NCT00735371

Efficacy and Safety of Lisdexamfetamine Dimesylate (LDX) in Adolescents With Attention-Deficit/Hyperactivity Disorder (ADHD)

Completed Phase 3 Results posted Last updated 14 June 2021

What this trial tests

Phase 3 trial testing LDX 30 mg in Attention Deficit Hyperactivity Disorder (ADHD) in 314 participants. Completed in 6 April 2009.

Timeline

8 October 2008

Primary endpoint
6 April 2009

6 April 2009

Quick facts

Lead sponsor	Shire
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	314
Start date	8 October 2008
Primary completion	6 April 2009
Estimated completion	6 April 2009
Sites	45 locations across United States

Drugs / interventions tested

• LDX 30 mg — full drug profile →
• LDX 50 mg — full drug profile →
• LDX 70 mg — full drug profile →
• Placebo

Conditions studied

• Attention Deficit Hyperactivity Disorder (ADHD) — all drugs for Attention Deficit Hyperactivity Disorder (ADHD) →

Sponsor

Shire — full company profile →

Who can join

Adults 13 to 17, any sex, with Attention Deficit Hyperactivity Disorder (ADHD). Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Total Score at up to 4 Weeks Primary · Baseline and 1, 2, 3 and 4 weeks

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.

Group	Value	95% CI
Lisdexamfetamine Dimesylate (LDX) 30 mg	-18.3	± 1.25
LDX 50 mg	-21.1	± 1.28
LDX 70 mg	-20.7	± 1.25
Placebo	-12.8	± 1.25

Number of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores Secondary · 1, 2, 3 and 4 Weeks

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.

Group	Value	95% CI
Lisdexamfetamine Dimesylate (LDX) 30 mg	44
LDX 50 mg	53
LDX 70 mg	57
Placebo	30

Youth Quality of Life-Research Version (YQOL-R) Total Score Secondary · Baseline and 4 weeks

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.

Baseline

Group	Value	95% CI
Lisdexamfetamine Dimesylate (LDX) 30 mg	79.3	± 10.03
LDX 50 mg	80.5	± 10.63
LDX 70 mg	78.8	± 15.38
Placebo	79.2	± 11.08

4 Weeks

Group	Value	95% CI
Lisdexamfetamine Dimesylate (LDX) 30 mg	81.1	± 11.09
LDX 50 mg	81.3	± 11.86
LDX 70 mg	81.3	± 14.66
Placebo	81.3	± 12.16

Adverse events — posted to ClinicalTrials.gov

Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Lisdexamfetamine Dimesylate (LDX) 30 mg

Serious: 0/78 (0%)

Deaths: —

LDX 50 mg

Serious: 0/77 (0%)

Deaths: —

LDX 70 mg

Serious: 0/78 (0%)

Deaths: —

Placebo

Serious: 0/77 (0%)

Deaths: —

Other adverse events (13 terms — click to expand)

Reaction	System	Lisdexamfetamine Dimesylat…	LDX 50 mg	LDX 70 mg	Placebo
Decreased appetite	Metabolism and nutrition disorders	—	—	—	—
Headache	Nervous system disorders	—	—	—	—
Weight decreased	Investigations	—	—	—	—
Insomnia	Psychiatric disorders	—	—	—	—
Irritability	General disorders	—	—	—	—
Upper respiratory tract infection	Infections and infestations	—	—	—	—
Dry mouth	Gastrointestinal disorders	—	—	—	—
Dizziness	Nervous system disorders	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—
Nasal congestion	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Fatigue	General disorders	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—
Nasopharyngitis	Infections and infestations	—	—	—	—

Data from ClinicalTrials.gov NCT00735371 adverse events section.

Sponsor's own description

The study will evaluate the efficacy of LDX treatment group compared to placebo on the change from Baseline ADHD-RS-IV score at endpoint.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Efficacy and safety of lisdexamfetamine dimesylate in adolescents with attention-deficit/hyperactivity disorder.
   Findling RL, Childress AC, Cutler AJ, Gasior M, et al · · 2011 · cited 95× · PMID 21421179 · DOI 10.1016/j.jaac.2011.01.007
2. Amphetamines for attention deficit hyperactivity disorder (ADHD) in children and adolescents.
   Punja S, Shamseer L, Hartling L, Urichuk L, et al · · 2016 · cited 69× · PMID 26844979 · DOI 10.1002/14651858.cd009996.pub2
3. Efficacy and Tolerability of Different Interventions in Children and Adolescents with Attention Deficit Hyperactivity Disorder.
   Luan R, Mu Z, Yue F, He S. · · 2017 · cited 8× · PMID 29180967 · DOI 10.3389/fpsyt.2017.00229
4. A simple formula for enumerating comparisons in trials and network meta-analysis.
   Shokraneh F, Adams CE. · · 2019 · cited 2× · PMID 30863537 · DOI 10.12688/f1000research.17352.2