scholarly journals Single-arm, open-label, multicentre first in human study to evaluate the safety and performance of dural sealant patch in reducing CSF leakage following elective cranial surgery: the ENCASE trial

BMJ Open ◽  
2021 ◽  
Vol 11 (7) ◽  
pp. e049098
Author(s):  
Tristan Van Doormaal ◽  
Menno R Germans ◽  
Mariska Sie ◽  
Bart Brouwers ◽  
Andrew Carlson ◽  
...  
Keyword(s):  
Adverse Events ◽  
Primary Endpoint ◽  
User Satisfaction ◽  
Neurosurgical Procedures ◽  
Open Label ◽  
Cranial Surgery ◽  
Dural Closure ◽  
Handling Characteristics ◽  
Csf Leakage ◽  
And Performance

ObjectiveThe dural sealant patch (DSP) is designed for watertight dural closure after cranial surgery. The goal of this study is to assess, for the first time, safety and performance of the DSP as a means of reducing cerebrospinal fluid (CSF) leakage in patients undergoing elective cranial intradural surgery with a dural closure procedure.DesignFirst in human, open-label, single-arm, multicentre study with 360-day (12 months) follow-up.SettingThree large tertiary reference neurosurgical centres, two in the Netherlands and one in Switzerland.ParticipantsForty patients undergoing elective cranial neurosurgical procedures, stratified into 34 supratentorial and six infratentorial trepanations.InterventionEach patient received one DSP after cranial surgery and closure of the dura mater with sutures.Outcome measuresPrimary composite endpoint was occurrence of one of the following events: postoperative percutaneous CSF leakage, intraoperative leakage at 20 cm H2O positive end-expiratory pressure or postoperative wound infection. Overall success was defined as achieving the primary endpoint in no more than two patients. Secondary endpoints were device-related serious adverse events or adverse events (AEs), pseudomeningocele and thickness of dura+DSP. Additional endpoints were reoperation in 30 days and user satisfaction.ResultsNo patients met the primary endpoint. No device-related (serious) AEs were observed. There were two incidences of self-limiting pseudomeningocele as confirmed on MRI. Thickness of dura and DSP were (mean±SD) 3.5 mm±2.0 at day 7 and 2.1 mm±1.2 at day 90. No patients were reoperated within 30 days. Users reported a satisfactory design and intuitive application.ConclusionsDSP, later officially named Liqoseal, is a safe and potentially efficacious device for reducing CSF leakage after intracranial surgery, with favourable clinical handling characteristics. A randomised controlled trial is needed to assess Liqoseal efficacy against the best current practice for reducing postoperative CSF leakage.Trial registration numberNCT03566602.

scholarly journals Single-Arm, Open-Label, Multicenter Study to Evaluate the Safety and Performance of Dura Sealant Patch in Reducing Cerebrospinal Fluid Leakage Following Elective Cranial Surgery: The ENCASE Trial Study Protocol

Neurosurgery ◽  
2019 ◽  
Author(s):  
Tristan P C van Doormaal ◽  
Menno R Germans ◽  
Mariska Sie ◽  
Bart Brouwers ◽  
Jorn Fierstra ◽  
...  
Keyword(s):  
Cerebrospinal Fluid ◽  
Primary Endpoint ◽  
Multicenter Study ◽  
Controlled Trial ◽  
Cerebrospinal Fluid Leakage ◽  
Open Label ◽  
Cranial Surgery ◽  
Dural Closure ◽  
Csf Leakage ◽  
And Performance

Abstract BACKGROUND Cerebrospinal fluid (CSF) leakage is one of the most common neurosurgical complications, occurring in 4% to 32% of surgical cases, with a higher incidence in complicated skull base surgery, intradural spine surgery, and the surgery of the posterior fossa. Our group developed a Dural Sealant Patch (DSP) for watertight dural closure after cranial surgery. OBJECTIVE To clinically study for the first time the safety and performance of the DSP as a means of reducing CSF leakage in patients undergoing elective cranial intradural surgery with a dural closure procedure. METHODS We will conduct an open-label, single-arm, multicenter study with a 360 d (12 mo) follow-up. A total of 40 patients will be enrolled at 3 sites. The primary endpoint is a combination of occurrences of one of the following events: postoperative percutaneous CSF leakage, intraoperative leakage at 20 cm H2O, or postoperative wound infection. The secondary endpoints are pseudomeningocele and thickness of dura + DSP. EXPECTED OUTCOMES Not more than 3 patients will meet the primary endpoint suggesting safety and efficacy. DISCUSSION As a next step, a randomized controlled trial against the best current practice will follow to evaluate if DSP reduces CSF leakage while its safety is noninferior.

scholarly journals Carfilzomib Thalidomide and Dexamethasone Is Safe and Effective in the Treatment of Relapsed/Refractory Multiple Myeloma: An Open Label Phase II Australasian Leukaemia and Lymphoma Group (ALLG) MM 018/ Asian Myeloma Network (AMN) 002 Study

Blood ◽  
2020 ◽  
Vol 136 (Supplement 1) ◽  
pp. 39-40
Author(s):  
Hang Quach ◽  
Simon J Harrison ◽  
Je-Jung Lee ◽  
Nichloas Murphy ◽  
Jae Hoon Lee ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Adverse Events ◽  
Board Of Directors ◽  
Phase Ii ◽  
Primary Endpoint ◽  
Research Funding ◽  
Open Label ◽  
Advisory Committees ◽  
Open Label Phase ◽  
Grade 3

Background: The combination of carfilzomib with immunomodulatory drugs (IMiDs) and dexamethasone is active in multiple myeloma (MM). Carfilzomib, thalidomide, and dexamethasone (KTd) has been studied in upfront MM treatment but has not been studied in the setting of relapsed/refractory myeloma (RRMM). The ALLG MM018/ AMN002 is an open-label phase II study of KTd in patients with RRMM. This study was conducted across 16 sites across Australia, New-Zealand, Singapore, South Korea and Taiwan. Method: Patients with RRMM with 1-3 prior lines of treatment were given carfilzomib [K: 20mg/m2 IV cycle 1 days 1 and 2, 56mg/m2 (36mg/m2 for patients age ≥75 years) from cycle 1 day 8 onwards], thalidomide (T: 100mg po nocte) and dexamethasone [dex: 40mg (20mg for patients age ≥75 years) po weekly], in a 28-day cycle. After 12 cycles, T was omitted, and K was given on days 1,2,15,16 and dex days 1,15 every 28-day cycles for a further six cycles. The primary endpoint was PFS. Secondary endpoints were ORR, overall survival, adverse events, and quality of life (QoL). The study had an 80% power to detect a ≥70% PFS at 6.5 months compared to historical ≤50% PFS at 6.5 months expected with Td (Kropff, M. et al. Haematologica 2012), at a significance level of 0.05. Results: This study has completed accrual. Eighty-three patients [median age of 66 years (42-85)] were enrolled with a median follow up of 15.9 (0.9-26) months. ORR rates were 86.4% (≥VGPR 70.2%). Median PFS was 20m (95% CI 15.9-26m). PFS at 6.5 months was 76.2% (95% CI 73.6-84.9%). Median OS has not been reached, and was 75% at 20 months. The most common grade ≥3/4 AEs were peripheral neuropathy (16%), upper respiratory tract infections (12%), dyspnoea (14%), and hypertension (10%). Grade ≥3/4 cardiac AEs occurred in 6%. The median carfilzomib dose that was delivered was 70.7% (32.8-92.6%) of the target dose. Thus far, 41% of patients have completed the intended 18 cycles of treatment. 21% of patients ceased therapy early. The most common reason for early treatment cessation was disease progression (30%) and adverse events (15%). Fifteen patients (18%) have died, 11 were due to MM, two from infection, one from an ischaemic cardiac event, and one from a traffic accident. QoL, as measured by the EQ-5D-5L instrument, remained stable throughout treatment. Conclusion: The ALLG MM018/AMN 002 study has met its primary endpoint. The KTd schedule as outlined in this study is efficacious in patients with RRMM, resulting in a prolonged PFS and a safety profile in line with previous reports for each of carfilzomib and thalidomide. KTd is an active option in jurisdictions where the cost of other IMiDs prohibits regulatory funding. Comparisons of efficacy and adverse events between the Caucasian and Asian populations will be presented at the meeting. Disclosures Quach: Celgene: Consultancy, Honoraria, Research Funding; GlaxoSmithKline: Consultancy, Honoraria, Research Funding; Amgen: Consultancy, Honoraria, Research Funding; Glaxo Kline Smith: Consultancy, Research Funding; Karyopharm: Consultancy, Honoraria, Research Funding; Janssen Cilag: Consultancy, Honoraria; Sanofi: Consultancy, Research Funding. Harrison:Takeda: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; GSK: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; F. Hoffmann-La Roche: Consultancy, Honoraria; Janssen-Cilag: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; AbbVie: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Amgen: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Celgene: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Janssen: Honoraria; CRISPR Therapeutics: Consultancy, Honoraria; BMS: Consultancy, Honoraria; Novartis: Consultancy, Honoraria, Patents & Royalties: wrt panobinostat; Haemalogix: Consultancy. Augustson:Roche: Other: Support of parent study and funding of editorial support. Campbell:Amgen, Novartis, Roche, Janssen, Celgene (BMS): Research Funding; AstraZeneca, Janssen, Roche, Amgen, CSL Behring, Novartis: Consultancy. Soo:Hanmi: Research Funding. Durie:Amgen, Celgene, Johnson & Johnson, and Takeda: Consultancy.

The safety and effectiveness of a dural sealant system for use with nonautologous duraplasty materials

2010 ◽  
Vol 112 (2) ◽  
pp. 428-433 ◽  
Author(s):  
Jason S. Weinstein ◽  
Kenneth C. Liu ◽  
Johnny B. Delashaw ◽  
Kim J. Burchiel ◽  
Harry R. van Loveren ◽  
...  
Keyword(s):  
Polyethylene Glycol ◽  
Adverse Events ◽  
Surgical Site Infections ◽  
Study Group ◽  
Pivotal Trial ◽  
Safety And Efficacy ◽  
Dural Closure ◽  
System A ◽  
Csf Leakage ◽  
Csf Leaks

Object The DuraSeal dural sealant system, a polyethylene glycol hydrogel, has been shown to be safe and effective when used with commercial and autologous duraplasty materials. The authors report on the safety and effectiveness of this sealant when used in conjunction with nonautologous duraplasty materials. Methods In this retrospective, nonrandomized, multicenter study, the safety and efficacy of a dural sealant system was assessed in conjunction with primarily collagen-based nonautologous duraplasty materials in a sample of 66 patients undergoing elective cranial procedures at 3 institutions. This cohort was compared with 50 well-matched patients from the DuraSeal Pivotal Trial who were treated with this sealant system and autologous duraplasty material. Results The key end points of the study were the incidences of CSF leaks, surgical site infections, and meningitis 90 days after surgery. The incidence of postoperative CSF leakage was 7.6% in the study group (retrospective population) and 6.0% in the Pivotal Trial population. The incidence of meningitis was 0% and 4.0% in the retrospective and Pivotal Trial groups, respectively. There were no serious device-related adverse events or unanticipated adverse device effects noted for either population. Conclusions This study demonstrates that the DuraSeal sealant system is safe and effective when used for watertight dural closure in conjunction with nonautologous duraplasty materials.

scholarly journals A multicenter, prospective, single arm, open label, observational study of sTMS for migraine prevention (ESPOUSE Study)

Cephalalgia ◽  
2018 ◽  
Vol 38 (6) ◽  
pp. 1038-1048 ◽  
Author(s):  
Amaal J Starling ◽  
Stewart J Tepper ◽  
Michael J Marmura ◽  
Ejaz A Shamim ◽  
Matthew S Robbins ◽  
...  
Keyword(s):  
Adverse Events ◽  
Observational Study ◽  
Primary Endpoint ◽  
Medication Use ◽  
Responder Rate ◽  
Migraine Prevention ◽  
Performance Goal ◽  
Open Label ◽  
Data Set ◽  
Headache Diary

Objective To evaluate the efficacy and tolerability of single pulse transcranial magnetic stimulation (sTMS) for the preventive treatment of migraine. Background sTMS was originally developed for the acute treatment of migraine with aura. Open label experience has suggested a preventive benefit. The objective of this trial was to evaluate the efficacy and tolerability of sTMS for migraine prevention. Methods The eNeura SpringTMS Post-Market Observational U.S. Study of Migraine (ESPOUSE) Study was a multicenter, prospective, open label, observational study. From December 2014 to March 2016, patients with migraine (n = 263) were consented to complete a 1-month baseline headache diary followed by 3 months of treatment. The treatment protocol consisted of preventive (four pulses twice daily) and acute (three pulses repeated up to three times for each attack) treatment. Patients reported daily headache status, medication use, and device use with a monthly headache diary. The primary endpoint, mean reduction of headache days compared to baseline, was measured over the 28-day period during weeks 9 to 12. The primary endpoint was compared to a statistically-derived placebo estimate (performance goal). Secondary endpoints included: 50% responder rate, acute headache medication consumption, HIT-6, and mean reduction in total headache days from baseline of any intensity. Results Of a total of 263 consented subjects, 229 completed a baseline diary, and 220 were found to be eligible based on the number of headache days. The device was assigned to 217 subjects (Safety Data Set) and 132 were included in the intention to treat Full Analysis Set. For the primary endpoint, there was a −2.75 ± 0.40 mean reduction of headache days from baseline (9.06 days) compared to the performance goal (−0.63 days) ( p < 0.0001). The 50% responder rate of 46% (95% CI 37%, 56%) was also significantly higher ( p < 0.0001) than the performance goal (20%). There was a reduction of −2.93 (5.24) days of acute medication use, headache impact measured by HIT-6, −3.1 (6.4) ( p < 0.0001), and total headache days of any intensity −3.16 days (5.21) compared to the performance goal (−0.63 days) ( p < 0.0001). The most common adverse events were lightheadedness (3.7%), tingling (3.2%), and tinnitus (3.2%). There were no serious adverse events. Conclusions This open label study suggests that sTMS may be an effective, well-tolerated treatment option for migraine prevention. Trial registration number NCT02357381

scholarly journals Daptomycin Plus Fosfomycin Versus Daptomycin Alone for Methicillin-resistant Staphylococcus aureus Bacteremia and Endocarditis: A Randomized Clinical Trial

2020 ◽  
Author(s):  
Miquel Pujol ◽  
José-María Miró ◽  
Evelyn Shaw ◽  
Jose-María Aguado ◽  
Rafael San-Juan ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Staphylococcus Aureus ◽  
Adverse Events ◽  
Primary Endpoint ◽  
Methicillin Resistant Staphylococcus Aureus ◽  
Statistical Significance ◽  
Treatment Success ◽  
Open Label ◽  
Methicillin Resistant ◽  
Staphylococcus Aureus Bacteremia

Abstract Background We aimed to determine whether daptomycin plus fosfomycin provides higher treatment success than daptomycin alone for methicillin-resistant Staphylococcus aureus (MRSA) bacteremia and endocarditis. Methods A randomized (1:1) phase 3 superiority, open-label, and parallel group clinical trial of adult inpatients with MRSA bacteremia was conducted at 18 Spanish hospitals. Patients were randomly assigned to receive either 10 mg/kg of daptomycin intravenously daily plus 2 g of fosfomycin intravenously every 6 hours, or 10 mg/kg of daptomycin intravenously daily. Primary endpoint was treatment success 6 weeks after the end of therapy. Results Of 167 patients randomized, 155 completed the trial and were assessed for the primary endpoint. Treatment success at 6 weeks after the end of therapy was achieved in 40 of 74 patients who received daptomycin plus fosfomycin and in 34 of 81 patients who were given daptomycin alone (54.1% vs 42.0%; relative risk, 1.29 [95% confidence interval, .93–1.8]; P = .135). At 6 weeks, daptomycin plus fosfomycin was associated with lower microbiologic failure (0 vs 9 patients; P = .003) and lower complicated bacteremia (16.2% vs 32.1%; P = .022). Adverse events leading to treatment discontinuation occurred in 13 of 74 patients (17.6%) receiving daptomycin plus fosfomycin, and in 4 of 81 patients (4.9%) receiving daptomycin alone (P = .018). Conclusions Daptomycin plus fosfomycin provided 12% higher rate of treatment success than daptomycin alone, but this difference did not reach statistical significance. This antibiotic combination prevented microbiological failure and complicated bacteremia, but it was more often associated with adverse events. Clinical Trials Registration NCT01898338.

scholarly journals Preliminary results of an adaptive randomized open-label controlled study on the efficacy and safety of enisamium iodide for outpatient treatment of the COVID-19 infection

2021 ◽  
Vol 5 (11) ◽  
pp. 705-711
Author(s):  
N.Yu. Pshenichnaya ◽  
◽  
K.V. Zhdanov ◽  
Keyword(s):  
Respiratory Failure ◽  
Adverse Events ◽  
Primary Endpoint ◽  
Outpatient Treatment ◽  
Comparison Group ◽  
Controlled Study ◽  
Study Group ◽  
Efficacy And Safety ◽  
Open Label ◽  
Iodide Film

Aim: to assess the efficacy and safety of enisamium iodide (film-coated tablets, 250 mg) for outpatient treatment of moderate-to-severe COVID-19 infection. Patients and Methods: this adaptive, randomized, open-label controlled study on the efficacy and safety of enisamium iodide enrolled 194 patients. The study group included 97 patients, and the comparison group included 97 patients. Comparison group patients received standard therapy. Study group patients received orally 500 mg of enisamium iodide three times daily for seven days. In addition, pathogenic and symptomatic treatment was prescribed. The first component of the primary endpoint was composite efficiency parameter. The second component of the primary endpoint was the proportion of patients with respiratory failure. Registration of deaths, adverse events and serious adverse events was carried out by standard methods. Results: cohort enrollment into part 1 of the study and treatment of all patients were completed. The mean time of the relief of major COVID-19 symptoms (primary combination endpoint) and differences between the study and comparison groups (8 days and 9 days, respectively, p=0.028) were revealed. The rate of respiratory failure in the study group and comparison group was: 4 (4,12%) versus 8 (8,25%) cases respectively. In addition, the effect of this drug on mortality in the groups was compared (one death in the study group and five deaths in the comparison group). The statistical reliability of these differences will be determined during part 2 of this study that started in September 2021. Conclusions: the efficacy and safety of enisamium iodide (film-coated tablets, 250 mg) for the COVID-19 were evaluated. A significant reduction in the time to clinical recovery (by one day) was reported in patients who received enisamium iodide. In addition, the rate of severe respiratory failure and associated mortality also tends to reduce after therapy that includes enisamium iodide. KEYWORDS: enisamium iodide, antivirals, etiopathogenic treatment, SARS-CoV-2, COVID-19, viral lung damage, pneumonia, randomized controlled study, adaptive study, open-label study. FOR CITATION: N.Yu. Pshenichnaya, Zhdanov K.V. Preliminary results of an adaptive randomized open-label controlled study on the efficacy and safety of enisamium iodide for outpatient treatment of the COVID-19 infection. Russian Medical Inquiry. 2021;5(11):705–711 (in Russ.). DOI: 10.32364/2587-6821-2021-5-11-705-711.

scholarly journals Initial Clinical Experience with a New Complex-Shaped Detachable Platinum Coil System for the Treatment of Intracranial Cerebral Aneurysms

2006 ◽  
Vol 12 (2) ◽  
pp. 123-130 ◽  
Author(s):  
R.T. Higashida ◽  
C. Cognard ◽  
S. Bracard
Keyword(s):  
Adverse Events ◽  
Cerebral Aneurysms ◽  
Complication Rates ◽  
Open Label ◽  
Detachable Coil ◽  
Serious Adverse Events ◽  
Unruptured Aneurysms ◽  
Coil System ◽  
Aneurysm Occlusion ◽  
And Performance

Endovascular coil occlusion of cerebral aneurysms is increasing as a viable treatment for both ruptured and unruptured aneurysms. The purpose of this study was to evaluate the safety and performance of a newer generation of complex-shaped, geometrically conformable, platinum coils, the TRUFILL DCS Detachable Coil System. From September 2000 to December 2002, 112 patients with 116 aneurysms, either ruptured or unruptured, deemed by an attending neuro-in-terventionalist to be acceptable candidates for endovascular coil embolization, were recruited into an open-label, prospective, multi-center, international registry study from 23 centers in Europe. Information on relevant clinical characteristics, device and procedure performance, and angiographic occlusion data were collected for all patients. An Independent Medical Monitor collected and reviewed information on all device- and procedure-related complications resulting in serious adverse events. Angiographic evaluation immediately following treatment of 116 aneurysms showed a mean ± SD percent of aneurysm occlusion of 93.5% ± 14.2, with 90.2% of aneurysms occluded at least 90%. The desired occlusion was achieved in 94.9% of aneurysms. Success was defined as the ability to obtain ≥ 90% aneurysm occlusion. The proportion achieving greater than 90% occlusion was statistically equivalent (at least as good) to the 80% registry standard. Complication rates were 6.9% device-related and 2.6% procedure-related. Only two complications were categorized as serious adverse events. The TRUFILL DCS coil system provided good to excellent complete occlusion of the aneurysm at initial treatment, as compared to other published studies, and proved effective and safe to use in treating both ruptured and unruptured cerebral aneurysms.

Neurosurgical Applications of Fibrin Glue: Augmentation of Dural Closure in 134 Patients

Neurosurgery ◽  
1990 ◽  
Vol 26 (2) ◽  
pp. 207-210 ◽  
Author(s):  
Christopher I. Shaffrey ◽  
William D. Spotnitz ◽  
Mark E. Shaffrey ◽  
John A. Jane
Keyword(s):  
Success Rate ◽  
Fibrin Glue ◽  
Disease Transmission ◽  
Neurosurgical Procedures ◽  
Clinical Tool ◽  
Dural Closure ◽  
Single Donor ◽  
Csf Leakage ◽  
Group 2 ◽  
Group 1

Abstract In a wide variety of neurosurgical procedures performed on 134 patients over a 3-year period. fibrin glue has been applied as an adjunct to dural closure. Overall success at preventing cerebrospinal fluid (CSF) leakage was 90% (121 of 134, 90% effective). In patients considered to be at high risk for CSF leakage intraoperatively but without pre-established fistulae (Group 1), the success rate was higher (111 of 119, 93% effective). In patients with pre-established CSF fistulae (Group 2), the success rate was lower (10 of 15, 67% effective). As single donor sources of concentrated fibrinogen are now available with reduced risks of blood-borne disease transmission, fibrin glue may be a valuable clinical tool for the neurosurgeon. (Neurosurgery 26:207-210, 1990)

scholarly journals T96. RESULTS OF THE HUMMINGBIRD STUDY A MULTICENTRE, PRAGMATIC TRIAL OF A DIGITAL MEDICINE SYSTEM

2020 ◽  
Vol 46 (Supplement_1) ◽  
pp. S267-S268
Author(s):  
Justin Fowler ◽  
Nathan Cope ◽  
Jonathan Knights ◽  
Hui Fang ◽  
Taisa Skubiak ◽  
...  
Keyword(s):  
Adverse Events ◽  
Health Care Professionals ◽  
Treatment Plan ◽  
Pragmatic Trial ◽  
Current Treatment ◽  
First Episode ◽  
Open Label ◽  
Serious Adverse Events ◽  
Digital Medicine ◽  
And Performance

Abstract Background This was a multicentre, 8-week, single-arm, open-label, pragmatic trial to explore the acceptance and performance of using the Digital Medicine System (DMS) with health care professionals (HCPs) and adult subjects with schizophrenia, schizoaffective disorder (SAD), or first episode psychosis (FEP) on an oral atypical antipsychotic (aripiprazole, olanzapine, quetiapine, or risperidone). Methods Subjects received an initial introduction to the DMS, and had HCP visits at screening/baseline, Week 4, Week 8/early termination (ET), and as directed by the HCP for the duration of the subject’s participation in the trial. Safety and tolerability data was collected and evaluated on an ongoing basis, as assessed by the frequency and severity of serious adverse events (SAEs), and device-related non-serious adverse events (AEs). Subjects were monitored on the DMS technology by the HCPs through review of the HCP dashboard data at a minimum of every 2 weeks and to make changes to the current treatment plan and therapy at their discretion. The study initiated in May 2018 and concluded in September 2019. NCT03568500 Results Fifty-five (55) subjects were screened, and forty-three (43) subjects were treated and included in the sample analysis. Subjects enrolled were on average 34.4 years old. There were twenty-eight (28) male and fifteen (15) female subjects in the study. The most common reasons for discontinuation was subject withdrawal of consent (5 subjects, 11.6%), loss to follow-up (4 subjects, 9.3%), and adverse events (4 subjects, 9.3%). The primary endpoint was the proportion of days with good patch coverage during the trial, calculated by the number of days with good patch coverage divided by the total number of trial days for each subject. Over the duration of the study, subjects had 63.4 % (SD = 26.6%) of days with good patch coverage during the trial time. No notable differences were observed across the disease types, with schizophrenic subject 64.3% (SD=20.2%), FEP subject 62.5% (SD = 27.5%), and SAD subject 63.0% (SD = 37.7%). The secondary endpoint was subject adherence, defined as the proportion of detected ingestible events markers (IEM) over the expected during the trial days with good patch coverage. Overall, subjects had a mean of 86.6% (SD = 14.5%) IEMs detected during the good patch coverage days. The proportion of IEM detected by disease type were: FEP 91.0% (SD = 7.4%), schizophrenic 88.9% (SD = 8.1%), and SAD 72.3% (SD=25.7%). There were nine (9) subjects (20.9%) who had eleven (11) AEs during the study, all were non-serious. Out of all the AEs, nine (9) subjects had nine (9) treatment emergent adverse events (TEAE) that were all reported as medical device site irritation, and four (4) subjects discontinued the study due to AEs. Discussion In conclusion, during the 8-week treatment with the DMS, subjects reported good patch coverage 63.4% of the time on average for this pragmatic study. Using the DMS, subjects’ medication adherence reached 86.6% on average when subjects were having good patch coverage. The acceptance and performance of DMS is considered safe and there were no SAEs associated with its use. Funding This study was supported by Otsuka Pharmaceutical Development & Commercialization, Inc.

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