Trial Outcomes & Findings for Lisdexamfetamine's Effect In ADHD in the Brain and Cognition (NCT NCT02170298)
NCT ID: NCT02170298
Last Updated: 2019-12-26
Results Overview
Working memory performance, as measured by the percent of items correct on the Span Working Memory Task.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
6 participants
Primary outcome timeframe
Baseline, 9 weeks
Results posted on
2019-12-26
Participant Flow
Participant milestones
| Measure |
Placebo
Participants may be randomized into the placebo comparator arm. Participants in this group will be given a sugar pill titrated up to 70 mg daily over the course of 9 weeks.
Drug: Placebo
Lisdexamfetamine: Participants will be given either the study drug or placebo in tablet form. All participants will start with a 20 mg dose and will be titrated up to a 70 mg daily dose over 9 weeks. Participants between 12-18 years of age will be titrated in 10 mg increments and participants between 18-25 years of age in 10-20 mg increments.
|
Lisdexamfetamine
Participants may be randomized into the experimental arm. Participants in this arm will be given lisdexamfetamine titrated up to 70 mg daily over the course of 9 weeks.
Drug: Lisdexamfetamine
Lisdexamfetamine: Participants will be given either the study drug or placebo in tablet form. All participants will start with a 20 mg dose and will be titrated up to a 70 mg daily dose over 9 weeks. Participants between 12-18 years of age will be titrated in 10 mg increments and participants between 18-25 years of age in 10-20 mg increments.
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
5
|
|
Overall Study
COMPLETED
|
0
|
4
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Placebo
Participants may be randomized into the placebo comparator arm. Participants in this group will be given a sugar pill titrated up to 70 mg daily over the course of 9 weeks.
Drug: Placebo
Lisdexamfetamine: Participants will be given either the study drug or placebo in tablet form. All participants will start with a 20 mg dose and will be titrated up to a 70 mg daily dose over 9 weeks. Participants between 12-18 years of age will be titrated in 10 mg increments and participants between 18-25 years of age in 10-20 mg increments.
|
Lisdexamfetamine
Participants may be randomized into the experimental arm. Participants in this arm will be given lisdexamfetamine titrated up to 70 mg daily over the course of 9 weeks.
Drug: Lisdexamfetamine
Lisdexamfetamine: Participants will be given either the study drug or placebo in tablet form. All participants will start with a 20 mg dose and will be titrated up to a 70 mg daily dose over 9 weeks. Participants between 12-18 years of age will be titrated in 10 mg increments and participants between 18-25 years of age in 10-20 mg increments.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
unblinded, rerandomized to intervention
|
1
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Placebo
n=1 Participants
Participants may be randomized into the placebo comparator arm. Participants in this group will be given a sugar pill titrated up to 70 mg daily over the course of 9 weeks.
Drug: Placebo
Lisdexamfetamine: Participants will be given either the study drug or placebo in tablet form. All participants will start with a 20 mg dose and will be titrated up to a 70 mg daily dose over 9 weeks. Participants between 12-18 years of age will be titrated in 10 mg increments and participants between 18-25 years of age in 10-20 mg increments.
|
Lisdexamfetamine
n=4 Participants
Participants may be randomized into the experimental arm. Participants in this arm will be given lisdexamfetamine titrated up to 70 mg daily over the course of 9 weeks.
Drug: Lisdexamfetamine
Lisdexamfetamine: Participants will be given either the study drug or placebo in tablet form. All participants will start with a 20 mg dose and will be titrated up to a 70 mg daily dose over 9 weeks. Participants between 12-18 years of age will be titrated in 10 mg increments and participants between 18-25 years of age in 10-20 mg increments.
|
Total
n=5 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=1 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=1 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=1 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=1 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=1 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=5 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: Baseline, 9 weeksPopulation: Data were not analyzed due to early study termination. Unable to recruit a sufficient number of subjects. Data on this measure is highly variable and low subject numbers will not produce reliable or valid data.
Working memory performance, as measured by the percent of items correct on the Span Working Memory Task.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Baseline, 9 weeksPopulation: Data were not analyzed due to early study termination. Unable to recruit a sufficient number of subjects. Data on this measure is highly variable and low subject numbers will not produce reliable or valid data.
Level of self-control, as demonstrated on the Delay Discounting Task.
Outcome measures
Outcome data not reported
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Lisdexamfetamine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place