Trial Outcomes & Findings for Safety and Efficacy of GTS21 in Adults With Attention-deficit Hyperactivity Disorder (NCT NCT00419445)
NCT ID: NCT00419445
Last Updated: 2010-09-10
Results Overview
The proportion of subjects with Treatment Emergent Adverse Events.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
37 participants
Primary outcome timeframe
Baseline to study completion
Results posted on
2010-09-10
Participant Flow
Participant milestones
| Measure |
25 mg Tid
|
75 mg Tid
|
150 mg Tid
|
|---|---|---|---|
|
Overall Study
STARTED
|
8
|
16
|
8
|
|
Overall Study
COMPLETED
|
7
|
14
|
7
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Efficacy of GTS21 in Adults With Attention-deficit Hyperactivity Disorder
Baseline characteristics by cohort
| Measure |
25 mg Tid
n=8 Participants
|
75 mg Tid
n=16 Participants
|
150 mg Tid
n=8 Participants
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age Continuous
|
41.5 years
STANDARD_DEVIATION 9.47 • n=5 Participants
|
371. years
STANDARD_DEVIATION 10.24 • n=7 Participants
|
34.8 years
STANDARD_DEVIATION 15.42 • n=5 Participants
|
39.2 years
STANDARD_DEVIATION 10.69 • n=4 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=5 Participants
|
16 participants
n=7 Participants
|
8 participants
n=5 Participants
|
32 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline to study completionThe proportion of subjects with Treatment Emergent Adverse Events.
Outcome measures
| Measure |
25 mg Tid
n=8 Participants
|
75 mg Tid
n=16 Participants
|
150 mg Tid
n=8 Participants
|
|---|---|---|---|
|
To Assess the Safety and Tolerability of GTS21 (25 mg Tid, 75 mg Tid, 150 mg Tid).
|
67 % of subjects
|
72 % of subjects
|
100 % of subjects
|
Adverse Events
25 mg Tid
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
75 mg Tid
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
150 mg Tid
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
25 mg Tid
n=8 participants at risk
|
75 mg Tid
n=18 participants at risk；n=16 participants at risk
|
150 mg Tid
n=8 participants at risk
|
|---|---|---|---|
|
Nervous system disorders
Headache
|
25.0%
2/8 • Number of events 2
|
5.6%
1/18 • Number of events 1
|
25.0%
2/8 • Number of events 2
|
|
Nervous system disorders
Dizziness
|
0.00%
0/8
|
11.1%
2/18 • Number of events 2
|
0.00%
0/8
|
|
Nervous system disorders
Somnolence
|
0.00%
0/8
|
11.1%
2/18 • Number of events 2
|
12.5%
1/8 • Number of events 1
|
|
Nervous system disorders
Sinus headache
|
12.5%
1/8 • Number of events 1
|
5.6%
1/18 • Number of events 1
|
0.00%
0/8
|
|
Psychiatric disorders
Insomnia
|
12.5%
1/8 • Number of events 1
|
11.1%
2/18 • Number of events 2
|
0.00%
0/8
|
|
General disorders
Fatigue
|
25.0%
2/8 • Number of events 2
|
11.1%
2/18 • Number of events 2
|
37.5%
3/8 • Number of events 3
|
|
General disorders
Pain
|
12.5%
1/8 • Number of events 1
|
0.00%
0/18
|
0.00%
0/8
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/8
|
22.2%
4/18 • Number of events 4
|
37.5%
3/8 • Number of events 3
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/8
|
0.00%
0/18
|
25.0%
2/8 • Number of events 2
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/8
|
11.1%
2/18 • Number of events 2
|
0.00%
0/8
|
|
Gastrointestinal disorders
Gastroesophageal Reflux Disease
|
0.00%
0/8
|
0.00%
0/18
|
25.0%
2/8 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/8
|
5.6%
1/18 • Number of events 1
|
12.5%
1/8 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/8
|
11.1%
2/18 • Number of events 2
|
25.0%
2/8 • Number of events 2
|
|
Metabolism and nutrition disorders
Decreased appetite
|
12.5%
1/8 • Number of events 1
|
5.6%
1/18 • Number of events 1
|
0.00%
0/8
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/8
|
0.00%
0/18
|
12.5%
1/8 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60