Phase 2
N=83
SPD503 in Subjects Aged 6-17 Years With Generalized Anxiety Disorder (GAD), Separation Anxiety Disorder (SAD), or Social Phobia (SoP)
Generalized Anxiety Disorder (GAD) · Anxiety, Separation · Phobia, Social
Bottom Line
View on ClinicalTrials.gov: NCT01470469 ↗Enrolled (actual)
83
Serious AEs
0.0%
Results posted
May 2014
Primary outcome: Primary: Change From Baseline in Systolic Blood Pressure at Up to 12 Weeks — -1.7; -2.3 mmHg
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- SPD503 (extended-release Guanfacine hydrochloride) (Drug); Placebo (Drug)
- Age
- Pediatric · 6+ yrs
- Sex
- All
- Sponsor
- Shire
- Primary completion
- Jul 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Systolic Blood Pressure at Up to 12 Weeks |
-1.7; -2.3 | — |
| PRIMARY Change From Baseline in Diastolic Blood Pressure at Up to 12 Weeks |
0.9; -1.3 | — |
| PRIMARY Change From Baseline in Pulse Rate at Up to 12 Weeks |
-0.5; -1.8 | — |
| PRIMARY Change From Baseline in Height at up to 12 Weeks |
0.5; 1.0 | — |
| PRIMARY Change From Baseline in Weight at up to 12 Weeks |
0.7; 1.3 | — |
| PRIMARY Change From Baseline in Electrocardiogram (ECG) QRS Interval at up to 12 Weeks |
0.7; 0.1 | — |
| PRIMARY Change From Baseline in ECG QTcF Interval at up to 12 Weeks |
0.3; 4.1 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Outpatient subjects aged 6-17 years inclusive at the time of consent/assent (Screening Visit [Visit 1] only).
- Subject's parent or legally authorized representative (LAR) must provide signature of informed consent, and there must be documentation of assent by the subject indicating that the subject is aware of the investigational nature of the study and the required procedures in accordance with the International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) Guidance E6 (1996) and applicable regulations before completing any study-related procedures (Screening Visit [Visit 1] only).
- Subject meets Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) criteria for a Primary Diagnosis of 1 or any combination of the following; GAD, SAD or SoP (300.02, 309.21 and 300.23), based on a detailed psychiatric evaluation at screening including completion of the Anxiety Disorders Interview Schedule for DSM-IV Child Version (ADIS-C).
- Subject has a score of >/= 4 on the Clinician Severity Rating Scale for the Principal Diagnosis on the ADIS-C CSR) at the Screening Visit (Visit 1) and the Baseline Visit (Visit 2).
- Subject is functioning at an age-appropriate level intellectually, as determined by the Investigator.
- Subject and parent/LAR understand, are able, willing, and likely to fully comply with the study procedures and restrictions defined in this protocol, in the opinion of the Investigator.
- Subject is able to swallow intact tablets.
- Subjects who are females of child-bearing potential (FOCP), defined as >/= 9 years of age or if 95th percentile for this study.
- Subject has a known or suspected allergy, hypersensitivity, or clinically significant intolerance to guanfacine hydrochloride or any components found in SPD503.
- Subject is female and is pregnant or currently lactating.
- Subject failed screening or was previously enrolled in this study.
- Subject has another member of the same household currently participating in this study.
Data sourced from ClinicalTrials.gov (NCT01470469). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.