Trial Outcomes & Findings for IMProving Executive Function Study (NCT NCT03187353)

Last Updated: 2023-11-18

Results Overview

The Brown Attention Deficit Disorder Scale (BADDS) (Brown, 1996) is a 40-item questionnaire that assesses five subscales of executive functioning. For each item in the questionnaire, participants reported the extent to which it had been a problem over the last six months (0 = never, 1 = once a week or less, 2 = twice a week, or 3 = almost daily). Total BADDS scores can range from 0-120, with higher scores indicating more self-reported difficulties with executive functioning. Outcome measures are reported as change scores for end of trial (6 weeks) minus baseline.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

69 participants

Primary outcome timeframe

Outcome measure change score represents end of trial (6 weeks) minus baseline.

Results posted on

2023-11-18

Participant Flow

Participant milestones

Participant milestones
Measure	Lisdexamfetamine, Then Placebo Participants will have a 50% chance of first receiving the active study medication. They will begin at 20 mg/d and will increase up to 60 mg/d after 4 weeks, if well tolerated. Total time on the study drug is up to 6 weeks. After a washout period of 2 weeks they will begin with 1 sugar pill and will increase up to 3 pills after 4 weeks. Maximum time for taking the placebo is 6 weeks.	Placebo, Then Lisdexamfetamine Participants will have a 50% chance of first receiving the placebo, beginning with 1 sugar pill and increasing up to 3 pills after 4 weeks. Maximum time for taking the placebo is 6 weeks. After a washout period of 2 weeks, they will begin active study medication at 20 mg/d and will increase up to 60 mg/d after 4 weeks, if well tolerated. Total time on the study drug is up to 6 weeks.
First Intervention (6 Weeks) STARTED	36	33
First Intervention (6 Weeks) COMPLETED	33	30
First Intervention (6 Weeks) NOT COMPLETED	3	3
Washout (2 Weeks) STARTED	33	30
Washout (2 Weeks) COMPLETED	29	29
Washout (2 Weeks) NOT COMPLETED	4	1
Second Intervention (6 Weeks) STARTED	29	29
Second Intervention (6 Weeks) COMPLETED	28	29
Second Intervention (6 Weeks) NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Lisdexamfetamine, Then Placebo Participants will have a 50% chance of first receiving the active study medication. They will begin at 20 mg/d and will increase up to 60 mg/d after 4 weeks, if well tolerated. Total time on the study drug is up to 6 weeks. After a washout period of 2 weeks they will begin with 1 sugar pill and will increase up to 3 pills after 4 weeks. Maximum time for taking the placebo is 6 weeks.	Placebo, Then Lisdexamfetamine Participants will have a 50% chance of first receiving the placebo, beginning with 1 sugar pill and increasing up to 3 pills after 4 weeks. Maximum time for taking the placebo is 6 weeks. After a washout period of 2 weeks, they will begin active study medication at 20 mg/d and will increase up to 60 mg/d after 4 weeks, if well tolerated. Total time on the study drug is up to 6 weeks.
First Intervention (6 Weeks) Adverse Event	3	2
First Intervention (6 Weeks) Withdrawal by Subject	0	1
Washout (2 Weeks) Lost to Follow-up	1	0
Washout (2 Weeks) Withdrawal by Subject	1	1
Washout (2 Weeks) Adverse Event	2	0
Second Intervention (6 Weeks) Adverse Event	1	0

Baseline Characteristics

IMProving Executive Function Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lisdexamfetamine, Then Placebo n=36 Participants Participants will have a 50% chance of first receiving the active study medication. They will begin at 20 mg/d and will increase up to 60 mg/d after 4 weeks, if well tolerated. Total time on the study drug is up to 6 weeks. After a washout period of 2 weeks they will begin with 1 sugar pill and will increase up to 3 pills after 4 weeks. Maximum time for taking the placebo is 6 weeks.	Placebo, Then Lisdexamfetamine n=33 Participants Participants will have a 50% chance of first receiving the placebo, beginning with 1 sugar pill and increasing up to 3 pills after 4 weeks. Maximum time for taking the placebo is 6 weeks. After a washout period of 2 weeks, they will begin active study medication at 20 mg/d and will increase up to 60 mg/d after 4 weeks, if well tolerated. Total time on the study drug is up to 6 weeks.	Total n=69 Participants Total of all reporting groups
Age, Continuous	46.8 years STANDARD_DEVIATION 5.4 • n=5 Participants	47.3 years STANDARD_DEVIATION 5.8 • n=7 Participants	47.0 years STANDARD_DEVIATION 5.5 • n=5 Participants
Sex: Female, Male Female	36 Participants n=5 Participants	33 Participants n=7 Participants	69 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	32 Participants n=5 Participants	30 Participants n=7 Participants	62 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	34 Participants n=5 Participants	32 Participants n=7 Participants	66 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Outcome measure change score represents end of trial (6 weeks) minus baseline.

Outcome measures

Outcome measures
Measure	Lisdexamfetamine (Per Intervention) n=57 Participants Participants who received Lisdexamfetamine (20-60mg/d) in the first 6 weeks or last 6 weeks of the study.	Placebo (Per Intervention) n=57 Participants Participants who received placebo (1 sugar pill and will increase up to 3 pills after 4 weeks) in either the first 6 weeks or last six weeks of the study.
Brown Attention Deficit Disorder Scale (BADDS) Change Score (End of Trial Minus Baseline).	-19.68 score on a scale Interval -23.17 to -16.18	-4.31 score on a scale Interval -7.84 to -0.78

SECONDARY outcome

Timeframe: 6 weeks

Population: In response to the COVID -19 pandemic baseline neuroimaging data was only collected and analyzed on a subset of study participant (n=14).

To measure the effects of Lisdexamfetamine on objective report of executive function difficulties proton magnetic resonance spectroscopy (1H-MRS) was utilized to assess the relative importance of dorsolateral prefrontal cortex (DLPFC) glutamate (Glut) contrast levels during working memory task performance. Measurement of glutamate contrast range from 0 to 15% with higher levels associated with optimal performance. Glutamate contrast is calculated by: GluCEST contrast (%) = \[(Msat(-3ppm) - Msat(+3ppm))/Msat(-3ppm)\]\*100.

Outcome measures

Outcome measures
Measure	Lisdexamfetamine (Per Intervention) n=14 Participants Participants who received Lisdexamfetamine (20-60mg/d) in the first 6 weeks or last 6 weeks of the study.	Placebo (Per Intervention) n=14 Participants Participants who received placebo (1 sugar pill and will increase up to 3 pills after 4 weeks) in either the first 6 weeks or last six weeks of the study.
Brain Activation (Glutamate Contrast)	8.4 percentage of Glutmate Contrast Standard Deviation 1.03	8.91 percentage of Glutmate Contrast Standard Deviation .86

SECONDARY outcome

Timeframe: 6 weeks

Population: In response to the COVID -19 pandemic baseline neuroimaging data was only collected and analyzed on a subset of study participant (n=14).

To measure the effects of Lisdexamfetamine on objective report of executive function difficulties functional magnetic resonance imaging (fMRI) were utilized to assess the relative importance of dorsolateral prefrontal cortex (DLPFC) blood oxygen dependent (BOLD) signals during working memory task performance and the effect of LDX on the executive system activation. Measurement of BOLD perecent signal change range is 0 to 2%. Percent signal change is the difference in fMRI signal between the baseline condition (B) and the task condition (T) and calculated here as: percent signal change = (T-B)/B×100%. Higher percent signal change in the DLPFC is generally associated with better executive function.

Outcome measures

Outcome measures
Measure	Lisdexamfetamine (Per Intervention) n=14 Participants Participants who received Lisdexamfetamine (20-60mg/d) in the first 6 weeks or last 6 weeks of the study.	Placebo (Per Intervention) n=14 Participants Participants who received placebo (1 sugar pill and will increase up to 3 pills after 4 weeks) in either the first 6 weeks or last six weeks of the study.
Brain Activation (BOLD Percent Signal Change)	.42 percentage of signal change Standard Deviation .229	.21 percentage of signal change Standard Deviation .223

Adverse Events

Lisdexamfetamine, 20 mg

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Lisdexamfetamine, 40 mg

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Lisdexamfetamine, 60 mg

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Lisdexamfetamine, 20 mg n=64 participants at risk Reporting AEs experienced for all participants who were exposed to Lisdexamfetamine at 20 mg. In total, 64 participants were exposed to 20mg of the drug (all participants who were exposed to LDX are included in this grouping). All AEs reported while on the 20mg dose are listed below. During active study participation, Participants had a 50% chance of receiving the active study medication during trial A. They began at 20 mg/d and increased up to 40 mg after 1 week and then up to 60 mg/d after 4 weeks, if well tolerated. Total time on the study drug is up to 6 weeks. Lisdexamfetamine: Stimulant medications are used to reduce interruptive behavior, fidgeting, and other hyperactive symptoms, as well as help a person finish tasks and improve his or her relationships for adults who have ADHD. Please note that the FDA has not approved the use of Vyvanse® for the treatment of memory and concentration difficulties related to medically induced menopause.	Lisdexamfetamine, 40 mg n=59 participants at risk Reporting AEs experienced for all participants who were exposed to Lisdexamfetamine at 40 mg. In total, 59 participants were exposed to 40mg of the drug (5 people remained on 20mg for the duration of their trial and are not included in the 40mg or 60mg groupings). All AEs reported while on the 40mg dose are listed below. During active study participation, Participants had a 50% chance of receiving the active study medication during trial A. They began at 20 mg/d and increased up to 40 mg after 1 week and then up to 60 mg/d after 4 weeks, if well tolerated. Total time on the study drug is up to 6 weeks. Lisdexamfetamine: Stimulant medications are used to reduce interruptive behavior, fidgeting, and other hyperactive symptoms, as well as help a person finish tasks and improve his or her relationships for adults who have ADHD. Please note that the FDA has not approved the use of Vyvanse® for the treatment of memory and concentration difficulties related to medically induced menopause.	Lisdexamfetamine, 60 mg n=43 participants at risk Reporting AEs experienced for all participants who were exposed to Lisdexamfetamine at 60 mg. In total, 43 participants were exposed to 60mg of the drug (16 people remained at 40mg, but did not increase to 60mg and therefore are not included in this 60mg grouping). All AEs reported while on the 60mg dose are listed below. During active study participation, Participants had a 50% chance of receiving the active study medication during trial A. They began at 20 mg/d and increased up to 40 mg after 1 week and then up to 60 mg/d after 4 weeks, if well tolerated. Total time on the study drug is up to 6 weeks. Lisdexamfetamine: Stimulant medications are used to reduce interruptive behavior, fidgeting, and other hyperactive symptoms, as well as help a person finish tasks and improve his or her relationships for adults who have ADHD. Please note that the FDA has not approved the use of Vyvanse® for the treatment of memory and concentration difficulties related to medically induced menopause.	Placebo n=58 participants at risk Reporting AEs experienced for all participants who were exposed to placebo capsules. In total, 58 participants were exposed to the placebo. All AEs reported while on placebo are listed below. Participants will have a 50% chance of receiving the placebo for this study. They will begin with 1 sugar pill and will increase up to 3 pills after 4 weeks. Maximum time for taking the placebo is 6 weeks. Placebo oral capsule: The placebo capsule will be filled with microcellulose.
Metabolism and nutrition disorders Change in Appetite	0.00% 0/64 • 6 months We collected and reported all untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	3.4% 2/59 • Number of events 2 • 6 months We collected and reported all untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	20.9% 9/43 • Number of events 9 • 6 months We collected and reported all untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	1.7% 1/58 • Number of events 1 • 6 months We collected and reported all untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
General disorders Difficulty falling or staying asleep	0.00% 0/64 • 6 months We collected and reported all untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	1.7% 1/59 • Number of events 1 • 6 months We collected and reported all untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	4.7% 2/43 • Number of events 2 • 6 months We collected and reported all untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	3.4% 2/58 • Number of events 2 • 6 months We collected and reported all untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Nervous system disorders Dizziness/Disorientation	0.00% 0/64 • 6 months We collected and reported all untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	1.7% 1/59 • Number of events 1 • 6 months We collected and reported all untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	0.00% 0/43 • 6 months We collected and reported all untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	0.00% 0/58 • 6 months We collected and reported all untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
General disorders Dry Mouth	0.00% 0/64 • 6 months We collected and reported all untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	3.4% 2/59 • Number of events 2 • 6 months We collected and reported all untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	20.9% 9/43 • Number of events 9 • 6 months We collected and reported all untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	0.00% 0/58 • 6 months We collected and reported all untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Nervous system disorders mild to moderate headache	1.6% 1/64 • Number of events 1 • 6 months We collected and reported all untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	0.00% 0/59 • 6 months We collected and reported all untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	4.7% 2/43 • Number of events 2 • 6 months We collected and reported all untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	1.7% 1/58 • Number of events 1 • 6 months We collected and reported all untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Gastrointestinal disorders Nausea	0.00% 0/64 • 6 months We collected and reported all untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	3.4% 2/59 • Number of events 2 • 6 months We collected and reported all untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	2.3% 1/43 • Number of events 1 • 6 months We collected and reported all untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	0.00% 0/58 • 6 months We collected and reported all untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Cardiac disorders Increased blood pressure	1.6% 1/64 • Number of events 1 • 6 months We collected and reported all untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	0.00% 0/59 • 6 months We collected and reported all untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	0.00% 0/43 • 6 months We collected and reported all untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	0.00% 0/58 • 6 months We collected and reported all untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Nervous system disorders Drowsiness	0.00% 0/64 • 6 months We collected and reported all untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	0.00% 0/59 • 6 months We collected and reported all untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	2.3% 1/43 • Number of events 1 • 6 months We collected and reported all untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	0.00% 0/58 • 6 months We collected and reported all untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Gastrointestinal disorders Diarrhea/Gas	0.00% 0/64 • 6 months We collected and reported all untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	0.00% 0/59 • 6 months We collected and reported all untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	4.7% 2/43 • Number of events 2 • 6 months We collected and reported all untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	1.7% 1/58 • Number of events 1 • 6 months We collected and reported all untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Nervous system disorders Jitters	0.00% 0/64 • 6 months We collected and reported all untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	5.1% 3/59 • Number of events 3 • 6 months We collected and reported all untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	7.0% 3/43 • Number of events 3 • 6 months We collected and reported all untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	3.4% 2/58 • Number of events 2 • 6 months We collected and reported all untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Respiratory, thoracic and mediastinal disorders Nasal Congestion	0.00% 0/64 • 6 months We collected and reported all untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	0.00% 0/59 • 6 months We collected and reported all untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	4.7% 2/43 • Number of events 2 • 6 months We collected and reported all untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	3.4% 2/58 • Number of events 2 • 6 months We collected and reported all untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Skin and subcutaneous tissue disorders Soreness/Tingling Skin	0.00% 0/64 • 6 months We collected and reported all untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	1.7% 1/59 • Number of events 3 • 6 months We collected and reported all untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	7.0% 3/43 • Number of events 4 • 6 months We collected and reported all untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	3.4% 2/58 • Number of events 2 • 6 months We collected and reported all untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
General disorders Increased Thirst	0.00% 0/64 • 6 months We collected and reported all untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	0.00% 0/59 • 6 months We collected and reported all untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	0.00% 0/43 • 6 months We collected and reported all untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	1.7% 1/58 • Number of events 1 • 6 months We collected and reported all untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.

Additional Information

James Loughead, Ph.D.

Perlman School of Medicine, University of Pennsylvania

Phone: 215-205-1876

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place