Success Metrics

Clinical Success Rate
75.0%

Based on 6 completed trials

Completion Rate
75%(6/8)
Active Trials
2(15%)
Results Posted
50%(3 trials)
Terminated
2(15%)

Phase Distribution

Ph phase_1
4
31%
Ph phase_3
5
38%
Ph phase_4
1
8%
Ph phase_2
1
8%

Phase Distribution

4

Early Stage

1

Mid Stage

6

Late Stage

Phase Distribution11 total trials
Phase 1Safety & dosage
4(36.4%)
Phase 2Efficacy & side effects
1(9.1%)
Phase 3Large-scale testing
5(45.5%)
Phase 4Post-market surveillance
1(9.1%)

Highest Phase Reached

Phase 4

Trial Status & Enrollment

Completion Rate

75.0%

6 of 8 finished

Non-Completion Rate

25.0%

2 ended early

Currently Active

2

trials recruiting

Total Trials

13

all time

Status Distribution
Active(3)
Completed(6)
Terminated(2)
Other(2)

Detailed Status

Completed6
unknown2
Terminated2
Enrolling by invitation1
Recruiting1
Active, not recruiting1

Development Timeline

Analytics

Development Status

Total Trials
13
Active
2
Success Rate
75.0%
Most Advanced
Phase 4

Trials by Phase

Phase 14 (36.4%)
Phase 21 (9.1%)
Phase 35 (45.5%)
Phase 41 (9.1%)

Trials by Status

completed646%
enrolling_by_invitation18%
recruiting18%
unknown215%
active_not_recruiting18%
terminated215%

Recent Activity

Clinical Trials (13)

Showing 13 of 13 trials
NCT05536011

WAKIX® (Pitolisant) Pregnancy Registry

Recruiting
NCT07219485Phase 3

A Study of Pitolisant in Participants With Prader-Willi Syndrome

Enrolling By Invitation
NCT05458128Phase 3

A Long-Term Safety and Effectiveness Study to Evaluate Pitolisant in Adult Patients With Idiopathic Hypersomnia

Completed
NCT05953389Phase 2

Proof of Concept Study on Pitolisant Effect on Autism Spectrum Disorders in Children and Adolescents

Active Not Recruiting
NCT02611687Phase 3

Efficacy and Safety of Pitolisant in Pediatric Narcoleptic Patients With or Without Cataplexy, Double-blind Study Followed by a Prolonged Open-label Period

Completed
NCT04596267Phase 1

Pitolisant Effects on Alcohol Self-Administration in Heavy Drinkers

Terminated
NCT05223166Phase 3

A Clinical Study to Evaluate the Efficacy and Safety of Pitolisant in the Treatment of EDS in Patients With OSA

Completed
NCT05581576Phase 4

Pitolisant in Refractory Restless Legs Syndrome

Unknown
NCT04026750Phase 1

Insulin Tolerance Test Study in Patients With Type 1 Diabetes

Terminated
NCT03433131

Expanded Access Program to Provide Treatment With Pitolisant to Adult Patients in the U.S. With Excessive Daytime Sleepiness Associated With Narcolepsy With or Without Cataplexy

Unknown
NCT03152123Phase 1

Determination the Abuse Potential of Pitolisant in Healthy, Non-Dependent Recreational Stimulant Users

Completed
NCT02929342Phase 1

Study to Assess the Absorption, Distribution, Metabolism and Excretion (ADME) of [14C]-Pitolisant in Healthy Male Volunteers

Completed
NCT01800045Phase 3

Pitolisant to Assess Weekly Frequency of Cataplexy Attacks and EDS in Narcoleptic Patients (HARMONY CTP)

Completed

All 13 trials loaded

Drug Details

Intervention Type
DRUG
Total Trials
13