Trial Outcomes & Findings for Study for Efficacy and Dose Escalation of AD313 + Atomoxetine (SEED) (NCT NCT05101122)
NCT ID: NCT05101122
Last Updated: 2023-04-07
Results Overview
Compares high dose atomoxetine (80/10) versus baseline
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
15 participants
Primary outcome timeframe
28 days
Results posted on
2023-04-07
Participant Flow
Participants will be recruited from an existing medical clinic and will have up to three weeks screening.
Participant milestones
| Measure |
Dosing Periods
Participants who meet all enrollment criteria will receive an escalating dose of atomoxetine the first week: 3 days of atomoxetine 40 mg followed by 4 days of atomoxetine 80 mg. Participants will then receive escalating dose combinations of atomoxetine and dronabinol for the next 3 weeks.
|
|---|---|
|
Atomoxetine Only
STARTED
|
15
|
|
Atomoxetine Only
COMPLETED
|
14
|
|
Atomoxetine Only
NOT COMPLETED
|
1
|
|
AD313 40/2.5
STARTED
|
14
|
|
AD313 40/2.5
COMPLETED
|
12
|
|
AD313 40/2.5
NOT COMPLETED
|
2
|
|
AD313 80/5
STARTED
|
12
|
|
AD313 80/5
COMPLETED
|
11
|
|
AD313 80/5
NOT COMPLETED
|
1
|
|
AD313 80/10
STARTED
|
11
|
|
AD313 80/10
COMPLETED
|
10
|
|
AD313 80/10
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Dosing Periods
Participants who meet all enrollment criteria will receive an escalating dose of atomoxetine the first week: 3 days of atomoxetine 40 mg followed by 4 days of atomoxetine 80 mg. Participants will then receive escalating dose combinations of atomoxetine and dronabinol for the next 3 weeks.
|
|---|---|
|
Atomoxetine Only
Withdrawal by Subject
|
1
|
|
AD313 40/2.5
Withdrawal by Subject
|
2
|
|
AD313 80/5
Withdrawal by Subject
|
1
|
|
AD313 80/10
Physician Decision
|
1
|
Baseline Characteristics
Study for Efficacy and Dose Escalation of AD313 + Atomoxetine (SEED)
Baseline characteristics by cohort
| Measure |
Dosing Periods
n=15 Participants
Participants who meet all enrollment criteria will receive an escalating dose of atomoxetine the first week: 3 days of atomoxetine 40 mg followed by 4 days of atomoxetine 80 mg. Participants will then receive escalating dose combinations of atomoxetine and dronabinol for the next 3 weeks.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
|
Body Mass Index (BMI)
|
31.9 kg/m2
STANDARD_DEVIATION 4.5 • n=5 Participants
|
PRIMARY outcome
Timeframe: 28 daysCompares high dose atomoxetine (80/10) versus baseline
Outcome measures
| Measure |
Baseline
n=15 Participants
Participants at baseline
|
AD313 80/10
n=10 Participants
Atomoxetine 80 mg/ dronabinol 10 mg
|
|---|---|---|
|
Apnea-Hypopnea Index (AHI)4% Events Per Hour
|
28.6 events/hour
Interval 16.19 to 33.65
|
26.6 events/hour
Interval 8.78 to 31.93
|
Adverse Events
Dosing Period 1: Atomoxetine Alone
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Dosing Period 3: Atomoxetine 40 + Dronabinol 2.5 mg
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Dosing Period 4: Atomoxetine 80 + Dronabinol 5mg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Dosing Period 5: Atomoxetine 80 + Dronabinol 10mg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Dosing Period 1: Atomoxetine Alone
n=15 participants at risk
Participants who meet all enrollment criteria received an escalating dose of atomoxetine the first week: 3 days of atomoxetine 40 mg followed by 4 days of atomoxetine 80 mg. Participants then received escalating dose combinations of atomoxetine and dronabinol for the next 3 weeks.
|
Dosing Period 3: Atomoxetine 40 + Dronabinol 2.5 mg
n=14 participants at risk
Participants who meet all enrollment criteria received an escalating dose of atomoxetine the first week: 3 days of atomoxetine 40 mg followed by 4 days of atomoxetine 80 mg. Participants then received escalating dose combinations of atomoxetine and dronabinol for the next 3 weeks.
|
Dosing Period 4: Atomoxetine 80 + Dronabinol 5mg
n=12 participants at risk
Participants who meet all enrollment criteria received an escalating dose of atomoxetine the first week: 3 days of atomoxetine 40 mg followed by 4 days of atomoxetine 80 mg. Participants then received escalating dose combinations of atomoxetine and dronabinol for the next 3 weeks.
|
Dosing Period 5: Atomoxetine 80 + Dronabinol 10mg
n=11 participants at risk
Participants who meet all enrollment criteria received an escalating dose of atomoxetine the first week: 3 days of atomoxetine 40 mg followed by 4 days of atomoxetine 80 mg. Participants then received escalating dose combinations of atomoxetine and dronabinol for the next 3 weeks.
|
|---|---|---|---|---|
|
Nervous system disorders
Hypersomnia
|
13.3%
2/15 • Adverse events were collected over 9 weeks
|
0.00%
0/14 • Adverse events were collected over 9 weeks
|
8.3%
1/12 • Adverse events were collected over 9 weeks
|
0.00%
0/11 • Adverse events were collected over 9 weeks
|
|
Reproductive system and breast disorders
Impotence, erectile dysfunction
|
20.0%
3/15 • Adverse events were collected over 9 weeks
|
7.1%
1/14 • Adverse events were collected over 9 weeks
|
0.00%
0/12 • Adverse events were collected over 9 weeks
|
0.00%
0/11 • Adverse events were collected over 9 weeks
|
|
Psychiatric disorders
Insomnia
|
26.7%
4/15 • Adverse events were collected over 9 weeks
|
21.4%
3/14 • Adverse events were collected over 9 weeks
|
16.7%
2/12 • Adverse events were collected over 9 weeks
|
18.2%
2/11 • Adverse events were collected over 9 weeks
|
|
Gastrointestinal disorders
Nausea
|
6.7%
1/15 • Adverse events were collected over 9 weeks
|
14.3%
2/14 • Adverse events were collected over 9 weeks
|
16.7%
2/12 • Adverse events were collected over 9 weeks
|
0.00%
0/11 • Adverse events were collected over 9 weeks
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/15 • Adverse events were collected over 9 weeks
|
0.00%
0/14 • Adverse events were collected over 9 weeks
|
8.3%
1/12 • Adverse events were collected over 9 weeks
|
0.00%
0/11 • Adverse events were collected over 9 weeks
|
|
Nervous system disorders
Dizziness, lightheadedness
|
6.7%
1/15 • Adverse events were collected over 9 weeks
|
0.00%
0/14 • Adverse events were collected over 9 weeks
|
0.00%
0/12 • Adverse events were collected over 9 weeks
|
9.1%
1/11 • Adverse events were collected over 9 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.7%
1/15 • Adverse events were collected over 9 weeks
|
7.1%
1/14 • Adverse events were collected over 9 weeks
|
8.3%
1/12 • Adverse events were collected over 9 weeks
|
0.00%
0/11 • Adverse events were collected over 9 weeks
|
|
Cardiac disorders
Hypertension
|
0.00%
0/15 • Adverse events were collected over 9 weeks
|
7.1%
1/14 • Adverse events were collected over 9 weeks
|
8.3%
1/12 • Adverse events were collected over 9 weeks
|
9.1%
1/11 • Adverse events were collected over 9 weeks
|
|
Nervous system disorders
Headache
|
0.00%
0/15 • Adverse events were collected over 9 weeks
|
7.1%
1/14 • Adverse events were collected over 9 weeks
|
0.00%
0/12 • Adverse events were collected over 9 weeks
|
0.00%
0/11 • Adverse events were collected over 9 weeks
|
|
Gastrointestinal disorders
Heartburn
|
6.7%
1/15 • Adverse events were collected over 9 weeks
|
0.00%
0/14 • Adverse events were collected over 9 weeks
|
0.00%
0/12 • Adverse events were collected over 9 weeks
|
0.00%
0/11 • Adverse events were collected over 9 weeks
|
|
Vascular disorders
Vasomotor symptoms - Hot flashes
|
0.00%
0/15 • Adverse events were collected over 9 weeks
|
0.00%
0/14 • Adverse events were collected over 9 weeks
|
8.3%
1/12 • Adverse events were collected over 9 weeks
|
0.00%
0/11 • Adverse events were collected over 9 weeks
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/15 • Adverse events were collected over 9 weeks
|
0.00%
0/14 • Adverse events were collected over 9 weeks
|
0.00%
0/12 • Adverse events were collected over 9 weeks
|
9.1%
1/11 • Adverse events were collected over 9 weeks
|
|
Nervous system disorders
Jitteriness
|
6.7%
1/15 • Adverse events were collected over 9 weeks
|
7.1%
1/14 • Adverse events were collected over 9 weeks
|
8.3%
1/12 • Adverse events were collected over 9 weeks
|
9.1%
1/11 • Adverse events were collected over 9 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
6.7%
1/15 • Adverse events were collected over 9 weeks
|
7.1%
1/14 • Adverse events were collected over 9 weeks
|
8.3%
1/12 • Adverse events were collected over 9 weeks
|
0.00%
0/11 • Adverse events were collected over 9 weeks
|
|
Skin and subcutaneous tissue disorders
Night time sweating
|
6.7%
1/15 • Adverse events were collected over 9 weeks
|
7.1%
1/14 • Adverse events were collected over 9 weeks
|
8.3%
1/12 • Adverse events were collected over 9 weeks
|
9.1%
1/11 • Adverse events were collected over 9 weeks
|
|
Psychiatric disorders
Paranoia
|
0.00%
0/15 • Adverse events were collected over 9 weeks
|
7.1%
1/14 • Adverse events were collected over 9 weeks
|
8.3%
1/12 • Adverse events were collected over 9 weeks
|
0.00%
0/11 • Adverse events were collected over 9 weeks
|
|
Skin and subcutaneous tissue disorders
Paresthesia
|
0.00%
0/15 • Adverse events were collected over 9 weeks
|
0.00%
0/14 • Adverse events were collected over 9 weeks
|
0.00%
0/12 • Adverse events were collected over 9 weeks
|
9.1%
1/11 • Adverse events were collected over 9 weeks
|
|
Skin and subcutaneous tissue disorders
Skin rash
|
0.00%
0/15 • Adverse events were collected over 9 weeks
|
0.00%
0/14 • Adverse events were collected over 9 weeks
|
8.3%
1/12 • Adverse events were collected over 9 weeks
|
0.00%
0/11 • Adverse events were collected over 9 weeks
|
|
Gastrointestinal disorders
Stomach discomfort
|
0.00%
0/15 • Adverse events were collected over 9 weeks
|
0.00%
0/14 • Adverse events were collected over 9 weeks
|
8.3%
1/12 • Adverse events were collected over 9 weeks
|
0.00%
0/11 • Adverse events were collected over 9 weeks
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/15 • Adverse events were collected over 9 weeks
|
0.00%
0/14 • Adverse events were collected over 9 weeks
|
8.3%
1/12 • Adverse events were collected over 9 weeks
|
0.00%
0/11 • Adverse events were collected over 9 weeks
|
|
Skin and subcutaneous tissue disorders
Tingling
|
6.7%
1/15 • Adverse events were collected over 9 weeks
|
0.00%
0/14 • Adverse events were collected over 9 weeks
|
0.00%
0/12 • Adverse events were collected over 9 weeks
|
0.00%
0/11 • Adverse events were collected over 9 weeks
|
|
Psychiatric disorders
Dissociative state
|
0.00%
0/15 • Adverse events were collected over 9 weeks
|
0.00%
0/14 • Adverse events were collected over 9 weeks
|
0.00%
0/12 • Adverse events were collected over 9 weeks
|
9.1%
1/11 • Adverse events were collected over 9 weeks
|
|
Renal and urinary disorders
Urinary hesitancy
|
13.3%
2/15 • Adverse events were collected over 9 weeks
|
14.3%
2/14 • Adverse events were collected over 9 weeks
|
16.7%
2/12 • Adverse events were collected over 9 weeks
|
18.2%
2/11 • Adverse events were collected over 9 weeks
|
|
Gastrointestinal disorders
Vomiting
|
6.7%
1/15 • Adverse events were collected over 9 weeks
|
0.00%
0/14 • Adverse events were collected over 9 weeks
|
0.00%
0/12 • Adverse events were collected over 9 weeks
|
0.00%
0/11 • Adverse events were collected over 9 weeks
|
|
Gastrointestinal disorders
Xerostomia
|
6.7%
1/15 • Adverse events were collected over 9 weeks
|
7.1%
1/14 • Adverse events were collected over 9 weeks
|
8.3%
1/12 • Adverse events were collected over 9 weeks
|
9.1%
1/11 • Adverse events were collected over 9 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Authorship will be determined by mutual agreement and in line with International Committee of Medical Journal Editors authorship requirements. The Sponsor retains the right to disapprove any submission for publication, including any publication using trial data, including abstracts, presentations or manuscripts. A summary of the study results will also be posted in a publicly accessible database (e.g., www.ClinTrials.gov).
- Publication restrictions are in place
Restriction type: OTHER