Trial Outcomes & Findings for Vyvanse and Glucose Intolerance in Children With Attention Deficit Hyperactivity Disorder (ADHD) and Obesity (NCT NCT01017263)

Results Overview

The study was terminated due to lack of enrollment therefore outcome measures were not assessed. If completed, the expected outcomes would have shown an improvement of the subject's fasting and 2 hour post prandial glucose values, insulin levels and HbA1c. However, all of the subjects recruited did not have abnormal values to start with. The two subjects who were enrolled were the younger kids to which the entry lab criteria do not apply.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

14 participants

Primary outcome timeframe

Baseline to end of study

Results posted on

2014-02-20

Participant Flow

Potential participants are pre-screened at the Duke Obesity Clinic. Eligible participants then come to the Duke ADHD Clinic for their first study visit.

At the screening visit, psychiatric evaluation and fasting labs were obtained to determine eligibility. Of the 14 subjects only 2 qualified and received study drug. Reasons for screen fails: 8-did not meet lab parameters for glucose intolerance, 1-elevated BP, 1- elevated TSH, 1- doing well with current ADHD treatment, 1- diagnosed with depression.

Participant milestones

Participant milestones
Measure	Open Label Vyvanse Eligible subjects will be dispensed open label LDX (Vyvanse). All subjects will start at 20 mg once a day dose and will be titrated up weekly by 10 mg increments up to a maximum dose of 70 mg. If a subject experiences intolerable side effects at a particular dose, a step down to the next tolerated level is allowed.
Overall Study STARTED	14
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	12

Reasons for withdrawal

Reasons for withdrawal
Measure	Open Label Vyvanse Eligible subjects will be dispensed open label LDX (Vyvanse). All subjects will start at 20 mg once a day dose and will be titrated up weekly by 10 mg increments up to a maximum dose of 70 mg. If a subject experiences intolerable side effects at a particular dose, a step down to the next tolerated level is allowed.
Overall Study not eligible	12

Baseline Characteristics

Vyvanse and Glucose Intolerance in Children With Attention Deficit Hyperactivity Disorder (ADHD) and Obesity

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Open Label Vyvanse n=14 Participants All subjects receive Vyvanse.
Age, Categorical <=18 years	14 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	10.92 years STANDARD_DEVIATION 2.73 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Region of Enrollment United States	14 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to end of study

Population: Study terminated early - no analysis performed on the single subject with data.

The study was terminated due to lack of enrollment therefore outcome measures were not assessed. If completed, the expected outcomes would have shown an improvement of the subject's fasting and 2 hour post prandial glucose values, insulin levels and HbA1c. However, all of the subjects recruited did not have abnormal values to start with. The two subjects who were enrolled were the younger kids to which the entry lab criteria do not apply.

Outcome measures

Outcome data not reported

Adverse Events

Open Label Vyvanse

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

Scott Kollins, PhD

Duke UMC

Phone: 9196810014

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place