Clinical trial NCT02168127: Long-Term Safety of PRC-063 in Adolescents and Adults With ADHD
Official title: A Six-month, Open-label, Multi-center Study of the Safety and Efficacy of PRC-063 in Adults and Adolescents With ADHD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: ADHD
Lead sponsor: Rhodes Pharmaceuticals, L.P.
Sponsor class: INDUSTRY
Collaborators: name: Purdue Pharma LP
First posted: 2014-06-20
Enrollment: 360
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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 β-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.

Primary outcomes:
measure: occurrence of treatment-emergent adverse events
timeFrame: Within 6 months
Secondary outcomes:
measure: Clinician-administered ADHD-5-Rating Scale
timeFrame: Within 6 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA
state: California
city: National City
country: United States
facility: Synergy Clinical Research
state: California
city: Newport Beach
country: United States
facility: Newport Beach Clinical Research Associates, Inc.
state: California
city: Orange
country: United States
facility: Orange County Neuro Phychiatry Research Centre
state: California
city: Bradenton
country: United States
facility: Florida Clinical Research Center
state: Florida
city: Gainesville
country: United States
facility: Sarkis Clinical Research
state: Florida
city: Gainesville
country: United States
facility: Sarkis Clinical Trials
state: Florida
city: Jacksonville
country: United States
facility: CNS Healthcare Jacksonville
state: Florida
city: Maitlin
country: United States
facility: Florida Clinical Research Center
state: Florida
city: Orlando
country: United States
facility: Clinical Neuroscience Solutions
state: Florida
city: Boise
country: United States
facility: Advanced Clinical Research
state: Idaho
city: Las Vegas
country: United States
facility: Center for Psychiatry and Behavioral Medicine Inc.
state: Nevada
city: New York
country: United States
facility: Medical Research Network
state: New York
city: Raleigh
country: United States
facility: Wake Research Associates
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Oklahoma City
country: United States
facility: IPS Research Company
state: Oklahoma
city: Portland
country: United States
facility: Oregon Center for Clinical Investigation
state: Oregon
city: Salem
country: United States
facility: Oregon Center for Clinical Investigation
state: Oregon
city: Memphis
country: United States
facility: Clinical Neuroscience Solutions Inc.
state: Tennessee
city: Austin
country: United States
facility: FutureSearch Clinical Trials, L.P.
state: Texas
city: Dallas
country: United States
facility: FutureSearch Trials of Dallas, L.P.
state: Texas
city: Houston
country: United States
facility: Red Oak Psychiatry Associates
state: Texas
city: Houston
country: United States
facility: Houston Clinical Trials
state: Texas
city: Lubbock
country: United States
facility: Westex Clinical Investigations
state: Texas
city: Clinton
country: United States
facility: Ericksen Research
state: Utah
city: Salt Lake City
country: United States
facility: Physiciatric and Behavioral Solutions
state: Utah
city: Woodstock
country: United States
facility: Woodstock Research Center at Neuropsychiatric Associates
state: Vermont
city: Herndon
country: United States
facility: NeuroScience
state: Virginia
city: Bellvue
country: United States
facility: Northwest Clinical Research Center
state: Washington
city: Kirkland
country: United States
facility: Eastside Therapeutic Resource
state: Washington
city: Vancouver
country: Canada
facility: Dr. Margaret Weiss
state: British Columbia
city: Niagara Falls
country: Canada
facility: Doctors Jackiewicz Professional Medical Corporation
state: Ontario
city: Ottawa
country: Canada
facility: Dr. Judy van Stralen
state: Ontario
city: Whitby
country: Canada
facility: The Kids Clinic
state: Ontario
city: Sherbrooke
country: Canada
facility: Diex Research Sherbrooke Inc.
state: Quebec
Study officials:
affiliation: Purdue Pharma LP
name: Joseph Reiz
role: STUDY_DIRECTOR
References:
citation: Weiss MD, Surman C, Khullar A, Owens J, He E, Cataldo M, Donnelly G. Effect of a Multilayer, Extended-Release Methylphenidate Formulation (PRC-063) on Sleep in Adolescents with Attention-Deficit/Hyperactivity Disorder: A Randomized, Double-Blind, Fixed-Dose, Placebo-Controlled Trial Followed by a 6-Month Open-Label Follow-Up. J Child Adolesc Psychopharmacol. 2021 Nov;31(9):623-630. doi: 10.1089/cap.2021.0087. Epub 2021 Oct 28.
citation: Weiss MD, Cutler AJ, Kollins SH, Donnelly GAE. Efficacy and Safety of a Long-Acting Multilayer-Release Methylphenidate Formulation (PRC-063) in the Treatment of Adolescent Attention-Deficit/Hyperactivity Disorder: A Randomized, Double-Blind Clinical Trial with a 6-Month Open-Label Extension. J Child Adolesc Psychopharmacol. 2021 Nov;31(9):610-622. doi: 10.1089/cap.2021.0034. Epub 2021 Oct 8.
citation: Weiss MD, Surman C, Khullar A, He E, Cataldo M, Donnelly G. Effect of a Multi-Layer, Extended-Release Methylphenidate Formulation (PRC-063) on Sleep in Adults with ADHD: A Randomized, Double-Blind, Forced-Dose, Placebo-Controlled Trial Followed by a 6-month Open-Label Extension. CNS Drugs. 2021 Jun;35(6):667-679. doi: 10.1007/s40263-021-00814-z. Epub 2021 May 31.