A long-term open-label study of oral almotriptan 12.5 mg for the treatment of acute migraine

OBJECTIVE: Evaluate the long-term tolerability of almotriptan 12.5 mg for the treatment of acute migraine attacks occurring over a 6-month period. BACKGROUND: Almotriptan is a second-generation 5-HT(1B/1D) agonist that exhibits vascular selectivity for meningeal arteries and has demonstrated efficacy for the treatment of acute migraine in short-term controlled trials. METHODS: This was a 6-month open-label study. Adults (18 years of age or older) were required to have a diagnosis of acute migraine with or without aura (according to the diagnostic criteria of the International Headache Society), a history of at least 1 year of moderate-to-severe migraine pain with at least two and a maximum of six migraines per month, and at least 24 hours of freedom from head pain between attacks. Patients were instructed to take a single 12.5-mg dose of almotriptan at the onset of a migraine attack. If migraine pain did not disappear in 2 hours, escape medication could be taken; if relapse occurred in less than 24 hours, a second 12.5-mg dose could be taken. Tolerability was assessed from the nature and incidence of all adverse events, and efficacy was assessed according to the end point of pain relief 2 hours following almotriptan administration. RESULTS: Of 585 patients treated, 582 were included in the intent-to-treat population. The most frequent drug-related adverse events were nausea (3.1%) and dizziness (2.4%). No serious drug-related adverse events were reported, and no deaths occurred. Adverse events led to discontinuation of treatment in 36 patients (6.2%). Drug-related chest pain was reported in 9 patients (1.5%). Seventy-six percent of patients achieved pain relief at 2 hours for all attacks treated, and 49% were pain-free at 2 hours. After a second dose of almotriptan 12.5 mg, pain relief was achieved in 87% of attacks, and 59% were pain-free. Pain relief and pain-free rates were higher among those with moderate baseline pain. CONCLUSIONS: When taken at attack onset, almotriptan 12.5 mg is well tolerated, safe, and effective for the long-term treatment of acute migraine.     

Lower cervical disc prolapse may cause cervicogenic headache: prospective study in patients undergoing surgery

In 1983 Sjaastad published for the first time diagnostic criteria for cervicogenic headache. Until now there have been no prospective studies investigating whether cervical disc prolapse can cause cervicogenic headache. Between July 2002 and July 2003 50 patients with cervical disc prolapse proven by computed tomography, myelography or magnetic resonance imaging were recruited and prospectively followed for 3 months. Patients were asked at different time points about headache and neck pain by questionnaires and structured interviews. These data were collected prior to and 7 and 90 days after surgery for the disc prolapse. Fifty patients with lumbar disc prolapse, matched for age and sex, undergoing surgery were recruited as controls. Headache and neck pain was diagnosed according to International Headache Society (IHS) criteria. Twelve of 50 patients with cervical disc prolapse reported new headache and neck pain. Seven patients (58%) fulfilled the 2004 IHS criteria for cervicogenic headache. Two of 50 patients with lumbar disc prolapse had new headaches. Their headaches did not fulfil the criteria for cervicogenic headache. One week after surgery, 8/12 patients with cervical disc prolapse and headache reported to be pain free. One patient was improved and three were unchanged. Three months after cervical prolapse surgery, seven patients were pain free, three improved and two unchanged. This prospective study shows an association of low cervical prolapse with cervicogenic headache: headache and neck pain improves or disappears in 80% of patients after surgery for the cervical disc prolapse. These results indicate that pain afferents from the lower cervical roots can converge on the cervical trigeminal nucleus and the nucleus caudalis.     

French general practitioners' management of children's migraine headaches

OBJECTIVES: This study sought to examine the treatment of children with migraine headaches in a prospective sample of children referred to a tertiary center for headaches. BACKGROUND: Despite the wide diffusion of guidelines for headache management in children, their application in general practice is far from optimal. METHODS: This prospective study analyzed previous headache treatment by general practitioners in 151 consecutive children (F/M: 0.82; mean age 10.4 +/- 3.2 years) referred for migraines to the Lille University Hospital Neuropediatric department between October 1, 2003, and November 30, 2005. The physician completed a questionnaire according to the parents' responses to questions about previous advice about life-style adjustments (diet, exercise, and sleep hygiene) and abortive and prophylactic treatment. Questions about abortive treatment covered ergot derivatives, triptans, and 3 aspects of ibuprofen use-appropriate dose (ie, more than 7.5 mg/kg), recommendation to administer the drug early in attacks, and warnings about drug abuse. Under the topic of prophylactic treatment, we asked about information from general practitioners about preventive therapy and advice to keep a headache diary. RESULTS: Fewer than 15% of patients had received advice about life-style adjustments. Only 30.3% had received ibuprofen at a correct dose (more than 7.5 mg/kg); only 26.5% were told to use it early during the headache; and only 9.1% were warned about drug abuse. Ergot derivatives were prescribed to 4.6% of children and triptans to 9.1%. Families of 17.9% reported that the general practitioners gave them information about prophylactic treatment. Only 8.0% were advised to keep a headache diary. CONCLUSION: This study shows the need to increase the role and the involvement of family doctors in the management of primary headache in children in general, and of pediatric migraine in particular.     

Preventive Effects of Hyperbaric Oxygen in Cluster Headache

The effect of a 2-week course of hyperbaric oxygen on both the duration and frequency of cluster headache attacks was tested in four patients suffering from chronic cluster headache with no clear response to pharmacological treatments. Two patients (two courses in one case) dramatically improved while on hyperbaric oxygen treatment, this positive response remaining for 2 and 31 days posttreatment. Case 3 only improved in frequency, while the remaining patient showed no benefit. These findings suggest that daily hyperbaric oxygen treatment can be used as a transient preventive treatment for desperate cluster headache sufferers.     

An MMPI Control Study: Chinese Migraineurs During Frequent Headache Attack Intervals

The investigation of personality traits of migraineurs with the Minnesota Multiphasic Personality Inventory (MMPI) is an important line of research, but so far has led to diverse conclusions. In this study, the MMPI (Chinese edition) responses of 50 Chinese subjects (10 men, 40 women) with migraine (4 migraine with aura, 46 without aura), during frequent headache attacks were compared with 30 nonheadache healthy control subjects (6 men, 24 women). Statistical analysis was made between the two groups. The results revealed that subjects in the migraine group had significantly higher scores on subtests of neurotic, (hypochondriasis, depression, hysteria, and psychasthenia), schizophrenia, and social introversion ( P <0.05 to 0.001). Utilizing the American T-score, we found the migraine group's MMPI profile was a typical 1.2.3.7 model. These results suggest migraineurs with frequent headache attacks have multiphasic personality abnormalities and partial cerebral function disturbances.     

Relaxation treatment of adolescent headache sufferers: results from a school-based replication series

BACKGROUND: In recent reviews of psychological and drug treatment, relaxation training approaches have been found to be efficacious for children and adolescents suffering from recurrent tension-type headache (TTH), while biofeedback procedures provide effective help for migraine headache sufferers, primarily treated in tertiary clinics. OBJECTIVE: In a school-based replication series, the effectiveness and efficiency of relaxation training provided within school settings were examined, in addition to the effects on various headache features and the maintenance of treatment gains at a 6 to 10-month follow-up. METHODS: Over a 20-year period, 288 adolescents aged 10 to 18 years participated in seven randomized, controlled trials conducted within regular school health service settings. Subjects were included if they had suffered from frequent migraine or TTHs, or from both headache types for at least 1 year. Various formats of standardized relaxation training procedures were contrasted to different attention-control (ATCO) approaches or self-monitoring (SM) of headaches in prospective diary recordings. RESULTS: The results showed that a therapist-administered relaxation approach was superior to self-help or school-nurse administered relaxation training approaches, ATCO conditions or SM of headaches. Students with TTHs responded positively to any form of relaxation training, whereas those with frequent migraine responded well only to therapist-administered relaxation. However, school-nurse administered procedures were found to be the most efficient form of relaxation treatment, in particular for adolescents suffering from TTHs. Total headache activity, the number of headache days and peak headache intensity were significantly reduced after relaxation treatment, in addition to medication usage. Treatment gains were well maintained at the 6 to 10-month follow-up. CONCLUSION: Therapist-assisted relaxation training is an effective treatment for adolescents suffering from frequent TTHs or migraine. However, such treatment administered by school-nurses administered within school health care settings is an efficient treatment approach for adolescents suffering from the most common form of primary headache, ie, TTHs.     

Frequent triptan use: observations on safety issues

OBJECTIVE: To examine the safety of frequent triptan use over extended periods. For a small group of patients with refractory migraine plus chronic daily headache, triptans are effective. METHODS: This retrospective study primarily evaluated the cardiac safety of daily triptan use in 118 patients and, in addition, hematologic tests were assessed. Each patient had utilized a triptan for a minimum of 4 days per week for at least 6 months. Patients with rebound headache had been withdrawn from the triptans. Most patients (97 of 118) averaged 1 tablet daily; most would occasionally go for several days without a triptan. Forty patients had taken a triptan for 6 months to 2 years, 37 patients from 2 to 4 years, and 41 for 4 or more years. RESULTS: Routine hematologic tests were performed periodically on all patients, and no abnormalities were attributable to triptans. Almost all patients had an electrocardiogram, and no abnormal electrocardiograms were felt to be related to triptans. Cardiac echocardiography was performed in 57 patients. The 10 abnormal echocardiograms were not due to triptans. All 20 cardiac stress tests revealed normal findings. Adverse events were minimal; 9 patients described fatigue due to triptans, and 5 had mild chest tightness. CONCLUSION: This long-term study of 118 patients indicates that frequent triptan use may be relatively safe.     

Short-lasting, Unilateral, Neuralgiform Headache Attacks with Conjunctival Injection and Tearing (SUNCT Syndrome): IV. Respiratory sinus arrhythmia during and outside paroxysms

SUNCT is a headache syndrome characterized by short-lasting (usually 15-120 sec), unilateral head pain paroxysms localized in the peri-ocular area, accompanied by conjunctival injection, lacrimation, nasal stuffiness, rhinorrhea, and subclinical forehead sweating, all on the symptomatic side. A relative bradycardia seems to be an integral part of the paroxysm; a parasympathetic stimulation could theoretically be the causative factor for the bradycardia. In 3 SUNCT patients, vagal nerve function (E:I ratio) has been monitored outside and during pain paroxysms, while 3 other patients could be studied in the attack-free period only. E:I ratio is obtainable in the course of a maximally deep breath and represents the ratio of the longest R-R interval during a 5 sec long expiration to the shortest R-R interval during a 5 sec long expiration. The mean E:I ratio of SUNCT patients outside paroxysms was significantly higher than the mean E:I ratio in an aged-matched control group. The E:I ratio was, however, significantly decreased during paroxysms in comparison with ratios obtained outside the pain paroxysms. After 0.6 mg atropine administration s.c. to one of the patients in the symptomatic phase, the heart rate increased, and the relative bradycardia during headache paroxysm was diminished (but not completely abolished). The E:I ratio was lowered but it was still slightly larger outside than during attacks. The reason for the abrupt and seemingly clear attack-related decrement in E:I ratio together with the previously described relative bradycardia remains enigmatic, however the possibility of increased parasympathetic tone cannot be excluded.     

Children's ibuprofen suspension for the acute treatment of pediatric migraine

OBJECTIVE: To compare the efficacy of a single over-the-counter dose (7.5 mg/kg, p.o.) of children's ibuprofen suspension vs. placebo for the acute treatment of pediatric migraine. BACKGROUND: Migraine occurs in 4% of young children. There is a paucity of controlled clinical research in the treatment of childhood migraine and there are currently no approved drugs in the USA for treatment of migraine in children < or = 12 years of age. The purpose of this study is to assess the efficacy and tolerability of a single OTC dose of ibuprofen suspension for the acute treatment of childhood migraine. METHODS: Prospective, double-blind, placebo-controlled, parallel group, randomized study of children 6-12 yrs with migraine (I.H.S.-R 1997) treating 1 attack with a 7.5 mg/kg liq. ibuprofen vs matching placebo. Efficacy measures: (1). Headache severity based upon a 4 pt scale (severe, mod., mild, no headache) at 30, 60, 90, 120, 180 and 240 minutes post dose, and (2). nausea, vomiting, and photo/phonophobia at 120 min. The 1 degrees endpoint was cumulative % of responders (severe or mod. headache reduced to mild or none) by 120 minutes. Secondary endpoints were headache recurrence within 4-24 hours and need for rescue medicines within 4 hours. RESULTS: 138 enrolled; 84 treated/completed diary. 45 active agent, 39 placebo. The 2 groups were comparable (active: placebo) - Ages: 9: 9.1, gender boy/girl - 1.25: 1.6, and diagnosis: migraine w/o aura - 86%: 79%. Concomitant use of prophylactic Rx: 24%: 10% (Table 3). Nausea was eliminated in 60% of the ibuprofen treated patients and 39% of the placebo group (p<0.001). Vomiting, photophobia and phonophobia had marginal, but not statistically significant, decreases at 2 hours. A striking gender difference was noted (Table 4): No AE's were reported. CONCLUSION: Children's ibuprofen suspension at an OTC dose of 7.5 mg/kg is an effective and well-tolerated agent for pain relief in the acute treatment of childhood migraine, particularly in boys. There is a striking difference in gender response rates and placebo responder rates between girls and boys. The boys responded at a statistically significant rate, and girls failed to do so because of a very high placebo responder rate. Multi-center trials are recommended.