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| Name | Class |
|---|---|
| American Academy of Sleep Medicine | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Modafinil | Active Comparator | Participants in this study arm will take modafinil. |
|
| Amphetamine-dextroamphetamine | Experimental | Participants in this study arm will take amphetamine-dextroamphetamine (amphetamine salts). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Modafinil | Drug | Participants will received 100-400 milligrams (mg) per day of modafinil for 12 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lynn Marie Trotti, MD, MSc | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory Sleep Center | Atlanta | Georgia | 30329 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39306601 | Derived | Trotti LM, Blake T, Hoque R, Rye DB, Sharma S, Bliwise DL. Modafinil Versus Amphetamine-Dextroamphetamine For Idiopathic Hypersomnia and Narcolepsy Type 2: A Randomized, Blinded, Non-inferiority Trial. CNS Drugs. 2024 Nov;38(11):909-920. doi: 10.1007/s40263-024-01122-y. Epub 2024 Sep 21. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Modafinil | Participants with narcolepsy type 2 or idiopathic hypersomnia randomized to take modafinil. Participants received 100-400 milligrams (mg) per day of modafinil for 12 weeks. |
| FG001 | Amphetamine-dextroamphetamine | Participants with narcolepsy type 2 or idiopathic hypersomnia randomized to take amphetamine-dextroamphetamine (amphetamine salts). Participants received 10-40 mg/day of oral amphetamine salts for 12 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Modafinil | Participants with narcolepsy type 2 or idiopathic hypersomnia randomized to take modafinil. Participants received 100-400 mg/day of modafinil for 12 weeks. |
| BG001 | Amphetamine-dextroamphetamine |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | This analysis includes the modified intent to treat study population consisting of all participants who were randomized and took at least one dose of study medication. The last observation is used for participants who did not complete the study or had missing responses. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 12 |
Information on adverse events was collected once participants began taking the study medication and continued through the final assessment at Week 12.
Only treatment-emergent adverse events were collected for this study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Modafinil | Participants with narcolepsy type 2 or idiopathic hypersomnia randomized to take modafinil. Participants received 100-400 mg/day of modafinil for 12 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization due to suicidal ideation | Psychiatric disorders | Non-systematic Assessment | The participant's psychiatric team continued the study medication and symptoms were successfully managed. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Reduced appetite | General disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Lynn Marie Trotti | Emory University | 404-712-7240 | lbecke2@emory.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 25, 2020 | Mar 13, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D020177 | Idiopathic Hypersomnia |
| ID | Term |
|---|---|
| D006970 | Disorders of Excessive Somnolence |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
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| ID | Term |
|---|---|
| D000077408 | Modafinil |
| C449521 | SLI381 |
| C090411 | Adderall |
| ID | Term |
|---|---|
| D001559 | Benzhydryl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| Amphetamine-Dextroamphetamine | Drug | Participants will receive 10-40 mg/day of oral amphetamine salts for 12 weeks. |
|
|
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Baseline, Week 12 |
Participants with narcolepsy type 2 or idiopathic hypersomnia randomized to take amphetamine-dextroamphetamine (amphetamine salts). Participants received 10-40 mg/day of oral amphetamine salts for 12 weeks.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Hypersomnolence diagnosis | Count of Participants | Participants |
|
| Newly diagnosed at study entry | Count of Participants | Participants |
|
| Prior exposure to modafinil | Count of Participants | Participants |
|
| Prior exposure to amphetamine-dextroamphetamine | Count of Participants | Participants |
|
| Baseline Epworth Sleepiness Scale (ESS) Score | The 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. | Mean | Standard Deviation | units on a scale |
|
| Hypersomnia Severity Index (HSI) Score | 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. | Mean | Standard Deviation | score on a scale |
|
| Sleep Inertia Questionnaire (SIQ) Score | 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, the sum of the 21 items is reported, ranging from 21 to 105, with higher scores indicating increased difficulty with awakening. | Mean | Standard Deviation | score on a scale |
|
| ID | Title | Description |
|---|---|---|
| OG000 | Modafinil | Participants with narcolepsy type 2 or idiopathic hypersomnia randomized to take modafinil. Participants received 100-400 mg/day of modafinil for 12 weeks. |
| OG001 | Amphetamine-dextroamphetamine | Participants with narcolepsy type 2 or idiopathic hypersomnia randomized to take amphetamine-dextroamphetamine (amphetamine salts). Participants received 10-40 mg/day of oral amphetamine salts for 12 weeks. |
|
|
| Secondary | 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. | This analysis includes the modified intent to treat study population consisting of all participants who were randomized and took at least one dose of study medication. The last observation is used for participants who did not complete the study or had missing responses. Two participants in the amphetamine-dextroamphetamine group withdrew prior to completing any PGIC scales and are not included in this analysis. | Posted | Count of Participants | Participants | Week 12 |
|
|
|
| Secondary | 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. | This analysis includes the modified intent to treat study population consisting of all participants who were randomized and took at least one dose of study medication. The last observation is used for participants who did not complete the study or had missing responses. Two participants in the amphetamine-dextroamphetamine group withdrew prior to completing any PGIC scales and are not included in this analysis. | Posted | Count of Participants | Participants | Week 12 |
|
|
|
| Secondary | 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. | This analysis includes the modified intent to treat study population consisting of all participants who were randomized and took at least one dose of study medication. The last observation is used for participants who did not complete the study or had missing responses. Two participants in the amphetamine-dextroamphetamine group withdrew prior to completing any PGIC scales and are not included in this analysis. | Posted | Count of Participants | Participants | Week 12 |
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|
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| Secondary | 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. | This analysis includes the modified intent to treat study population consisting of all participants who were randomized and took at least one dose of study medication. The last observation is used for participants who did not complete the study or had missing responses. Two participants in the amphetamine-dextroamphetamine group withdrew prior to completing any PGIC scales and are not included in this analysis. | Posted | Count of Participants | Participants | Week 12 |
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|
| Secondary | 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. | This analysis includes the modified intent to treat study population consisting of all participants who were randomized and took at least one dose of study medication. The last observation is used for participants who did not complete the study or had missing responses. Two participants in the amphetamine-dextroamphetamine group withdrew prior to completing any PGIC scales and are not included in this analysis. | Posted | Count of Participants | Participants | Week 12 |
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| Secondary | 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. | This analysis includes the modified intent to treat study population consisting of all participants who were randomized and took at least one dose of study medication. The last observation is used for participants who did not complete the study or had missing responses. Two participants in the amphetamine-dextroamphetamine group withdrew prior to completing any PGIC scales and are not included in this analysis. | Posted | Count of Participants | Participants | Week 12 |
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| Secondary | 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. | This analysis includes the modified intent to treat study population consisting of all participants who were randomized and took at least one dose of study medication. The last observation is used for participants who did not complete the study or had missing responses. Two participants in the amphetamine-dextroamphetamine group withdrew prior to completing any PGIC scales and are not included in this analysis. | Posted | Count of Participants | Participants | Week 12 |
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| Secondary | 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. | This analysis includes the modified intent to treat study population consisting of all participants who were randomized and took at least one dose of study medication. The last observation is used for participants who did not complete the study or had missing responses. Two participants in the amphetamine-dextroamphetamine group withdrew prior to completing any PGIC scales and are not included in this analysis. | Posted | Count of Participants | Participants | Week 12 |
|
|
|
| Secondary | 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. | This analysis includes the modified intent to treat study population consisting of all participants who were randomized and took at least one dose of study medication. The last observation is used for participants who did not complete the study or had missing responses. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 12 |
|
|
|
| Secondary | 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. | This analysis includes the modified intent to treat study population consisting of all participants who were randomized and took at least one dose of study medication. The last observation is used for participants who did not complete the study or had missing responses. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 12 |
|
|
|
| 0 |
| 22 |
| 1 |
| 22 |
| 17 |
| 22 |
| EG001 | Amphetamine-dextroamphetamine | Participants with narcolepsy type 2 or idiopathic hypersomnia randomized to take amphetamine-dextroamphetamine (amphetamine salts). Participants received 10-40 mg/day of oral amphetamine salts for 12 weeks. | 0 | 22 | 0 | 22 | 17 | 22 |
|
| Headache | General disorders | Non-systematic Assessment |
|
| Insomnia | General disorders | Non-systematic Assessment |
|
| Anxiety symptoms | Psychiatric disorders | Non-systematic Assessment |
|
| Dizziness | General disorders | Non-systematic Assessment |
|
| Elevated heart rate/palpitations | Cardiac disorders | Non-systematic Assessment |
|
| Jitteriness | General disorders | Non-systematic Assessment |
|
| Depressive symptoms | Psychiatric disorders | Non-systematic Assessment |
|
| Nausea | General disorders | Non-systematic Assessment |
|
| Dry mouth | General disorders | Non-systematic Assessment |
|
| Elevated blood pressure | Vascular disorders | Non-systematic Assessment |
|
Not provided
Not provided
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| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |