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ADHDPhase 3NCT02168127

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

A Phase 3 study testing Drug: PRC-063 and PRC-063 in people with ADHD, run by Rhodes Pharmaceuticals, L.P. at 35 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
ADHD
What is being tested?
Drug: PRC-063 and PRC-063
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
360 participants
Where
35 sitesin 2 countries
Study dates
May 2014to Jun 2015
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

None listed.

Who cannot join

  • • 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).
Show all 13Show fewer
  • 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.

Trial locations and contacts

35 sites in 2 countries.

35 sites in 2 countries

United States30 sites

  • FutureSearch Clinical Trials, L.P.

    Austin, Texas, 78731

  • Advanced Clinical Research

    Boise, Idaho, 83642

  • Florida Clinical Research Center

    Bradenton, Florida, 34201

  • University of Cincinnati

    Cincinnati, Ohio, 45219

  • Ericksen Research

    Clinton, Utah, 84015

  • FutureSearch Trials of Dallas, L.P.

    Dallas, Texas, 75231

  • Northwest Clinical Research Center

    Friday Harbor, Washington, 98007

  • Sarkis Clinical Research

    Gainesville, Florida, 32607

  • Sarkis Clinical Trials

    Gainesville, Florida, 32607

  • NeuroScience

    Herndon, Virginia, 20170

  • Red Oak Psychiatry Associates

    Houston, Texas, 77090

  • Houston Clinical Trials

    Houston, Texas, 77098

  • CNS Healthcare Jacksonville

    Jacksonville, Florida, 32256

  • Eastside Therapeutic Resource

    Kirkland, Washington, 98033

  • Center for Psychiatry and Behavioral Medicine Inc.

    Las Vegas, Nevada, 89128

  • UCLA

    Los Angeles, California, 90095

  • Westex Clinical Investigations

    Lubbock, Texas, 79423

  • Florida Clinical Research Center

    Maitlin, Florida, 32751

  • Clinical Neuroscience Solutions Inc.

    Memphis, Tennessee, 38105

  • Synergy Clinical Research

    National City, California, 91950

  • Medical Research Network

    New York, New York, 10128

  • Newport Beach Clinical Research Associates, Inc.

    Newport Beach, California, 92663

  • IPS Research Company

    Oklahoma City, Oklahoma, 73103

  • Orange County Neuro Phychiatry Research Centre

    Orange, California, 92868

  • Clinical Neuroscience Solutions

    Orlando, Florida, 32806

  • Oregon Center for Clinical Investigation

    Portland, Oregon, 92714

  • Wake Research Associates

    Raleigh, North Carolina, 27612

  • Oregon Center for Clinical Investigation

    Salem, Oregon, 97301

  • Physiciatric and Behavioral Solutions

    Salt Lake City, Utah, 84105

  • Woodstock Research Center at Neuropsychiatric Associates

    Woodstock, Vermont, 05091

Other trials in United States

Canada5 sites

  • Doctors Jackiewicz Professional Medical Corporation

    Niagara Falls, Ontario, L2E 6A4

  • Dr. Judy van Stralen

    Ottawa, Ontario, K2G 1W2

  • Diex Research Sherbrooke Inc.

    Sherbrooke, Quebec, J1H 1Z1

  • Dr. Margaret Weiss

    Vancouver, British Columbia, V7V 3R8

  • The Kids Clinic

    Whitby, Ontario, L1N 2L1

Other trials in Canada

About this study

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

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.

Read the 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.

Conditions
ADHD
Being tested
Drug: PRC-063, PRC-063
Medical subject headings
Attention Deficit Disorder with Hyperactivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Drug: PRC-063Drug

    Also called Methylphenidate

    Methylphenidate Hydrochloride Extended-Release Capsules

  • PRC-063Drug

    Also called Methylphenidate

    Methylphenidate Hydrochloride Extended-Release Capsules

Study groups in NCT02168127
Study groupRoleWhat they receive
Active drug groupExperimentalPRC-063 - Active methylphenidate hydrochloride extended-release capsules drug group
Receives: Drug: Drug: PRC-063; Drug: PRC-063

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. occurrence of treatment-emergent adverse events

    Measured: Within 6 months

Secondary outcomes (1)

  1. Clinician-administered ADHD-5-Rating Scale

    Measured: Within 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jun 2014 (estimated)
  2. Study startMay 2014
  3. Primary completionMay 2015
  4. Study completionJun 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
360 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02168127
Sponsor's protocol ID
063-012
Status last verified
Jul 2015
First submitted
14 Jun 2014
Last updated
8 Jul 2015
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 34714112

  • 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.

    PubMed 34637343

  • 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.

    PubMed 34057707

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Drug: PRC-063 and PRC-063 in people with ADHD, run by Rhodes Pharmaceuticals, L.P. at 35 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 35 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

occurrence of treatment-emergent adverse events (time frame: Within 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02168127, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2015.

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