EpilepsyPhase 4NCT04967326
Role of Clinical Pharmacists in Epilepsy Management
A Phase 4 study testing Optimizing therapy with antiepileptic drugs (carbamazepine, phenytoin, valproic acid) in people with Epilepsy, run by Gia Dinh People Hospital.
Trial summary
Clinical pharmacists have an important role in inter-professional healthcare collaboration for epilepsy management. However, the pharmacy practices of managing epilepsy are still limited in Vietnam, deterring pharmacists from routine adjustments of antiepileptic drugs, which could decrease the patients' quality of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epilepsy
- What is being tested?
- Optimizing therapy with antiepileptic drugs (carbamazepine, phenytoin, valproic acid)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 141 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2016to 31 Dec 2018
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- were prescribed a monotherapy or polytherapy of phenytoin, carbamazepine, or valproic acid.
- were treated for more than one month.
Who cannot join
- were pregnant or breastfeeding women.
- had a history of alcoholism.
- had liver or renal disease.
- were using drugs known to have an influence on cytochrome P450 enzymes.
About this study
Official title: Role of Clinical Pharmacists in Epilepsy Management at a General Hospital in Vietnam: A Before-and-after Study
Clinical pharmacists have an important role in inter-professional healthcare collaboration for epilepsy management. However, the pharmacy practices of managing epilepsy are still limited in Vietnam, deterring pharmacists from routine adjustments of antiepileptic drugs, which could decrease the patients' quality of life. This study aimed to assess the effectiveness of pharmacist interventions in epilepsy treatment at a Vietnamese general hospital.
Read the detailed description
Phenytoin, carbamazepine, and valproic acid, which are among the first-generation AEDs, are prescribed in many countries around the world, including Vietnam. These agents have complicated pharmacokinetics, which may result in alterations in absorption, distribution, and metabolism. This means that, given the same dose, the serum concentration of each drug may vary between patients. The management of epilepsy, as a result, requires inter-professional collaboration to ensure therapeutic optimization. As healthcare professionals, clinical pharmacists play an important role in epilepsy management, which includes establishing a therapeutic drug monitoring (TDM) protocol, adjusting doses, monitoring ADRs, etc.
However, the clinical pharmacy practices in epilepsy management are quite limited in Vietnam. The treatment gap-the proportion of people with epilepsy who are not adequately treated-still remains very high, especially in rural areas (84.7%), which probably results from discontinuing the treatment or refusing to take medications. This shows a need for pharmacist consultations for patients with epilepsy and their family members, as they may be lack information about AEDs or motivation in controlling potential seizures. In addition, the adjustments of antiepileptic drugs by pharmacists are not routine procedures, nor are monitored for effectiveness in many Vietnamese hospitals. This lack of engagement threatens the patients' safety and decreases their quality of life. To address this issue, certain interventions are needed to enable pharmacists to manage patients with epilepsy more systematically. This study was therefore conducted to evaluate the effectiveness of pharmacist interventions in epilepsy treatment at a general hospital in Vietnam.
- Conditions
- Epilepsy
- Being tested
- Optimizing therapy with antiepileptic drugs (carbamazepine, phenytoin, valproic acid)
- Keywords
- epilepsy, role of pharmacist, adverse drug reaction, antiepileptic drug, Vietnam
- Medical subject headings
- Epilepsy, 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.
Optimizing therapy with antiepileptic drugs (carbamazepine, phenytoin, valproic acid)Drug
| Study group | Role | What they receive |
|---|---|---|
| Patients with epilepsy | Experimental | The therapies of patients with epilepsy were optimized using pharmacists' interventions, including medication consultation, dosage adjustment, medication switching/discontinuation, or combination therapy. Receives: Drug: Optimizing therapy with antiepileptic drugs (carbamazepine, phenytoin, valproic acid) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with two seizures or less
Patients with two seizures or less in a year were categorized as having good control, whereas those who had more were considered to have poor control.
Measured: One year from the start of the study
Secondary outcomes (1)
Number of patients who maintained an optimized concentration of antiepileptic drugs
The targeted therapeutic ranges for carbamazepine, phenytoin, and valproic acid were 4-12 mg/L, 10-20 mg/L, and 50-100 mg/L, respectively.
Measured: One year from the start of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2021
- Study start1 Jan 2016
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
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 EpilepsyStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gia Dinh People Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pham Hong Tham, Gia Dinh People Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04967326
- Sponsor's protocol ID
- 23-2015/CN-HĐĐĐ
- Status last verified
- Jul 2021
- First submitted
- 8 Jul 2021
- Last updated
- 2 Aug 2021
- Results posted
- No
Publications
Pham HT, Tran MH, Nguyen NQ, Tan Vo V, Tran MH. Role of clinical pharmacists in epilepsy management at a general hospital in Vietnam: a before-and-after study. J Pharm Policy Pract. 2021 Dec 20;14(1):109. doi: 10.1186/s40545-021-00394-9.
PubMed 34930487
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Clinical Pharmacists in Epilepsy Management at a General Hospital in Vietnam: A Before-and-after Study
- ClinicalTrials.gov ID
- NCT04967326
- Acronym / sponsor ID
- 23-2015/CN-HĐĐĐ
- Conditions
- Epilepsy
- Keywords
- epilepsy, role of pharmacist, adverse drug reaction, antiepileptic drug, Vietnam
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- Gia Dinh People HospitalUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 19 Jul 2021 (actual)
- 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.
Clinical pharmacists have an important role in inter-professional healthcare collaboration for epilepsy management. However, the pharmacy practices of managing epilepsy are still limited in Vietnam, deterring pharmacists from routine adjustments of antiepileptic drugs, which could decrease the patients' quality of life. This study aimed to assess the effectiveness of pharmacist interventions in epilepsy treatment at a Vietnamese general hospital.
Detailed description
Phenytoin, carbamazepine, and valproic acid, which are among the first-generation AEDs, are prescribed in many countries around the world, including Vietnam. These agents have complicated pharmacokinetics, which may result in alterations in absorption, distribution, and metabolism. This means that, given the same dose, the serum concentration of each drug may vary between patients. The management of epilepsy, as a result, requires inter-professional collaboration to ensure therapeutic optimization. As healthcare professionals, clinical pharmacists play an important role in epilepsy management, which includes establishing a therapeutic drug monitoring (TDM) protocol, adjusting doses, monitoring ADRs, etc.
However, the clinical pharmacy practices in epilepsy management are quite limited in Vietnam. The treatment gap-the proportion of people with epilepsy who are not adequately treated-still remains very high, especially in rural areas (84.7%), which probably results from discontinuing the treatment or refusing to take medications. This shows a need for pharmacist consultations for patients with epilepsy and their family members, as they may be lack information about AEDs or motivation in controlling potential seizures. In addition, the adjustments of antiepileptic drugs by pharmacists are not routine procedures, nor are monitored for effectiveness in many Vietnamese hospitals. This lack of engagement threatens the patients' safety and decreases their quality of life. To address this issue, certain interventions are needed to enable pharmacists to manage patients with epilepsy more systematically. This study was therefore conducted to evaluate the effectiveness of pharmacist interventions in epilepsy treatment at a general hospital in Vietnam.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with epilepsy | Experimental | Drug: Optimizing therapy with antiepileptic drugs (carbamazepine, phenytoin, valproic acid)The therapies of patients with epilepsy were optimized using pharmacists' interventions, including medication consultation, dosage adjustment, medication switching/discontinuation, or combination therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- were prescribed a monotherapy or polytherapy of phenytoin, carbamazepine, or valproic acid.
- were treated for more than one month.
Key exclusion criteria (4 listed)
- were pregnant or breastfeeding women.
- had a history of alcoholism.
- had liver or renal disease.
- were using drugs known to have an influence on cytochrome P450 enzymes.
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 |
|---|---|---|
| Optimizing therapy with antiepileptic drugs (carbamazepine, phenytoin, valproic acid) | Drug | Patients with epilepsy |
Primary outcome
Number of patients with two seizures or less
Time frame: One year from the start of the study
Patients with two seizures or less in a year were categorized as having good control, whereas those who had more were considered to have poor control.
1 secondary outcome
Number of patients who maintained an optimized concentration of antiepileptic drugs
Time frame: One year from the start of the study
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 2 Aug 2021.
- Derived from this study: PubMed 34930487Pham HT, Tran MH, Nguyen NQ, Tan Vo V, Tran MH. Role of clinical pharmacists in epilepsy management at a general hospital in Vietnam: a before-and-after study. J Pharm Policy Pract. 2021 Dec 20;14(1):109. doi: 10.1186/s40545-021-00394-9.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Optimizing therapy with antiepileptic drugs (carbamazepine, phenytoin, valproic acid) in people with Epilepsy, run by Gia Dinh People Hospital.
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 2 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 2 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Number of patients with two seizures or less (time frame: One year from the start of the study). 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 NCT04967326, 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 2 Aug 2021.