A Phase 2 interventional study of Modafinil and Amphetamine-Dextroamphetamine in Idiopathic Hypersomnia and Narcolepsy Without Cataplexy, sponsored by Emory University. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-05-23.
Sponsored by Emory University · Phase 2, Interventional, and Treatment
Among 30 studies in Idiopathic Hypersomnia with a site in United States — 12 open to participants now, 13 under way, 4 of them phase 3. Idiopathic Hypersomnia · United States.
Among the 30 studies in Idiopathic Hypersomnia with a site in United States, this one is the 20th largest by enrollment of the 27 interventional ones, is one of 2 that started in 2019, is one of 10 in phase 2, and was the 8th registered.
52 studies on the registry are indexed under Idiopathic Hypersomnia; 23 are open to participants now.
This study's enrollment of 44 is below the median of 82 across 40 interventional studies indexed under Idiopathic Hypersomnia.
Browse Idiopathic Hypersomnia studies →12 of the 30 studies in Idiopathic Hypersomnia with a site in United States are open now, in 12 countries. Each count lists the studies.
Of the 17 Idiopathic Hypersomnia studies recruiting now, 4 (24%) set no upper age limit and 12 (71%) stop at 75 or younger; 2 take children under 18; 4 take healthy volunteers.
This study: 18 Years to 65 Years · all sexes · no healthy volunteers.
The full table on the hub →30 studies; the count open now beside each. This study's row is marked.
First in 2010; this study’s year is marked. 2 started in 2019.
Median enrollment 100 across the 27 interventional studies, 100 across the 3 observational. Of the 16 that completed or were terminated, 9 (56%) have results posted.
18 of 30 have an industry lead sponsor. The 10 most frequent:
Emory University is the lead sponsor of 1,405 studies on the registry; 225 are open to participants now.
Of its 237 completed or terminated interventional studies of FDA-regulated products, 178 (75%) have results posted.
Emory University has 3 studies filed under Idiopathic Hypersomnia — fewer than ten, so there is no comparison to draw.
5 of the studies in Idiopathic Hypersomnia with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07500090Phase 3Harmony Biosciences Management, Inc.A Phase 3 Efficacy and Safety Study of HBS-301 in Participants With Idiopathic Hypersomnia (IH) | 2027-10 |
| NCT06843590Alkermes, Inc.A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Idiopathic Hypersomnia | 2026-11 |
| NCT06812078TakedaA Study of TAK-360 in Adults With Idiopathic Hypersomnia | 2026-11-30 |
| NCT06752668Centessa Pharmaceuticals (UK) LimitedA Study of ORX750 in Participants With Narcolepsy and Idiopathic Hypersomnia | 2026-12 |
| NCT05837091Mayo ClinicLow Sodium Oxybate in Patients With Idiopathic Hypersomnia | 2027-01-29 |
Among the 30 studies in Idiopathic Hypersomnia with a site in United States, from their registry updates:
For diseases that cause excessive daytime sleepiness (such as narcolepsy and idiopathic hypersomnia), there are several medications that can be used to treat sleepiness. However, it can be difficult to decide which medication to use for a particular individual for several reasons: 1) there are very few studies that directly compare two medications to see which works best; 2) there are very few studies that include people with a disorder of sleepiness called idiopathic hypersomnia.
To address this gap in knowledge, the researchers propose a randomized clinical trial comparing modafinil and amphetamine salts in patients with narcolepsy type 2 or idiopathic hypersomnia. All participants will either receive modafinil or amphetamine salts - no participant will receive placebo.
This study will evaluate which medication works better to improve sleepiness. The researchers will also see which medication is better for other symptoms including difficulty waking up and difficulty thinking, as well as seeing which medication causes fewer side effects. Finally, this study will see if any information about patients (such as age or sleep study features) predicts responding better to one medication or the other.
Currently, there are insufficient data to guide clinical practice regarding the use of amphetamines for the treatment of narcolepsy. This may be particularly important in the case of narcolepsy type 2, for which randomized, controlled trial data show that other treatments are less beneficial than they are for participants with narcolepsy type 1. For the closely related disorder of idiopathic hypersomnia, clinical trial data to guide treatment decision-making are even more limited, with only three published controlled trials ever performed.
To address these evidence gaps, the researchers propose a randomized, active-treatment controlled trial comparing modafinil and amphetamine salts for the treatment of narcolepsy type 2 and idiopathic hypersomnia. The primary outcome will be reduction in excessive daytime sleepiness, as measured by change in Epworth Sleepiness Scale scores from baseline to week 12 on treatment. Other important patient-reported outcomes will be considered as secondary outcomes, including Patient Global Impression of Change for overall severity, sleep inertia, cognitive dysfunction, and sleepiness, as well as other symptom questionnaires.
In addition to directly comparing the efficacy of these two medications for hypersomnolent patients, this study will also evaluate for relatively safety in this population. Further, this study will assess clinical predictors of treatment response. All three of these aims will be complementary in informing shared decision-making about whether to treat with modafinil or amphetamine salts.
Forty-four adult patients seeking evaluation at the Emory Sleep Center for narcolepsy type 2 or idiopathic hypersomnia will be invited to participate and will be randomized to one of the treatment arms upon consent. Participants will receive study treatment for 12 weeks. Participants complete questionnaires at baseline, week 4, week 8, and week 12, with week 12 as the pre-specified primary time point of assessment.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in this study arm will take modafinil.
Drug: Modafinil
Participants in this study arm will take amphetamine-dextroamphetamine (amphetamine salts).
Drug: Amphetamine-Dextroamphetamine
Participants will received 100-400 milligrams (mg) per day of modafinil for 12 weeks.
Also known as: Provigil
Participants will receive 10-40 mg/day of oral amphetamine salts for 12 weeks.
Also known as: Adderall
Change in Epworth Sleepiness Scale (ESS) Score
The Epworth Sleepiness Scale (ESS) asks respondents to indicate how likely they are to doze off or fall asleep during daytime situations such as reading or talking to someone. There are 8 items which are answered on a scale of 0 to 4 where 0 = would never doze and 4 = high chance of dozing. Total score can range from 0 to 24, with higher scores indicating more sleepiness. A score of 0 to 5 can be interpreted as "lower normal daytime sleepiness", a score of 6 to 10 is "higher normal daytime sleepiness", score between 11 to 12 are "mild excessive daytime sleepiness, scores of 13 to 15 are "moderate excessive daytime sleepiness" and scores of 16 to 24 indicate "severe excessive daytime sleepiness". The change in ESS score is obtained by subtracting the total score at week 12 from the baseline score. Scores above 0 mean that the mean score at Week 12 was lower than the mean score at Baseline, indicating less sleepiness.
Time frame: Baseline, Week 12
Number of Participants Reporting Any Improvement by Patient Global Impression of Change (PGIC) for Overall Disease Severity Score
The PGIC for Overall Severity asks respondents to rate their overall disease compared to baseline. Responses are indicated on a 7-point scale where 1 = "very much improved", 2 = "much improved", 3 = "minimally improved" 4 = "no change", 5 = "minimally worse", 6 = "much worse" and 7 = "very much worse". Responses were dichotomized into groups of participants who were treatment responders having any level of improvement (responses of "minimally improved", "much improved", or "very much improved") and treatment non-responders (responses of "no change" to "very much worse"). The number of participants reporting any improvement at the Week 12 assessment compared to how they felt right before starting the study medication was examined.
Time frame: Week 12
Number of Participants Reporting Much or Very Much Improvement by Patient Global Impression of Change (PGIC) for Overall Disease Severity Score
The PGIC for Overall Severity asks respondents to rate their overall disease compared to baseline. Responses are indicated on a scale of 1 to 7 where 1 = "very much improved", 2 = "much improved", 3 = "minimally improved" 4 = "no change", 5 = "minimally worse", 6 = "much worse" and 7 = "very much worse". The number of participants reporting "much improved" or "very much improved" at the Week 12 assessment compared to how they felt right before starting the study medication was examined.
Time frame: Week 12
Number of Participants Reporting Any Improvement From Baseline on Patient Global Impression of Change (PGIC) for Sleepiness Score
The PGIC for Sleepiness asks respondents to rate their sleepiness compared to baseline. Responses are indicated on a 7-point scale where 1 = "very much improved", 2 = "much improved", 3 = "minimally improved" 4 = "no change", 5 = "minimally worse", 6 = "much worse" and 7 = "very much worse". Responses were dichotomized into groups of participants who were treatment responders having any level of improvement (responses of "minimally improved", "much improved", or "very much improved") and treatment non-responders (responses of "no change" to "very much worse"). The number of participants reporting any improvement at the Week 12 assessment compared to how they felt right before starting the study medication was examined.
Time frame: Week 12
Number of Participants Reporting Much or Very Much Improvement From Baseline on Patient Global Impression of Change (PGIC) for Sleepiness Score
The PGIC for Sleepiness asks respondents to rate their sleepiness compared to baseline. Responses are indicated on a 7-point scale where 1 = "very much improved", 2 = "much improved", 3 = "minimally improved" 4 = "no change", 5 = "minimally worse", 6 = "much worse" and 7 = "very much worse". The number of participants reporting "much improved" or "very much improved" at the Week 12 assessment compared to how they felt right before starting the study medication was examined.
Time frame: Week 12
Number of Participants Reporting Any Improvement With Patient Global Impression of Change (PGIC) for Cognitive Dysfunction Score
The PGIC for Cognitive Dysfunction asks respondents to rate their cognitive dysfunction compared to baseline. Cognitive dysfunction is defined for participants as "difficulty with thinking, problems with attention or concentration, and/or brain fog". Responses are indicated on a scale of 1 to 7 where where 1 = "very much improved", 2 = "much improved", 3 = "minimally improved" 4 = "no change", 5 = "minimally worse", 6 = "much worse" and 7 = "very much worse". Responses were dichotomized into groups of participants who were treatment responders having any level of improvement (responses of "minimally improved", "much improved", or "very much improved") and treatment non-responders (responses of "no change" to "very much worse"). The number of participants reporting any improvement at the Week 12 assessment compared to how they felt right before starting the study medication was examined.
Time frame: Week 12
Number of Participants Reporting Much or Very Much Improvement With Patient Global Impression of Change (PGIC) for Cognitive Dysfunction Score
The PGIC for Cognitive Dysfunction asks respondents to rate their cognitive dysfunction compared to baseline. Cognitive dysfunction is defined for participants as "difficulty with thinking, problems with attention or concentration, and/or brain fog". Responses are indicated on a scale of 1 to 7 where 1 = "very much improved", 2 = "much improved", 3 = "minimally improved" 4 = "no change", 5 = "minimally worse", 6 = "much worse" and 7 = "very much worse". The number of participants reporting "much improved" or "very much improved" at the Week 12 assessment compared to how they felt right before starting the study medication was examined.
Time frame: Week 12
Number of Participants Reporting Any Improvement by Patient Global Impression of Change (PGIC) for Sleep Inertia Score
The PGIC for Sleep Inertia asks respondents to rate their sleep inertia compared to baseline. Sleep inertia is defined for participants as "difficulty waking up and getting out of bed in the morning because of sleepiness". Responses are indicated on a scale of 1 to 7 where 1 = "very much improved", 2 = "much improved", 3 = "minimally improved" 4 = "no change", 5 = "minimally worse", 6 = "much worse" and 7 = "very much worse". Responses were dichotomized into groups of participants who were treatment responders having any level of improvement (responses of "minimally improved", "much improved", or "very much improved") and treatment non-responders (responses of "no change" to "very much worse"). The number of participants reporting any improvement at the Week 12 assessment compared to how they felt right before starting the study medication was examined.
Time frame: Week 12
Number of Participants Reporting Much or Very Much Improvement by Patient Global Impression of Change (PGIC) for Sleep Inertia Score
The PGIC for Sleep Inertia asks respondents to rate their sleep inertia compared to baseline. Sleep inertia is defined for participants as "difficulty waking up and getting out of bed in the morning because of sleepiness". Responses are indicated on a scale of 1 to 7 where 1 = "very much improved", 2 = "much improved", 3 = "minimally improved" 4 = "no change", 5 = "minimally worse", 6 = "much worse" and 7 = "very much worse". The number of participants reporting "much improved" or "very much improved" at the Week 12 assessment compared to how they felt right before starting the study medication was examined.
Time frame: Week 12
Change in Hypersomnia Severity Index (HSI) From Baseline
The HSI is a 9-item instrument assessing the severity of excessive sleepiness (hypersomnolence). Items are scored on a Likert scale where 0 = not at all and 4 = very much. Total scores range from 0 to 36 and higher scores indicate greater severity of symptoms of hypersomnia. The change in HSI score is obtained by subtracting the total score at week 12 from the baseline score. Scores above 0 signify that the mean score at Week 12 was lower than the mean score at Baseline, indicating reduced severity of hypersomnia symptoms.
Time frame: Baseline, Week 12
Change in Sleep Inertia Questionnaire (SIQ) Score From Baseline
The SIQ is an instrument with 21 items with responses on a 5-point scale where 1 = "not at all" and 5 = "all the time". Two additional questions relate to how much time it takes for the respondent to wake up in the morning. For these analyses, a total score for the 21 items was generated. The change in SIQ score is obtained by subtracting the total score at week 12 from the baseline score. Scores above 0 signify that the mean score at Week 12 was lower than the mean score at Baseline, indicating reduced difficulty awakening.
Time frame: Baseline, Week 12
Participants were recruited from the Emory Sleep Center in Atlanta, Georgia, USA. Participant enrollment began April 15, 2019 and all follow-up assessments were completed by April 3, 2023.
| Milestone | Modafinil | Amphetamine-dextroamphetamine |
|---|---|---|
| Started | 22 | 22 |
| Completed | 15 | 20 |
| Not completed | 7 | 2 |
| Withdrew: Adverse event | 7 | 2 |
The Epworth Sleepiness Scale (ESS) asks respondents to indicate how likely they are to doze off or fall asleep during daytime situations such as reading or talking to someone. There are 8 items which are answered on a scale of 0 to 4 where 0 = would never doze and 4 = high chance of dozing. Total score can range from 0 to 24, with higher scores indicating more sleepiness. A score of 0 to 5 can be interpreted as "lower normal daytime sleepiness", a score of 6 to 10 is "higher normal daytime sleepiness", score between 11 to 12 are "mild excessive daytime sleepiness, scores of 13 to 15 are "moderate excessive daytime sleepiness" and scores of 16 to 24 indicate "severe excessive daytime sleepiness". The change in ESS score is obtained by subtracting the total score at week 12 from the baseline score. Scores above 0 mean that the mean score at Week 12 was lower than the mean score at Baseline, indicating less sleepiness.
| score on a scale | Modafinil | Amphetamine-dextroamphetamine |
|---|---|---|
| Change in Epworth Sleepiness Scale (ESS) Score | 5.0 ± 2.7 | 4.4 ± 4.7 |
The PGIC for Overall Severity asks respondents to rate their overall disease compared to baseline. Responses are indicated on a 7-point scale where 1 = "very much improved", 2 = "much improved", 3 = "minimally improved" 4 = "no change", 5 = "minimally worse", 6 = "much worse" and 7 = "very much worse". Responses were dichotomized into groups of participants who were treatment responders having any level of improvement (responses of "minimally improved", "much improved", or "very much improved") and treatment non-responders (responses of "no change" to "very much worse"). The number of participants reporting any improvement at the Week 12 assessment compared to how they felt right before starting the study medication was examined.
| Participants | Modafinil | Amphetamine-dextroamphetamine |
|---|---|---|
| Number of Participants Reporting Any Improvement by Patient Global Impression of Change (PGIC) for Overall Disease Severity Score | 18 | 16 |
The PGIC for Overall Severity asks respondents to rate their overall disease compared to baseline. Responses are indicated on a scale of 1 to 7 where 1 = "very much improved", 2 = "much improved", 3 = "minimally improved" 4 = "no change", 5 = "minimally worse", 6 = "much worse" and 7 = "very much worse". The number of participants reporting "much improved" or "very much improved" at the Week 12 assessment compared to how they felt right before starting the study medication was examined.
| Participants | Modafinil | Amphetamine-dextroamphetamine |
|---|---|---|
| Number of Participants Reporting Much or Very Much Improvement by Patient Global Impression of Change (PGIC) for Overall Disease Severity Score | 13 | 10 |
The PGIC for Sleepiness asks respondents to rate their sleepiness compared to baseline. Responses are indicated on a 7-point scale where 1 = "very much improved", 2 = "much improved", 3 = "minimally improved" 4 = "no change", 5 = "minimally worse", 6 = "much worse" and 7 = "very much worse". Responses were dichotomized into groups of participants who were treatment responders having any level of improvement (responses of "minimally improved", "much improved", or "very much improved") and treatment non-responders (responses of "no change" to "very much worse"). The number of participants reporting any improvement at the Week 12 assessment compared to how they felt right before starting the study medication was examined.
| Participants | Modafinil | Amphetamine-dextroamphetamine |
|---|---|---|
| Number of Participants Reporting Any Improvement From Baseline on Patient Global Impression of Change (PGIC) for Sleepiness Score | 19 | 16 |
The PGIC for Sleepiness asks respondents to rate their sleepiness compared to baseline. Responses are indicated on a 7-point scale where 1 = "very much improved", 2 = "much improved", 3 = "minimally improved" 4 = "no change", 5 = "minimally worse", 6 = "much worse" and 7 = "very much worse". The number of participants reporting "much improved" or "very much improved" at the Week 12 assessment compared to how they felt right before starting the study medication was examined.
| Participants | Modafinil | Amphetamine-dextroamphetamine |
|---|---|---|
| Number of Participants Reporting Much or Very Much Improvement From Baseline on Patient Global Impression of Change (PGIC) for Sleepiness Score | 14 | 10 |
The PGIC for Cognitive Dysfunction asks respondents to rate their cognitive dysfunction compared to baseline. Cognitive dysfunction is defined for participants as "difficulty with thinking, problems with attention or concentration, and/or brain fog". Responses are indicated on a scale of 1 to 7 where where 1 = "very much improved", 2 = "much improved", 3 = "minimally improved" 4 = "no change", 5 = "minimally worse", 6 = "much worse" and 7 = "very much worse". Responses were dichotomized into groups of participants who were treatment responders having any level of improvement (responses of "minimally improved", "much improved", or "very much improved") and treatment non-responders (responses of "no change" to "very much worse"). The number of participants reporting any improvement at the Week 12 assessment compared to how they felt right before starting the study medication was examined.
| Participants | Modafinil | Amphetamine-dextroamphetamine |
|---|---|---|
| Number of Participants Reporting Any Improvement With Patient Global Impression of Change (PGIC) for Cognitive Dysfunction Score | 16 | 13 |
The PGIC for Cognitive Dysfunction asks respondents to rate their cognitive dysfunction compared to baseline. Cognitive dysfunction is defined for participants as "difficulty with thinking, problems with attention or concentration, and/or brain fog". Responses are indicated on a scale of 1 to 7 where 1 = "very much improved", 2 = "much improved", 3 = "minimally improved" 4 = "no change", 5 = "minimally worse", 6 = "much worse" and 7 = "very much worse". The number of participants reporting "much improved" or "very much improved" at the Week 12 assessment compared to how they felt right before starting the study medication was examined.
| Participants | Modafinil | Amphetamine-dextroamphetamine |
|---|---|---|
| Number of Participants Reporting Much or Very Much Improvement With Patient Global Impression of Change (PGIC) for Cognitive Dysfunction Score | 5 | 10 |
The PGIC for Sleep Inertia asks respondents to rate their sleep inertia compared to baseline. Sleep inertia is defined for participants as "difficulty waking up and getting out of bed in the morning because of sleepiness". Responses are indicated on a scale of 1 to 7 where 1 = "very much improved", 2 = "much improved", 3 = "minimally improved" 4 = "no change", 5 = "minimally worse", 6 = "much worse" and 7 = "very much worse". Responses were dichotomized into groups of participants who were treatment responders having any level of improvement (responses of "minimally improved", "much improved", or "very much improved") and treatment non-responders (responses of "no change" to "very much worse"). The number of participants reporting any improvement at the Week 12 assessment compared to how they felt right before starting the study medication was examined.
| Participants | Modafinil | Amphetamine-dextroamphetamine |
|---|---|---|
| Number of Participants Reporting Any Improvement by Patient Global Impression of Change (PGIC) for Sleep Inertia Score | 11 | 11 |
The PGIC for Sleep Inertia asks respondents to rate their sleep inertia compared to baseline. Sleep inertia is defined for participants as "difficulty waking up and getting out of bed in the morning because of sleepiness". Responses are indicated on a scale of 1 to 7 where 1 = "very much improved", 2 = "much improved", 3 = "minimally improved" 4 = "no change", 5 = "minimally worse", 6 = "much worse" and 7 = "very much worse". The number of participants reporting "much improved" or "very much improved" at the Week 12 assessment compared to how they felt right before starting the study medication was examined.
| Participants | Modafinil | Amphetamine-dextroamphetamine |
|---|---|---|
| Number of Participants Reporting Much or Very Much Improvement by Patient Global Impression of Change (PGIC) for Sleep Inertia Score | 4 | 4 |
The HSI is a 9-item instrument assessing the severity of excessive sleepiness (hypersomnolence). Items are scored on a Likert scale where 0 = not at all and 4 = very much. Total scores range from 0 to 36 and higher scores indicate greater severity of symptoms of hypersomnia. The change in HSI score is obtained by subtracting the total score at week 12 from the baseline score. Scores above 0 signify that the mean score at Week 12 was lower than the mean score at Baseline, indicating reduced severity of hypersomnia symptoms.
| score on a scale | Modafinil | Amphetamine-dextroamphetamine |
|---|---|---|
| Change in Hypersomnia Severity Index (HSI) From Baseline | 8.0 ± 5.6 | 10.4 ± 6.8 |
The SIQ is an instrument with 21 items with responses on a 5-point scale where 1 = "not at all" and 5 = "all the time". Two additional questions relate to how much time it takes for the respondent to wake up in the morning. For these analyses, a total score for the 21 items was generated. The change in SIQ score is obtained by subtracting the total score at week 12 from the baseline score. Scores above 0 signify that the mean score at Week 12 was lower than the mean score at Baseline, indicating reduced difficulty awakening.
| score on a scale | Modafinil | Amphetamine-dextroamphetamine |
|---|---|---|
| Change in Sleep Inertia Questionnaire (SIQ) Score From Baseline | 19.0 ± 15.9 | 18.2 ± 18.4 |
Collected over Information on adverse events was collected once participants began taking the study medication and continued through the final assessment at Week 12.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Modafinil | 0/22 (0%) | 1/22 (4.5%) | 17/22 (77.3%) |
| Amphetamine-dextroamphetamine | 0/22 (0%) | 0/22 (0%) | 17/22 (77.3%) |
| Event | Modafinil | Amphetamine-dextroamphetamine |
|---|---|---|
| Hospitalization due to suicidal ideationPsychiatric disorders | 1/22 | 0/22 |
| Event | Modafinil | Amphetamine-dextroamphetamine |
|---|---|---|
| Reduced appetiteGeneral disorders | 2/22 | 8/22 |
| HeadacheGeneral disorders | 4/22 | 6/22 |
| InsomniaGeneral disorders | 5/22 | 3/22 |
| Anxiety symptomsPsychiatric disorders | 5/22 | 0/22 |
| DizzinessGeneral disorders | 1/22 | 4/22 |
| Depressive symptomsPsychiatric disorders | 3/22 | 1/22 |
| NauseaGeneral disorders | 3/22 | 1/22 |
| Dry mouthGeneral disorders | 1/22 | 3/22 |
| Elevated heart rate/palpitationsCardiac disorders | 2/22 | 2/22 |
| JitterinessGeneral disorders | 2/22 | 2/22 |
| Age, Continuous(years) | Modafinil | Amphetamine-dextroamphetamine | Total |
|---|---|---|---|
| Mean | 35.0 ± 8.9 | 35.8 ± 9.1 | 35.4 ± 8.9 |
| Sex: Female, Male(Participants) | Modafinil | Amphetamine-dextroamphetamine | Total |
|---|---|---|---|
| Female | 17 | 20 | 37 |
| Male | 5 | 2 | 7 |
| Race and Ethnicity Not Collected(Participants) | Modafinil | Amphetamine-dextroamphetamine | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(Participants) | Modafinil | Amphetamine-dextroamphetamine | Total |
|---|---|---|---|
| United States | 22 | 22 | 44 |
| Hypersomnolence diagnosis(Participants) | Modafinil | Amphetamine-dextroamphetamine | Total |
|---|---|---|---|
| Narcolepsy type 2 (NT2) | 5 | 6 | 11 |
| Idiopathic hypersomnia (IH), | 17 | 16 | 33 |
| Newly diagnosed at study entry(Participants) | Modafinil | Amphetamine-dextroamphetamine | Total |
|---|---|---|---|
| Count of participants | 17 | 16 | 33 |
| Prior exposure to modafinil(Participants) | Modafinil | Amphetamine-dextroamphetamine | Total |
|---|---|---|---|
| Count of participants | 0 | 1 | 1 |
| Prior exposure to amphetamine-dextroamphetamine(Participants) | Modafinil | Amphetamine-dextroamphetamine | Total |
|---|---|---|---|
| Count of participants | 1 | 2 | 3 |
3 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Apr 2019 to primary completion in May 2023, 48 months.
Results were first posted in May 2024, 1 year after primary completion.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: Adderall