F Stocchi

Publications (100)409.92 Total impact

• Article: Long-term efficacy and safety of safinamide as add-on therapy in early Parkinson's disease.

  A H V Schapira, F Stocchi, R Borgohain, M Onofrj, M Bhatt, P Lorenzana, V Lucini, R Giuliani, R Anand
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  ABSTRACT: BACKGROUND AND PURPOSE: Safinamide is an α-aminoamide with both dopaminergic and non-dopaminergic mechanisms of action in Phase III clinical development as a once-daily add-on to dopamine agonist (DA) therapy for early Parkinson's disease (PD). METHODS: Study 017 was a 12-month, randomized, double-blind, placebo-controlled pre-planned extension study to the previously reported Study 015. Patients received safinamide 100 or 200 mg/day or placebo added to a single DA in early PD. The primary efficacy endpoint was the time from baseline (Study 015 randomization) to 'intervention', defined as: increase in DA dose; addition of another DA, levodopa or other PD treatment; or discontinuation due to lack of efficacy. Safinamide groups were pooled for the primary efficacy endpoint analysis; post-hoc analyses were performed on each separate dose group. RESULTS: Of the 269 patients randomized in Study 015, 227 (84%) enrolled in Study 017 and 187/227 (82%) patients completed the extension study. Median time to intervention was 559 and 466 days in the pooled safinamide and placebo groups, respectively (log-rank test; P = 0.3342). In post-hoc analyses, patients receiving safinamide 100 mg/day experienced a significantly lower rate of intervention compared with placebo (25% vs. 51%, respectively) and delay in median time to intervention of 9 days (P < 0.05; 240- to 540-day analysis). CONCLUSIONS: The pooled data from the safinamide groups failed to reach statistical significance for the primary endpoint of median time from baseline to additional drug intervention. Post-hoc analyses indicate that safinamide 100 mg/day may be effective as add-on treatment to DA in PD.
  European Journal of Neurology 09/2012; · 3.69 Impact Factor
• Article: Observational study of sleep-related disorders in Italian patients with Parkinson's disease: usefulness of the Italian version of Parkinson's disease sleep scale.

  M T Pellecchia, A Antonini, U Bonuccelli, G Fabbrini, L Ferini Strambi, F Stocchi, A Battaglia, P Barone
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  ABSTRACT: Sleep disturbances are common in patients with Parkinson's disease (PD). We aimed to evaluate prevalence and severity of nighttime sleep disturbances in Italian PD patients and to validate the Italian version of the Parkinson's disease sleep scale. A total of 221 PD patients and 57 healthy controls participated in a cross-sectional study with retest. PDSS, Epworth Sleepiness Scale (ESS), Hamilton Depression Rating Scale, Unified Parkinson's Disease Rating Scale (UPDRS), and Hoehn and Yahr staging were applied. PDSS total and individual items scores from patients were significantly lower than those in controls. Internal consistency of PDSS scale was satisfactory and intraclass correlation coefficient for test-retest reliability was 0.96 for total PDSS score. A significant negative correlation was found between total PDSS and ESS scores, and between total PDSS and HDRS scores. PDSS scores were also related to UPDRS sections II, III and IV, and H&Y stage. PDSS and ESS scores were not related to levodopa equivalent dose. Daytime sleepiness, depressive symptoms and disease severity correlate with sleep disturbances in Italian PD patients. The PDSS is a valid and reliable tool to evaluate sleep disturbances in Italian patients.
  Neurological Sciences 11/2011; 33(3):689-94. · 1.32 Impact Factor
• Source

  Available from: Joaquim Ferreira

  Article: ATP13A2 missense mutations in juvenile parkinsonism and young onset Parkinson disease.

  A Di Fonzo, H F Chien, M Socal, S Giraudo, C Tassorelli, G Iliceto, G Fabbrini, R Marconi, E Fincati, G Abbruzzese, [......], F Stocchi, S Goldwurm, J J Ferreira, G Meco, E Martignoni, L Lopiano, L B Jardim, B A Oostra, E R Barbosa, V Bonifati
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  ABSTRACT: To assess the prevalence, nature, and associated phenotypes of ATP13A2 gene mutations among patients with juvenile parkinsonism (onset <21 years) or young onset (between 21 and 40 years) Parkinson disease (YOPD). We studied 46 patients, mostly from Italy or Brazil, including 11 with juvenile parkinsonism and 35 with YOPD. Thirty-three cases were sporadic and 13 had positive family history compatible with autosomal recessive inheritance. Forty-two had only parkinsonian signs, while four (all juvenile-onset) had multisystemic involvement. The whole ATP13A2 coding region (29 exons) and exon-intron boundaries were sequenced from genomic DNA. A novel homozygous missense mutation (Gly504Arg) was identified in one sporadic case from Brazil with juvenile parkinsonism. This patient had symptoms onset at age 12, levodopa-responsive severe akinetic-rigid parkinsonism, levodopa-induced motor fluctuations and dyskinesias, severe visual hallucinations, and supranuclear vertical gaze paresis, but no pyramidal deficit nor dementia. Brain CT scan showed moderate diffuse atrophy. Furthermore, two Italian cases with YOPD without atypical features carried a novel missense mutation (Thr12Met, Gly533Arg) in single heterozygous state. We confirm that ATP13A2 homozygous mutations are associated with human parkinsonism, and expand the associated genotypic and clinical spectrum, by describing a homozygous missense mutation in this gene in a patient with a phenotype milder than that initially associated with ATP13A2 mutations (Kufor-Rakeb syndrome). Our data also suggest that ATP13A2 single heterozygous mutations might be etiologically relevant for patients with YOPD and further studies of this gene in Parkinson disease are warranted.
  Neurology 05/2007; 68(19):1557-62. · 8.31 Impact Factor
• Article: Symptom relief in Parkinson disease by safinamide: Biochemical and clinical evidence of efficacy beyond MAO-B inhibition.

  F Stocchi, L Vacca, P Grassini, M F De Pandis, G Battaglia, C Cattaneo, R G Fariello
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  ABSTRACT: In an open pilot study, doses of safinamide (100, 150, and 200 mg once a day, higher than previously tested) were administered to 13 parkinsonian patients along with a stable dose of dopamine (DA) agonist, causing a significant progressive improvement in motor performance as evaluated by the Unified Parkinson Disease Rating Scale (UPDRS) part III over an 8-week period (4.2 points; P < 0.001). In association with levodopa, the same doses of safinamide in another group of patients (N = 11) induced a significant decrease in motor fluctuations (UPDRS part IV, 2.1 points; P < 0.001), accompanied by a dose-proportional increase of the levodopa AUC, up to 77% from baseline. Because MAO-B was fully inhibited (95%) at all doses tested, we suggest that these biochemical and symptomatic dose-dependent effects must be related to additional mechanisms of action, such as inhibition of glutamate release, increased dopamine release, or inhibition of dopamine re-uptake. These hypotheses are under investigation and will pursue confirmation in controlled clinical trials.
  Neurology 11/2006; 67(7 Suppl 2):S24-9. · 8.31 Impact Factor
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  Available from: Angelo Antonini

  Article: The G6055A (G2019S) mutation in LRRK2 is frequent in both early and late onset Parkinson's disease and originates from a common ancestor.

  S Goldwurm, A Di Fonzo, E J Simons, C F Rohé, M Zini, M Canesi, S Tesei, A Zecchinelli, A Antonini, C Mariani, [......], C Diroma, P Lamberti, C Sampaio, G Meco, E Barbosa, A M Bertoli-Avella, G J Breedveld, B A Oostra, G Pezzoli, V Bonifati
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  ABSTRACT: Mutations in the gene Leucine-Rich Repeat Kinase 2 (LRRK2) were recently identified as the cause of PARK8 linked autosomal dominant Parkinson's disease. To study recurrent LRRK2 mutations in a large sample of patients from Italy, including early (<50 years) and late onset familial and sporadic Parkinson's disease. Among 629 probands, 13 (2.1%) were heterozygous carriers of the G2019S mutation. The mutation frequency was higher among familial (5.1%, 9/177) than among sporadic probands (0.9%, 4/452) (p<0.002), and highest among probands with one affected parent (8.7%, 6/69) (p<0.001). There was no difference in the frequency of the G2019S mutation in probands with early v late onset disease. Among 600 probands, one heterozygous R1441C but no R1441G or Y1699C mutations were detected. None of the four mutations was found in Italian controls. Haplotype analysis in families from five countries suggested that the G2019S mutation originated from a single ancient founder. The G2019S mutation was associated with the classical Parkinson's disease phenotype and a broad range of onset age (34 to 73 years). G2019S is the most common genetic determinant of Parkinson's disease identified so far. It is especially frequent among cases with familial Parkinson's disease of both early and late onset, but less common among sporadic cases. These findings have important implications for diagnosis and genetic counselling in Parkinson's disease.
  Journal of Medical Genetics 11/2005; 42(11):e65. · 6.36 Impact Factor
• Article: Early-onset parkinsonism associated with PINK1 mutations: frequency, genotypes, and phenotypes.

  V Bonifati, C F Rohé, G J Breedveld, E Fabrizio, M De Mari, C Tassorelli, A Tavella, R Marconi, D J Nicholl, H F Chien, [......], G Fabbrini, S Goldwurm, A de Klein, E Barbosa, L Lopiano, E Martignoni, P Lamberti, N Vanacore, G Meco, B A Oostra
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  ABSTRACT: To assess the prevalence, nature, and associated phenotypes of PINK1 gene mutations in a large series of patients with early-onset (<50 years) parkinsonism. The authors studied 134 patients (116 sporadic and 18 familial; 77% Italian) and 90 Italian controls. The whole PINK1 coding region was sequenced from genomic DNA; cDNA was analyzed in selected cases. Homozygous pathogenic mutations were identified in 4 of 90 Italian sporadic cases, including the novel Gln456Stop mutation; single heterozygous truncating or missense mutations were found in another 4 Italian sporadic cases, including two novel mutations, Pro196Leu and Gln456Stop. Pathogenic mutations were not identified in the familial cases. Novel (Gln115Leu) and known polymorphisms were identified with similar frequency in cases and controls. In cases carrying single heterozygous mutation, cDNA analysis detected no additional mutations, and revealed a major pathogenic effect at mRNA level for the mutant C1366T/Gln456Stop allele. All patients with homozygous mutations had very early disease onset, slow progression, and excellent response to l-dopa, including, in some, symmetric onset, dystonia at onset, and sleep benefit, resembling parkin-related disease. Phenotype in patients with single heterozygous mutation was similar, but onset was later. PINK1 homozygous mutations are a relevant cause of disease among Italian sporadic patients with early-onset parkinsonism. The role of mutations found in single heterozygous state is difficult to interpret. Our study suggests that, at least in some patients, these mutations are disease causing, in combination with additional, still unknown factors.
  Neurology 08/2005; 65(1):87-95. · 8.31 Impact Factor
• Article: Improvement of motor function in early Parkinson disease by safinamide.

  F Stocchi, G Arnold, M Onofrj, H Kwiecinski, A Szczudlik, A Thomas, U Bonuccelli, A Van Dijk, C Cattaneo, P Sala, R G Fariello
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  ABSTRACT: A median safinamide (SAF) dose of 70 mg/day (range 40 to 90 mg/day) increased the percentage of parkinsonian patients improving their motor scores by > or =30% from baseline (responders) after 3 months from 21.4% (placebo) to 37.5% (p < 0.05, calculated by logistic regression analysis). In a subgroup of 101 patients under stable treatment with a single dopamine agonist, addition of SAF magnified the response (47.1% responders, mean 4.7-point motor score decrease; p > or = 0.05). These results suggest that doses of SAF exerting ion channel block and glutamate release inhibition add to its symptomatic effect and warrant exploration of higher doses.
  Neurology 09/2004; 63(4):746-8. · 8.31 Impact Factor
• Article: Entacapone improves the pharmacokinetic and therapeutic response of controlled release levodopa/carbidopa in Parkinson's patients.

  F Stocchi, L Barbato, G Nordera, A Bolner, T Caraceni
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  ABSTRACT: The aim of this trial was to evaluate the effects of the COMT inhibitor entacapone on both the pharmacokinetic profile and clinical efficacy of controlled release levodopa in Parkinson's disease (PD) patients. Twelve PD patients experiencing "end-of-dose" type motor fluctuations were evaluated in this single-blind, randomized cross-over study. A single dose of either entacapone (200 mg) or placebo was co-administered with controlled release levodopa. Blood samples were taken every 30 minutes for 3 hours, and in 6 patients, sampling was continued for a further 3 hours. The clinical response to treatment was evaluated using the Unified Parkinson's Disease Rating Scale motor score. Addition of entacapone to levodopa treatment prolonged the "on" phase of the PD patients by 37% (p<0.05). This increased duration of 'on' time was concomitant with a significant increase in levodopa bioavailability (AUC). These data confirm the ability of entacapone to enhance the clinical efficacy of controlled release levodopa formulations, and provide further evidence that entacapone is of value in extending the benefits of levodopa in PD patients experiencing motor fluctuations.
  Acta Neurovegetativa 03/2004; 111(2):173-80. · 2.73 Impact Factor
• Article: Continuous apomorphine infusion (CAI) and neuropsychiatric disorders in patients with advanced Parkinson's disease: a follow-up of two years.

  L Morgante, G Basile, A Epifanio, E Spina, A Antonini, F Stocchi, E Di Rosa, G Martino, R Marconi, P La Spina, V Nicita-Mauro, A E Di Rosa
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  ABSTRACT: This study was performed to assess whether patients with Parkinson's disease (PD)develop cognitive and psychiatric impairments more frequently during therapy with continuous subcutaneous apomorphine infusion (CAI) compared to the standard oral treatment. Thirty consecutive PD patients with severe motor fluctuations were included. Of them, 12 patients received the CAI treatment, while the remaining 18 continued the treatment with oral dopaminergic drugs. The two groups were evaluated with neuropsychological,psychiatric and motor tests at baseline and after two years. The off-awake daily duration and the levodopa dosage were significantly reduced in the patients infused with apomorphine.In comparison with the baseline evaluation, the neuropsychiatric assessment did not change in either of groups at the follow-up, except for a significant improvement of mood in the CAI treated group.
  Archives of gerontology and geriatrics. Supplement 02/2004;
• Source

  Available from: limpe.it

  Article: Optimizing levodopa pharmacokinetics in Parkinson's disease: the role of COMT inhibitor.

  F Stocchi, L Vacca, P Grassini, G Battaglia, M Onofrj, M Valente, S Ruggieri
  Neurological Sciences 11/2003; 24(3):217-8. · 1.32 Impact Factor
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  Available from: Giorgio Basile

  Article: Continuous apomorphine infusion and neuropsychiatric disorders: a controlled study in patients with advanced Parkinson's disease.

  A E Di Rosa, A Epifanio, A Antonini, F Stocchi, G Martino, L Di Blasi, A Tetto, G Basile, D Imbesi, P La Spina, G Di Raimondo, L Morgante
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  ABSTRACT: The aim of this study was to assess whether patients with Parkinson's disease (PD) develop cognitive and psychiatric complications more frequently during prolonged therapy with continuous apomorphine infusion compared with standard oral treatment. Thirty consecutive PD patients with severe motor fluctuations were included in the study. Twelve patients accepted the treatment with subcutaneous continuous apomorphine infusion, while the remaining 18 preferred to continue with oral dopaminergic therapy. The two groups were evaluated with neuropsychological, psychiatric, and motor tests at baseline and after 1 year. The off daily duration and the levodopa dosage were significantly reduced in infused patients. The neuropsychiatric assessment did not change in both groups compared with baseline, except for a significant improvement of mood in the apomorphine group.
  Neurological Sciences 11/2003; 24(3):174-5. · 1.32 Impact Factor
• Article: Continuous apomorphine infusion and neuropsychiatric disorders: a controlled study in patients with advanced Parkinson’s disease

  A.E. Rosa, A. Epifanio, A. Antonini, F. Stocchi, G. Martino, L. Blasi, A. Tetto, G. Basile, D. Imbesi, P. Spina, G. Raimondo, L. Morgante
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  ABSTRACT: The aim of this study was to asses whether patients with Parkinsons disease (PD) develop cognitive and psychiatric complications more frequently during prolonged therapy with continuous apomorphine infusion compared with standard oral treatment. Thirty consecutive PD patients with severe motor fluctuations were included in the study. Twelve patients accepted the treatment with subcutaneous continuous apomorphine infusion, while the remaining 18 preferred to continue with oral dopaminergic therapy. The two groups were evaluated with neuropsychological, psychiatric, and motor tests at baseline and after 1 year. The off daily duration and the levodopa dosage were significantly reduced in infused patients. The neuropsychiatric assessment did not change in both groups compared with baseline, except for a significant improvement of mood in the apomorphine group.
  Neurological Sciences 09/2003; 24(3):174-175. · 1.32 Impact Factor
• Source

  Available from: limpe.it

  Article: Optimizing levodopa pharmacokinetics in Parkinson’s disease: the role of COMT inhibitor

  F. Stocchi, L. Vacca, P. Grassini, G. Battaglia, M. Onofrj, M. Valente, S. Ruggieri
  Neurological Sciences 01/2003; 24(3):217-218. · 1.32 Impact Factor
• Article: Autosomal recessive early onset parkinsonism is linked to three loci: PARK2, PARK6, and PARK7.

  V Bonifati, M C J Dekker, N Vanacore, G Fabbrini, F Squitieri, R Marconi, A Antonini, P Brustenghi, A Dalla Libera, M De Mari, F Stocchi, P Montagna, V Gallai, P Rizzu, J C van Swieten, B Oostra, C M van Duijn, G Meco, P Heutink
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  ABSTRACT: Autosomal recessive, early onset parkinsonism (AREP) is genetically heterogeneous. Mutations in the parkin gene (PARK2 locus, chromosome 6q) account for up to 50% of AREP families. The parkin protein displays ubiquitin-ligase activity for different targets, which accumulate in the brain of patients with parkin defect and might cause neurodegeneration. Two new AREP loci (PARK6 and PARK7) have been recently mapped on chromosome 1p and confirmed in independent datasets, suggesting that both might be frequent. The three AREP forms display similar clinical phenotypes. Recruiting new families will help cloning the defective genes at PARK6 and PARK7 loci. This will contribute to unraveling the pathogenesis of AREP, and it is also expected to foster our understanding of molecular events underlying classic Parkinson's disease.
  Neurological Sciences 10/2002; 23 Suppl 2:S59-60. · 1.32 Impact Factor
• Article: Combination of two different dopamine agonists in the management of Parkinson's disease.

  F Stocchi, A Berardelli, L Vacca, A Thomas, M F De Pandis, N Modugno, M Valente, S Ruggieri
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  ABSTRACT: An alternative approach to the symptomatic treatment of parkinsonian patients with and without motor fluctuations is to use dual dopamine agonists. The aim of this study was to investigate the symptomatic effect of administrating a second dopamine agonist to parkinsonian patients already assuming pramipexole or ropinirole. As the second dopamine agonist we chose cabergoline, a drug with a long half life, whose pharmacological profile differs from that of the newer non-ergot-derived dopamine-receptor agonists. In this pilot study we enrolled 27 patients: 21 patients had motor fluctuations and were receiving levodopa plus a dopamine agonist, and 6 patients without motor fluctuations were receiving a dopamine agonist without levodopa. This open study shows that dual dopamine agonist therapy (cabergoline plus pramipexole or ropinirole) may be used in the symptomatic treatment of patients with Parkinson's disease receiving therapy with or without levodopa.
  Neurological Sciences 10/2002; 23 Suppl 2:S115-6. · 1.32 Impact Factor
• Article: Modification of respiratory function parameters in patients with severe Parkinson's disease.

  M F De Pandis, A Starace, F Stefanelli, P Marruzzo, I Meoli, G De Simone, R Prati, F Stocchi
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  ABSTRACT: Respiratory dysfunction remains one of the most common causes of death in patients with complicated Parkinson's disease (PD). The aim of this study was to investigate pulmonary function in fluctuating PD patients during "on" and "off" states of the disease. We studied 12 fluctuating, non-smoking PD patients (H&Y stages 3-5) without a history of lung or cardiovascular disease; all patients underwent Hoehn and Yahr scale (H&Y) and Unified Parkinson Disease Rating Scale (UPDRS items 18-31) to evaluate extrapyramidal impairment, as well as pulmonary function tests (PFT) and arterial blood gas analyses to assess respiratory function. All evaluations were performed during a stable on state of disease and in an off state produced by 12 hours of therapy withdrawal. A restrictive pattern of flow-volume loop was observed both in on and off states of disease. In the off state, we found a significant worsening in both FEV1 and FVC; the FEV1/FVC ratio was unmodified. These results suggest a restrictive pattern of flow-volume loop in these patients.
  Neurological Sciences 09/2002; 23 Suppl 2:S69-70. · 1.32 Impact Factor
• Article: Modification of respiratory function parameters in patients with severe Parkinson's disease

  M.F. De Pandis, A. Starace, F. Stefanelli, P. Marruzzo, I. Meoli, G. De Simone, R. Prati, F. Stocchi
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  ABSTRACT: Respiratory dysfunction remains one of the most common causes of death in patients with complicated Parkinson's disease (PD). The aim of this study was to investigate pulmonary function in fluctuating PD patients during "on" and "off" states of the disease. We studied 12 fluctuating, non-smoking PD patients (H&Y stages 3-5) without a history of lung or cardiovascular disease; all patients underwent Hoehn and Yahr scale (H&Y) and Unified Parkinson Disease Rating Scale (UPDRS items 18-31) to evaluate extrapyramidal impairment, as well as pulmonary function tests (PFT) and arterial blood gas analyses to assess respiratory function. All evaluations were performed during a stable on state of disease and in an off state produced by 12 hours of therapy withdrawal. Arestrictive pattern of flow-volume loop was observed both in on and off states of disease. In the off state, we found a significant worsening in both FEV1 and FVC; the FEV1/FVC ratio was unmodified. These results suggest a restrictive pattern of flow-volume loop in these patients.
  Neurological Sciences 08/2002; 23:s69-s70. · 1.32 Impact Factor
• Article: A six-month multicentre, double-blind, bromocriptine-controlled study of the safety and efficacy of ropinirole in the treatment of patients with Parkinson's disease not optimally controlled by L-dopa.

  E R Brunt, D J Brooks, A D Korczyn, J-L Montastruc, F Stocchi
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  ABSTRACT: To compare the safety and efficacy of ropinirole and bromocriptine as adjunct therapy in patients with Parkinson's disease (PD) not optimally controlled by L-dopa. A randomised, double-blind trial in which 555 patients were assigned to three treatment groups according to the level of daily dosage of L-dopa, presence of motor fluctuations, and use of dopamine agonist before study entry. Patient response was defined as at least a 20% reduction in daily L-dopa dose plus: for patients with no prior treatment and no motor fluctuations, a 20% reduction in UPDRS motor score; for patients with motor fluctuations, a 20% reduction in time spent "off"; and for patients already taking an agonist, an improvement on the CGI scale. Safety assessments showed no significant differences in the two treatment groups for patients without prior dopamine-agonist therapy. In the group of patients with prior dopamine-agonist therapy, more patients reported adverse events in the ropinirole group (90% versus 79%, p < 0.001). The proportions of responders tended to be higher in ropinirole groups compared with bromocriptine groups and, in the subgroup with motor fluctuations, this difference was statistically significant (9.1% versus 0.0%, respectively; p < 0.05). Both drugs were well tolerated. In patients receiving a relatively high dose of L-dopa and requiring the addition of a dopamine agonist to control motor fluctuations or dyskinesias, ropinirole was significantly more effective than bromocriptine.
  Acta Neurovegetativa 05/2002; 109(4):489-502. · 2.73 Impact Factor
• Article: Combination of two different dopamine agonists in the management of Parkinson's disease

  F. Stocchi, A. Berardelli, L. Vacca, A. Thomas, M.F. De Pandis, N. Modugno, M. Valente, S. Ruggieri
  [show abstract] [hide abstract]
  ABSTRACT: An alternative approach to the symptomatic treatment of parkinsonian patients with and without motor fluctuations is to use dual dopamine agonists. The aim of this study was to investigate the symptomatic effect of administrating a second dopamine agonist to parkinsonian patients already assuming pramipexole or ropinirole. As the second dopamine agonist we chose cabergoline, a drug with a long half life, whose pharmacological profile differs from that of the newer non-ergot-derived dopamine-receptor agonists. In this pilot study we enrolled 27 patients: 21 patients had motor fluctuations and were receiving levodopa plus a dopamine agonist, and 6 patients without motor fluctuations were receiving a dopamine agonist without levodopa. This open study shows that dual dopamine agonist therapy (cabergoline plus pramipexole or ropinirole) may be used in the symptomatic treatment of patients with Parkinson's disease receiving therapy with or without levodopa.
  Neurological Sciences 01/2002; 23:s115-s116. · 1.32 Impact Factor
• Article: A six-month multicentre, double-blind, bromocriptine-controlled study of the safety and efficacy of ropinirole in the treatment of patients with Parkinson's disease not optimally controlled by l -dopa

  E. R. Brunt, D. J. Brooks, A. D. Korczyn, J.-L. Montastruc, F. Stocchi, on behalf of the Study Group
  [show abstract] [hide abstract]
  ABSTRACT: Objectives: To compare the safety and efficacy of ropinirole and bromocriptine as adjunct therapy in patients with Parkinson's disease (PD) not optimally controlled by L-dopa. Methods: A randomised, double-blind trial in which 555 patients were assigned to three treatment groups according to the level of daily dosage of L-dopa, presence of motor fluctuations, and use of dopamine agonist before study entry. Patient response was defined as at least a 20% reduction in daily L-dopa dose plus: for patients with no prior treatment and no motor fluctuations, a 20% reduction in UPDRS motor score; for patients with motor fluctuations, a 20% reduction in time spent "off"; and for patients already taking an agonist, an improvement on the CGI scale. Results: Safety assessments showed no significant differences in the two treatment groups for patients without prior dopamine-agonist therapy. In the group of patients with prior dopamine-agonist therapy, more patients reported adverse events in the ropinirole group (90% versus 79%, p < 0.001). The proportions of responders tended to be higher in ropinirole groups compared with bromocriptine groups and, in the subgroup with motor fluc-tuations, this difference was statistically significant (9.1% versus 0.0%, respectively; p < 0.05). Conclusions: Both drugs were well tolerated. In patients receiving a relatively high dose of L-dopa and requiring the addition of a dopamine agonist to control motor fluctuations or dyskinesias, ropinirole was significantly more effective than bromocriptine.
  Acta Neurovegetativa 01/2002; 109(4):489-501. · 2.73 Impact Factor