A 12-week, multicenter, randomized, placebo-controlled trial was conducted to evaluate the safety and efficacy of selegiline tablet ODT as adjunctive therapy in patients with PD. A total of 140 patients were assigned to two treatment arms; 94 patients received selegiline ODT, and 46 patients received placebo.

Individuals who were older than 30 years of age with a confirmed diagnosis of idiopathic PD and with deterioration at the end of levodopa therapy, with at least three hours of off time per day recorded in weekly diaries, were included in the study. Patients were also eligible if they had a documented response to levodopa with a dopa-decarboxylase inhibitor.

The treated patients received a daily dose of selegiline ODT 1.25 mg for the first six weeks and a daily dose of 2.5 mg for the final six weeks. All of these patients were treated with concomitant lev-odopa products and could have been taking dopamine agonists, anticholinergic agents, generic amantadine (Symmetrel, Endo), or any combination of these during the trial.

Patients were ineligible for the study:

• if they had taken selegiline during the previous three months.
• if they were known to be hypersensitive to selegiline.
• if they were taking COMT inhibitors, MAO inhibitors, opioid analgesics, or any selective serotonin reuptake inhibitor (SSRI).
• if they had severe depression, psychosis, or impaired cognitive function, characterized by a score below 24 on the Mini-Mental State Examination (MMSE).

Anticholinergic medications were permitted only if the dose remained stable throughout the study.

Patients were assessed via the sub-scales of the Unified Parkinson’s Disease Rating Scale (UPDRS) for motor symptoms (Part III) and Activities of Daily Living (ADL, Part II), the Clinical Global Impression (CGI) scale (ranging from 1 = normal to 7 = extremely ill), and the Patient’s Global Impression (PGI) scale (ranging from 1 = very much improved to 7 = very much worse). suhagra 100

The primary endpoint measured was the percent reduction in total daily off time over 12 weeks, as documented in patient diaries compared with the baseline value. Secondary efficacy outcomes consisted of fewer hours off, changes in the motor and ADL subscales in the UPDRS, and changes in CGI and PGI scores.

Motor offscores were evaluated in the morning before the patients took levo-dopa and selegiline ODT or placebo. Motor on scores were assessed after dosing and after patients were judged to be clinically on, as defined between the patient and the treating physician at the first visit.

Patient demographics were similar; no significant differences were detected between the two arms at the baseline examination. The mean age of the selegiline ODT participants was 66 years, and they had been living with PD for a mean duration of 6.3 years. The mean age of the placebo participants was 64 years, with a mean duration of PD of 7.5 years.

Patients receiving selegiline ODT experienced significant reductions in the percentage of off time at both weeks four to six (P = 0.003) and at weeks 10 to 12 (P < 0.001). The total number of off hours was reduced by 2.2 hours/day from baseline, whereas the placebo group experienced a reduction of 0.6 hours/day.

Additional dyskinesia-free on time was also observed. Mean percentages of dys-kinesia-free on time during the sixth week had improved significantly by 9.5% with selegiline ODT and by 3.3% with placebo (P = 0.038). At the 12th week, an improvement of 12% in dyskinesia-free on time relative to baseline was noted, compared with a 3% change observed in patients taking placebo (P = 0.008). canadian antibiotics

The physician-rated CGI scale and the PGI scales that were used to address the control of PD symptoms were also used to evaluate secondary efficacy measurements. During weeks 10 and 12, the selegiline ODT group showed significantly improved CGI scores, compared with the placebo group (P = 0.004 and P = 0.026, respectively). Significant differences in PGI scores were observed at week four (P = 0.028) and continued throughout weeks eight to 12 (P< 0.05).

The most frequently observed adverse drug events with selegiline ODT were dizziness, dyskinesias, hallucinations, headache, and dyspepsia. Most of these side effects were reported during the first six weeks of treatment at a dose of 1.25 mg.

Overall, the authors of this placebo-controlled clinical trial suggested that se-legiline ODT was safe and effective as an adjunct therapy to levodopa in PD patients who were experiencing motor fluctuations. The percentage of offtime improved significantly in the selegiline ODT group at both weeks four to six (1.4 fewer off hours/day) and at weeks 10 to 12 and (2.2 fewer offhours/ day). trusted canadian pharmacy