Outcomes research: Clinical trials in the elderly

Leppik, Ilo E.; Brodie, Martin J.; Sætre, Erik; Rowan, Alison; Ramsay, R. Eugene; Jacobs, Margaret P.

doi:10.1016/j.eplepsyres.2005.07.019

Cited by 32 publications

(17 citation statements)

References 5 publications

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“…Elderly patients frequently use several drugs to treat multiple morbidities (polypharmacy), increasing their risk for clinically important drug interactions (Perucca et al, 2006). In addition, the efficacy of therapies may be compromised by comorbidities (Brodie et al, 2009;Leppik et al, 2006).…”

Section: Discussionmentioning

confidence: 99%

“…Moreover, identifying the presence and types of seizures in older patients, and distinguishing them from other neurological conditions, can be difficult and can predispose to misdiagnosis (Brodie et al, 2009). Recruiting elderly patients for phase III studies is also challenging, since comorbidities (e.g., dementia or diabetes) or physical frailty may interfere with trial participation and affect outcomes (Brodie et al, 2009;Leppik et al, 2006).…”

Section: Introductionmentioning

confidence: 98%

“…Evaluating AEDs in elderly patients has been challenging, and these patients have been underrepresented in clinical studies, partly due to intentional exclusion of patients aged ≥65 years in many studies. Studies that do include older patients are generally small, making safety and efficacy analyses difficult or impossible (Leppik et al, 2006). Moreover, identifying the presence and types of seizures in older patients, and distinguishing them from other neurological conditions, can be difficult and can predispose to misdiagnosis (Brodie et al, 2009).…”

Section: Introductionmentioning

confidence: 99%

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Efficacy and safety of perampanel in the subgroup of elderly patients included in the phase III epilepsy clinical trials

Leppik¹,

Wechsler²,

Williams³

et al. 2015

Epilepsy Research

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Clinical data regarding use of antiepileptic drugs in the elderly are generally scarce. Therefore, a subanalysis of subjects aged ≥ 65 years who participated in the 3 phase III perampanel studies was undertaken to determine efficacy and safety in these patients. Efficacy (change in seizure frequency/28 days and 50% responder rate) in the elderly subgroup was found to be consistent with the adult population. Adverse event rates were also largely similar, with some exceptions. Because risks of falls, dizziness, and fatigue were greater in the elderly, careful titration of perampanel in patients aged ≥ 65 years is suggested, especially at higher doses, where balancing tolerability and clinical response is necessary.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 98%

Section: Introductionmentioning

confidence: 99%

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Efficacy and safety of perampanel in the subgroup of elderly patients included in the phase III epilepsy clinical trials

Leppik¹,

Wechsler²,

Williams³

et al. 2015

Epilepsy Research

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“…These factors include age, race, gender, and psychosocial influences (1,(4)(5)(6)(7)(8)(9). However, considerably less attention has been given to the effects of baseline health history characteristics on trial adherence and many of these studies included predominantly Caucasian participants (10,11). Questions remain about the effect of baseline health history characteristics on trial adherence in diverse population groups.…”

Section: Introductionmentioning

confidence: 99%

Effects of Baseline Comorbidities on Cancer Screening Trial Adherence among Older African American Men

Ford

Havstad

Fields

et al. 2008

Cancer Epidemiology, Biomarkers &Amp; Prevention

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Background: The purpose of this study was to examine the effects of baseline comorbidities on screening adherence in a sample of older African American men (ages z55 years) enrolled in a case management intervention in a cancer screening trial. Methods: Baseline comorbidity data were obtained from 683 African American men who were randomly assigned to a case management intervention group (n = 344) or to a case management control group (n = 339). The effects of comorbidities on the screening adherence rates of each group were then assessed. Results: No statistically significant interactions were found between each health history characteristic and the intervention. Therefore, analyses were not stratified by intervention status. In general, participants with comorbidities were no less likely to adhere to trial screening than participants without comorbidities.

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“…The number of papers in journals addressing clinical trial methodology in individual neurological or psychiatric disorders is limited. [3][4][5] The few present do not adequately address when combined neuropsychiatric issues are present in a single trial. The purpose of this report is to describe Address correspondence to Dr. LaFrance, Rhode Island Hospital, 593 Eddy Street, Potter 3, Neuropsychiatry, Providence, RI 02903; William_LaFrance_Jr@Brown.edu (e-mail).…”

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confidence: 99%

Methodological Issues in Conducting Treatment Trials for Psychological Nonepileptic Seizures

LaFrance

Blum²,

Miller³

et al. 2007

JNP

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A randomized, placebo-controlled trial has yet to be completed in patients with psychological nonepileptic seizures (NES). Treatment publications for NES are limited to class III trials and class IV reports. Little is written on the methodology of treatment trials in NES. The authors describe the procedures and limitations of such a trial to inform future NES treatment trials, based on their prospective, open-label pharmacological, feasibility trial. The authors review the recruitment, enrollment, completion of surveys, compliance, and follow-up of patients with NES. The majority of patients who enrolled, readily completed surveys and took the medication during the trial. Twelve patients were screened, eight enrolled, and six completed the trial. The authors discuss the use of outcomes and the various symptoms scales in the trial. A comprehensive neuropsychiatric initial assessment and assessing cognitive, emotional, behavioral, and psychosocial measures are important for monitoring the outcomes in NES treatment RCTs.Patients with psychological nonepileptic seizures are often severely disabled, refractory to treatment, and frequently are encountered in neurology, psychiatry, and emergency departments. Nonepileptic seizures (NES), also referred to as pseudoseizures, are paroxysmal behaviors which have psychological comorbidities and are unresponsive to treatment with antiepileptic drugs. The phenomenology of NES is well delineated, including a preliminary understanding of risk factors and prognostic features. 1 A number of studies exist on the diagnosis of NES, ictal semiology, comorbid psychiatric diagnoses, and neurological and neuropsychological characteristics of patients with NES. To date, no double-blinded, randomized, placebo-controlled trial has been completed for patients diagnosed with NES.Given the paucity of systematic treatment trials for NES, much less is known about treatments of NES. A review of the literature reveals that only class III and IV studies are available, and no effective treatments have been developed. 2 Patients with NES present unique challenges, given the overlap of neurological and psychiatric presentations. The number of papers in journals addressing clinical trial methodology in individual neurological or psychiatric disorders is limited. [3][4][5] The few present do not adequately address when combined neuropsychiatric issues are present in a single trial. The purpose of this report is to describe Address correspondence to Dr. LaFrance, Rhode Island Hospital, 593 Eddy Street, Potter 3, Neuropsychiatry, Providence, RI 02903; William_LaFrance_Jr@Brown.edu (e-mail). Portions of this paper were presented at a poster session at the NINDS/American Neurological Association Symposium, in Toronto, Ontario, Canada, October 2, 2004. Patients with NES often have comorbid psychiatric conditions, such as major depressive disorder and anxiety disorders, including PTSD, or symptoms of depression, anxiety, and impulsivity seen in characterological disorders. 6 Mood, anxiety, and impulsi...

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Outcomes research: Clinical trials in the elderly

Cited by 32 publications

References 5 publications

Efficacy and safety of perampanel in the subgroup of elderly patients included in the phase III epilepsy clinical trials

Efficacy and safety of perampanel in the subgroup of elderly patients included in the phase III epilepsy clinical trials

Effects of Baseline Comorbidities on Cancer Screening Trial Adherence among Older African American Men

Methodological Issues in Conducting Treatment Trials for Psychological Nonepileptic Seizures

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