NCT01470469

SPD503 in Subjects Aged 6-17 Years With Generalized Anxiety Disorder (GAD), Separation Anxiety Disorder (SAD), or Social Phobia (SoP)

Completed Phase 2 Results posted Last updated 10 June 2021

What this trial tests

Phase 2 trial testing SPD503 (extended-release Guanfacine hydrochloride) in Generalized Anxiety Disorder (GAD) in 83 participants. Completed in 15 July 2013.

Timeline

4 January 2012

Primary endpoint
15 July 2013

15 July 2013

Quick facts

Lead sponsor	Shire
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	83
Start date	4 January 2012
Primary completion	15 July 2013
Estimated completion	15 July 2013
Sites	33 locations across United States

Drugs / interventions tested

• SPD503 (extended-release Guanfacine hydrochloride)
• Placebo

Conditions studied

• Generalized Anxiety Disorder (GAD) — all drugs for Generalized Anxiety Disorder (GAD) →
• Anxiety, Separation — all drugs for Anxiety, Separation →
• Phobia, Social — all drugs for Phobia, Social →

Sponsor

Shire — full company profile →

Who can join

Adults 6 to 17, any sex, with Generalized Anxiety Disorder (GAD) or Anxiety, Separation. 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 Systolic Blood Pressure at Up to 12 Weeks Primary · Baseline and up to 12 weeks

Group	Value	95% CI
PLACEBO	-1.7	± 11.18
SPD503	-2.3	± 11.40

Change From Baseline in Diastolic Blood Pressure at Up to 12 Weeks Primary · Baseline and up to 12 weeks

Group	Value	95% CI
PLACEBO	0.9	± 7.37
SPD503	-1.3	± 9.09

Change From Baseline in Pulse Rate at Up to 12 Weeks Primary · Baseline and up to 12 weeks

Group	Value	95% CI
PLACEBO	-0.5	± 11.09
SPD503	-1.8	± 11.54

Change From Baseline in Height at up to 12 Weeks Primary · Baseline and up to 12 weeks

Group	Value	95% CI
PLACEBO	0.5	± 0.91
SPD503	1.0	± 1.79

Change From Baseline in Weight at up to 12 Weeks Primary · Baseline and up to 12 weeks

Group	Value	95% CI
PLACEBO	0.7	± 1.73
SPD503	1.3	± 1.57

Change From Baseline in Electrocardiogram (ECG) QRS Interval at up to 12 Weeks Primary · Baseline and up to 12 weeks

QRS complex is a portion of the ECG tracing that represents depolarization of the ventricular myocardium.

Group	Value	95% CI
PLACEBO	0.7	± 6.50
SPD503	0.1	± 5.33

Change From Baseline in ECG QTcF Interval at up to 12 Weeks Primary · Baseline and up to 12 weeks

The QT interval is the time from the start of the Q wave to the end of the T wave. It is a portion of the ECG tracing that represents the time taken for ventricular depolarisation and repolarisation. The QTcF includes a correction factor to help account for changes in heart rate.

Group	Value	95% CI
PLACEBO	0.3	± 9.38
SPD503	4.1	± 14.01

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.

PLACEBO

Serious: 0/21 (0%)

Deaths: —

SPD503

Serious: 0/62 (0%)

Deaths: —

Other adverse events (20 terms — click to expand)

Reaction	System	PLACEBO	SPD503
Headache	Nervous system disorders	—	—
Somnolence	Nervous system disorders	—	—
Fatigue	General disorders	—	—
Abdominal pain upper	Gastrointestinal disorders	—	—
Dizziness	Nervous system disorders	—	—
Dizziness postural	Nervous system disorders	—	—
Constipation	Gastrointestinal disorders	—	—
Vomiting	Gastrointestinal disorders	—	—
Decreased appetite	Metabolism and nutrition disorders	—	—
Sedation	Nervous system disorders	—	—
Nausea	Gastrointestinal disorders	—	—
Diarrhoea	Gastrointestinal disorders	—	—
Dry mouth	Gastrointestinal disorders	—	—
Irritability	General disorders	—	—
Pharyngitis streptococcal	Infections and infestations	—	—
Initial insomnia	Psychiatric disorders	—	—
Joint sprain	Injury, poisoning and procedural complications	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—
Upper respiratory tract infection	Infections and infestations	—	—
Increased appetite	Metabolism and nutrition disorders	—	—

Data from ClinicalTrials.gov NCT01470469 adverse events section.

Sponsor's own description

This study will evaluate the safety and tolerability of SPD503 in subjects aged 6-17 years with GAD, SAD, or SoP based on treatment emergent adverse events (TEAEs), vital signs and ECGs.

Publications & conference data

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

1. Assessment and treatment of anxiety disorders in children and adolescents.
   Wehry AM, Beesdo-Baum K, Hennelly MM, Connolly SD, et al · · 2015 · cited 129× · PMID 25980507 · DOI 10.1007/s11920-015-0591-z
2. Emerging drugs for the treatment of anxiety.
   Murrough JW, Yaqubi S, Sayed S, Charney DS. · · 2015 · cited 91× · PMID 26012843 · DOI 10.1517/14728214.2015.1049996
3. Extended Release Guanfacine in Pediatric Anxiety Disorders: A Pilot, Randomized, Placebo-Controlled Trial.
   Strawn JR, Compton SN, Robertson B, Albano AM, et al · · 2017 · cited 34× · PMID 28165762 · DOI 10.1089/cap.2016.0132