Trial Outcomes & Findings for Vyvanse Adolescent Open-Label Safety and Efficacy Extension Study (NCT NCT00764868)
NCT ID: NCT00764868
Last Updated: 2021-06-14
Results Overview
The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
269 participants
Primary outcome timeframe
Baseline and up to 52 weeks
Results posted on
2021-06-14
Participant Flow
Subjects had to have satisfied all entry criteria for the antecedent study (SPD489-305, NCT00735371) and completed a minimum of 3 weeks of double-blind treatment and reached Visit 3 of the antecedent study (SPD489-305), without experiencing any clinically significant adverse events that would preclude exposure to LDX.
269 subjects were enrolled, but 4 were not dosed during the study and thus excluded from the Safety Population.
Participant milestones
| Measure |
Lisdexamfetamine Dimesylate (LDX)
Subjects who received either Lisdexamfetamine Dimesylate (LDX) or placebo during antecedent study 489-305 were eligible for 489-306. All subjects were titrated to their optimal dose of LDX (30, 50 or 70 mg per day).
|
|---|---|
|
Overall Study
STARTED
|
269
|
|
Overall Study
COMPLETED
|
156
|
|
Overall Study
NOT COMPLETED
|
113
|
Reasons for withdrawal
| Measure |
Lisdexamfetamine Dimesylate (LDX)
Subjects who received either Lisdexamfetamine Dimesylate (LDX) or placebo during antecedent study 489-305 were eligible for 489-306. All subjects were titrated to their optimal dose of LDX (30, 50 or 70 mg per day).
|
|---|---|
|
Overall Study
Adverse Event
|
18
|
|
Overall Study
Withdrawal by Subject
|
31
|
|
Overall Study
Non-compliance
|
16
|
|
Overall Study
Lost to Follow-up
|
25
|
|
Overall Study
Lack of Efficacy
|
5
|
|
Overall Study
Subject moved
|
7
|
|
Overall Study
Pregnancy
|
3
|
|
Overall Study
Prohibited medication
|
1
|
|
Overall Study
Out of town
|
1
|
|
Overall Study
Misuse and compliance of study drug
|
1
|
|
Overall Study
Subject sent to boarding school
|
1
|
|
Overall Study
Met an exclusion criteria
|
1
|
|
Overall Study
Positive drug screen
|
2
|
|
Overall Study
Sponsor requested withdrawal
|
1
|
Baseline Characteristics
Vyvanse Adolescent Open-Label Safety and Efficacy Extension Study
Baseline characteristics by cohort
| Measure |
Lisdexamfetamine Dimesylate (LDX)
n=265 Participants
Subjects who received either Lisdexamfetamine Dimesylate (LDX) or placebo during antecedent study 489-305 were eligible for 489-306. All subjects were titrated to their optimal dose of LDX (30, 50 or 70 mg per day).
|
|---|---|
|
Age, Continuous
|
14.5 years
STANDARD_DEVIATION 1.30 • n=5 Participants
|
|
Age, Customized
13 to 14 years
|
144 Participants
n=5 Participants
|
|
Age, Customized
15 to 17 years
|
121 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
78 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
187 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
265 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and up to 52 weeksPopulation: Full Analysis Set (FAS) defined as all subjects who took at least 1 dose of investigational product and have a valid baseline and at least 1 valid follow-up assessment of the primary outcome measure.
The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54.
Outcome measures
| Measure |
Lisdexamfetamine Dimesylate (LDX)
n=265 Participants
Subjects who received either Lisdexamfetamine Dimesylate (LDX) or placebo during antecedent study 489-305 were eligible for 489-306. All subjects were titrated to their optimal dose of LDX (30, 50 or 70 mg per day).
|
|---|---|
|
Change From Baseline (From the Antecedent Study, SPD489-305) in the Attention-Deficit/Hyperactivity Disorder Rating Scale, Fourth Edition (ADHD-RS-IV) Total Score at up to 52 Weeks
|
-26.2 Units on a scale
Standard Deviation 9.75
|
SECONDARY outcome
Timeframe: up to 52 weeksPopulation: FAS
Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.
Outcome measures
| Measure |
Lisdexamfetamine Dimesylate (LDX)
n=265 Participants
Subjects who received either Lisdexamfetamine Dimesylate (LDX) or placebo during antecedent study 489-305 were eligible for 489-306. All subjects were titrated to their optimal dose of LDX (30, 50 or 70 mg per day).
|
|---|---|
|
Percent of Participants With Improvement in Clinical Global Impression-Improvement (CGI-I)
|
87.2 Percent of participants
|
SECONDARY outcome
Timeframe: Baseline and Up to 52 weeksPopulation: FAS
The Youth Quality of Life-research version (YQOL-R) is a validated 56-item generic instrument for comparing quality of life of adolescents across condition groups that scores each question on a scale from 0 (never) to 4 (very often). The YQOL scores are transformed to a 0-100 scale for easy interpretability. Higher scores indicate better quality of life.
Outcome measures
| Measure |
Lisdexamfetamine Dimesylate (LDX)
n=237 Participants
Subjects who received either Lisdexamfetamine Dimesylate (LDX) or placebo during antecedent study 489-305 were eligible for 489-306. All subjects were titrated to their optimal dose of LDX (30, 50 or 70 mg per day).
|
|---|---|
|
Change From Baseline (From the Antecedent Study, SPD489-305) in the Youth Quality of Life Instrument-Research Version (YQOL-R) Total Score at up to 52 Weeks
|
3.9 Units on a scale
Standard Deviation 9.73
|
Adverse Events
Lisdexamfetamine Dimesylate (LDX)
Serious events: 10 serious events
Other events: 230 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Lisdexamfetamine Dimesylate (LDX)
n=265 participants at risk
Subjects who received either Lisdexamfetamine Dimesylate (LDX) or placebo during antecedent study 489-305 were eligible for 489-306. All subjects were titrated to their optimal dose of LDX (30, 50 or 70 mg per day).
|
|---|---|
|
Congenital, familial and genetic disorders
Hydrocele
|
0.38%
1/265 • Number of events 1
Safety population is defined as all subjects who take at least 1 dose of investigational product. In the Serious Adverse Events, the same subject reported multiple adverse events.
|
|
Infections and infestations
Pneumonia
|
0.38%
1/265 • Number of events 1
Safety population is defined as all subjects who take at least 1 dose of investigational product. In the Serious Adverse Events, the same subject reported multiple adverse events.
|
|
Injury, poisoning and procedural complications
Joint Sprain
|
0.38%
1/265 • Number of events 1
Safety population is defined as all subjects who take at least 1 dose of investigational product. In the Serious Adverse Events, the same subject reported multiple adverse events.
|
|
Injury, poisoning and procedural complications
Pelvic Fracture
|
0.38%
1/265 • Number of events 1
Safety population is defined as all subjects who take at least 1 dose of investigational product. In the Serious Adverse Events, the same subject reported multiple adverse events.
|
|
Injury, poisoning and procedural complications
Traumatic Liver Injury
|
0.38%
1/265 • Number of events 1
Safety population is defined as all subjects who take at least 1 dose of investigational product. In the Serious Adverse Events, the same subject reported multiple adverse events.
|
|
Injury, poisoning and procedural complications
Wrist Fracture
|
0.38%
1/265 • Number of events 1
Safety population is defined as all subjects who take at least 1 dose of investigational product. In the Serious Adverse Events, the same subject reported multiple adverse events.
|
|
Nervous system disorders
Syncope
|
1.1%
3/265 • Number of events 4
Safety population is defined as all subjects who take at least 1 dose of investigational product. In the Serious Adverse Events, the same subject reported multiple adverse events.
|
|
Nervous system disorders
Syncope Vasovagal
|
0.38%
1/265 • Number of events 1
Safety population is defined as all subjects who take at least 1 dose of investigational product. In the Serious Adverse Events, the same subject reported multiple adverse events.
|
|
Pregnancy, puerperium and perinatal conditions
Ectopic Pregnancy
|
0.38%
1/265 • Number of events 1
Safety population is defined as all subjects who take at least 1 dose of investigational product. In the Serious Adverse Events, the same subject reported multiple adverse events.
|
|
Psychiatric disorders
Aggression
|
0.75%
2/265 • Number of events 2
Safety population is defined as all subjects who take at least 1 dose of investigational product. In the Serious Adverse Events, the same subject reported multiple adverse events.
|
|
Reproductive system and breast disorders
Testicular Torsion
|
0.38%
1/265 • Number of events 1
Safety population is defined as all subjects who take at least 1 dose of investigational product. In the Serious Adverse Events, the same subject reported multiple adverse events.
|
Other adverse events
| Measure |
Lisdexamfetamine Dimesylate (LDX)
n=265 participants at risk
Subjects who received either Lisdexamfetamine Dimesylate (LDX) or placebo during antecedent study 489-305 were eligible for 489-306. All subjects were titrated to their optimal dose of LDX (30, 50 or 70 mg per day).
|
|---|---|
|
Gastrointestinal disorders
Dry Mouth
|
5.3%
14/265 • Number of events 15
Safety population is defined as all subjects who take at least 1 dose of investigational product. In the Serious Adverse Events, the same subject reported multiple adverse events.
|
|
General disorders
Irritability
|
12.5%
33/265 • Number of events 36
Safety population is defined as all subjects who take at least 1 dose of investigational product. In the Serious Adverse Events, the same subject reported multiple adverse events.
|
|
Infections and infestations
Influenza
|
6.8%
18/265 • Number of events 18
Safety population is defined as all subjects who take at least 1 dose of investigational product. In the Serious Adverse Events, the same subject reported multiple adverse events.
|
|
Infections and infestations
Nasopharyngitis
|
7.2%
19/265 • Number of events 26
Safety population is defined as all subjects who take at least 1 dose of investigational product. In the Serious Adverse Events, the same subject reported multiple adverse events.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
21.9%
58/265 • Number of events 74
Safety population is defined as all subjects who take at least 1 dose of investigational product. In the Serious Adverse Events, the same subject reported multiple adverse events.
|
|
Investigations
Weight Decreased
|
16.2%
43/265 • Number of events 46
Safety population is defined as all subjects who take at least 1 dose of investigational product. In the Serious Adverse Events, the same subject reported multiple adverse events.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
21.1%
56/265 • Number of events 71
Safety population is defined as all subjects who take at least 1 dose of investigational product. In the Serious Adverse Events, the same subject reported multiple adverse events.
|
|
Nervous system disorders
Dizziness
|
5.3%
14/265 • Number of events 16
Safety population is defined as all subjects who take at least 1 dose of investigational product. In the Serious Adverse Events, the same subject reported multiple adverse events.
|
|
Nervous system disorders
Headache
|
20.8%
55/265 • Number of events 81
Safety population is defined as all subjects who take at least 1 dose of investigational product. In the Serious Adverse Events, the same subject reported multiple adverse events.
|
|
Psychiatric disorders
Insomnia
|
12.1%
32/265 • Number of events 43
Safety population is defined as all subjects who take at least 1 dose of investigational product. In the Serious Adverse Events, the same subject reported multiple adverse events.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.
- Publication restrictions are in place
Restriction type: OTHER