Are branded and generic extended-release ropinirole formulations equally efficacious? A...

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Page 1: Are branded and generic extended-release ropinirole formulations equally efficacious? A rater-blinded, cross-over, multicenter study

Abstract — WCN 2013No: 446Topic: 2 — Movement DisordersNew treatment for clinical stabilization in Parkinson's Disease(Cervô): Results in 32 patients at 29 months of follow-up

E. de Font-Réaulx R. Centro Neurológico, ABC Medical Center, MethodistInternational Network, Mexico City, Mexico

It is mandatory to have a safe and effective treatment to stop theneurodegenerative disease's progression. Previous clinical trialsdesigned to stop Parkinson's Disease (PD) progression have failedto demonstrate significant clinical stabilization. We administrated toPD patients the first oral treatment designed to stop the disease'sprogression. This treatment called Cervô, contains four substancesthat have effect in controlling themost important knownmechanismsof disease progression as: aberrant apoptosis, oxidative damage,mitochondrial degeneration, caspases andMitogen-Activated Protein-Kinases (MAPK) activation, among others. We had previouslydemonstrated that it is safe to use Cervô in humans. Before beginningthe clinical trial, we administrated the best medical symptomatictherapy to each patient and they remainedwith the same prescriptionduring the observation period. Then, we added Cervô twice per day toall the patients.Results: We included 31 patients with PD. Age: 32 to 86 years old(mean 66.3 years, SD +/− 13.5), 16 female (51.6%), 15 male (48.4%).Initial United Parkinson's Disease Rating Scale (UPDRS) score: 1–15(mean 5, SD+/− 3). Follow-up period: 12–57 months (mean29months, SD+/− 14.5).Clinical evaluations: There was no increase in the UPDRS score in 30patients (96.77%) in the follow-up period, and 25 (80.64%) patientsimproved their basal UPDRS score. The mean UPDRS scores were 3.5at 12 months and 2.5 at 24 months.Conclusions: Cervô is a new and promising medication, specificallydesigned to stop neurodegenerative disease's progression. This needsto be confirmed with a randomized multi-centric study.

doi:10.1016/j.jns.2013.07.475

Abstract — WCN 2013No: 427Topic: 2 — Movement DisordersREM sleep behavior disorder in Parkinson disease: Associationwith abnormal ocular motor findings

B.S. Jeona, Y.E. Kimb, H.-J. Kima. aSeoul National University Hospital,Seoul, Republic of Korea; bSeoul National University Bundang Hospital,Seoul, Republic of Korea

REM sleep behavior disorder (RBD) is related with brainstem pa-thology. We examined whether patients with RBD have abnormalocular movements suggesting brainstem or cerebellar dysfunctionin Parkinson's disease (PD). A total 202 patients were included inthis study. Ocular movements were examined by video-oculography(VOG). 116 (57.4%) of the 202 patients have clinically probable RBD,and 32 (27.6%) of the 116 with clinically probable RBD patients hadabnormal VOG findings suggesting brainstem or cerebellar dysfunc-tion; whereas 86 of the 202 patients did not have clinically probableRBD, and only 8 (9.3%) of 86 patients had abnormal VOG findingssuggesting brainstem or cerebellar dysfunction. (P= .001). This studysuggests that the presences of RBD are associated with more severebrainstem pathology in PD.

doi:10.1016/j.jns.2013.07.476

Abstract — WCN 2013No: 440Topic: 2 — Movement DisordersTIC disorders (TD) in children: The kindergarten matters

V. Sajina,b, I. Moldovanua. aInstitute of Neurology and Neurosurgery,Republic of Moldova; bState Medical and Pharmaceutical University‘Nicolae Testemitanu’, Chisinau, Republic of Moldova

Background: Tics are sudden, rapid, recurrent, non-rhythmic motormovements or vocalizations (European clinical guidelines for Tourettesyndrome and other tic disorders, 2011)with the prevalence in childrenof 0.77–1% (2.99% for transient tics) (Robertson, 2008; Knight et al.,2012).The poor knowledge about TD leads to the delayed diagnosisand wrong management of TD. Kindergarten teachers (KTs) couldcontribute to a better behavioral and social integration of childrenwith tics and their parents.On our knowledge, no precedent informational campaign on TD wasperformed in Republic of Moldova (RM).Aims: to assess the necessity to inform KTs about TDMaterials, subjects and methods:

• Video presentation about the TD• Short questionnaires• Twenty two kindergarten teachers (mean age 50.86 ± 11.07 yrs) from4 kindergartens from RM (549 children). Each teacher supervisedabout 20 children (2–3 yrs (84 children), 3–4 yrs (128), 4–5 yrs (29),5–6 yrs (189) and 6–7 yrs (119) old).

Results: Before the presentation, the majority of KTs mistook tics formuscle fasciculations or hysterical reactions. Only two children withTD from 549 were initially reported.After the presentation, 15 teachers gave a right description of tics,their evolution and educational particularities of children with TD.Fifteen children with TD (2.73%), 11 boys and 4 girls (3:1) werereported by KTs.Conclusion: The presented information improved the kindergartenteachers' knowledge about the tic disorders and their communicativeand educational skills, as well as their attitude toward such children.KTs can contribute to the active detection and right managementof TD.

doi:10.1016/j.jns.2013.07.477

Abstract — WCN 2013No: 384Topic: 2 — Movement DisordersAre branded and generic extended-release ropiniroleformulations equally efficacious? A rater-blinded, cross-over,multicenter study

N. Kovácsa,b, E. Bosnyáka, M. Hercegc, E. Pála, Z. Aschermanna,J. Janszkyb, I. Késmárkid, K. Karádia, T. Dóczib, F. Nagyc, S. Komolya.aDepartment of Neurology, University of Pécs, Hungary; bMTA-PTEResearch Group, Hungary; cDepartment of Neurology, Kaposi MórCounty Hospital, Kaposvár, Hungary; dDepartment of Neurology,Health Center of City of Pécs, Pécs, Hungary

Objectives: The aim of this rater-blinded multicenter study was tocompare the efficacy of branded (Requip modutab®) and generic(Ralnea®) extended-release ropinirole formulations in the treatmentof Parkinson's disease (PD).Methods: Of 32 enrolled patients 29 completed the study. A raterblinded to treatment evaluated Unified Parkinson's Disease Rating

Abstracts / Journal of the Neurological Sciences 333 (2013) e109–e151 e143

Page 2: Are branded and generic extended-release ropinirole formulations equally efficacious? A rater-blinded, cross-over, multicenter study

Scale (UPDRS), Fahn–Tolosa–Marin Tremor Rating Scale (FTMTRS),Non-motor Symptom Assessment Scale (NMSS), Montgomery–AsbergDepression Rating Scale (MADRS), and a structured questionnaire onropinirole side-effects. Besides, the patients self-administered EQ-5Dand Parkinson's Disease Sleep Scale 2nd version (PDSS-2).Results: Branded and generic ropinirole usage achieved similarscores on tests measuring motor symptoms (UPDRS-III 23.5 ± 8.2vs. 26.9 ± 9.1 points, UPDRS-total: 46.2 ± 16.0 vs. 50.4 ± 18.7points and FTMTRS 24.2 ± 9.5 vs. 24.93 ± 10.4 points, respectively,p N 0.05). The results of questionnaires on the sleep-quality (PDSS-214.6 ± 10.5 vs. 14.5 ± 11.2 points, p N 0.05), non-motor symptoms(NMSS, 78.5 ± 49.5 vs. 82.3 ± 48.2 points, p N 0.05), quality oflife (EQ-5D 0.72 ± 0.22 vs. 0.71 ± 0.21, p N 0.05) and depression(MADRS: 11.1 ± 9.3 vs. 11.9 ± 9.2, p N 0.05) were comparable.Except for gastrointestinal problems, both medications had compa-rable side-effect profile. After completion of the study, the subjectsdid not prefer neither of the formulations significantly (19 vs. 10 patientsintended to continue with the branded or the generic formulation,p = 0.095).Conclusions:Although this study has to be interpretedwith limitations,our findings suggest that both branded and generic ropinirole for-mulations have similar control on themotor- andnon-motor symptomsof PD.

doi:10.1016/j.jns.2013.07.478

Abstract — WCN 2013No: 320Topic: 2 — Movement DisordersParkinson's disease: Molecular-genetic investigationsin Uzbekistan

M.M. Raimova, K.M. Khalimova, R.J. Matmurodov. Tashkent MedicalAcademy, Tashkent, Uzbekistan

Today, the study of the molecular nature of Parkinson' disease (PD) isone of the priorities.Aim: To analyze molecular-genetic aspects of PD among indigenouspopulation of Uzbekistan Republic.Мethods: The number of patients was 180 (mean age: 54.8 ±11.8 years). Control group consisted of 80 persons not sufferingfrom this pathology at the similar age and gender. We carry out theanalysis on the presence of associations with PD: mutations Ala53Thrin gene PARK1, T240M gene PARK2, homozygosis for null alleles (0/0)of GSTT1 and GSTM1 genes.Results: Mutations Ala53Thr in gene PARK1 and T240M in genePARK2 in investigated population of patients were absent at allpatients both in the group with PD and in control group. 0/0 poly-morphism for GSTT1 gene was 54.4% and for gene GSTM1—62.8%identified in PD patients. Analysis of the distribution of combinedgenotypes GSTT1/GSTM1 showed statistically significant differencesbetween PD and control groups in the form of prevalence of com-binations of GSTT1 (0/0)/GSTM1/(0/0) genotypes in the group withPD. Clinical and genotypic comparisons showed more early debutof the disease, and prevalence of expanded-mixed form and rapidprogression of PD in patients with “null” genotypes of GSTT1 andGSTM1 genes.Conclusions: High frequency of bearing of null alleles of genes ofdetoxication GSTT1 and GSTM1, and also their combinations wasrevealed that indicates to their certain role in the development ofParkinson's disease.

doi:10.1016/j.jns.2013.07.479

Abstract — WCN 2013No: 321Topic: 2 — Movement DisordersParkinson's disease: Sanitary–hygienic investigations in Uzbekistan

M.M. Raimova, K.M. Khalimova, R.J. Matmurodov. Tashkent MedicalAcademy, Tashkent, Uzbekistan

In the whole world, the increase of new cases of Parkinson's disease(PD), among cities, is observed, especially, among agricultural popula-tion. It explains the given tendency partially due to the improvementof quality of diagnostics of the disease. However, there are also otherreasons for the increase in PD frequency which need to be studied.Aim: To analyze sanitary–hygienic aspects of PD among indigenouspopulation of Uzbekistan Republic.Methods: The number of patients was 180 (88 women and 92 men).Sanitary–hygienic researches were made with the help of a speciallydeveloped questionnaire, which covered all major factors of biologicalor sanitary–hygienic character.Results: Results of questioning of patients with PD among indige-nous population of Uzbekistan have shown that the most significantrisk factors of PD development were work with pesticides, drinkingwater from open reservoirs and work in the chemical industry.Influence of harmful factors was not only the risk factor for the diseasedevelopment, but it also modified clinical picture of disease thus, themedian age of patients—countrymen was 53.08 ± 9.14, patients—cityinhabitants—58.5 ± 10.7, and the tendency to earlier debut of diseasein the agricultural population in comparison with city inhabitants(48.8 ± 9.9 and 53.6 ± 9.9 accordingly) was also observed.Conclusions: The analysis of the sanitary–hygienic factors of PD hasallowed one to reveal most significant of them with high degree ofreliability that is important at a substantiation of the concept of PDdevelopment, and gives the chance to predict the probability of PDdevelopment in persons of Uzbek nationality.

doi:10.1016/j.jns.2013.07.480

Abstract — WCN 2013No: 245Topic: 2 — Movement DisordersPostural abnormality as a risk marker for leg deep venousthrombosis (DVT) in Parkinson's disease

F. Kimura, K. Yamane, M. Ota, H. Tani, T. Hirose. The First Departmentof Internal Medicine, Osaka Medical College, Takatsuk-City, Japan

Purpose: Pulmonary thromboembolism is a common cause of deathin patients with autopsy-confirmed Parkinsonism. This study inves-tigated the frequency of leg DVT in Parkinson's disease and rela-tionships between DVT and clinical/laboratory findings, includingpostural abnormalities as assessed by photographic measurements.Methods: This cross-sectional study assessed the presence of DVTusing bilateral leg Doppler ultrasonography in 114 asymptomaticoutpatients with Parkinson's disease.Results: DVT was detected in 23 patients (20%) with Parkinson'sdisease. DVT was located in the distal portion in 18 patients and in theproximal portion in 5 patients. No significant differences in age, sex,bodymass index, disease duration, Hoehn–Yahr stage, anti-Parkinson'sdrugs, or daily levodopa-equivalent dose were seen between DVT-positive and DVT-negative groups. Univariate analysis for developingDVT in patients with Parkinson's disease identified the followingfactors: long-term wheelchair use, bent knee, bent spine, and D-dimerelevation. Bending angles were significantly higher in the DVT-positivegroup at the knee (19.8°, p b 0.001) and spine (14.9°, p= 0.002) than inthe DVT-negative group. In diabetes mellitus cases, long-term wheel-chair use, bent knee over 15°, camptocormia, D-dimer elevation, and

Abstracts / Journal of the Neurological Sciences 333 (2013) e109–e151e144