Phase 3
Completed N=214
Access to Extended Release Guanfacine HCl for Subjects Who Participated in Studies SPD503-315 or SPD503-316 in Europe
Source: ClinicalTrials.gov NCT01500694 ↗Enrolled (actual)
214
Serious AEs
4.7%
Results posted
May 2017
Primary outcomePrimary: Change From Baseline in Mean Systolic Blood Pressure at Final Assessment — 107.5; 113.5; 0.9; 0.3 millimeter of mercury (mmHg)
◆ Published Evidence
Established
29citations · ~4 / year
Long-term safety and efficacy of guanfacine extended release in children and adolescents with ADHD.
Summary
For subjects in Europe that have already participated in either Study SPD503-315 or SPD503-316. This is an extension study that will allow participants access to Extended-release Guanfacine Hydrochloride (HCl) for up to 2 years. This study will help the sponsor evaluate long-term safety and tolerability of Extended-release Guanfacine HCl (SPD503).
Linked Publications
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Long-term safety and efficacy of guanfacine extended release in children and adolescents with ADHD.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Mean Systolic Blood Pressure at Final Assessment |
107.5; 113.5; 0.9; 0.3 | — |
| PRIMARY Change From Baseline in Mean Diastolic Blood Pressure at Final Assessment |
64.3; 66.8; 0.2; 0.1 | — |
| PRIMARY Change From Baseline in Mean Supine Pulse at Final Assessment |
79.3; 72.1; -7.1; -2.9 | — |
| PRIMARY Change From Baseline in Mean Height at Final Assessment |
142.03; 166.32; 8.80; 5.54 | — |
| PRIMARY Change From Baseline in Mean Weight at Final Assessment |
37.29; 58.53; 8.96; 6.74 | — |
| PRIMARY Change From Baseline in Electrocardiogram Result (QRS Interval) at Final Assessment |
84.9; 89.7; 1.8; 1.8 | — |
| PRIMARY Change From Baseline in Electrocardiogram Result (QT Interval) at Final Assessment |
361.4; 375.9; 16.9; 9.5 | — |
| PRIMARY Number of Participants With Suicidal Behavior and / or Ideation ("Yes" Response) on the Columbia Suicide Severity Rating Scale (C-SSRS) |
0; 1; 0; 0; 0; 0 | — |
| SECONDARY Change From Baseline in Attention-deficit and Hyperactivity Disorder Rating Scale-IV (ADHD-RS-IV) - Total Score at Final Assessment |
40.0; 31.2; -20.2; -19.3 | — |
| SECONDARY Number of Participants Assessed With Clinical Global Impression Severity of Illness (CGI-S) Scale |
0; 2; 127; 79; 45; 51 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects where Study SPD503-318 was not available at the time of their final visit in the antecedent study (SPD503-315 or SPD503-316), may still be screened unless they are well-controlled on another ADHD medication with acceptable tolerability and the parent/caregiver is satisfied with their current ADHD medication.
- Subject satisfied all entry criteria for the antecedent study (SPD503 315 or SPD503-316).
- Subject who is a female of child-bearing potential (FOCP), defined as >9 years of age or 95th percentile.
- Children aged 6 12 years with a body weight of less than 25.0kg or adolescents aged 13 years and older with a body weight of less than 34.0kg at the Screening Visit (Visit 1).
- Subject has any condition or illness including clinically significant abnormal laboratory values at the Screening Visit (Visit 1) which, in the opinion of the Investigator, represents an inappropriate risk to the subject and/or could confound the interpretation of the study.
- Subject is currently considered a suicide risk in the opinion of the Investigator, has previously made a suicide attempt, or has a prior history of, or is currently demonstrating active suicidal ideation. Subjects with intermittent passive suicidal ideation are not necessarily excluded based on the assessment of the Investigator.
- Subject has clinically significant ECG findings, as judged by the Investigator with consideration of the central ECG laboratory's interpretation, at the Baseline Visit (Visit 2).
- Subject has a known or suspected allergy, hypersensitivity, or clinically significant intolerance to guanfacine hydrochloride, or any components found in SPD503.
- Subject has a history of alcohol or other substance abuse or dependence, as defined by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition-Text RevisionÒ (DSM-IV-TRÒ; with the exception of nicotine) within the last 6 months.
- Subject has a history of a seizure disorder (other than a single childhood febrile seizure occurring before the age of 3 years) or the presence of a serious tic disorder including Tourette's syndrome.
- Subject has a known history or presence of structural cardiac abnormalities, serious heart rhythm abnormalities, syncope, cardiac conduction problems (eg, clinically significant heart block), exercise related cardiac events including syncope and pre syncope, or clinically significant bradycardia.
- Subject with orthostatic hypotension or a known history of controlled or uncontrolled hypertension.
- Current use of any prohibited medication or other medications, including herbal supplements, that affect BP or heart rate or that have central nervous system (CNS) effects or affect cognitive performance, such as sedating antihistamines and decongestant sympathomimetics (inhaled bronchodilators are permitted) or a history of chronic use of sedating medications (ie, antihistamines) in violation of the protocol specified washout criteria at the Baseline Visit (Visit 2).
- Subject has a medical condition, other than ADHD, that requires treatment with medications that have CNS effects and/or affect performance.
- Subject is female and is pregnant or currently lactating.
- Subject failed screening or was previously enrolled in this study.
Data sourced from ClinicalTrials.gov (NCT01500694) and the linked publication. 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. Informational only — not medical advice.