Trial · NCT05687903
A Study of TAK-861 in Participants With Narcolepsy Type 1
NCT05687903, Phase 2, Completed, Takeda; results first posted 2025-01-09
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of TAK-861 in Participants With Narcolepsy Type 1. Trials, record NCT05687903. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05687903
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of TAK-861 in Participants With Narcolepsy Type 1
- NCT number
- NCT05687903
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 112 participants, actual
- Lead sponsor
- Takeda
- Conditions
- Narcolepsy Type 1
- Interventions
- TAK-861, Placebo
- First posted
- 2023-01-18
- Last updated
- 2025-01-09
- Other registries' IDs
- eudract:2022-001654-38
- Results first posted
- 2025-01-09
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in the Average Sleep Latency as Determined From the MWT at Week 8 | Baseline, Week 8 | The MWT is a validated, objective measure that evaluates a participant's ability to remain awake under soporific conditions for a defined period. During each MWT session (1 session = 40 minutes), participants were instructed to sit quietly and remain awake for as long as possible. Sleep latency in each session was recorded on EEG. If no sleep was observed according to these rules, then the latency was defined as 40 minutes. The linear mixed effects model for repeated measures (MMRM) was used for analysis. |
| Secondary | Change From Baseline in Epworth Sleepiness Scale (ESS) Total Score at Week 8 | Baseline, Week 8 | The ESS is a subjective, self-administered, validated scale (scored 0 to 3) to respond to each of the 8 questions of daily life that asks participants how likely they are to fall asleep in those situations. The scores are summed to give an overall score of 0 to 24. Higher scores indicate stronger subjective daytime sleepiness, and scores below 10 are considered to be within the normal range. The MMRM was used for analysis. |
| Secondary | Weekly Cataplexy Rate (WCR) at Week 8 | Week 8 | Participants completed a daily patient-reported sleep diary to record self-reported narcolepsy symptoms. Participants recorded episodes of cataplexy attacks in the diary. The total number of events averaged for a week were reported. WCR = (total number of cataplexy attacks over a number of non-missing diary days for a given duration/number of non-missing diary days in that duration)\*7. The generalized estimating equations (GEE) model was used for analysis. |
| Secondary | Number of Participants With at Least One Treatment-emergent Adverse Event (TEAE) | From first dose of the study drug up to end of the study (up to 3 months) | An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of the study intervention, whether or not the occurrence was considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE was defined as an AE with an onset that occurred after receiving study drug. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in the Average Sleep Latency as Determined From the MWT at Week 8 | Baseline, Week 8 | Full Analysis Set included all participants who were randomized and received at least one dose of study drug and had at least one post-dose efficacy measurement. Overall number of participants analyzed is the number of participants with data available for analyses. | minutes | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Epworth Sleepiness Scale (ESS) Total Score at Week 8 | Baseline, Week 8 | Full Analysis Set included all participants who were randomized and received at least one dose of study drug and had at least one post-dose efficacy measurement. Overall number of participants analyzed is the number of participants with data available for analyses. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Weekly Cataplexy Rate (WCR) at Week 8 | Week 8 | Full Analysis Set included all participants who were randomized and received at least one dose of study drug and had at least one post-dose efficacy measurement. Overall number of participants analyzed is the number of participants with data available for analyses. | cataplexy attacks per week | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Participants With at Least One Treatment-emergent Adverse Event (TEAE) | From first dose of the study drug up to end of the study (up to 3 months) | Safety Analysis Set included all participants who received at least one dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in the Average Sleep Latency as Determined From the MWT at Week 8 | Placebo | -1.16 | Standard Error 2.061 | minutes | |
| Change From Baseline in the Average Sleep Latency as Determined From the MWT at Week 8 | TAK-861 0.5 mg BID | 12.49 | Standard Error 2.128 | minutes | |
| Change From Baseline in the Average Sleep Latency as Determined From the MWT at Week 8 | TAK-861 2 mg BID | 23.50 | Standard Error 2.042 | minutes | |
| Change From Baseline in the Average Sleep Latency as Determined From the MWT at Week 8 | TAK-861 2 mg and 5 mg | 25.42 | Standard Error 2.071 | minutes | |
| Change From Baseline in the Average Sleep Latency as Determined From the MWT at Week 8 | TAK-861 7 mg QD | 14.96 | Standard Error 1.953 | minutes | |
| Change From Baseline in Epworth Sleepiness Scale (ESS) Total Score at Week 8 | Placebo | -2.50 | Standard Error 1.109 | score on a scale | |
| Change From Baseline in Epworth Sleepiness Scale (ESS) Total Score at Week 8 | TAK-861 0.5 mg BID | -8.92 | Standard Error 1.085 | score on a scale | |
| Change From Baseline in Epworth Sleepiness Scale (ESS) Total Score at Week 8 | TAK-861 2 mg BID | -13.79 | Standard Error 1.115 | score on a scale | |
| Change From Baseline in Epworth Sleepiness Scale (ESS) Total Score at Week 8 | TAK-861 2 mg and 5 mg | -12.81 | Standard Error 1.073 | score on a scale | |
| Change From Baseline in Epworth Sleepiness Scale (ESS) Total Score at Week 8 | TAK-861 7 mg QD | -11.29 | Standard Error 1.064 | score on a scale |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 22 | |
| Overall Study | STARTED | TAK-861 0.5 mg BID | 23 | |
| Overall Study | STARTED | TAK-861 2 mg BID | 21 | |
| Overall Study | STARTED | TAK-861 2 mg and 5 mg | 23 | |
| Overall Study | STARTED | TAK-861 7 mg QD | 23 | |
| Overall Study | COMPLETED | Placebo | 21 | |
| Overall Study | COMPLETED | TAK-861 0.5 mg BID | 22 | |
| Overall Study | COMPLETED | TAK-861 2 mg BID | 21 | |
| Overall Study | COMPLETED | TAK-861 2 mg and 5 mg | 22 | |
| Overall Study | COMPLETED | TAK-861 7 mg QD | 23 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events75
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Constipation | Gastrointestinal disorders | Placebo | 0 | 22 | |
| other | Constipation | Gastrointestinal disorders | TAK-861 0.5 mg BID | 0 | 23 | |
| other | Constipation | Gastrointestinal disorders | TAK-861 2 mg BID | 0 | 21 | |
| other | Constipation | Gastrointestinal disorders | TAK-861 2 mg/5 mg | 0 | 23 | |
| other | Constipation | Gastrointestinal disorders | TAK-861 7 mg QD | 2 | 23 | |
| other | Decreased appetite | Metabolism and nutrition disorders | Placebo | 0 | 22 | |
| other | Decreased appetite | Metabolism and nutrition disorders | TAK-861 0.5 mg BID | 0 | 23 | |
| other | Decreased appetite | Metabolism and nutrition disorders | TAK-861 2 mg BID | 0 | 21 | |
| other | Decreased appetite | Metabolism and nutrition disorders | TAK-861 2 mg/5 mg | 1 | 23 | |
| other | Decreased appetite | Metabolism and nutrition disorders | TAK-861 7 mg QD | 2 | 23 |
1 to 10 of 75Source ClinicalTrials.gov
See all 75 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 22 |
| Total, all-cause mortality | TAK-861 0.5 mg BID | 0 | 23 |
| Total, all-cause mortality | TAK-861 2 mg BID | 0 | 21 |
| Total, all-cause mortality | TAK-861 2 mg/5 mg | 0 | 23 |
| Total, all-cause mortality | TAK-861 7 mg QD | 0 | 23 |
| Total, other adverse events | Placebo | 5 | 22 |
| Total, other adverse events | TAK-861 0.5 mg BID | 11 | 23 |
| Total, other adverse events | TAK-861 2 mg BID | 15 | 21 |
| Total, other adverse events | TAK-861 2 mg/5 mg | 20 | 23 |
| Total, other adverse events | TAK-861 7 mg QD | 20 | 23 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers2
The papers the trial lists on ClinicalTrials.gov.
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.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
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/NCT05687903
GET https://conductscience.org/api/trials/v1/NCT05687903/events?page=2