Cytochrome P450 CYP2D6 Enzyme DeficiencyNCT02428660
Drug & Gene Interaction Risk Analysis With & Without Genetic Testing Among Patients Undergoing MTM
A study testing Pharmacogenetic testing, Software-based drug & gene interaction risk analysis and MTM in people with Cytochrome P450 CYP2D6 Enzyme Deficiency and Poor Metabolizer Due to Cytochrome P450 CYP2D6 Variant, run by Genelex Corporation at 1 site in United States.
Trial summary
This randomized controlled trial will evaluate whether the use of pharmacogenetic testing through a Medication Therapy Management (MTM) program has a beneficial impact on drug therapy problems. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Cytochrome P450 CYP2D6 Enzyme Deficiency, Poor Metabolizer Due to Cytochrome P450 CYP2D6 Variant, Ultrarapid Metabolizer Due to Cytochrome P450 CYP2D6 Variant
- What is being tested?
- Pharmacogenetic testing, Software-based drug & gene interaction risk analysis and MTM
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 341 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2015to Feb 2017
- Phase
- Interventional
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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Aged 65 or over and enrolled in a Medicare Part-D Prescription Drug Plan.
- Currently prescribed ≥6 chronic medications.
- Have ≥3 chronic disease states including osteoarthritis, rheumatoid arthritis, heart failure, diabetes, dyslipidemia, hypertension, asthma, chronic obstructive pulmonary disease, atrial fibrillation, and coronary artery disease.
- Participant incurred the Medicare-mandated dollar amount in medication-related costs in the previous quarter.
Who cannot join
- Inability to perform MTM encounter due to living situation (e.g. patient is enrolled in hospice, or is in long term care facility).
- Patient is unable to perform MTM encounter due to metal health barriers as described by Brief Interview for Mental Status (BIMS) score of <13 points.
- Patient identifies themselves as being unable to perform the oral swab function of the genetic test.
- Patient had a known MTM session within the preceding 12 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Medication Therapy Management Combined With Drug and Gene Interaction Software and Cytochrome DNA Testing Among a Population of Polypharmacy Medicare Patients
This randomized controlled trial will evaluate whether the use of pharmacogenetic testing through a Medication Therapy Management (MTM) program has a beneficial impact on drug therapy problems. More specifically, cytochrome DNA testing, which provides information with regards to participant specific metabolism of medications, will be used in the evaluation of participant medication regimens. The overall aim of the project is to evaluate if the addition of genetic CYP testing to a standardized MTM Program provides increased clinical value. To answer this question, the investigators will look at the drug therapy problems (DTPs) identified by the genetic test compared to those DTPs discovered without the test.
Read the detailed description
All study participants will receive a Comprehensive Medication Review (CMR). One third will have standard MTM conducted. Another third of the participants will be randomized to MTM plus drug interaction risk analysis via YouScript software. The remaining third will be randomized to MTM along with drug interaction risk analysis via YouScript software and genetic testing. The software will identify polypharmacy patients who may benefit from pharmacogenetic testing based on their current medication regimen. Results of the testing will be mailed to both the participant and their provider. Participants who undergo testing will also receive a follow-up phone call. All participants, including those who receive MTM alone, will receive a contact 3 months later to assess quality of life.
- Conditions
- Cytochrome P450 CYP2D6 Enzyme Deficiency, Poor Metabolizer Due to Cytochrome P450 CYP2D6 Variant, Ultrarapid Metabolizer Due to Cytochrome P450 CYP2D6 Variant, Extensive Metabolizer Due to Cytochrome P450 CYP2D6 Variant, Cytochrome P450 CYP2C9 Enzyme Deficiency, Cytochrome P450 CYP2C19 Enzyme Deficiency
- Being tested
- Pharmacogenetic testing, Software-based drug & gene interaction risk analysis, MTM
- Keywords
- Polypharmacy, Chronic conditions, Drug Therapy Problems, Medication Therapy Management, Medication-Related Problems, CYP3A4, CYP3A5, Drug-drug interactions, Drug-gene interactions, Drug-drug-gene interactions, Adverse Drug Reactions, Activities of Daily Living
- Medical subject headings
- Drug Metabolism, Poor, CYP2D6-Related, Drug Metabolism, Poor, CYP2C19-Related, Chronic Disease, Drug-Related Side Effects and Adverse Reactions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacogenetic testingGenetic
Also called YouScript(R) Personalized Prescribing System
Genetic testing for 2D6, 2C9, 2C19, 3A4, 3A5 polymorphisms
Software-based drug & gene interaction risk analysisOther
By assessing a patient's medication list along with the frequencies of variant phenotypes in the population, YouScript is able to identify whether a patient might be at risk for an adverse drug event and suggest when testing might be appropriate.
MTMOther
Medication Therapy Management
| Study group | Role | What they receive |
|---|---|---|
| Controls (no analysis or testing) | Other | MTM alone (i.e. Treatment As Usual) Receives: Other: MTM |
| Group 1 | Experimental | MTM + software-based drug \& gene interaction risk analysis + pharmacogenetic testing Receives: Genetic: Pharmacogenetic testing; Other: Software-based drug & gene interaction risk analysis; Other: MTM |
| Group 2 | Active comparator | MTM + software-based drug \& gene interaction risk analysis only Receives: Other: Software-based drug & gene interaction risk analysis; Other: MTM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Drug Therapy Problems (DTPs)
Tabulation of the number of drug therapy problems identified by drug \& gene interaction risk analysis, with and without genetic testing.
Measured: Baseline
Secondary outcomes (2)
Number of adverse drug reactions
Tabulation of adverse drug reactions.
Measured: 8 months
Quality of Life
Assessment of quality of life score via SF-12.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2015 (estimated)
- Study startFeb 2015
- Primary completionFeb 2017
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cytochrome P450 CYP2D6 Enzyme DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 341 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genelex Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jonathan W Magness, PharmD, Principal investigator, VRx Pharmacy Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02428660
- Sponsor's protocol ID
- Genelex 2014-02
- Status last verified
- Feb 2017
- First submitted
- 21 Apr 2015
- Last updated
- 23 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Kim K, Magness JW, Nelson R, Baron V, Brixner DI. Clinical Utility of Pharmacogenetic Testing and a Clinical Decision Support Tool to Enhance the Identification of Drug Therapy Problems Through Medication Therapy Management in Polypharmacy Patients. J Manag Care Spec Pharm. 2018 Dec;24(12):1250-1259. doi: 10.18553/jmcp.2018.24.12.1250.
PubMed 30479202