Trial Outcomes & Findings for Safety and Efficacy of Vyvanse in Adults With Attention-Deficit/Hyperactivity Disorder (NCT NCT00877487)

NCT ID: NCT00877487

Last Updated: 2021-06-22

Results Overview

Treatment failure defined as \> or equal to 50% increase in the ADHD-RS with adult prompts total score and a \> or equal to 2 point increase in the CGI-S score.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 123 participants
• Primary outcome timeframe: Up to 6 weeks
• Results posted on: 2021-06-22

Participant Flow

Subjects had been on stable treatment with commercial SPD489 (30, 50, or 70 mg/day) for at least 6 months. They then entered a 3-week open-label treatment phase on SPD489 (30, 50, or 70 mg/day). They then entered a 6-week double-blind randomized withdrawal phase where they were assigned to either SPD489 or placebo treatment group.

Participant milestones

Measure	SPD489 Subjects receive SPD489 at 30, 50, or 70 mg/day.	Placebo Subjects who previously were receiving SPD489 are now only getting placebo.
Open-label Treatment Phase STARTED	123	0
Open-label Treatment Phase COMPLETED	116	0
Open-label Treatment Phase NOT COMPLETED	7	0
Double-blind Randomized Withdrawal Phase STARTED	56	60
Double-blind Randomized Withdrawal Phase COMPLETED	50	13
Double-blind Randomized Withdrawal Phase NOT COMPLETED	6	47

Reasons for withdrawal

Measure	SPD489 Subjects receive SPD489 at 30, 50, or 70 mg/day.	Placebo Subjects who previously were receiving SPD489 are now only getting placebo.
Open-label Treatment Phase Adverse Event	1	0
Open-label Treatment Phase Protocol Violation	3	0
Open-label Treatment Phase Withdrawal by Subject	1	0
Open-label Treatment Phase Lost to Follow-up	1	0
Open-label Treatment Phase Out of country for business	1	0
Double-blind Randomized Withdrawal Phase Relapse criteria met	5	45
Double-blind Randomized Withdrawal Phase Adverse Event	0	1
Double-blind Randomized Withdrawal Phase Protocol Violation	0	1
Double-blind Randomized Withdrawal Phase Moved out of state	1	0

Baseline Characteristics

Safety and Efficacy of Vyvanse in Adults With Attention-Deficit/Hyperactivity Disorder

Baseline characteristics by cohort

Measure	SPD489 n=122 Participants Subjects receive SPD489 at 30, 50, or 70 mg/day.
Age, Continuous	35.4 years STANDARD_DEVIATION 11.16 • n=5 Participants
Age, Customized Between 18 and 55 years	122 Participants n=5 Participants
Sex: Female, Male Female	68 Participants n=5 Participants
Sex: Female, Male Male	54 Participants n=5 Participants
Region of Enrollment United States	122 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 6 weeks

Population: Full Analysis Set (FAS) defined as all subjects who were randomized and received at least 1 dose of investigational product.

Treatment failure defined as > or equal to 50% increase in the ADHD-RS with adult prompts total score and a > or equal to 2 point increase in the CGI-S score.

Outcome measures

Measure	SPD489 n=56 Participants Subjects receive SPD489 at 30, 50, or 70 mg/day.	Placebo n=60 Participants Subjects who previously were receiving SPD489 are now only getting placebo.
Percent of Treatment Failures at up to 6 Weeks	8.9 Percent of participants	75.0 Percent of participants

SECONDARY outcome

Timeframe: Up to 6 weeks

Population: FAS

The ADHD-RS 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	SPD489 n=56 Participants Subjects receive SPD489 at 30, 50, or 70 mg/day.	Placebo n=60 Participants Subjects who previously were receiving SPD489 are now only getting placebo.
Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS) With Adult Prompts Total Score at up to 6 Weeks	1.6 Units on a scale Standard Error 1.39	16.8 Units on a scale Standard Error 1.35

SECONDARY outcome

Timeframe: Up to 6 weeks

Population: FAS

CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)

Outcome measures

Measure	SPD489 n=56 Participants Subjects receive SPD489 at 30, 50, or 70 mg/day.	Placebo n=60 Participants Subjects who previously were receiving SPD489 are now only getting placebo.
Assessment of Clinical Global Impression-Severity of Illness (CGI-S) at up to 6 Weeks Normal, not at all ill	32.1 Percent of Participants	5.0 Percent of Participants
Assessment of Clinical Global Impression-Severity of Illness (CGI-S) at up to 6 Weeks Borderline mentally ill	35.7 Percent of Participants	11.7 Percent of Participants
Assessment of Clinical Global Impression-Severity of Illness (CGI-S) at up to 6 Weeks Mildly ill	17.9 Percent of Participants	11.7 Percent of Participants
Assessment of Clinical Global Impression-Severity of Illness (CGI-S) at up to 6 Weeks Moderately ill	7.1 Percent of Participants	33.3 Percent of Participants
Assessment of Clinical Global Impression-Severity of Illness (CGI-S) at up to 6 Weeks Markedly ill	7.1 Percent of Participants	35.0 Percent of Participants
Assessment of Clinical Global Impression-Severity of Illness (CGI-S) at up to 6 Weeks Severely ill	0 Percent of Participants	3.3 Percent of Participants
Assessment of Clinical Global Impression-Severity of Illness (CGI-S) at up to 6 Weeks Among the most extremely ill	0 Percent of Participants	0 Percent of Participants

Adverse Events

SPD489

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Measure	SPD489 n=56 participants at risk Subjects receive SPD489 at 30, 50, or 70 mg/day.	Placebo n=60 participants at risk Subjects who previously were receiving SPD489 are now only getting placebo.
Psychiatric disorders Suicidal ideation	0.00% 0/56 Safety Population defined as all subjects who entered the open-label treatment phase and took at least 1 dose of investigational product (SPD489).	1.7% 1/60 • Number of events 1 Safety Population defined as all subjects who entered the open-label treatment phase and took at least 1 dose of investigational product (SPD489).

Other adverse events

Measure	SPD489 n=56 participants at risk Subjects receive SPD489 at 30, 50, or 70 mg/day.	Placebo n=60 participants at risk Subjects who previously were receiving SPD489 are now only getting placebo.
Nervous system disorders Headache	14.3% 8/56 • Number of events 8 Safety Population defined as all subjects who entered the open-label treatment phase and took at least 1 dose of investigational product (SPD489).	5.0% 3/60 • Number of events 3 Safety Population defined as all subjects who entered the open-label treatment phase and took at least 1 dose of investigational product (SPD489).
Psychiatric disorders Insomnia	5.4% 3/56 • Number of events 3 Safety Population defined as all subjects who entered the open-label treatment phase and took at least 1 dose of investigational product (SPD489).	5.0% 3/60 • Number of events 3 Safety Population defined as all subjects who entered the open-label treatment phase and took at least 1 dose of investigational product (SPD489).
Infections and infestations Upper respiratory tract infection	8.9% 5/56 • Number of events 5 Safety Population defined as all subjects who entered the open-label treatment phase and took at least 1 dose of investigational product (SPD489).	0.00% 0/60 Safety Population defined as all subjects who entered the open-label treatment phase and took at least 1 dose of investigational product (SPD489).

Additional Information

Study Director

Shire

Phone: +1 866 842 5335

Email: ClinicalTransparency@shire.com

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