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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SPD503 | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SPD503 (extended-release Guanfacine hydrochloride) | Drug | Once-daily oral dosing of SPD503 in the evening ranging from 1-6 mg for 12 weeks (6 week dose optimization and 6 week dose maintenance). |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Systolic Blood Pressure at Up to 12 Weeks | Baseline and up to 12 weeks | |
| Change From Baseline in Diastolic Blood Pressure at Up to 12 Weeks | Baseline and up to 12 weeks | |
| Change From Baseline in Pulse Rate at Up to 12 Weeks | Baseline and up to 12 weeks | |
| Change From Baseline in Height at up to 12 Weeks | Baseline and up to 12 weeks | |
| Change From Baseline in Weight at up to 12 Weeks | Baseline and up to 12 weeks | |
| Change From Baseline in Electrocardiogram (ECG) QRS Interval at up to 12 Weeks | QRS complex is a portion of the ECG tracing that represents depolarization of the ventricular myocardium. | Baseline and up to 12 weeks |
| Change From Baseline in ECG QTcF Interval at 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. | Baseline and up to 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham Research Group, Inc | Birmingham | Alabama | 35216 | United States | ||
| Dr. Joseph H. Rodd |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28165762 | Derived | Strawn JR, Compton SN, Robertson B, Albano AM, Hamdani M, Rynn MA. Extended Release Guanfacine in Pediatric Anxiety Disorders: A Pilot, Randomized, Placebo-Controlled Trial. J Child Adolesc Psychopharmacol. 2017 Feb;27(1):29-37. doi: 10.1089/cap.2016.0132. Epub 2017 Feb 6. |
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| ID | Title | Description |
|---|---|---|
| FG000 | PLACEBO | Once-daily oral dosing in the evening for 12 weeks. |
| FG001 | SPD503 | Once-daily oral dosing of SPD503 in the evening ranging from 1-6 mg for 12 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo | Drug | Once-daily oral dosing in the evening for 12 weeks. |
|
| Carson |
| California |
| 90746 |
| United States |
| Sun Valley Research | Imperial | California | 92251 | United States |
| Irvine Center for Clinical Research | Irvine | California | 92618 | United States |
| Sharp Mesa Vista Hospital, Clinical Research Department | San Diego | California | 92123 | United States |
| Elite Clinical Trials, Inc | Wildomar | California | 92595 | United States |
| Florida Clinical Research Center | Bradenton | Florida | 34201 | United States |
| Sarkis Clinical Trials | Gainesville | Florida | 32607 | United States |
| Kolin Research Group | Winter Park | Florida | 32789 | United States |
| Atlanta Center for Medical Research | Atlanta | Georgia | 30308 | United States |
| Institute of Behavioral Medicine, LLC | Smyrna | Georgia | 30080-6315 | United States |
| Lake Charles Clinical Trials | Lake Charles | Louisiana | 70629 | United States |
| Rochester Center for Behavioral Medicine | Rochester Hills | Michigan | 48307 | United States |
| Midwest Research Group | Saint Charles | Missouri | 63301 | United States |
| Premier Psychiatric Group, LLC | Lincoln | Nebraska | 68526 | United States |
| Center for Psychiatry and Behavioral Medicine, Inc | Las Vegas | Nevada | 89128 | United States |
| Center for Emotional Fitness | Cherry Hill | New Jersey | 08002 | United States |
| Columbia University, NY State Psychiatric Institute | New York | New York | 10032 | United States |
| Weill Cornell Medical Center | New York | New York | 10065 | United States |
| Finger Lakes Clinical Research | Rochester | New York | 14618 | United States |
| Richmond Behavioral Associates | Staten Island | New York | 10312 | United States |
| Duke University Medical Center, Duke Child and Family Study Center | Durham | North Carolina | 27705-4596 | United States |
| University of Cincinnati, Department of Psychiatry and Behavioral Neuroscience | Cincinnati | Ohio | 45219 | United States |
| University Hospitals of Cleveland Medical Center | Cleveland | Ohio | 44012 | United States |
| Professional Psychiatric Services | Mason | Ohio | 45040 | United States |
| North Star Research | Middleburg Heights | Ohio | 44130 | United States |
| IPS Research Company | Oklahoma City | Oklahoma | 73103 | United States |
| Coastal Carolina Research Center | Mt. Pleasant | South Carolina | 29464 | United States |
| Research Strategies of Memphis, LLC | Memphis | Tennessee | 38119 | United States |
| FutureSearch Clinical Trials, LP | Austin | Texas | 78731 | United States |
| Houston Clinical Trials LLC | Houston | Texas | 77098 | United States |
| Ericksen Research and Development | Clinton | Utah | 84015 | United States |
| NeuroScience, Inc. | Herndon | Virginia | 20170 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | PLACEBO | Once-daily oral dosing in the evening for 12 weeks. |
| BG001 | SPD503 | Once-daily oral dosing of SPD503 in the evening ranging from 1-6 mg for 12 weeks. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Systolic Blood Pressure at Up to 12 Weeks | Safety Analysis Set consisted of all subjects who had taken at least 1 dose of investigational product and had at least 1 post-dose safety assessment. | Posted | Mean | Standard Deviation | mmHg | Baseline and up to 12 weeks |
|
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| |||||||||||||||||||||||||||||
| Primary | Change From Baseline in Diastolic Blood Pressure at Up to 12 Weeks | Safety Analysis Set consisted of all subjects who had taken at least 1 dose of investigational product and had at least 1 post-dose safety assessment. | Posted | Mean | Standard Deviation | mmHg | Baseline and up to 12 weeks |
|
| ||||||||||||||||||||||||||||||
| Primary | Change From Baseline in Pulse Rate at Up to 12 Weeks | Safety Analysis Set consisted of all subjects who had taken at least 1 dose of investigational product and had at least 1 post-dose safety assessment. | Posted | Mean | Standard Deviation | beats/min | Baseline and up to 12 weeks |
|
| ||||||||||||||||||||||||||||||
| Primary | Change From Baseline in Height at up to 12 Weeks | Safety Analysis Set consisted of all subjects who had taken at least 1 dose of investigational product and had at least 1 post-dose safety assessment. | Posted | Mean | Standard Deviation | cm | Baseline and up to 12 weeks |
|
| ||||||||||||||||||||||||||||||
| Primary | Change From Baseline in Weight at up to 12 Weeks | Safety Analysis Set consisted of all subjects who had taken at least 1 dose of investigational product and had at least 1 post-dose safety assessment. | Posted | Mean | Standard Deviation | kg | Baseline and up to 12 weeks |
|
| ||||||||||||||||||||||||||||||
| Primary | Change From Baseline in Electrocardiogram (ECG) QRS Interval at up to 12 Weeks | QRS complex is a portion of the ECG tracing that represents depolarization of the ventricular myocardium. | Safety Analysis Set consisted of all subjects who had taken at least 1 dose of investigational product and had at least 1 post-dose safety assessment. | Posted | Mean | Standard Deviation | msec | Baseline and up to 12 weeks |
|
| |||||||||||||||||||||||||||||
| Primary | Change From Baseline in ECG QTcF Interval at 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. | Safety Analysis Set consisted of all subjects who had taken at least 1 dose of investigational product and had at least 1 post-dose safety assessment. | Posted | Mean | Standard Deviation | msec | Baseline and up to 12 weeks |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PLACEBO | Once-daily oral dosing in the evening for 12 weeks. | 0 | 21 | 10 | 21 | ||
| EG001 | SPD503 | Once-daily oral dosing of SPD503 in the evening ranging from 1-6 mg for 12 weeks. | 0 | 62 | 48 | 62 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain upper | Gastrointestinal disorders |
| |||
| Constipation | Gastrointestinal disorders |
| |||
| Diarrhoea | Gastrointestinal disorders |
| |||
| Dry mouth | Gastrointestinal disorders |
| |||
| Nausea | Gastrointestinal disorders |
| |||
| Vomiting | Gastrointestinal disorders |
| |||
| Fatigue | General disorders |
| |||
| Irritability | General disorders |
| |||
| Pharyngitis streptococcal | Infections and infestations |
| |||
| Upper respiratory tract infection | Infections and infestations |
| |||
| Joint sprain | Injury, poisoning and procedural complications |
| |||
| Decreased appetite | Metabolism and nutrition disorders |
| |||
| Increased appetite | Metabolism and nutrition disorders |
| |||
| Dizziness | Nervous system disorders |
| |||
| Dizziness postural | Nervous system disorders |
| |||
| Headache | Nervous system disorders |
| |||
| Sedation | Nervous system disorders |
| |||
| Somnolence | Nervous system disorders |
| |||
| Initial insomnia | Psychiatric disorders |
| |||
| Cough | Respiratory, thoracic and mediastinal disorders |
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Efficacy endpoints were exploratory. No statistical testing was performed because the study was not powered.
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Shire | +1 866 842 5335 | ClinicalTransparency@shire.com |
| ID | Term |
|---|---|
| D000098647 | Generalized Anxiety Disorder |
| D001010 | Anxiety, Separation |
| D000072861 | Phobia, Social |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
| D065886 | Neurodevelopmental Disorders |
| D010698 | Phobic Disorders |
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| ID | Term |
|---|---|
| D016316 | Guanfacine |
| ID | Term |
|---|---|
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D010648 | Phenylacetates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
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| Age 13-17 years |
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| Male |
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