European neurology
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Randomized Controlled Trial Multicenter Study Clinical Trial Controlled Clinical Trial
Studies to assess if pizotifen prophylaxis improves migraine beyond the benefit offered by acute sumatriptan therapy alone.
Two multi-centre studies-one double-blind, placebo-controlled (study 1) and one open (study 2)-were set up to assess if pizotifen prophylaxis improved migraine beyond the benefit offered by acute sumatriptan therapy alone. Eighty-eight patients completed the blinded study and 63 patients completed the open study. Both studies were of crossover design with patients undertaking a 4 week run-in period prior to a 12-week treatment period. ⋯ In these studies, where the average number of migraine attacks was around 4 per month, the benefits conferred by pizotifen were at the expense of the adverse events associated with the drug, particularly weight gain. Therefore the clinical benefit of treatment with pizotifen for patients who have less than 4 attacks per month should be carefully reviewed as acute treatment with sumatriptan may be the most appropriate treatment. Pizotifen may be better reserved for those patients who have 4 of more attacks per month.
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Review Randomized Controlled Trial Clinical Trial
The clinical profile of sumatriptan: cluster headache.
Cluster headache is a rare form of severe idiopathic headache characterized by unilateral short-lasting episodes of excruciating pain in association with autonomic disturbances. Subcutaneous sumatriptan has been investigated as an acute treatment for cluster headache in two randomized, double-blind, placebo-controlled, crossover trials. ⋯ The need for rescue medication (100% oxygen by inhalation) at 15 min was significantly lower after sumatriptan treatment as were the severity of functional disability and incidence of non-headache symptoms. Results of a long-term study indicate that the tolerability and efficacy of sumatriptan 6 mg is maintained in long-term use, and that there is no evidence of tachyphylaxis.
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Randomized Controlled Trial Multicenter Study Comparative Study Clinical Trial
An interim report of the effect of selegiline (L-deprenyl) on the progression of disability in early Parkinson's disease. The Parkinson Study Group.
The pathogenesis of Parkinson's disease (PD) has been linked to oxidative-mediated events including increased monoamine oxidase (MAO) and free-radical generation. We are investigating the ability of the MAO inhibitor, selegiline (deprenyl), and of the free-radical scavenger, tocopherol, to delay the onset of disability requiring levodopa therapy (primary end point) in patients with early PD. Eight hundred patients with early, untreated PD were enrolled in the multi-center placebo-controlled, double-blind clinical trial 'Deprenyl and Tocopherol Antioxidative Therapy of Parkinsonism (DATATOP)'. ⋯ We conclude from these preliminary results that selegiline (10 mg/day) delays the onset of disability associated with early, otherwise untreated PD. It remains unclear whether these benefits derive from mechanisms that are symptomatic (dopaminergic), protective (anti-neurotoxic), or both. The DATATOP study is ongoing to examine the long-term effects of selegiline and the independent and interactive effects of tocopherol.
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Randomized Controlled Trial Multicenter Study Comparative Study Clinical Trial
A study to compare oral sumatriptan with oral aspirin plus oral metoclopramide in the acute treatment of migraine. The Oral Sumatriptan and Aspirin plus Metoclopramide Comparative Study Group.
In a double-blind, placebo-controlled study, the efficacy, safety and tolerability of 100 mg oral sumatriptan, given as a dispersible tablet, was compared with that of 900 mg oral aspirin plus 10 mg oral metoclopramide in the acute treatment of migraine. A total of 358 patients treated up to three migraine attacks within 3 months, recording clinical information on a diary card. In attack 1, headache relief after 2 h, defined as a reduction in severity from severe or moderate pain to mild or no pain, was recorded in 56% (74/133) of patients who took sumatriptan and 45% (62/138) of patients who took aspirin plus metoclopramide (p = 0.078). ⋯ Rescue medication was required by fewer patients treated with sumatriptan than by those who received aspirin plus metoclopramide (attack 1, 34 versus 56%, p less than 0.001; attack 2, 32 versus 51%, p = 0.001, and attack 3, 35 versus 54%, p = 0.001). Sumatriptan also produced a faster improvement and resolution of migraine attacks. Comparing the sumatriptan and aspirin plus metoclopramide treatment groups, complete resolution of the attack occurred within 6 h in 32 versus 19% (attack 1), 35 versus 23% (attack 2) and 32 versus 20% of patients (attack 3).(ABSTRACT TRUNCATED AT 250 WORDS)
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Randomized Controlled Trial Multicenter Study Comparative Study Clinical Trial
A randomized, double-blind comparison of sumatriptan and Cafergot in the acute treatment of migraine. The Multinational Oral Sumatriptan and Cafergot Comparative Study Group.
The efficacy and safety of oral sumatriptan as a 100-mg dispersible tablet was compared with oral Cafergot (2 mg ergotamine tartrate, 200 mg caffeine) in a multicentre, randomized, double-blind, double-dummy, parallel-group trial. In the trial, 580 patients were treated from 47 investigating centres in nine European countries. Sumatriptan was significantly more effective than Cafergot at reducing the intensity of headache from severe or moderate to mild or none; 66% (145/220) of those treated with sumatriptan improved in this way by 2 h, compared with 48% (118/246) of those treated with Cafergot (p less than 0.001). ⋯ The most commonly reported events in the sumatriptan-treated patients were malaise or fatigue and bad taste; these were generally mild and transient. Nausea and/or vomiting, abdominal discomfort, and dizziness or vertigo were reported by a greater proportion of Cafergot-treated patients. It is concluded that oral sumatriptan was well tolerated and is a more effective acute treatment for migraine than Cafergot.