF2.649 in Renal Impairment BF2.649 - Renal Impairment | Phase 1 | Completed | Bioprojet | 25 | 2011-07-01 | 2013-04-12 |
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Disorders of Excessive Somnolence (12) · Narcolepsy (7) · Cataplexy (5) · Sleep Apnea, Obstructive (5) · Sleep Wake Disorders (5) · Parkinson Disease (3) · Alcohol-Induced Disorders, Nervous System (1) · Alcoholism (1) · Autism Spectrum Disorder (1) · Binge-Eating Disorder (1) · Essential Tremor (1) · Fatigue (1) · Premature Birth (1) · Renal Insufficiency (1) · Restless Legs Syndrome (1)
pitolisant (21) · Modafinil (3) · Diphenhydramine (1) · FANG vaccine (1) · Phentermine (1) · Starch (1)
France (20) · Switzerland (3) · Bulgaria (2) · Italy (2) · Netherlands (2) · Russia (2) · Canada (1) · Finland (1) · Germany (1) · Hungary (1) · North Macedonia (1) · Spain (1) · United Kingdom (1) · United States (1)
Evelyne De Paillette, MD (3) · Kati Gutierrez, PharmD (3) · Claudio Bassetti (2) · Carol A Tamminga, MD (1) · Carsten Moeller (1) · Claudio Bassetti, MD, Prof. (1) · Evelyne De Paillette, Dr (1) · Evgeny Krupitsky, Pr (1) · Giuseppe Plazzi, MD (1) · Imad Ghorayeb, MD (1)
PMID 34822113, PMID 34935103, PMID 37979718, PMID 24107292, PMID 28129985, PMID 31626696, PMID 31917607, PMID 33121980, PMID 36931805
2008 (2), 2009 (2), 2016 (2), 2017 (1)