Efficacy of galcanezumab in patients with episodic cluster headaches and a history of preventive treatment failure

2021 ◽  
Vol 4 ◽  
pp. 251581632110156
Author(s):  
Brian Plato ◽  
J Scott Andrews ◽  
Mallikarjuna Rettiganti ◽  
Antje Tockhorn-Heidenreich ◽  
Jennifer Bardos ◽  
...  
Keyword(s):  
Cluster Headache ◽  
Treatment Failure ◽  
Preventive Treatment ◽  
Mean Difference ◽  
Least Square ◽  
Double Blind Study ◽  
Double Blind ◽  
Cluster Headache Attack ◽  
Episodic Cluster Headache ◽  
History Of

Objective: The efficacy of galcanezumab was evaluated in patients with episodic cluster headache and history of preventive treatment failure. Methods: In the randomized, 8-week, double-blind study (CGAL), patients with episodic cluster headache received once-monthly subcutaneous injections of galcanezumab 300 mg or placebo. Patients who completed CGAL and enrolled in an open-label study were queried for preventive treatment history. In a subset of patients with a known history of failure of verapamil or any other prior preventive treatment, a post hoc analysis of least square mean change from baseline in weekly cluster headache attack frequency across Weeks 1 to 3 was assessed. Results: Fifteen patients provided data for known history of prior preventive treatment failure (6 placebo, 9 galcanezumab), of whom 11 failed verapamil. The mean reduction in the weekly frequency of cluster headache attacks was greater with galcanezumab compared to placebo among patients with prior preventive treatment failure (8.2 versus 2.4); mean difference 5.8 (95% confidence interval [CI] 2.0, 13.6) and among patients with verapamil failure (10.1 versus 1.6); mean difference 8.5 (95% CI 0.4, 16.7). Conclusion: In this exploratory analysis of patients with a known history of prior preventive treatment failures, treatment with galcanezumab resulted in greater mean reductions in weekly cluster headache attacks compared with placebo. ClinicalTrials.gov: NCT02397473 (I5Q-MC-CGAL) NCT02797951 (I5Q-MC-CGAR)

Verapamil in the prophylaxis of episodic cluster headache: A double-blind study versus placebo

Neurology ◽  
2000 ◽  
Vol 54 (6) ◽  
pp. 1382-1385 ◽  
Author(s):  
M. Leone ◽  
D. D'Amico ◽  
F. Frediani ◽  
F. Moschiano ◽  
L. Grazzi ◽  
...  
Keyword(s):  
Cluster Headache ◽  
Blind Study ◽  
Double Blind Study ◽  
Double Blind ◽  
Episodic Cluster Headache

Oxybutynin Efficacy in the Treatment of Primary Enuresis

PEDIATRICS ◽  
1988 ◽  
Vol 82 (1) ◽  
pp. 104-106
Author(s):  
John S. Lovering ◽  
Susan E. Tallett ◽  
James B. J. McKendry
Keyword(s):  
Urinary Tract ◽  
Side Effects ◽  
Treatment Period ◽  
Nocturnal Enuresis ◽  
Drug Regimen ◽  
Double Blind Study ◽  
Double Blind ◽  
History Of ◽  
Clinic Population ◽  
Or History

The effectiveness of oxybutynin in the treatment of primary enuresis was evaluated in a double-blind study. A total of 30 children (25 boys, five girls), at least 6 years of age, with primary enuresis and no daytime incontinence or history of other urinary tract problems were selected at random from an enuresis clinic population. The study was explained to the families and they were told how to keep records of nocturnal bed-wetting episodes and side effects. The patients were treated with a 10 mg of oxybutynin at suppertime for 28 days. Before or after the treatment period, all children received an identical placebo for 4 weeks. Two-sided paired t tests were used to compare frequency of nocturnal enuresis. Frequency during the drug regimen did not differ significantly from that during the placebo study. There were no differences in findings between boys and girls or between children who had previously taken imipramine and those who had not. The study showed no evidence that oxybutynin is effective in treating primary enuresis.

Psychophysiologic Changes accompanying Oral Contraceptive Use

1970 ◽  
Vol 116 (531) ◽  
pp. 165-167 ◽  
Author(s):  
David B. Marcotte ◽  
Francis J. Kane ◽  
Paul Obrist ◽  
Morris A. Lipton
Keyword(s):  
Oral Contraceptive ◽  
Contraceptive Use ◽  
Emotional Reactions ◽  
Temporal Association ◽  
Double Blind Study ◽  
Double Blind ◽  
Premenstrual Tension ◽  
The Past ◽  
Oral Contraceptive Use ◽  
History Of

There have been many studies (3,15,4) on the effects of oral contraceptive hormonal agents, though relatively few have concerned themselves with the possible adverse emotional reactions accompanying their use. To date, seven women (8, 6, 5, 13) have had psychotic episodes in temporal association with drug use, one patient having reported two such episodes. Four of these seven women had a history of severe postpartum disturbance in the past, and two others had previous psychiatric illness. There have been reports of varying incidence of depression, anxiety, increased or decreased sexual desire and relief of premenstrual tension. We wish to present data from a pilot double blind study of one combination oral contraceptive.

Fatal Cardiac Event following Initiation of Risperidone Therapy

1997 ◽  
Vol 31 (7-8) ◽  
pp. 867-870 ◽  
Author(s):  
Donna S. Ravin ◽  
James W. Levenson
Keyword(s):  
Electrical Activity ◽  
Pulseless Electrical Activity ◽  
Chronic Schizophrenia ◽  
Double Blind Study ◽  
Qtc Interval ◽  
Cardiac Events ◽  
Double Blind ◽  
Case Summary ◽  
Adverse Cardiac Events ◽  
History Of

OBJECTIVE: To describe a patient who developed fatal pulseless electrical activity following treatment with risperidone. CASE SUMMARY: A 34-year-old white woman with no history of cardiac disease was initiated on risperidone therapy for an acute exacerbation of chronic schizophrenia. The patient developed postural hypotension and the risperidone dosage was held at 2 mg bid. On day 5 of risperidone therapy, the patient developed cardiac arrest and was treated for pulseless electrical activity. Her electrocardiogram revealed a prolonged QRS interval of 160 msec and an abnormal QTc interval of 480 msec. Despite resuscitative efforts, the patient became asystolic and was pronounced dead. DISCUSSION: Adverse cardiac events are rarely associated with risperidone therapy. Prolongation of the QRS and QTc intervals have been reported to occur following two cases of presumed risperidone overdose and also in 8 of 380 patients in a double-blind study reported by the manufacturer. Although other possibilities exist, risperidone cannot be ruled out as the cause of this patient's fatal episode of pulseless electrical activity. CONCLUSIONS: Prolongation of the QTc interval with severe adverse effects remains a possibility with the use of risperidone.

Increased VIP levels in peripheral blood outside migraine attacks as a potential biomarker of cranial parasympathetic activation in chronic migraine

Cephalalgia ◽  
2014 ◽  
Vol 35 (4) ◽  
pp. 310-316 ◽  
Author(s):  
Eva Cernuda-Morollón ◽  
Pablo Martínez-Camblor ◽  
Rocío Alvarez ◽  
Davinia Larrosa ◽  
César Ramón ◽  
...  
Keyword(s):  
Cluster Headache ◽  
Chronic Migraine ◽  
Peripheral Blood ◽  
Preventive Treatment ◽  
Episodic Migraine ◽  
Healthy Women ◽  
Symptomatic Medication ◽  
Episodic Cluster Headache ◽  
Potential Biomarker ◽  
The Right

Aim The aim of this article is to determine vasoactive intestinal peptide (VIP) levels outside migraine attacks in peripheral blood as a potential biomarker for chronic migraine (CM). Methods Women older than 17 and diagnosed as CM were recruited. Matched healthy women with no headache history and women with episodic migraine (EM) served as control groups, together with a series of patients with episodic cluster headache in a pain-free period. VIP levels were determined in blood samples obtained from the right antecubital vein by ELISA outside a migraine attack, the patients having taken no symptomatic medication the day before. For ethical reasons, preventives were not stopped. Results We assessed plasma samples from 119 women with CM, 33 healthy women, 51 matched women with EM and 18 patients (16 males) with cluster headache matched for age. VIP levels were significantly increased in CM (165.1 pg/ml) as compared to control healthy women (88.5 pg/ml) and episodic cluster headache patients (101.1 pg/ml). VIP levels in EM (134.9 pg/ml) were significantly higher compared to controls and numerically lower than those of CM. Thresholds of 71.8 and 164.5 pg/ml optimized the sensitivity and specificity to differentiate CM from healthy controls and EM, respectively. Variables such as age, CM duration, the presence of aura, analgesic overuse, depression, fibromyalgia, vascular risk factors, history of triptan consumption or kind of preventive treatment did not significantly influence VIP levels. Conclusion Increased interictal VIP level measured in peripheral blood could be a biomarker helping in CM diagnosis, though it does not clearly differentiate between EM and CM.

Double-Blind Placebo-Controlled Trial of Lithium in Episodic Cluster Headache

Cephalalgia ◽  
1997 ◽  
Vol 17 (6) ◽  
pp. 673-675 ◽  
Author(s):  
TJ Steiner ◽  
R Hering ◽  
EGM Couturier ◽  
PTG Davies ◽  
TE Whitmarsh
Keyword(s):  
Cluster Headache ◽  
Sequential Analysis ◽  
Lithium Treatment ◽  
Controlled Trial ◽  
Placebo Response ◽  
Lithium Carbonate ◽  
Double Blind ◽  
Improvement Rate ◽  
Double Blind Placebo ◽  
Episodic Cluster Headache

Lithium is widely used in the prophylaxis of episodic cluster headache without formal evidence of efficacy. Placebo-controlled clinical trials are not easy in conditions characterized by frequent severe pain. In this study, it was assumed that lithium would work quickly if at all, and placebo response would be zero. Strict diagnostic criteria excluded uncertain or atypical cases Patients were male in so-far untreated episodes expected to last for at least 3 weeks more. In a double-blind, placebo-controlled comparison of matched parallel groups, treatment was either slow-release lithium carbonate, 800 mg/day, or placebo. After 7 days, compliance was estimated by tablet count, blood was taken for lithium assay, efficacy was assessed (attacks stopped or substantially improved) and adverse reactions were recorded. The study was stopped after planned sequential analysis of the 27th patient (13 on lithium, 14 on placebo). Estimated compliance was usually but not always good. Plasma lithium levels were mostly in the range 0.5–0.6 mmol/1 on lithium, zero on placebo. Cessation of attacks within 1 week occurred in two patients in each group, substantial improvement in 6/14 (43%) on placebo, 8/13 (62%; NS) on lithium. Only minor adverse events were reported. Lithium treatment was therefore associated with a useful subjective improvement rate but the assumptions made at outset had proved wrong. The trial was stopped because superiority over placebo could not be demonstrated. There were lessons for future trials. □ Episodic cluster headache, lithium, placebo response, randomized controlled trial, treatment

scholarly journals Oxytocin amplifies sex differences in human mate choice

2018 ◽  
Author(s):  
Lei Xu ◽  
Benjamin Becker ◽  
Ruixue Luo ◽  
Xiaoxiao Zheng ◽  
Weihua Zhao ◽  
...  
Keyword(s):  
Sex Differences ◽  
Mate Choice ◽  
Sexual Relationships ◽  
Blind Study ◽  
Double Blind Study ◽  
Short Term ◽  
Double Blind ◽  
Oxytocin Release ◽  
History Of

AbstractInfidelity is the major cause of breakups and individuals with a history of infidelity are more likely to repeat it, but may also present a greater opportunity for short-term sexual relationships. Here in a pre-registered, double-blind study involving 160 subjects we report that while both sexes valued faithful individuals most for long-term relationships, both single men and those in a relationship were more interested in having short-term relationships with previously unfaithful individuals than women. Oxytocin administration resulted in men rating the faces of unfaithful women as more attractive but in women rating those of unfaithful men as less attractive and also finding them less memorable. Oxytocin also increased men’s interest in having short-term relationships with previously unfaithful women whereas it increased women’s interest in having long-term relationships with faithful men. Thus, oxytocin release during courtship may first act to amplify sex-dependent priorities in attraction and mate choice before subsequently promoting romantic bonds.

Abstract 2114: Antihypertensive Efficacy And Cerebral Hemodynamic Advantage Of Olmesartan Medoxomil Compared With Amlodipine In Post-stroke Patients

Circulation ◽  
2007 ◽  
Vol 116 (suppl_16) ◽  
Author(s):  
Shuji Matsumoto ◽  
Megumi Shimodozono ◽  
Ryuji Miyata ◽  
Kazumi Kawahira
Keyword(s):  
Blood Pressure ◽  
Blood Pressure Monitoring ◽  
Antihypertensive Agents ◽  
Olmesartan Medoxomil ◽  
Antihypertensive Efficacy ◽  
Double Blind Study ◽  
List Type ◽  
Double Blind ◽  
Hypertensive Patients ◽  
History Of

In patients with severe hypertension, chronic heart failure or a history of stroke, the lower limit of autoregulation of cerebral blood flow (CBF) is shifted to higher levels of blood pressure (BP) than those observed in healthy subjects. The effects of anigiotensin II receptor blocker (ARB) on cerebral hemodynamics in humans have not been well elucidated. The antihypertensive efficacy of ARB olmesartan medoxomil (olmesartan) has been shown to compare favourably with that of other antihypertensive agents. We objected: To compare the effects of olmesartan and amlodipine on 24-h ambulatory blood pressure monitoring (ABPM); To compare the advantage of CBF of olmesartan and amlodipine on xenon-computed tomography (Xe-CT) after administration of either drug for 8 weeks. 24 hypertensive patients who had an episode of stroke more than 4 weeks previously were recruited for this randomized double-blind study. Olmesartan 10 –20mg (12 patients) or amlodipine 2.5–5mg (12 patients) was administered once daily for 8 weeks. During 24-h monitoring, both drugs caused a decrease in systolic BP of 14 mmHg, and caused a decrease in diastolic BP of 8 mmHg. The Xe-CT results indicated that the increase of CBF of olmesartan was 3.3 ± 1.1 ml/min/100g and that of amlodipine was 0.2 ± 1.3 ml/min/100g. Thus, despite the reduction in BP, CBF was significantly increased in olmesartan group compared with amlodipine group. We consider the use of olmesartan is advantageous for hypertensive patients with a history of stroke in whom autoregulation of CBF is potentially impaired.

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