Tolerability and Efficacy of AM and PM Once Daily Dosing With Extended-release Guanfacine Hydrochloride in Children 6-12 With Attention-Deficit/Hyperactivity Disorder (ADHD) (The ADHD Tempo Study)
Public ClinicalTrials.gov record NCT00997984. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 3, Double-blind, Randomized, Multicenter, Placebo-controlled, Dose Optimization Study Evaluating the Tolerability and Efficacy of AM and PM Once Daily Dosing With Extended-release Guanfacine Hydrochloride in Children Aged 6-12 With a Diagnosis of Attention-Deficit/Hyperactivity Disorder
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The primary purpose is to assess the efficacy of once daily dosing with optimized SPD503 (1, 2, 3 and 4mg/day), dosed either in the morning or evening, compared to placebo, in children with ADHD as measured by change from baseline score at endpoint on the ADHD-RS-IV.
Study identification
- NCT ID
- NCT00997984
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 340 participants
Conditions and interventions
Conditions
Interventions
- extended-release guanfacine hydrochloride (SPD503) Drug
- placebo Drug
- extended-release guanfacine hydrochloride Drug
Drug
Eligibility (public fields only)
- Age range
- 6 Years to 12 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 17, 2009 (Actual)
- Primary completion
- Oct 9, 2010 (Actual)
- Completion
- Oct 9, 2010 (Actual)
- Last update posted
- Jun 8, 2021
2009 – 2010
United States locations
- U.S. sites
- 42
- U.S. states
- 24
- U.S. cities
- 41
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Clinical Study Centers, LLC | Little Rock | Arkansas | 72205 | — |
| Valley Clinical Research, Inc. | El Centro | California | 92243 | — |
| Peninsula Research Associates, Inc. | Rolling Hills Estates | California | 90274 | — |
| Psychiatric centers at San Diego, Feighner Research | San Diego | California | 92108 | — |
| Elite Clinical Trials, Inc. | Wildomar | California | 92595 | — |
| Florida Clinical Research Center, LLC | Bradenton | Florida | 34208 | — |
| Sarkis Clinical Trials | Gainesville | Florida | 32607 | — |
| Clinical Neuroscience Solutions, Inc. | Jacksonville | Florida | 32216 | — |
| Florida Clinical Research Center, LLC | Maitland | Florida | 32751 | — |
| Clinical Neuroscience Solutions, Inc. | Orlando | Florida | 32806 | — |
| Janus Centerfor Psychiatric Research | West Palm Beach | Florida | 33407 | — |
| Atlanta Center for Medical Research | Atlanta | Georgia | 30308 | — |
| Northwest Clincial Research Group | Marietta | Georgia | 30060 | — |
| Mountain West Clinical Trials | Boise | Idaho | 83704 | — |
| University of Illinois Chicago | Chicago | Illinois | 60608 | — |
| American Medical research, Inc. | Oak Brook | Illinois | 60523 | — |
| Goldpoint Clinical Research, LLC | Indianapolis | Indiana | 46260 | — |
| Clinco | Terre Haute | Indiana | 47802 | — |
| Psychiatric Associates | Overland Park | Kansas | 66211 | — |
| Vince and Associates Clinical Research | Overland Park | Kansas | 66212 | — |
| Four Rivers Clinical Research, Inc. | Paducah | Kentucky | 42003 | — |
| Louisiana Research Associates, Inc. | New Orleans | Louisiana | 70114 | — |
| Marc Hertzman, M.D., P.C. | Rockville | Maryland | 20852 | — |
| Richester Center for Behavioral Medicine | Rochester Hills | Michigan | 48307 | — |
| Midwest research Group | Saint Charles | Missouri | 63301 | — |
| Center for Psychiatry and Behavioral Medicine, Inc. | Las Vegas | Nevada | 89128 | — |
| Children's Specialized Hospital | Toms River | New Jersey | 08755 | — |
| Innovis Health | Fargo | North Dakota | 58104 | — |
| IPS Research Company | Oklahoma City | Oklahoma | 73103 | — |
| CRI Worldwide, LLC | Philadelphia | Pennsylvania | 19139 | — |
| Western Psychiatric Institute and Clinic | Pittsburgh | Pennsylvania | 15213 | — |
| Rhode Island Hospital | Providence | Rhode Island | 02903 | — |
| Clinical Neuroscience Solutions, Inc. | Memphis | Tennessee | 38119 | — |
| FutureSearch Clinical Trials | Austin | Texas | 78756 | — |
| Claghorn-Lesem research Clinic | Houston | Texas | 77008 | — |
| R/D Clinical Research, Inc. | Lake Jackson | Texas | 77566 | — |
| Western Clinical Investigations | Lubbock | Texas | 79423 | — |
| Cerebral Research, LLC | San Antonio | Texas | 78247 | — |
| Vermont Clinical Study Center | Burlington | Vermont | 05401 | — |
| NeuroScience Inc | Herndon | Virginia | 20170 | — |
| Alliance Research Group, LLC | Richmond | Virginia | 23230 | — |
| Northwest Clinical Research Center | Bellevue | Washington | 98007 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 4 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00997984, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 8, 2021 · Synced Oct 22, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00997984 live on ClinicalTrials.gov.