Trial Outcomes & Findings for Modafinil Versus Amphetamines for the Treatment of Narcolepsy Type 2 and Idiopathic Hypersomnia (NCT NCT03772314)
NCT ID: NCT03772314
Last Updated: 2024-05-23
Results Overview
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.
COMPLETED
PHASE2
44 participants
Baseline, Week 12
2024-05-23
Participant Flow
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.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
22
|
22
|
|
Overall Study
COMPLETED
|
15
|
20
|
|
Overall Study
NOT COMPLETED
|
7
|
2
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Adverse Event
|
7
|
2
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Modafinil
n=22 Participants
Participants with narcolepsy type 2 or idiopathic hypersomnia randomized to take modafinil. Participants received 100-400 mg/day of modafinil for 12 weeks.
|
Amphetamine-dextroamphetamine
n=22 Participants
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.
|
Total
n=44 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
35.0 years
STANDARD_DEVIATION 8.9 • n=22 Participants
|
35.8 years
STANDARD_DEVIATION 9.1 • n=22 Participants
|
35.4 years
STANDARD_DEVIATION 8.9 • n=44 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=22 Participants
|
20 Participants
n=22 Participants
|
37 Participants
n=44 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=22 Participants
|
2 Participants
n=22 Participants
|
7 Participants
n=44 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
22 Participants
n=22 Participants
|
22 Participants
n=22 Participants
|
44 Participants
n=44 Participants
|
|
Hypersomnolence diagnosis
Narcolepsy type 2 (NT2)
|
5 Participants
n=22 Participants
|
6 Participants
n=22 Participants
|
11 Participants
n=44 Participants
|
|
Hypersomnolence diagnosis
Idiopathic hypersomnia (IH),
|
17 Participants
n=22 Participants
|
16 Participants
n=22 Participants
|
33 Participants
n=44 Participants
|
|
Newly diagnosed at study entry
|
17 Participants
n=22 Participants
|
16 Participants
n=22 Participants
|
33 Participants
n=44 Participants
|
|
Prior exposure to modafinil
|
0 Participants
n=22 Participants
|
1 Participants
n=22 Participants
|
1 Participants
n=44 Participants
|
|
Prior exposure to amphetamine-dextroamphetamine
|
1 Participants
n=22 Participants
|
2 Participants
n=22 Participants
|
3 Participants
n=44 Participants
|
|
Baseline Epworth Sleepiness Scale (ESS) Score
|
14.0 units on a scale
STANDARD_DEVIATION 5.3 • n=22 Participants
|
15.2 units on a scale
STANDARD_DEVIATION 3.8 • n=22 Participants
|
14.6 units on a scale
STANDARD_DEVIATION 4.6 • n=44 Participants
|
|
Hypersomnia Severity Index (HSI) Score
|
25.0 score on a scale
STANDARD_DEVIATION 5.9 • n=22 Participants
|
26.5 score on a scale
STANDARD_DEVIATION 6.4 • n=22 Participants
|
25.8 score on a scale
STANDARD_DEVIATION 6.1 • n=44 Participants
|
|
Sleep Inertia Questionnaire (SIQ) Score
|
76.5 score on a scale
STANDARD_DEVIATION 17.5 • n=22 Participants
|
74.0 score on a scale
STANDARD_DEVIATION 13.8 • n=22 Participants
|
75.2 score on a scale
STANDARD_DEVIATION 15.6 • n=44 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 12Population: 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.
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.
Outcome measures
| Measure |
Modafinil
n=22 Participants
Participants with narcolepsy type 2 or idiopathic hypersomnia randomized to take modafinil. Participants received 100-400 mg/day of modafinil for 12 weeks.
|
Amphetamine-dextroamphetamine
n=22 Participants
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.
|
|---|---|---|
|
Change in Epworth Sleepiness Scale (ESS) Score
|
5.0 score on a scale
Standard Deviation 2.7
|
4.4 score on a scale
Standard Deviation 4.7
|
SECONDARY outcome
Timeframe: Week 12Population: 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.
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.
Outcome measures
| Measure |
Modafinil
n=22 Participants
Participants with narcolepsy type 2 or idiopathic hypersomnia randomized to take modafinil. Participants received 100-400 mg/day of modafinil for 12 weeks.
|
Amphetamine-dextroamphetamine
n=20 Participants
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.
|
|---|---|---|
|
Number of Participants Reporting Any Improvement by Patient Global Impression of Change (PGIC) for Overall Disease Severity Score
|
18 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: Week 12Population: 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.
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.
Outcome measures
| Measure |
Modafinil
n=22 Participants
Participants with narcolepsy type 2 or idiopathic hypersomnia randomized to take modafinil. Participants received 100-400 mg/day of modafinil for 12 weeks.
|
Amphetamine-dextroamphetamine
n=20 Participants
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.
|
|---|---|---|
|
Number of Participants Reporting Much or Very Much Improvement by Patient Global Impression of Change (PGIC) for Overall Disease Severity Score
|
13 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: Week 12Population: 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.
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.
Outcome measures
| Measure |
Modafinil
n=22 Participants
Participants with narcolepsy type 2 or idiopathic hypersomnia randomized to take modafinil. Participants received 100-400 mg/day of modafinil for 12 weeks.
|
Amphetamine-dextroamphetamine
n=20 Participants
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.
|
|---|---|---|
|
Number of Participants Reporting Any Improvement From Baseline on Patient Global Impression of Change (PGIC) for Sleepiness Score
|
19 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: Week 12Population: 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.
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.
Outcome measures
| Measure |
Modafinil
n=22 Participants
Participants with narcolepsy type 2 or idiopathic hypersomnia randomized to take modafinil. Participants received 100-400 mg/day of modafinil for 12 weeks.
|
Amphetamine-dextroamphetamine
n=20 Participants
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.
|
|---|---|---|
|
Number of Participants Reporting Much or Very Much Improvement From Baseline on Patient Global Impression of Change (PGIC) for Sleepiness Score
|
14 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: Week 12Population: 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.
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.
Outcome measures
| Measure |
Modafinil
n=22 Participants
Participants with narcolepsy type 2 or idiopathic hypersomnia randomized to take modafinil. Participants received 100-400 mg/day of modafinil for 12 weeks.
|
Amphetamine-dextroamphetamine
n=20 Participants
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.
|
|---|---|---|
|
Number of Participants Reporting Any Improvement With Patient Global Impression of Change (PGIC) for Cognitive Dysfunction Score
|
16 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: Week 12Population: 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.
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.
Outcome measures
| Measure |
Modafinil
n=22 Participants
Participants with narcolepsy type 2 or idiopathic hypersomnia randomized to take modafinil. Participants received 100-400 mg/day of modafinil for 12 weeks.
|
Amphetamine-dextroamphetamine
n=20 Participants
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.
|
|---|---|---|
|
Number of Participants Reporting Much or Very Much Improvement With Patient Global Impression of Change (PGIC) for Cognitive Dysfunction Score
|
5 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: Week 12Population: 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.
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.
Outcome measures
| Measure |
Modafinil
n=22 Participants
Participants with narcolepsy type 2 or idiopathic hypersomnia randomized to take modafinil. Participants received 100-400 mg/day of modafinil for 12 weeks.
|
Amphetamine-dextroamphetamine
n=20 Participants
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.
|
|---|---|---|
|
Number of Participants Reporting Any Improvement by Patient Global Impression of Change (PGIC) for Sleep Inertia Score
|
11 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: Week 12Population: 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.
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.
Outcome measures
| Measure |
Modafinil
n=22 Participants
Participants with narcolepsy type 2 or idiopathic hypersomnia randomized to take modafinil. Participants received 100-400 mg/day of modafinil for 12 weeks.
|
Amphetamine-dextroamphetamine
n=20 Participants
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.
|
|---|---|---|
|
Number of Participants Reporting Much or Very Much Improvement by Patient Global Impression of Change (PGIC) for Sleep Inertia Score
|
4 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: 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.
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.
Outcome measures
| Measure |
Modafinil
n=22 Participants
Participants with narcolepsy type 2 or idiopathic hypersomnia randomized to take modafinil. Participants received 100-400 mg/day of modafinil for 12 weeks.
|
Amphetamine-dextroamphetamine
n=22 Participants
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.
|
|---|---|---|
|
Change in Hypersomnia Severity Index (HSI) From Baseline
|
8.0 score on a scale
Standard Deviation 5.6
|
10.4 score on a scale
Standard Deviation 6.8
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: 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.
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.
Outcome measures
| Measure |
Modafinil
n=22 Participants
Participants with narcolepsy type 2 or idiopathic hypersomnia randomized to take modafinil. Participants received 100-400 mg/day of modafinil for 12 weeks.
|
Amphetamine-dextroamphetamine
n=22 Participants
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.
|
|---|---|---|
|
Change in Sleep Inertia Questionnaire (SIQ) Score From Baseline
|
19.0 score on a scale
Standard Deviation 15.9
|
18.2 score on a scale
Standard Deviation 18.4
|
Adverse Events
Modafinil
Amphetamine-dextroamphetamine
Serious adverse events
| Measure |
Modafinil
n=22 participants at risk
Participants with narcolepsy type 2 or idiopathic hypersomnia randomized to take modafinil. Participants received 100-400 mg/day of modafinil for 12 weeks.
|
Amphetamine-dextroamphetamine
n=22 participants at risk
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.
|
|---|---|---|
|
Psychiatric disorders
Hospitalization due to suicidal ideation
|
4.5%
1/22 • 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.
|
0.00%
0/22 • 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.
|
Other adverse events
| Measure |
Modafinil
n=22 participants at risk
Participants with narcolepsy type 2 or idiopathic hypersomnia randomized to take modafinil. Participants received 100-400 mg/day of modafinil for 12 weeks.
|
Amphetamine-dextroamphetamine
n=22 participants at risk
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.
|
|---|---|---|
|
General disorders
Dry mouth
|
4.5%
1/22 • 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.
|
13.6%
3/22 • 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.
|
|
General disorders
Reduced appetite
|
9.1%
2/22 • 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.
|
36.4%
8/22 • 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.
|
|
General disorders
Headache
|
18.2%
4/22 • 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.
|
27.3%
6/22 • 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.
|
|
General disorders
Insomnia
|
22.7%
5/22 • 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.
|
13.6%
3/22 • 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.
|
|
Psychiatric disorders
Anxiety symptoms
|
22.7%
5/22 • 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.
|
0.00%
0/22 • 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.
|
|
General disorders
Dizziness
|
4.5%
1/22 • 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.
|
18.2%
4/22 • 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.
|
|
Cardiac disorders
Elevated heart rate/palpitations
|
9.1%
2/22 • 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.
|
9.1%
2/22 • 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.
|
|
General disorders
Jitteriness
|
9.1%
2/22 • 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.
|
9.1%
2/22 • 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.
|
|
Psychiatric disorders
Depressive symptoms
|
13.6%
3/22 • 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.
|
4.5%
1/22 • 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.
|
|
General disorders
Nausea
|
13.6%
3/22 • 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.
|
4.5%
1/22 • 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.
|
|
Vascular disorders
Elevated blood pressure
|
9.1%
2/22 • 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.
|
4.5%
1/22 • 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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place