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
- 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 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
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medication Therapy Management Combined With Drug and Gene Interaction Software and Cytochrome DNA Testing Among a Population of Polypharmacy Medicare Patients
- ClinicalTrials.gov ID
- NCT02428660
- Acronym / sponsor ID
- Genelex 2014-02
- 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
- Keywords
- Polypharmacy, Chronic conditions, Drug Therapy Problems, Medication Therapy Management, Medication-Related Problems, CYP3A4, CYP3A5, Drug-drug interactions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 341 participants (actual)
- Lead sponsor
- Genelex CorporationIndustry (pharma, biotech, devices)
- Study start
- Feb 2015 (actual)
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 29 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Controls (no analysis or testing) | Other | Other: MTMMTM alone (i.e. Treatment As Usual) |
| Group 1 | Experimental | Genetic: Pharmacogenetic testing, Other: Software-based drug & gene interaction risk analysis, Other: MTMMTM + software-based drug \& gene interaction risk analysis + pharmacogenetic testing |
| Group 2 | Active comparator | Other: Software-based drug & gene interaction risk analysis, Other: MTMMTM + software-based drug \& gene interaction risk analysis only |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pharmacogenetic testingAlso: YouScript(R) Personalized Prescribing SystemGenetic testing for 2D6, 2C9, 2C19, 3A4, 3A5 polymorphisms | Genetic | Group 1 |
| Software-based drug & gene interaction risk analysisBy 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. | Other | Group 1, Group 2 |
| MTMMedication Therapy Management | Other | Controls (no analysis or testing), Group 1, Group 2 |
Primary outcome
Number of Drug Therapy Problems (DTPs)
Time frame: Baseline
Tabulation of the number of drug therapy problems identified by drug \& gene interaction risk analysis, with and without genetic testing.
2 secondary outcomes
Number of adverse drug reactions
Time frame: 8 months
Quality of Life
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2017.
- Derived from this study: PubMed 30479202Kim 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.
- Demo of YouScript(R) Personalized Prescribing SystemLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan W Magness, PharmD principal investigator
VRx Pharmacy Services
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
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 4 inclusion and 4 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 23 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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.
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?
Number of Drug Therapy Problems (DTPs) (time frame: Baseline). 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 NCT02428660, which also lists 1 linked publication.
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 23 Feb 2017.