Trial · NCT05156047
A Phase 3 Study to Assess the Safety and Efficacy of Pitolisant in Adult Patients With Idiopathic Hypersomnia
NCT05156047, Phase 3, Completed, Harmony Biosciences Management, Inc.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Phase 3 Study to Assess the Safety and Efficacy of Pitolisant in Adult Patients With Idiopathic Hypersomnia. Trials, record NCT05156047. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05156047
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase 3 Study to Assess the Safety and Efficacy of Pitolisant in Adult Patients With Idiopathic Hypersomnia
- NCT number
- NCT05156047
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 214 participants, actual
- Lead sponsor
- Harmony Biosciences Management, Inc.
- Conditions
- Idiopathic Hypersomnia
- Interventions
- Open-label Pitolisant, Double-blind Placebo, Double-blind Pitolisant
- First posted
- 2021-12-14
- Last updated
- 2026-09-25
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Epworth Sleepiness Scale (ESS) Score From Week 8 to Week 12 | Week 8 to Week 12 | The Epworth Sleepiness Scale (ESS) is an 8-item, 4-point rating scale that asks participants to rate the likelihood of falling asleep over the past week. The rating scale ranges from 0 (no chance of dozing) to 3 (high chance of dozing). The total score is calculated by summing the item level ratings. Total scores range from 0 to 24. Higher point totals represent more severe daytime sleepiness. |
| Secondary | Change in Idiopathic Hypersomnia Severity Scale (IHSS) From Week 8 to Week 12 | Week 8 to Week 12 | The Idiopathic Hypersomnia Severity Scale (IHSS) is a self-administered questionnaire with a total of 14 items that assess long sleep duration and sleep inertia (5 items), daytime functioning (7 items), and napping (2 items). All items are scored from 0 to 3 or from 0 to 4. The total score is a sum of the item scores. The total score ranges from 0 to 50. A higher score indicates more severe and frequent symptoms. |
| Secondary | Proportion of Participants Who Worsened on the Patient Global Impression of Change for Idiopathic Hypersomnia (PGI-C [IH]) From Week 8 to Week 12 | Week 8 to Week 12 | The Patient Global Impression of Change for Idiopathic Hypersomnia (PGI-C \[IH\]) is a single-item questionnaire that assesses a participant's overall impression of the change in their symptoms of IH. The scale asks participants to rate their overall impression of the change in their symptoms of IH since a specific timepoint on a 5-point verbal rating scale ranging from "much better" to "much worse." |
| Secondary | Change in Clinical Global Impression of Severity for IH (CGI-S [IH]) From Week 8 to Week 12 | Week 8 to Week 12 | The CGI-S (IH) is an investigator-rated assessment. It uses a single-item, 5-point Likert-type rating scale that ranges from: none (1); mild (2); moderate (3); severe (4); very severe (5). An assessment of less severe symptoms represents an improvement in the investigator's perception of the participant's overall clinical status related to idiopathic hypersomnia and is reflected by a decrease in score. |
| Secondary | Change in Patient Global Impression of Severity Scale for Excessive Daytime Sleepiness (PGI-S [EDS]) From Week 8 to Week 12 | Week 8 to Week 12 | The Patient Global Impression of Severity for Excessive Daytime Sleepiness (PGI-S \[EDS\]) asks participants to rate their overall impression of the severity of their EDS over the past 7 days on a 5-point verbal rating scale ranging from "none" to "very severe". Scores are: 1=None, 2=Mild, 3=Moderate, 4=Severe, and 5=Very Severe. |
| Secondary | Change in Functional Outcomes of Sleep Questionnaire 10-Item Version (FOSQ-10) From Week 8 to Week 12 | Week 8 to Week 12 | The Functional Outcomes of Sleep Questionnaire 10-Item Version (FOSQ-10) consists of 10 items assessing the impact of sleepiness on daily functioning across 5 domains: vigilance, general productivity, social outcomes, intimacy, and activity level. Each item is rated on a scale of 0 (activity not performed for other reasons), 1 (extreme difficulty), 2 (moderate difficulty), 3 (a little difficulty), and 4 (no difficulty). The FOSQ-10 total score is calculated by multiplying the mean of the subscale scores by five, with final scores ranging from 5-20. Higher scores correspond to less impairment/symptomatic severity. |
| Secondary | Change in Patient-Reported Outcomes Measurement Information System Sleep-Related Impairment Short Form 8a (PROMIS-SRI SF 8a) From Week 8 to Week 12 | Week 8 to Week 12 | The PROMIS-SRI SF 8a is a self-report measure that includes 8 questions designed to assess a participant's perceptions of their waking alertness, sleepiness, and tiredness during usual waking hours, and the perceived functional impairments during wakefulness associated with sleep problems or impaired alertness over the past week. Responses are rated using a 5-point scale, with responses ranging from: 1=not at all; 2=a little bit; 3=somewhat; 4=quite a bit; 5=very much, with average scores ranging from 8 to 40. Raw scores are converted to a T-score using the conversion table from the PROMIS-SRI Scoring Manual. Raw score ranges from 8 to 40; T-score ranges from 30 to 80.1. Higher scores represent greater impairment. |
| Secondary | Change in Sleep Inertia Questionnaire (SIQ) From Week 8 to Week 12 | Week 8 to Week 12 | The Sleep Inertia Questionnaire (SIQ) consists of 21 questions that assess sleep inertia. Each question is rated on a scale of 1 to 5, where: 1=not at all; 2=a little; 3=somewhat; 4=often; 5=all the time. Total scores range from 21 to 105. Higher scores represent greater sleep inertia. |
| Secondary | Change in Cogstate One Back Test (ONB) From Week 8 to Week 12 | Week 8 to Week 12 | Cognition was assessed using the Cogstate Computerized Cognitive Battery tests. The cognitive domain of working memory was assessed specifically with the One Back Test (ONB), which measures the speed of the participant's response. Results are reported as the mean of the common logarithm (log 10) transformed reaction time (in milliseconds \[msec\]) for correct responses. A decrease in score represents an increase in working memory performance. |
| Secondary | Change in Cogstate Identification Test (IDN) From Week 8 to Week 12 | Week 8 to Week 12 | Cognition was assessed using the Cogstate Computerized Cognitive Battery tests. The cognitive domain of visual attention was assessed using the Identification Test (IDN). Results reported as the mean of the log 10 transformed reaction time for correct responses. A decrease in score represents an increase in visual attention performance. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests1
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as |
|---|---|
| 1-Back Task | Secondary outcome |
Source ConductCognition
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05156047
GET https://conductscience.org/api/trials/v1/NCT05156047/registered