![]() Subjects with fatigue had significantly worse scores on the mean Schwab and England Activities of Daily Living Scale, PD QUALIF, and Hamilton Depression Scale (Ham-D) ( table 1). It is of interest that all three subscales of the UPDRS were worse in the fatigued group than in the nonfatigued group (mentation p < 0.0001, activities of daily living p < 0.0001, motor p = 0.0014). However, the fatigued group was significantly more neurologically impaired at baseline than the nonfatigued group as indicated by higher scores on each subset of the UPDRS and Hoehn-Yahr stage ( table 1). ![]() Fatigued subjects did not differ significantly from nonfatigued subjects in age (mean age 63.9 years vs 64.9 years) or gender (men 66% vs 70%). ![]() A total of 128 of these 349 (37%) participants were classified as fatigued at baseline. Of the 361 patients enrolled in ELLDOPA, 9 349 completed fatigue measures. SPECT scans were performed immediately prior to baseline and week 40 visits. Assessments of fatigue, using the Fatigue Severity Scale (FSS), 12 were performed at baseline, and weeks 3, 9, 24, 40, and 42.Ī total of 131 subjects were also co-enrolled in an imaging study using iodine-123-labeled 2-β-carboxymethoxy-3-β-(4-iodopheyl)tropane (-β-CIT) SPECT to measure striatal dopamine transporter density. A second investigator (primary rater) assessed PD severity using the UPDRS 11 at baseline and week 42. At each visit, participants were assessed for adverse experiences and clinically evaluated using the UPDRS 11 by the treating investigator. Subjects remained on drug for 40 weeks, followed by a 3-day downtitration and 2-week washout period, and were re-evaluated at 3, 9, 24, 40, 41, and 42 weeks after randomization. 9ĮLLDOPA participants were randomly assigned to receive carbidopa-levodopa 37.5/150 mg, 75/300 mg, or 150/600 mg, or matching placebo daily with titration to full dose occurring over 9 weeks. Patients with tremor scores of 3 or greater on the Unified Parkinson's Disease Rating Scale (UPDRS), 11 freezing of gait, loss of postural reflexes, dementia, or major depression were excluded from participation in ELLDOPA. 9 Briefly, this cohort included 361 untreated, levodopa-naïve individuals with early PD, defined by 1) diagnosis of PD within 2 years prior to enrollment, and 2) a rating of less than stage 3 on the modified Hoehn-Yahr scale, 10 who were considered unlikely to require symptomatic treatment within 9 months of enrollment. In addition, the placebo-controlled nature of the ELLDOPA study provided an ideal setting to assess the response of fatigue to levodopa treatment and its relationship to motor changes.įatigue was evaluated in the context of the randomized, double-blind, placebo-controlled ELLDOPA clinical trial. ![]() In this regard, the Earlier vs Later Levodopa (ELLDOPA) trial 9 offered a unique opportunity for investigating the relationship between fatigue and measures of disease severity, function, and quality of life in a large cohort of early, untreated, levodopa naïve subjects with PD. In addition, the effect of levodopa on fatigue in patients with PD who are levodopa naïve has never been described to our knowledge. Little is known about the prevalence of fatigue in early PD. ![]() In fact, most of the published investigations have focused on subjects with PD at later stages of the disease, and usually while on dopaminergic treatment. 8 It is even less likely that fatigue would be assessed in the early diagnosis of PD. 4-6 Although fatigue affects 32% to 56% of the PD population, 1,4,5,7 this nonmotor symptom is still under-recognized in the routine evaluation of subjects with PD even by PD experts. Since the earliest reports, 1-3 fatigue has been confirmed as a frequent and disabling nonmotor symptom in Parkinson disease (PD). Fatigue is a common symptom reported in most medical, neurologic, and psychiatric disorders but is poorly understood. ![]()
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