Long-Term Safety of PRC-063 in Adolescents and Adults With ADHD

Completed · Phase 3

Conditions studied: ADHD

In brief

The purpose of this six month, open-label study is to evaluate the long-term safety and efficacy of PRC-063 in adults and adolescents with ADHD.

Key facts

Study ID

NCT02168127

Run by

Rhodes Pharmaceuticals, L.P.

People needed

360

Starts

2014-05-01

Expected to finish

2015-06-01

Last updated by the study team

2015-07-08

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• • Having met any exclusion criteria for Study 063-009 or 063-010.
• Having been diagnosed during Study 063-009 or 063-010 with strokes, epilepsy, migraine headaches (greater than 1 instance every two months), glaucoma, thyrotoxicosis, tachyarrhythmias or severe angina pectoris or have serious or unstable medical illness. Subjects with controlled or stable asthma or diabetes will be permitted.
• Elevated blood pressure, defined as any values above 89 diastolic or 139 systolic, as assessed at Visit 6 of Study 063-009 or 063-010.
• Clinically significant ECG abnormalities, as assessed at Visit 6 of Study 063-009 or 063-010 (data will not be available at the time of entry).
• Clinically significant laboratory abnormalities, as assessed at Visit 6 of Study 063-009 or 063-010 (data will not be available at the time of entry).
• Currently receiving guanethidine, pressor agents, MAO inhibitors, coumarin anticoagulants, anticonvulsants (e.g. phenobarbital, phenytoin, primidone), phenylbutazone, tricyclic antidepressants (e.g. imipramine, desipramine), selective serotonin reuptake inhibitors (SSRIs) or herbal remedies (unless on a stable dose for 4 weeks).
• If the Investigator judges that continued treatment with PRC-063 is not in the subject's best interest.
• Subjects who are currently considered a suicide risk by the investigator.
• Having been diagnosed during Study 063-009 or 063-010 with schizophrenia, schizoaffective disorder, primary affective disorder, schizotypal personality, major depression, bipolar disorder, generalized anxiety, borderline personality disorder, antisocial personality or another unstable psychiatric condition requiring treatment.
• Having been diagnosed during Study 063-009 or 063-010 with physiological dependence (excluding nicotine) on narcotic analgesics or other psychoactive drugs (including barbiturates, opiates, cocaine, cannabinoids, amphetamines and benzodiazepines).
• Excessive consumption of alcohol occurring during Study 063-009 or 063-010 (consumes alcohol in quantities greater than 15 drinks per week on average; 1 drink is defined as 360 mL/12 oz. of beer, 120 mL/4 oz. of wine, or 30 mL/1 oz. of hard liquor).
• Currently (or within 30 days before the planned start of treatment) receiving an investigational drug or using an experimental medical device, other than PRC-063.
• Homeless.

Where it is running

• UCLA — Los Angeles, California, United States
• Synergy Clinical Research — National City, California, United States
• Newport Beach Clinical Research Associates, Inc. — Newport Beach, California, United States
• Orange County Neuro Phychiatry Research Centre — Orange, California, United States
• Florida Clinical Research Center — Bradenton, Florida, United States
• Sarkis Clinical Research — Gainesville, Florida, United States
• Sarkis Clinical Trials — Gainesville, Florida, United States
• CNS Healthcare Jacksonville — Jacksonville, Florida, United States
• Florida Clinical Research Center — Maitlin, Florida, United States
• Clinical Neuroscience Solutions — Orlando, Florida, United States
• Advanced Clinical Research — Boise, Idaho, United States
• Center for Psychiatry and Behavioral Medicine Inc. — Las Vegas, Nevada, United States
• Medical Research Network — New York, New York, United States
• Wake Research Associates — Raleigh, North Carolina, United States
• University of Cincinnati — Cincinnati, Ohio, United States
• IPS Research Company — Oklahoma City, Oklahoma, United States
• Oregon Center for Clinical Investigation — Portland, Oregon, United States
• Oregon Center for Clinical Investigation — Salem, Oregon, United States
• Clinical Neuroscience Solutions Inc. — Memphis, Tennessee, United States
• FutureSearch Clinical Trials, L.P. — Austin, Texas, United States
• FutureSearch Trials of Dallas, L.P. — Dallas, Texas, United States
• Red Oak Psychiatry Associates — Houston, Texas, United States
• Houston Clinical Trials — Houston, Texas, United States
• Westex Clinical Investigations — Lubbock, Texas, United States
• Ericksen Research — Clinton, Utah, United States

Full record on ClinicalTrials.gov

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