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

ADHD Clinical Trial

Official title:

A Six-month, Open-label, Multi-center Study of the Safety and Efficacy of PRC-063 in Adults and Adolescents With ADHD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02168127
• Other study ID #: 063-012
• Status: Completed
• Phase: Phase 3
• First received: June 14, 2014
• Last updated: July 7, 2015
• Start date: May 2014
• Est. completion date: June 2015

Study information

• Verified date: July 2015
• Source: Rhodes Pharmaceuticals, L.P.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Description:

This is an open label, multicenter, phase 3 study to evaluate the safety and efficacy of PRC-063 (methylphenidate hydrochloride controlled-release capsules 25, 35, 45, 55, 70, 85 or 100 mg/day) in the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in adolescent subjects aged ≥12 to <18 years of age and adult subjects aged ≥18 years of age. In order to participate, subjects must have completed Purdue Pharma Study 063-009 or Purdue Pharma Study 063-010. This study will be conducted at approximately 50 centers across the United States and Canada. After giving written informed consent (as well as informed assent for subjects <18 years of age), subjects will be screened to ascertain their suitability for the study according to the inclusion and exclusion criteria. There will be seven monthly efficacy and safety visits during which subjects will be assessed on active, open-label PRC-063. The starting dose will be at the discretion of the Investigator. Dose-adjustment visits may occur weekly to optimize the subject's dose via titration. For adolescent subjects, the maximum dose will be 85 mg/day. For adult subjects, the maximum dose will be 100 mg/day.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 360
• Est. completion date: June 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

Inclusion Criteria: Subjects must satisfy the following criteria to be enrolled in the study as an adolescent:

• Male or non-pregnant, non-nursing female at least 12 years of age and less than 18 years of age.

Subjects must satisfy the following criteria to be enrolled in the study as an adult:

• Male or non-pregnant, non-nursing female at least 18 years of age and meeting the local, legal definition of adult.

All subjects must also satisfy the following criteria to be enrolled in the study:

• Confirmation of ADHD diagnosis made at Visit 1 of Study 063-009 or 063-010 (inattentive, hyperactive/impulsive or combined-type, as defined by the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition based on clinician assessment using multiple informants and a structured interview).

• Female subjects must be one of the following:

• Surgically sterile prior to screening

• Postmenopausal

• if of childbearing potential, abstinent or willing to use a reliable method of contraception, such as oral contraceptive, two barrier methods, a barrier method plus a spermicidal agent.

• Female subjects of Child-Bearing Potential (FOCP) must have a negative serum ß-hCG pregnancy test, as assessed at Visit 6 of Study 063-009 or 063-010 (data will not be available at the time of entry).

• If the subject is an adult, mentally and physically competent to sign an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study. If the subject is an adolescent, mentally and physically competent to sign an informed assent document, in the case of the subject, and an informed consent document, in the case of the parent/guardian, indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.

• Able and willing to comply with the study procedures for the entire length of the study.

Exclusion Criteria:

• • 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.

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• ADHD

Intervention

Drug:
• Drug: PRC-063
Methylphenidate Hydrochloride Extended-Release Capsules
• PRC-063
Methylphenidate Hydrochloride Extended-Release Capsules

Locations

Country	Name	City	State
Canada	Doctors Jackiewicz Professional Medical Corporation	Niagara Falls	Ontario
Canada	Dr. Judy van Stralen	Ottawa	Ontario
Canada	Diex Research Sherbrooke Inc.	Sherbrooke	Quebec
Canada	Dr. Margaret Weiss	Vancouver	British Columbia
Canada	The Kids Clinic	Whitby	Ontario
United States	FutureSearch Clinical Trials, L.P.	Austin	Texas
United States	Northwest Clinical Research Center	Bellvue	Washington
United States	Advanced Clinical Research	Boise	Idaho
United States	Florida Clinical Research Center	Bradenton	Florida
United States	University of Cincinnati	Cincinnati	Ohio
United States	Ericksen Research	Clinton	Utah
United States	FutureSearch Trials of Dallas, L.P.	Dallas	Texas
United States	Sarkis Clinical Research	Gainesville	Florida
United States	Sarkis Clinical Trials	Gainesville	Florida
United States	NeuroScience	Herndon	Virginia
United States	Houston Clinical Trials	Houston	Texas
United States	Red Oak Psychiatry Associates	Houston	Texas
United States	CNS Healthcare Jacksonville	Jacksonville	Florida
United States	Eastside Therapeutic Resource	Kirkland	Washington
United States	Center for Psychiatry and Behavioral Medicine Inc.	Las Vegas	Nevada
United States	UCLA	Los Angeles	California
United States	Westex Clinical Investigations	Lubbock	Texas
United States	Florida Clinical Research Center	Maitlin	Florida
United States	Clinical Neuroscience Solutions Inc.	Memphis	Tennessee
United States	Synergy Clinical Research	National City	California
United States	Medical Research Network	New York	New York
United States	Newport Beach Clinical Research Associates, Inc.	Newport Beach	California
United States	IPS Research Company	Oklahoma City	Oklahoma
United States	Orange County Neuro Phychiatry Research Centre	Orange	California
United States	Clinical Neuroscience Solutions	Orlando	Florida
United States	Oregon Center for Clinical Investigation	Portland	Oregon
United States	Wake Research Associates	Raleigh	North Carolina
United States	Oregon Center for Clinical Investigation	Salem	Oregon
United States	Physiciatric and Behavioral Solutions	Salt Lake City	Utah
United States	Woodstock Research Center at Neuropsychiatric Associates	Woodstock	Vermont

Sponsors (2)

Lead Sponsor	Collaborator
Rhodes Pharmaceuticals, L.P.	Purdue Pharma LP

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	occurrence of treatment-emergent adverse events		Within 6 months	Yes
Secondary	Clinician-administered ADHD-5-Rating Scale		Within 6 months	No