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4. Trial of Deferiprone in Parkinson's Disease

Author

Devos, D., Labreuche, J., Rascol, O., Corvol, J.C., Duhamel, A., Delannoy, P. Guyon, Poewe, W., Compta, Y., Pavese, N., Růžička, E., Dušek, P., Post, B., Bloem, B.R., Berg, D., Maetzler, W., Otto, M., Habert, M.O., Lehericy, S., Ferreira, J., Dodel, R., Tranchant, C., Eusebio, A., Thobois, S., Marques, A.R., Meissner, W.G., Ory-Magne, F., Walter, U., Bie, R.M. de, Gago, M., Vilas, D., Kulisevsky, J., Januario, C., Coelho, M.V.S., Behnke, S., Worth, P., Seppi, K., Ouk, T., Potey, C., Leclercq, C., Viard, R., Kuchcinski, G., Lopes, R., Pruvo, J.P., Pigny, P., Garçon, G., Simonin, O., Carpentier, J., Rolland, A.S., Nyholm, D., Scherfler, C., Mangin, J.F., Chupin, M., Bordet, R., Dexter, D.T., Fradette, C., Spino, M., Tricta, F., Ayton, S., Bush, A.I., Devedjian, J.C., Duce, J.A., Cabantchik, I., Defebvre, L., Deplanque, D., Moreau, C., Devos, D., Labreuche, J., Rascol, O., Corvol, J.C., Duhamel, A., Delannoy, P. Guyon, Poewe, W., Compta, Y., Pavese, N., Růžička, E., Dušek, P., Post, B., Bloem, B.R., Berg, D., Maetzler, W., Otto, M., Habert, M.O., Lehericy, S., Ferreira, J., Dodel, R., Tranchant, C., Eusebio, A., Thobois, S., Marques, A.R., Meissner, W.G., Ory-Magne, F., Walter, U., Bie, R.M. de, Gago, M., Vilas, D., Kulisevsky, J., Januario, C., Coelho, M.V.S., Behnke, S., Worth, P., Seppi, K., Ouk, T., Potey, C., Leclercq, C., Viard, R., Kuchcinski, G., Lopes, R., Pruvo, J.P., Pigny, P., Garçon, G., Simonin, O., Carpentier, J., Rolland, A.S., Nyholm, D., Scherfler, C., Mangin, J.F., Chupin, M., Bordet, R., Dexter, D.T., Fradette, C., Spino, M., Tricta, F., Ayton, S., Bush, A.I., Devedjian, J.C., Duce, J.A., Cabantchik, I., Defebvre, L., Deplanque, D., and Moreau, C.

Abstract

Item does not contain fulltext, BACKGROUND: Iron content is increased in the substantia nigra of persons with Parkinson's disease and may contribute to the pathophysiology of the disorder. Early research suggests that the iron chelator deferiprone can reduce nigrostriatal iron content in persons with Parkinson's disease, but its effects on disease progression are unclear. METHODS: We conducted a multicenter, phase 2, randomized, double-blind trial involving participants with newly diagnosed Parkinson's disease who had never received levodopa. Participants were assigned (in a 1:1 ratio) to receive oral deferiprone at a dose of 15 mg per kilogram of body weight twice daily or matched placebo for 36 weeks. Dopaminergic therapy was withheld unless deemed necessary for symptom control. The primary outcome was the change in the total score on the Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS; range, 0 to 260, with higher scores indicating more severe impairment) at 36 weeks. Secondary and exploratory clinical outcomes at up to 40 weeks included measures of motor and nonmotor disability. Brain iron content measured with the use of magnetic resonance imaging was also an exploratory outcome. RESULTS: A total of 372 participants were enrolled; 186 were assigned to receive deferiprone and 186 to receive placebo. Progression of symptoms led to the initiation of dopaminergic therapy in 22.0% of the participants in the deferiprone group and 2.7% of those in the placebo group. The mean MDS-UPDRS total score at baseline was 34.3 in the deferiprone group and 33.2 in the placebo group and increased (worsened) by 15.6 points and 6.3 points, respectively (difference, 9.3 points; 95% confidence interval, 6.3 to 12.2; P<0.001). Nigrostriatal iron content decreased more in the deferiprone group than in the placebo group. The main serious adverse events with deferiprone were agranulocytosis in 2 participants and neutropenia in 3 participants. CONCLUSIONS: In parti

Published
2022

6. INTEREST IN CD2, a global patient-centred study of long-term cervical dystonia treatment with botulinum toxin

Author

Misra, Vijay P., Colosimo, Carlo, Charles, David, Chung, Tae Mo, Maisonobe, Pascal, Om, Savary, Abdulnayef, A., Adatepe, N. U., Araujo Leite, M. A., Badarny, S., Bajenaru, O., Bares, M., Bejjani, P., Bergmans, B., Bhidayasiri, R., Bozic, H., Cardoso Costa, F. E., Carlstrom, C., Castelnovo, G., Chang, M. H., Chang, Y. Y., Coletti-Moja, M., Delvaux, V., Dioszhegy, P., Dogu, O., Duzynski, W., Ehler, E., Espinosa Sierra, L., Fabbrini, G., Ferreira, J., Ferreira Valadas, A., Foresti, C., Girlanda, P., Goh, K. J., Graca Velon, A., Grill, S., Gurevitch, T., Hadidi, M., Hamimed, M. A., Hamri, A., Harrower, T., Hassin, S., Hedera, P., Hernandez, J. F. J. G., Hernandez Franco, J., Ho, B., Ho, S. L., Hughes, A., Ilic, T., Inshasi, J. S., Ip, C. W., Jamieson, S., Jamora, R. D. G., Jech, R., Jeon, B. S., Kaminska, A., Karpova, M., Khasanova, D., Kim, J. M., Kim, J. W., Kok, C. Y., Korenko, A., Korv, J., Koussa, S., Kovacs, T., Kreisler, A., Krystkowiak, P., Kumthornthip, W., Lin, C. H., Lundin, F., Lus, G., Magalhaes, M., Masmoudi, A. N., Mercelis, R., Misbahuddin, A., Moebius, C., Mohammadi, B., Nazem, B., Ng, K., Nurlu, G., Nyberg, J., Nyholm, D., Ochudlo, S., Otruba, P., Pfister, R., Pirtosek, Z., Pokhabov, D., Quinones Aguilar, S., Quinones Canales, G., Raghev, S., Rickmann, H., Romano, M., Rosales, R. L., Rubanovits, I., Santilli, V., Schoels, L., Simonetta-Moreau, M., Simu, M. A., Sohn, Y. H., Soulayrol, S., Supe, I., Svetel, M., Sycha, T., Tan, E. K., Timerbaeva, S., Tokcaer, A. B., Trosch, R., Tugnoli, V., Tumas, V., van der Linden, C., Vetra, A., Vial, C., Vidry, E., Williams, D., Wimalaratna, S., Yiannikas, C., Misra, Vijay P., Colosimo, Carlo, Charles, David, Chung, Tae Mo, Maisonobe, Pascal, Om, Savary, Abdulnayef, A., Adatepe, N. U., Araujo Leite, M. A., Badarny, S., Bajenaru, O., Bares, M., Bejjani, P., Bergmans, B., Bhidayasiri, R., Bozic, H., Cardoso Costa, F. E., Carlstrom, C., Castelnovo, G., Chang, M. H., Chang, Y. Y., Coletti-Moja, M., Delvaux, V., Dioszhegy, P., Dogu, O., Duzynski, W., Ehler, E., Espinosa Sierra, L., Fabbrini, G., Ferreira, J., Ferreira Valadas, A., Foresti, C., Girlanda, P., Goh, K. J., Graca Velon, A., Grill, S., Gurevitch, T., Hadidi, M., Hamimed, M. A., Hamri, A., Harrower, T., Hassin, S., Hedera, P., Hernandez, J. F. J. G., Hernandez Franco, J., Ho, B., Ho, S. L., Hughes, A., Ilic, T., Inshasi, J. S., Ip, C. W., Jamieson, S., Jamora, R. D. G., Jech, R., Jeon, B. S., Kaminska, A., Karpova, M., Khasanova, D., Kim, J. M., Kim, J. W., Kok, C. Y., Korenko, A., Korv, J., Koussa, S., Kovacs, T., Kreisler, A., Krystkowiak, P., Kumthornthip, W., Lin, C. H., Lundin, F., Lus, G., Magalhaes, M., Masmoudi, A. N., Mercelis, R., Misbahuddin, A., Moebius, C., Mohammadi, B., Nazem, B., Ng, K., Nurlu, G., Nyberg, J., Nyholm, D., Ochudlo, S., Otruba, P., Pfister, R., Pirtosek, Z., Pokhabov, D., Quinones Aguilar, S., Quinones Canales, G., Raghev, S., Rickmann, H., Romano, M., Rosales, R. L., Rubanovits, I., Santilli, V., Schoels, L., Simonetta-Moreau, M., Simu, M. A., Sohn, Y. H., Soulayrol, S., Supe, I., Svetel, M., Sycha, T., Tan, E. K., Timerbaeva, S., Tokcaer, A. B., Trosch, R., Tugnoli, V., Tumas, V., van der Linden, C., Vetra, A., Vial, C., Vidry, E., Williams, D., Wimalaratna, S., and Yiannikas, C.

Subjects
Male, Neurology, SATISFACTION, International Cooperation, Cohort Studies, 0302 clinical medicine, QUALITY-OF-LIFE, Botulinum toxin, Observational study, Tremor, Epidemiology, 030212 general & internal medicine, Cervical dystonia, Botulinum Toxins, Type A, Torticollis, Neuroradiology, BLEPHAROSPASM, education.field_of_study, Original Communication, INTEREST IN CD2 study group, Middle Aged, Treatment Outcome, Neuromuscular Agents, Female, Life Sciences & Biomedicine, medicine.drug, Adult, medicine.medical_specialty, Population, Clinical Neurology, DIAGNOSIS, 03 medical and health sciences, Patient satisfaction, Neurology (clinical), Internal medicine, medicine, Humans, education, Aged, Science & Technology, Neurology & Neurosurgery, Electromyography, GUIDANCE, business.industry, 1103 Clinical Sciences, medicine.disease, NEUROTOXIN, REGISTRY, UPDATE, Neurosciences & Neurology, 1109 Neurosciences, business, 030217 neurology & neurosurgery
Abstract

Background Longitudinal cohort studies provide important information about the clinical effectiveness of an intervention in the routine clinical setting, and are an opportunity to understand how a population presents for treatment and is managed. Methods INTEREST IN CD2 (NCT01753349) is a prospective, international, 3-year, longitudinal, observational study following the course of adult idiopathic cervical dystonia (CD) treated with botulinum neurotoxin type A (BoNT-A). The primary objective is to document long-term patient satisfaction with BoNT-A treatment. Here we report baseline data. Results This analysis includes 1036 subjects (67.4% of subjects were female; mean age was 54.7 years old; mean TWSTRS Total score was 31.7). BoNT-A injections were usually given in line with BoNT-A prescribing information. The most commonly injected muscles were splenius capitis (87.3%), sternocleidomastoid (82.6%), trapezius (64.3%), levator scapulae (40.9%) and semispinalis capitis (26.9%); 35.5% of subjects were injected using a guidance technique. Most subjects (87.8%) had been previously treated with BoNT-A (median interval between last pre-study injection and study baseline was 4 months); of these 84.8% reported satisfaction with BoNT-A treatment at peak effect during their previous treatment cycle and 51.5% remained satisfied at the end of the treatment. Analyses by geographical region revealed heterogeneity in the clinical characteristics and BoNT-A injection practice of CD subjects presenting for routine treatment. Conclusions These baseline analyses provide sizeable data regarding the epidemiology and clinical presentation of CD, and demonstrate an international heterogeneity of clinical practice. Future longitudinal analyses of the full 3-year study will explore how these factors impact treatment satisfaction. Electronic supplementary material The online version of this article (10.1007/s00415-017-8698-2) contains supplementary material, which is available to authorized users.

Published
2017

10. PET molecular imaging of phosphodiesterase 10A: An early biomarker of Huntington's disease progression

Author

Fazio, P., Fitzer-Attas, C.J., Mrzljak, L., Bronzova, J., Nag, S., Warner, J.H., Landwehrmeyer, B., Al-Tawil, N., Halldin, C., Forsberg, A., Ware, J., Dilda, V., Wood, A., Sampaio, C., Varrone, A., Svenningsson, P., Paucar, M., Sundblom, J., Nyholm, D., Widner, H., Heiberg, A., Frich, J., Nielsen, J., Hjermind, L., Roos, R., PEARL-HD Collaborator, and LONGPDE10 Study Collaborator

Subjects
0301 basic medicine, Oncology, medicine.medical_specialty, Disease, Striatum, 03 medical and health sciences, 0302 clinical medicine, Huntington's disease, Internal medicine, medicine, Humans, PDE10A, business.industry, Phosphoric Diester Hydrolases, Putamen, Phosphodiesterase, imaging, medicine.disease, Molecular Imaging, 030104 developmental biology, Globus pallidus, Cross-Sectional Studies, Huntington Disease, Neurology, Positron-Emission Tomography, Disease Progression, Biomarker (medicine), biomarker, Neurology (clinical), business, 030217 neurology & neurosurgery, Biomarkers, Follow-Up Studies
Abstract

Background Changes in phosphodiesterase 10A enzyme levels may be a suitable biomarker of disease progression in Huntington's disease. Objectives To evaluate phosphodiesterase 10A PET imaging as a biomarker of HD progression using the radioligand, [18 F]MNI-659. Methods The cross-sectional study (NCT02061722) included 45 Huntington's disease gene-expansion carriers stratified into four disease stages (early and late premanifest and Huntington's disease stages 1 and 2) and 45 age- and sex-matched healthy controls. The primary analysis compared striatal and pallidal phosphodiesterase 10A availability between Huntington's disease gene-expansion carriers and healthy controls as assessed by [18 F]MNI-659 binding. We assessed changes in phosphodiesterase 10A expression using several PET methodologies and compared with previously proposed measures of Huntington's disease progression (PET imaging of D2/3 receptors and anatomical volume loss on MRI). The longitudinal follow-up study (NCT02956148) continued evaluation of phosphodiesterase 10A availability in 35 Huntington's disease gene-expansion carriers at a mean of 18 months from baseline of the cross-sectional study. Results Primary analyses revealed that phosphodiesterase 10A availability in caudate, putamen, and globus pallidus was significantly lower in Huntington's disease gene-expansion carriers versus healthy controls across all stages. Striatal and pallidal phosphodiesterase 10A availability progressively declined in the premanifest stages and appeared to plateau between stages 1 and 2. The percentage decline of phosphodiesterase 10A availability measured cross-sectionally between Huntington's disease gene-expansion carriers and healthy controls was greater than that demonstrated by D2/3 receptor availability or volumetric changes. Annualized rates of phosphodiesterase 10A change showed a statistically significant decline between the cross-sectional study and follow-up. Conclusions [18 F]MNI-659 PET imaging is a biologically plausible biomarker of Huntington's disease progression that is more sensitive than the dopamine-receptor and volumetric methods currently used. © 2020 International Parkinson and Movement Disorder Society.

Published
2020

23. How satisfied are cervical dystonia patients after 3 years of botulinum toxin type A treatment? Results from a prospective, long-term observational study

Author

Colosimo, C, Charles, D, Misra, VP, Maisonobe, P, Om, S, Abdulnayef, A, Adatepe, NU, Leite, AMA, Badarny, S, Bajenaru, O, Bares, M, Bejjani, P, Bergmans, B, Bhidayasiri, R, Bozic, H, Costa, CFE, Carlstrom, C, Castelnovo, G, Chang, MH, Chang, YY, Chung, TM, Coletti-Moja, M, Delvaux, V, Dioszhegy, P, Dogu, O, Duzynski, W, Ehler, E, Sierra, EL, Fabbrini, G, Ferreira, J, Valadas, FA, Foresti, C, Girlanda, P, Goh, KJ, Velon, GA, Grill, S, Gurevitch, T, Hadidi, M, Hamimed, MA, Hamri, A, Harrower, T, Hassin, S, Hedera, P, Hernandez, JFJG, Franco, HJ, Ho, B, Ho, SL, Hughes, A, Ilic, T, Inshasi, JS, Ip, CW, Jamieson, S, Jamora, RDG, Jech, R, Jeon, BS, Kaminska, A, Karpova, M, Khasanova, D, Kim, JM, Kim, JW, Kok, CY, Korenko, A, Korv, J, Koussa, S, Kovacs, T, Kreisler, A, Krystkowiak, P, Kumthornthip, W, Lin, CH, Lundin, F, Lus, G, Magalhaes, M, Masmoudi, AN, Mercelis, R, Misbahuddin, A, Moebius, C, Mohammadi, B, Nazem, B, Ng, K, Nurlu, G, Nyberg, J, Nyholm, D, Ochudlo, S, Otruba, P, Pfister, R, Pirtosek, Z, Pokhabov, D, Aguilar, QS, Canales, QG, Raghev, S, Rickmann, H, Romano, M, Rosales, RL, Rubanovits, I, Santilli, V, Schoels, L, Simonetta-Moreau, M, Ma, S, Sohn, YH, Soulayrol, S, Supe, I, Svetel, M, Sycha, T, Tan, EK, Timerbaeva, S, Tokcaer, AB, Trosch, R, Tugnoli, V, Tumas, V, Van der Linden, C, Vetra, A, Vial, C, Vidry, E, Williams, D, Wimalaratna, S, and Yiannikas, C

Subjects
0301 basic medicine, Male, Pediatrics, Neurology, SATISFACTION, Botulinum toxin, Cervical dystonia, Observational study, Satisfaction, Treatment, 0302 clinical medicine, QUALITY-OF-LIFE, Outcome Assessment, Health Care, Prospective Studies, Botulinum Toxins, Type A, Torticollis, Neuroradiology, BLEPHAROSPASM, INTEREST IN CD2 study group, Middle Aged, Neuromuscular Agents, Patient Satisfaction, SAFETY, Female, Life Sciences & Biomedicine, medicine.drug, Adult, medicine.medical_specialty, Adolescent, MEDLINE, Clinical Neurology, Treatment results, DIAGNOSIS, 03 medical and health sciences, Young Adult, medicine, Humans, Aged, Science & Technology, Neurology & Neurosurgery, business.industry, Correction, 1103 Clinical Sciences, medicine.disease, EFFICACY, 030104 developmental biology, Neurology (clinical), Neurosciences & Neurology, business, FOLLOW-UP, 1109 Neurosciences, 030217 neurology & neurosurgery, Botulinum toxin type
Abstract

Background Patients with cervical dystonia (CD) typically require regular injections of botulinum toxin to maintain symptomatic control. We aimed to document long-term patient satisfaction with CD symptom control in a large cohort of patients treated in routine practice. Methods This was a prospective, international, observational study (NCT01753349) following the course of adult CD treated with botulinum neurotoxin type A (BoNT-A) over 3 years. A comprehensive clinical assessment status was performed at each injection visit and subjects reported satisfaction in two ways: satisfaction with symptom control at peak effect and at the end of treatment cycle. Results Subject satisfaction remained relatively stable from the first to the last injection visit. At 3 years, 89.9% of subjects reported satisfaction with symptom control at peak effect and 55.6% reported satisfaction with symptom control at end of treatment cycle. By contrast, objective ratings of CD severity showed an overall reduction over 3 years. Mean ± SD Toronto Western Spasmodic Rating Scale (TWSTRS) Total scores (clinician assessed at end of treatment cycle) decreased from 31.59 ± 13.04 at baseline to 24.49 ± 12.43 at 3 years (mean ± SD reduction from baseline of − 6.97 ± 11.56 points). Tsui scale scores also showed gradual improvement; the percent of subjects with a tremor component score of 4 reduced from 12.4% at baseline to 8.1% at 3 years. Conclusions Despite objective clinical improvements over 3 years, subject satisfaction with symptom control remained relatively constant, indicating that factors other than symptom control also play a role in patient satisfaction.

Published
2019

32. Computer Vision Methods for Parkinsonian Gait Analysis : A Review on Patents

Author

Khan, Taha, Nyholm, Dag, Nyholm, D, Khan, Taha, Nyholm, Dag, and Nyholm, D

Abstract

Gait disturbance is an important symptom of Parkinson’s disease (PD). This paper presents a review of patents reported in the area of computerized gait disorder analysis. The feasibility of marker-less vision based systems has been examined for ‘at-home’ self-evaluation of gait taking into account the physical restrictions of patients arising due to PD. A three tier review methodology has been utilized to synthesize gait applications to investigate PD related gait features and to explore methods for gait classification based on symptom severities. A comparison between invasive and non-invasive methods for gait analysis revealed that marker-free approach can provide resource efficient, convenient and accurate gait measurements through the use of image processing methods. Image segmentation of human silhouette is the major challenge in the marker-free systems which can possibly be comprehended through the use of Microsoft Kinect application and motion estimation algorithms. Our synthesis further suggests that biorhythmic features in gait patterns have potential to discriminate gait anomalies based on the clinical scales., E-MOTIONS

Published
2013
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33. Selecting deep brain stimulation or infusion therapies in advanced Parkinson's disease: an evidence-based review

Author

Volkmann, J, Albanese, Alberto, Antonini, A, Chaudhuri, Kr, Clarke, Ce, De Bie, Rma, Deuschl, G, Eggert, K, Houeto, J, Kulisevsky, J, Nyholm, D, Odin, P, Østergaard, K, Poewe, W, Pollak, P, Rabey, Jm, Rascol, O, Ruzicka, E, Samuel, M, Speelman, H, Sydow, O, Valldeoriola, F, Van Der Linden, C, Oertel, W., Albanese, Alberto (ORCID:0000-0002-5864-0006), Volkmann, J, Albanese, Alberto, Antonini, A, Chaudhuri, Kr, Clarke, Ce, De Bie, Rma, Deuschl, G, Eggert, K, Houeto, J, Kulisevsky, J, Nyholm, D, Odin, P, Østergaard, K, Poewe, W, Pollak, P, Rabey, Jm, Rascol, O, Ruzicka, E, Samuel, M, Speelman, H, Sydow, O, Valldeoriola, F, Van Der Linden, C, Oertel, W., and Albanese, Alberto (ORCID:0000-0002-5864-0006)

Abstract

Motor complications in Parkinson's disease (PD) result from the short half-life and irregular plasma fluctuations of oral levodopa. When strategies of providing more continuous dopaminergic stimulation by adjusting oral medication fail, patients may be candidates for one of three device-aided therapies: deep brain stimulation (DBS), continuous subcutaneous apomorphine infusion, or continuous duodenal/jejunal levodopa/carbidopa pump infusion (DLI). These therapies differ in their invasiveness, side-effect profile, and the need for nursing care. So far, very few comparative studies have evaluated the efficacy of the three device-aided therapies for specific motor problems in advanced PD. As a result, neurologists currently lack guidance as to which therapy could be most appropriate for a particular PD patient. A group of experts knowledgeable in all three therapies reviewed the currently available literature for each treatment and identified variables of clinical relevance for choosing one of the three options such as type of motor problems, age, and cognitive and psychiatric status. For each scenario, pragmatic and (if available) evidence-based recommendations are provided as to which patients could be candidates for either DBS, DLI, or subcutaneous apomorphine.

Published
2013

34. Parametric methods for[11C]PE2I positron emission tomography

Author

Jonasson, M., Appel, L., Engman, Jonas, Frick, Andreas, Nyholm, D., Askmark, H., Danfors, T., Sörensen, J., Furmark, Tomas, Lubberink, M., Jonasson, M., Appel, L., Engman, Jonas, Frick, Andreas, Nyholm, D., Askmark, H., Danfors, T., Sörensen, J., Furmark, Tomas, and Lubberink, M.

Published
2012

35. Fluctuating functions related to quality of life in advanced Parkinson disease : effects of duodenal levodopa infusion

Author

Isacson, D, Bingefors, K, Kristiansen, I S, Nyholm, D, Isacson, D, Bingefors, K, Kristiansen, I S, and Nyholm, D

Abstract

OBJECTIVE: To assess fluctuations in quality of life (QoL) and motor performance in patients with advanced Parkinson disease (PD) treated with continuous daytime duodenal levodopa/carbidopa infusion or conventional therapy. METHODS: Of 18 patients completing a 6-week trial (DIREQT), 12 were followed for up to 6 months and assessed using electronic diaries and the PD Questionnaire-39 (PDQ-39). RESULTS: During the trial and follow-up, major diurnal fluctuations were observed, especially for hyperkinesia, 'off' time, ability to walk and depression. Duodenal infusion was associated with significantly more favourable outcomes compared with conventional treatment for satisfaction with overall functioning, 'off' time and ability to walk, with improved outcomes with PDQ-39. CONCLUSIONS: Relative to conventional treatment, infusion therapy may stabilize and significantly improve motor function and patient's QoL. The potential for daily fluctuation in PD symptoms means single measures of treatment effectiveness can result in bias in effect estimates and hence repeated measures are recommended.

Published
2008
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36. Transcutaneous port for levodopa/carbidopa intestinal gel administration in Parkinson's disease.

Author

Laar, T., Nyholm, D., and Nyman, R.

Subjects
*PARKINSON'S disease treatment, *CARBIDOPA, *DRUG administration, *INFUSION therapy, *MEDICATION safety, *DRUG tolerance, *GASTRIC bypass, *LONGITUDINAL method
Abstract

Objective To evaluate the safety and tolerability of the T-Port® for intestinal infusion of levodopa/carbidopa gel in patients with advanced Parkinson's disease ( PD). Methods This prospective study was carried out in 24 patients with PD (15 males, mean age 61.8 years, mean duration PD 18.7 years). All adverse device effects were evaluated at 2 weeks, 3 months and 6 months and until explantation or death. Results Post-operative complications were similar to endoscopic gastrojejunostomy placement (four peritoneal irritation, one pocket pain). Eight patients with prior experience with the endoscopic gastrojejunostomy preferred the T-Port. The total device experience was 83.6 years, and the average survival time was 3.6 (range 1.1-5.2) years. Six T-Ports were still in use, and two patients had died due to non-device-related reasons. Sixteen T-Ports had been explanted due to 15 stoma reactions (14 inflammations and one infection) and one tilting of the T-Port. The T-Ports were replaced with endoscopic gastrojejunostomy system as replacements with T-Ports were not part of the study. Only two device malfunctions occurred (one catheter breakage at 3 year post-implant and one T-Port leakage of levodopa/carbidopa gel). No tube kinking, dislocation or blockage occurred. The number of adverse device effects proved to be significantly lower as compared to the endoscopic gastrojejunostomy literature data. Conclusions The T-Port is safe and well tolerated, and the low number of tube problems is a potential advantage compared with the endoscopic gastrojejunostomy system. Proper cleaning and local treatment of the stoma site around the T-Port are essential to prolong its longevity. [ABSTRACT FROM AUTHOR]

Published
2016
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37. Duodenal levodopa infusion monotherapy vs oral polypharmacy in advanced Parkinson disease

Author

Nyholm, D, Nilsson Remahl, AIM, Dizdar Segrell, Nil, Constantinescu, R, Holmberg, B, Jansson, R, Aquilonius, SM, Askmark, H, Nyholm, D, Nilsson Remahl, AIM, Dizdar Segrell, Nil, Constantinescu, R, Holmberg, B, Jansson, R, Aquilonius, SM, and Askmark, H

Abstract

Objectives: To compare daytime intraduodenal levodopa/carbidopa infusion as monotherapy with individually optimized conventional combination therapies in patients with advanced Parkinson disease (PD) for motor fluctuations and quality of life (QoL). Methods: Twenty-four patients with motor fluctuations and dyskinesia were studied in a randomized crossover design to compare individualized conventional treatment and intraduodenal infusion of a levodopa/ carbidopa gel for 3 + 3 weeks. Video scoring of motor function was assessed by blinded assessors on a global Treatment Response Scale from -3 to 0 to +3 (from severe "off" to "on" to "on" with severe dyskinesia). Patient self-assessment of motor performance and QoL was done using an electronic diary. Results: Median percentage of ratings in a functional "on" interval (-1 to +1) was increased from 81 to 100% by infusion therapy (p < 0.01). This improvement was accompanied by a decrease in "off" state (p < 0.01) and no increase in dyskinesia. Median Unified Parkinson's Disease Rating Scale score decreased from 53 to 35 in favor of infusion (p < 0.05). QoL was improved, using the two instruments: Parkinson's Disease Questionnaire-39 and 15D Quality of Life Instrument (p < 0.01). Adverse events were similar for both treatment strategies. Conclusions: Continuous intraduodenal infusion of the levodopa/carbidopa enteral gel as monotherapy is safe and clinically superior to a number of individually optimized combinations of conventional oral and subcutaneous medications in patients with motor fluctuations. Intraduodenal infusion of levodopa offers an important alternative in treating patients with advanced Parkinson disease.

Published
2005

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