Trial · NCT02821715
Safety and Efficacy of THN102 on Sleepiness in Narcoleptic Patients
NCT02821715, Phase 2, Completed, Theranexus; results first posted 2020-09-04
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety and Efficacy of THN102 on Sleepiness in Narcoleptic Patients. Trials, record NCT02821715. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02821715
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy of THN102 on Sleepiness in Narcoleptic Patients
- NCT number
- NCT02821715
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 51 participants, actual
- Lead sponsor
- Theranexus
- Conditions
- Narcolepsy
- Interventions
- Active comparator: Modafinil + placebo, THN102 300/3, THN102 300/27
- First posted
- 2016-07-01
- Last updated
- 2020-09-04
- Other registries' IDs
- eudract:2015-005035-41
- Results first posted
- 2020-09-04
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Epworth Sleepiness Scale (ESS) | 14 days after the beginning of treatment period | Range 0 to 24, low score indicates good outcome |
| Secondary | 14-item Fatigue Scale | 14 days after the beginning of treatment period | Fatigue scale is a rating scale completed by the participants at each visit starting from baseline to last visit; 14 questions to be ticked off by "yes" or "No" by the patient. 0 : No fatigue 14 : worst fatigue condition |
| Secondary | Questionnaire EQ-5D (European Quality of Life EQ-5D) (Questionnaire Part) | 14 days after the beginning of the screening | EQ-5D is a quality of life questionnaire filled in by the participants from screening to the last visit (all visits). The EQ-5D assesses the status on the day of visit and not over the past week. It has two parts: The first part is a descriptive system that assesses five distinct health states/dimensions: Mobility (MO), Self-care (SC), Usual activities (UA), Pain/discomfort, Anxiety/depression (AD). A higher score signifies a higher number of symptoms present. The second part is a 100 mm VAS (EQ-VAS). An increase in VAS indicates an improvement in health state. |
| Secondary | Patient Global Impression of Change (PGI-C) | 14 days after the beginning of treatment period | PGI-C is a scale completed by the participants starting from screening to last Last visit (all the visits). Participants have to chose 1 condition among 7 : Very much improved/ Much improved/ Minimally improved/ No change/ Minimally worse/ Much worse/ Very much worse. 1 is the best score (very much improved) 7 is the worse score (very much worse) |
| Secondary | Clinical Global Impression of Change (CGI-C) Global Impression | 14 days after the end of treatment period I | CGI-C (change from baseline) is a scale completed by the investigator at V3, V4 , V5 and V6 for global impression the investigator or his/her designee has to score 3 items : global impression/ sleepiness and Cataplexy. For each item the investigator or his/her designee has to chose 1 condition among 7 : Very much improved/ Much improved/ Minimally improved/ No change/ Minimally worse/ Much worse/ Very much worse. 1 is the best score (very much improved) 7 is the worse score (very much worse) |
| Secondary | Beck Depression Inventory (BDI) | 14 days | Beck Depression Inventory (BDI) evaluation for depressive symptoms (including suicidal thoughts). The scale is completed by the participants from baseline, to last visit (all except screening visit). The questionnaire contains 21 items. Each must be scored from 0 to 3, minimum score = 0, maximum score = 63. A high score indicates increased severity of depression. |
| Secondary | Patient Global Impression for Severity (PGI-S) Global Score | 14 days | PGI-S us a scale filled by the participant from screening to last visit (all the visits) Participants have to chose 1 condition among 7 : 1 Normal-Not ill at all/ 2 borderline ill/ 3 mildly ill/ 4 moderately ill/ 5 markedly ill/ 6 severely ill/ 7 among the most extremely ill patient 1 is the best score (very much improved) 7 is the worse score (very much worse) |
| Secondary | Clinical Global Impression of Change (CGI-C) Sleepiness | 14 days after the end of treatment period I | CGI-C (change from baseline) is a scale completed by the investigator at V3, V4 , V5 and V6 for sleepiness the investigator or his/her designee has to score 3 items : global impression/ sleepiness and Cataplexy. For each item the investigator or his/her designee has to chose 1 condition among 7 : Very much improved/ Much improved/ Minimally improved/ No change/ Minimally worse/ Much worse/ Very much worse. 1 is the best score (very much improved) 7 is the worse score (very much worse) |
| Secondary | Clinical Global Impression of Change (CGI-C) Cataplexy | 14 days after the end of treatment period I | CGI-C (change from baseline) is a scale completed by the investigator at V3, V4 , V5 and V6 for Cataplexy the investigator or his/her designee has to score 3 items : global impression/ sleepiness and Cataplexy. For each item the investigator or his/her designee has to chose 1 condition among 7 : Very much improved/ Much improved/ Minimally improved/ No change/ Minimally worse/ Much worse/ Very much worse. 1 is the best score (very much improved) 7 is the worse score (very much worse) |
| Secondary | Clinical Global Impression for Severity (CGI-S) Global Score | 14 days after the end of treatment period I | CGI-S is a scale completed by the investigator at each visit : Item global impression CGI-S us a scale filled by the Investigator or his/her designee from screening to last visit (all the visits) Investigators have to chose 1 condition among 7 : 1 normal-not ill at all/ 2 borderline ill/ 3 mildly ill/ 4 moderately ill/ 5 markedly ill/ 6 severely ill/ 7 among hte most extremely ill patient 1 is the best score (very much improved) 7 is the worse score (very much worse) CGI-S scale explores 3 items : Global impression/ Sleepiness/ Cataplexy |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Epworth Sleepiness Scale (ESS) | 14 days after the beginning of treatment period | modified Intent To Treat population | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | 14-item Fatigue Scale | 14 days after the beginning of treatment period | modified Intent To Treat (mITT) | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Questionnaire EQ-5D (European Quality of Life EQ-5D) (Questionnaire Part) | 14 days after the beginning of the screening | mITT | score on a scale | MEAN |
| SECONDARY | Patient Global Impression of Change (PGI-C) | 14 days after the beginning of treatment period | mITT | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Clinical Global Impression of Change (CGI-C) Global Impression | 14 days after the end of treatment period I | mITT | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Beck Depression Inventory (BDI) | 14 days | mITT | score on a scale | MEAN |
| SECONDARY | Patient Global Impression for Severity (PGI-S) Global Score | 14 days | mITT | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Clinical Global Impression of Change (CGI-C) Sleepiness | 14 days after the end of treatment period I | mITT | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Clinical Global Impression of Change (CGI-C) Cataplexy | 14 days after the end of treatment period I | mITT | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Clinical Global Impression for Severity (CGI-S) Global Score | 14 days after the end of treatment period I | mITT | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group180
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Epworth Sleepiness Scale (ESS) | Modafinil + Placebo | 14.68 | Standard Error 0.689 | score on a scale | |
| Epworth Sleepiness Scale (ESS) | THN102 300/3 | 15.34 | Standard Error 0.695 | score on a scale | |
| Epworth Sleepiness Scale (ESS) | THN102 300/27 | 15.34 | Standard Error 0.694 | score on a scale | |
| 14-item Fatigue Scale | Modafinil + Placebo | 6.37 | Standard Error 0.545 | score on a scale | |
| 14-item Fatigue Scale | THN102 300/3 | 6.94 | Standard Error 0.549 | score on a scale | |
| 14-item Fatigue Scale | THN102 300/27 | 7.25 | Standard Error 0.549 | score on a scale | |
| Questionnaire EQ-5D (European Quality of Life EQ-5D) (Questionnaire Part) | Modafinil + Placebo | 0.86 | Standard Error 0.358 | score on a scale | |
| Questionnaire EQ-5D (European Quality of Life EQ-5D) (Questionnaire Part) | THN102 300/3 | 1.16 | Standard Error 0.189 | score on a scale | |
| Questionnaire EQ-5D (European Quality of Life EQ-5D) (Questionnaire Part) | THN102 300/27 | 1.24 | Standard Error 0.258 | score on a scale | |
| Patient Global Impression of Change (PGI-C) | Modafinil + Placebo | Very much improved | 2 | Participants |
1 to 10 of 180Source ClinicalTrials.gov
See all 180 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Sequence 1 : ABC | 8 | |
| Overall Study | STARTED | Sequence 2 : BCA | 8 | |
| Overall Study | STARTED | Sequence 3: CAB | 8 | |
| Overall Study | STARTED | Sequence 4: ACB | 9 | |
| Overall Study | STARTED | Sequence 5: CBA | 6 | |
| Overall Study | STARTED | Sequence 6: BAC | 9 | |
| Overall Study | COMPLETED | Sequence 1 : ABC | 7 | |
| Overall Study | COMPLETED | Sequence 2 : BCA | 8 | |
| Overall Study | COMPLETED | Sequence 3: CAB | 8 | |
| Overall Study | COMPLETED | Sequence 4: ACB | 9 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events96
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 | Abdominal pain upper | Gastrointestinal disorders | THN102 300/0 | 1 | 48 | |
| other | Abdominal pain upper | Gastrointestinal disorders | THN102 300/3 | 0 | 47 | |
| other | Abdominal pain upper | Gastrointestinal disorders | THN102 300/27 | 0 | 47 | |
| other | Palpitation | Cardiac disorders | THN102 300/0 | 1 | 48 | |
| other | Palpitation | Cardiac disorders | THN102 300/3 | 0 | 47 | |
| other | Palpitation | Cardiac disorders | THN102 300/27 | 0 | 47 | |
| other | vertigo | Ear and labyrinth disorders | THN102 300/0 | 0 | 48 | |
| other | vertigo | Ear and labyrinth disorders | THN102 300/3 | 1 | 47 | |
| other | vertigo | Ear and labyrinth disorders | THN102 300/27 | 0 | 47 | |
| other | chalazion | Eye disorders | THN102 300/0 | 0 | 48 |
1 to 10 of 96Source ClinicalTrials.gov
See all 96 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | THN102 300/0 | 0 | 48 |
| Total, all-cause mortality | THN102 300/3 | 0 | 48 |
| Total, all-cause mortality | THN102 300/27 | 0 | 48 |
| Total, other adverse events | THN102 300/0 | 9 | 48 |
| Total, other adverse events | THN102 300/3 | 15 | 47 |
| Total, other adverse events | THN102 300/27 | 13 | 47 |
| Total, serious adverse events | THN102 300/0 | 0 | 48 |
| Total, serious adverse events | THN102 300/3 | 0 | 48 |
| Total, serious adverse events | THN102 300/27 | 0 | 48 |
Source ClinicalTrials.gov
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.
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/NCT02821715
GET https://conductscience.org/api/trials/v1/NCT02821715/results?page=2