Reinhard Hiersemenzel - Academia.edu (original) (raw)

Papers by Reinhard Hiersemenzel

With regard to proving the clinical efficacy of nootropic substances there has been intense metho... more With regard to proving the clinical efficacy of nootropic substances there has been intense methodological discussion since 1975 (Kanowski 1975, 1986; Coper and Kanowski 1976, 1983; Kanowski and Hedde 1986; Comittee for Geriatric Diseases and Asthenias at BGA 1986). Both the selection of target parameters (outcome measures) and definition of diagnoses for inclusion are the subject of current debate, particularly given some of the differences in approach between research in the United States and that in Europe. In the United States, for instance, there has recently been a move to stop the use of traditional performance tests and symptom rating scales as therapeutic outcome measures and to adopt improvements within global clinical diagnostic rating scales instead, for example, a refinement to the Global Deterioration Scale (GDS; Reisberg 1982) as a target criterion (Gamzu 1987). It has been argued that an improvement from, say, GDS stage 4 (moderate impairment of cognitive function) to stage 3 (slight cognitive impairment) would certainly represent a change in elderly patients that is relevant to their daily lives.

Diagnosis and Treatment of Senile Dementia, 1989

The diagnostic label of dementia is not justified in all elderly patients with cognitive decline.... more The diagnostic label of dementia is not justified in all elderly patients with cognitive decline. However, an organic factor of unknown aetiology can also be assumed in patients suffering from a milder decline. Therefore, the term “organic brain syndrome” is quite common, especially in German-speaking countries, to characterize these patients as a diagnostic category [6, 8]. This term covers a broad range of dementing and non-dementing processes with different aetiologies [14].

Petr KAŇOVSKÝ, MD1, Elie P. ELOVIC, MD2, Michael C. MUNIN, MD3, Angelika HANSCHMANN, MSc4, Irena ... more Petr KAŇOVSKÝ, MD1, Elie P. ELOVIC, MD2, Michael C. MUNIN, MD3, Angelika HANSCHMANN, MSc4, Irena PULTE, MD4, Michael ALTHAUS, MD4, Reinhard HIERSEMENZEL, MD4 and Christina MARCINIAK, MD5 From the 1Faculty of Medicine and Dentistry and University Hospital, Palacký University Olomouc, Olomouc, Czech Republic, 2Moss Rehabilitation, Philadelphia, PA, USA, 3Department of Physical Medicine and Rehabilitation, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA, 4Merz Pharmaceuticals GmbH, Frankfurt am Main, Germany and 5Department of Physical Medicine and Rehabilitation and the Department of Neurology, Northwestern University Feinberg School of Medicine and Shirley Ryan AbilityLab, Chicago, IL, USA

Objective: To assess the efficacy and safety of incobotulinumtoxinA (Xeomin, Merz Pharmaceuticals... more Objective: To assess the efficacy and safety of incobotulinumtoxinA (Xeomin, Merz Pharmaceuticals GmbH) for upper-limb post-stroke spasticity. Background: Botulinum toxin injections are a recommended treatment for upper-limb spasticity. Data are reported from a 12-week, double-blind, placebo-controlled, Phase 3 study of incobotulinumtoxinA with a 36-week, open-label extension (OLEX) period. Design/Methods: In the placebo-controlled main period (MP), subjects (18-80 years) with upper-limb post-stroke spasticity (wrist, finger, and elbow flexor spasticity ≥2 [Ashworth Scale; AS]) were randomized 2:1 to incobotulinumtoxinA (fixed total dose 400U) or placebo. The OLEX comprised three incobotulinumtoxinA treatments (400U each), each followed by 12 weeks’ observation. Outcomes included AS response (≥1-point improvement from each injection to 4 weeks post-injection) and Disability Assessment Scale (DAS) response (≥1-point improvement in a subject-selected principal target domain [hygiene, ...

Archives of Physical Medicine and Rehabilitation, 2016

PM&R, 2014

Collective behaviour and social movements have been instrumental in engendering social change, in... more Collective behaviour and social movements have been instrumental in engendering social change, including regime change, and impacting the policy space in many societies. In fact, in the past 200 years, they have become a part of the popular and global expression of dissent. The political class, supported by elite groups and state institutions, most times, does not concede to popular demands until some form of public agitation and ruckus is witnessed. Therefore, social researchers have contemplated the rationale behind social change or social statics. This is because a decipherment of what social change drivers are will help social researchers better understand these "forces", know how to manage or regulate them and how or when to predict social change or otherwise. In Nigeria, an instance of social dynamics was the role Organised Labour and Civil Society groups played in vociferously demanding the return to democratic rule after many years under statocratic hegemony. This was achieved through the expression of different organised collective actions which forced the military overlords in power to acquiesce and capitulate to democratic governance. Akin to this, the passage of the Freedom of Information (FOI) bill by the legislature in Nigeria was an upshot of years of agitation by the intelligentsia, members of the fourth estate of the realm and the civil society sector. The FOI bill was conceived with the aim to hold the political and economic managers of the state more accountable to the people. This paper seeks to carry out a conceptual review of collective behaviour and social movements with some reflections on the Nigerian experience.

Muscle & Nerve, 2015

Introduction: Efficacy and safety of incobotulinum-toxinA in post-stroke upper-limb spasticity we... more Introduction: Efficacy and safety of incobotulinum-toxinA in post-stroke upper-limb spasticity were studied. Methods: Subjects randomized 2:1 to incobotulinumtoxinA (fixed dose 400 U) or placebo, with fixed doses for the primary target clinical pattern (PTCP; flexed elbow, 200 U; flexed wrist, 150 U; clenched fist, 100 U). Doses for non-primary patterns were flexible within predefined ranges. Results: At week 4, incobotulinumtoxinA led to larger improvements in PTCP Ashworth scale (AS) scores than placebo [least-squares mean change 6 standard error:-0.9 6 0.06 (n 5 171) vs.-0.5 6 0.08 (n 5 88); P < 0.001], and more subjects were PTCP AS responders (1-point improvement) with incobotulinumtoxinA (69.6%) than with placebo (37.5%; P < 0.001). Investigator's Global Impression of Change confirmed superiority of incobotulinumtoxinA vs. placebo (P 5 0.003). IncobotulinumtoxinA was associated with functional improvements, as demonstrated in responder rates for Disability Assessment Scale principal target at week 4 (P 5 0.007). Adverse events were mainly mild/moderate, and were reported by 22.4% (incobotulinumtoxinA) and 16.8% (placebo) of subjects. Conclusions: IncobotulinumtoxinA significantly improved upperlimb spasticity and associated disability, and was well-tolerated.

Journal of Sleep Research, 2002

SUMMAR Y Levetiracetam is a novel antiepileptic drug which has recently been released as an adjun... more SUMMAR Y Levetiracetam is a novel antiepileptic drug which has recently been released as an adjunctive treatment for partial epilepsy. In the two studies reported here we examined the objective and subjective effects of levetiracetam on sleep in 12 healthy volunteers and 17 patients [16 who could be evaluated for electroencephalogram (EEG) recordings] with a history of partial epilepsy on stable carbamazepine monotherapy. The studies were of a similar double-blind crossover placebo-controlled design with subjects' sleep being recorded in their own homes. The results from the two studies showed considerable similarities. In both, levetiracetam produced an increase in the time spent in stage 2 sleep, which in the patient study was accompanied by a decrease in the time spent in stage 4 sleep and in the volunteer study an increase in rapid eye movement (REM) latency. The subjective changes included reports that sleep was of a better quality with fewer awakenings and patients also reported that their sleep was more restful. Volunteers and patients did, however, feel less alert on waking in the morning. Therefore, both groups reported a decrease in awakenings after levetiracetam despite the finding from the EEG of no change in the actual number of awakenings. It may be concluded from both studies that levetiracetam does affect some indicators of subjective sleep perception, but does not influence objective sleep measures of sleep continuity. The results from the patient study during placebo add-on treatment also showed that patients on carbamazepine had a marked increase in SWS, an increase in stage 2 sleep and an increase in REM latency compared with healthy volunteers. Interestingly, levetiracetam also reduced bilateral epileptiform EEG activity, particularly in patients with more discharges.

$Research paper thumbnail of Efficacy and safety of levetiracetam 1000–3000mg/day in patients with refractory partial-onset seizures: a multicenter, open-label single-arm study$

Epilepsy Research, 2005

Purpose: To evaluate the efficacy and tolerability of levetiracetam as add-on therapy in patients... more Purpose: To evaluate the efficacy and tolerability of levetiracetam as add-on therapy in patients with refractory partial-onset seizures in a protocol designed to reflect clinical practice. Methods: All patients in this open-label, single-arm study entered an 8-week baseline period followed by a 4-week titration period and a 12-week maintenance period. Patients initially received levetiracetam 1000 mg/day (administered bid) and could increase to 2000 mg/day after 2 weeks, and to 3000 mg/day after another 2 weeks, to obtain adequate seizure control. During the 12-week maintenance period, the dose of levetiracetam could not be increased but could be decreased once if tolerability warranted. Seizure count and adverse events were recorded by patients in a diary. Quality of life and global evaluation of disease evolution were also evaluated. Results: Ninety-nine patients were enrolled and 91 completed the study. A steady dose was maintained over the last 8 weeks of treatment or longer in 84 patients, with 89.3% of these patients receiving 3000 mg/day, 9.5% receiving 2000 mg/day, and 1.2% receiving 1000 mg/day. A 35.9% median percent reduction from baseline in weekly frequency of partial-onset seizures was observed over the entire treatment period. The median partial-onset seizure count decreased from 2.3 per week during the

$Research paper thumbnail of Efficacy and Safety of Levetiracetam (up to 2000 mg/day) in Taiwanese Patients with Refractory Partial Seizures: A Multicenter, Randomized, Double-blind, Placebo-controlled Study$

Epilepsia, 2006

To assess the efficacy and safety of adjunctive levetiracetam (LEV) therapy in controlling partia... more To assess the efficacy and safety of adjunctive levetiracetam (LEV) therapy in controlling partial-onset seizures refractory to other antiepileptic drugs (AEDs) in a multicenter study in Taiwanese adults. Methods: Ninety-four patients aged 16-60 years with refractory partial seizures were randomized to receive LEV (n = 47) or placebo (47) for 14 weeks and composed the intention-to-treat (ITT) population. After the first 2 weeks, LEV patients had their dosage increased from 500 mg twice daily to 1,000 mg twice daily. A 12-week maintenance phase followed, after which patients switched to long-term, open-label LEV therapy or entered a 4-week phase of medication discontinuation. Results: All patients from the ITT population, except one LEVtreated patient with missing seizure-count data, were included in the primary efficacy analysis. The least square mean of logarithmically transformed weekly partial-seizure frequency was significantly lower in the LEV than in the placebo group (0.813 vs. 1.085; p = 0.001). LEV reduced log-transformed weekly partial-seizure frequency by 23.8% (95% confidence interval, 10.4-35.2%) relative to placebo. Significantly more LEV than placebo patients (43.5% vs. 10.6%) experienced a response of a ≥50% decrease from baseline in weekly frequency of partial seizures [odds ratio, 6.5 (95% CI, 2.2-19.3); p < 0.001]. Adverse events were reported in 34 (72.3%) of 47 LEV-treated patients and 32 (68.1%) of 47 placebo patients. The three most common adverse events in the LEV and placebo groups were somnolence (40.4% and 14.9%), dizziness (14.9% and 8.5%), and headache (10.6% and 8.5%), respectively. Only four patients (three LEVtreated patients and one placebo patient) were withdrawn from the study because of adverse events. Conclusions: Adjunctive LEV therapy, ≤1,000 mg twice daily, was significantly more effective than placebo and was generally well tolerated in Taiwanese adults with treatmentresistant partial-onset seizures.

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