TOP-PRO study: A randomized double-blind controlled trial of topiramate versus propranolol for prevention of chronic migraine

Cephalalgia ◽  
2021 ◽  
pp. 033310242110474
Author(s):  
Debashish Chowdhury ◽  
Luv Bansal ◽  
Ashish Duggal ◽  
Debabrata Datta ◽  
Ankit Mundra ◽  
...  
Keyword(s):  
Adverse Events ◽  
Chronic Migraine ◽  
Virus Disease ◽  
Controlled Trial ◽  
Preventive Treatment ◽  
Point Estimate ◽  
Tolerability Profile ◽  
Double Blind ◽  
Significant Difference ◽  
The Mean

Objective The aim of the TOP-PRO-study, a double-blind randomized controlled trial, was to assess the efficacy (non-inferiority) and tolerability of propranolol compared to topiramate for the prevention of chronic migraine. Background Except for topiramate, oral preventive treatment for chronic migraine lacks credible evidence. Methods Chronic migraine patients aged above 18 years and less than 65 years of age, not on any preventive treatment were randomly allocated to receive topiramate (100 mg/day) or propranolol (160 mg/day). The primary efficacy outcome was the mean change in migraine days per 28 days at the end of 24 weeks from baseline. A mean difference of 1.5 days per four weeks was chosen as the cut-off delta value. Multiple secondary efficacy outcomes and treatment emergent adverse events were also assessed. Results As against the planned sample size of 244, only 175 patients could be enrolled before the spread of the corona virus disease-2019 pandemic and enforcement of lockdown in India. Of the 175 randomized patients, 95 (topiramate 46 and propranolol 49) completed the trial. The mean change in migraine days was −5.3 ± 1.2 vs −7.3 ± 1.1 days (p = 0.226) for topiramate and propranolol groups respectively. Propranolol was found to be non-inferior and not superior to topiramate (point estimate of −1.99 with a 95% confidence interval of −5.23 to 1.25 days). Multiple secondary outcomes also did not differ between the two groups. Intention to treat analysis of 175 patients and per-protocol analysis of 95 patients yielded concordant results. There was no significant difference in the incidence of adverse events between the two groups. Conclusion Propranolol (160mg/day) was non-inferior, non-superior to topiramate (100mg/day) for the preventive treatment of chronic migraine and had a comparable tolerability profile. Trial Registration: Clinical Trials Registry-India CTRI/2019/05/018997)

Intravenous Tranexamic Acid for Brain Contusion with Intraparenchymal Hemorrhage: Randomized, Double‐Blind, Placebo-Controlled Trial

2020 ◽  
Vol 15 (1) ◽  
pp. 70-75 ◽  
Author(s):  
Maryam Mousavinejad ◽  
Javad Mozafari ◽  
Reza Bahrami Ilkhchi ◽  
Mohammad Ghasem Hanafi ◽  
Pouya Ebrahimi
Keyword(s):  
Tranexamic Acid ◽  
Brain Injuries ◽  
Controlled Trial ◽  
Intraparenchymal Hemorrhage ◽  
Double Blind ◽  
Brain Contusion ◽  
Significant Difference ◽  
Brain Ct Scan ◽  
Hemorrhage Volume ◽  
The Mean

Introduction: Controlling of secondary traumatic brain injuries (TBI) is necessary due to its salient effect on the improvement of patients with TBI and the final outcomes within early hours of trauma onset. This study aims to investigate the effect of intravenous tranexamic acid (TAX) administration on decreased hemorrhage during surgery. Methods: This double-blind, randomized, and placebo-controlled trial was conducted on patients referring to the emergency department (ED) with IPH due to brain contusion within 8 h of injury onset. The patients were evaluated by receiving TXA and 0.9% normal saline as a placebo. The following evaluation and estimations were performed: intracranial hemorrhage volume after surgery using brain CT-scan; hemoglobin (Hb) volume before, immediately after, and six hours after surgery; and the severity of TBI based on Glasgow Coma Score (GCS). Results: 40 patients with 55.02 ± 18.64 years old diagnosed with a contusion and intraparenchymal hemorrhage. Although the (Mean ± SD) hemorrhage during surgery in patients receiving TXA (784.21 ± 304.162) was lower than the placebo group (805.26 ± 300.876), no significant difference was observed between two groups (P=0.83). The (Mean ± SD) Hb volume reduction immediately during surgery (0.07 ± 0.001 and 0.23 ± 0.02) and six hours after surgery (0.04 ± 0.008 and 0.12 ± 0.006) was also lower in TXA group but had no significant difference (P = 0.89 and P = 0.97, respectively). Conclusion: Using TXA may reduce the hemorrhage in patients with TBI, but this effect, as in this study, was not statistically significant and it is suggested that a clinical trial with a larger population is employed for further investigation.

Topiramate Reduces Headache Days in Chronic Migraine: A Randomized, Double-Blind, Placebo-Controlled Study

Cephalalgia ◽  
2007 ◽  
Vol 27 (7) ◽  
pp. 814-823 ◽  
Author(s):  
H-C Diener ◽  
G Bussone ◽  
JC Van Oene ◽  
M Lahaye ◽  
S Schwalen ◽  
...  
Keyword(s):  
Chronic Migraine ◽  
Medication Overuse ◽  
Controlled Trial ◽  
Double Blind ◽  
Baseline Phase ◽  
Double Blind Placebo ◽  
The Mean ◽  
Intent To Treat ◽  
Treat Population

The aim of this study was to evaluate the efficacy and tolerability of topiramate for the prevention of chronic migraine in a randomized, double-blind, placebo-controlled trial. Chronic migraine is a common form of disabling headache presenting in headache subspecialty practice. Preventive treatments are essential for chronic migraine management, although there are few or no controlled empirical trial data on their use in this patient population. Topiramate is approved for the prophylaxis of migraine headache in adults. Patients (18–65 years) who experienced chronic migraine (defined as ≥15 monthly migraine days) for ≥3 months prior to trial entry and had ≥12 migraine days during the 4–week (28–day) baseline phase were randomized to topiramate or placebo for a 16–week, double-blind trial. Topiramate was titrated (25 mg weekly) to a target dose of 100 mg/day, allowing dosing flexibility from 50 to 200 mg/day, according to patient need. Existing migraine preventive treatments, except for antiepi-leptic drugs, were continued throughout the trial. The primary efficacy measure was the change in number of migraine days from the 28–day baseline phase to the last 28 days of the double-blind phase in the intent-to-treat population, which consisted of all patients who received at least one dose of study medication and had one outcome assessment during the double-blind phase. Health-related quality of life was evaluated with the Migraine Specific Quality of Life Questionnaire (MSQ, Version 2.1), the Headache Impact Test (HIT-6) and the Migraine Disability Assessment (MIDAS) questionnaires, and tolerability was assessed by adverse event (AE) reports and early trial discontinuations. Eighty-two patients were screened. Thirty-two patients in the intent-to-treat population (mean age 46 years; 75% female) received topiramate (mean modal dose ± SD = 100 ± 17 mg/day) and 27 patients received placebo. Mean (±SD) baseline number of migraine days per 4 weeks was 15.5 ± 4.6 in the topiramate group and 16.4 ± 4.4 in the placebo group. Most patients (78%) met the definition for acute medication overuse at baseline. The mean duration of treatment was 100 and 92 days for topiramate- and placebo-treated patients, respectively. Study completion rates for topiramate- and placebo-treated patients were 75% and 52%, respectively. Topiramate significantly reduced the mean number of monthly migraine days (±SD) by 3.5 ± 6.3, compared with placebo (-0.2 ± 4.7, P < 0.05). No significant intergroup differences were found for MSQ and HIT-6. MIDAS showed improvement with the topiramate treatment group (P = 0.042 vs. placebo). Treatment emergent adverse events were reported by 75% of topiramate-treated patients (37%, placebo). The most common AEs, paraesthesia, nausea, dizziness, dyspepsia, fatigue, anorexia and disturbance in attention, were reported by 53%, 9%, 6%, 6%, 6%, 6% and 6% of topiramate-treated patients, respectively, vs. 7%, 0%, 0%, 0%, 0%, 4% and 4% of placebo-treated patients. This randomized, double-blind, placebo-controlled trial demonstrates that topiramate is effective and reasonably well tolerated when used for the preventive treatment of chronic migraine, even in the presence of medication overuse.

Synbiotic supplementation is not effective on breast milk selenium concentrations and growth of exclusively breast fed infants: a pilot study

2019 ◽  
Vol 89 (1-2) ◽  
pp. 73-79 ◽  
Author(s):  
Leila Nikniaz ◽  
Reza Mahavi ◽  
Alireza Ostadrahimi ◽  
Zeinab Nikniaz ◽  
Sharare Taghipour
Keyword(s):  
Pilot Study ◽  
Breast Milk ◽  
Graphite Furnace ◽  
Controlled Trial ◽  
Study Groups ◽  
Z Score ◽  
Double Blind ◽  
Significant Difference ◽  
The Mean ◽  
Synbiotic Supplementation

Abstract. In this randomized, double-blind, placebo-controlled trial, 57 lactating mothers were randomly allocated into two groups to receive a daily supplement of synbiotic (n = 30) which contained different probiotic strains (2.0 × 108 CFU) and fructooligosaccharide (394 mg) or a placebo (n = 27) for 30 days. Dietary intake was collected from lactating women by 24-hour recall method. Breast milk selenium contents were determined by atomic absorption spectrometry with graphite furnace. Weight for age Z-score (WAZ) and Height for age Z-score (HAZ) were evaluated for infants. Data analyses were assessed using nutritionist IV, Epi Info and SPSS software and presented as mean ± sd or SEM. The total mean breast milk selenium levels were 50.1 ± 16.1 mcg L−1. At the baseline, the mean breast milk selenium concentrations in the synbiotic and placebo groups were 51.7 ± 20.2 and 48.5 ± 12.1 mcg L−1. The mean breast milk selenium levels increased and decreased in the symbiotic and placebo groups respectively, which were not significant (p > 0.05). Also, comparison of the changes in breast milk selenium concentration showed no significant difference between the two study groups after the intervention. At the baseline, the mean WAZ and HAZ of infants whose mothers’ milk selenium was more than 60 mcg/l was significantly (P < 0.05) higher than for others. In this pilot study, no significant effect was observed by synbiotic supplementation, however, for concise conclusion, more human studies with higher doses of supplements and longer duration of supplementation are needed to determine the effects of synbiotic supplementation on breast milk selenium contents and infants’ growth.

The effects of a multispecies probiotic supplement on inflammatory markers and episodic and chronic migraine characteristics: A randomized double-blind controlled trial

Cephalalgia ◽  
2019 ◽  
Vol 39 (7) ◽  
pp. 841-853 ◽  
Author(s):  
Fahimeh Martami ◽  
Mansoureh Togha ◽  
Maryam Seifishahpar ◽  
Zeinab Ghorbani ◽  
Hossein Ansari ◽  
...  
Keyword(s):  
Placebo Group ◽  
Chronic Migraine ◽  
Inflammatory Markers ◽  
Controlled Trial ◽  
Double Blind ◽  
Necrosis Factor Alpha ◽  
Probiotic Group ◽  
Mean Frequency ◽  
The Mean ◽  
Episodic Migraineurs

Background The current study was designed to assess the effect of supplementation with a 14-strain probiotic mixture on episodic and chronic migraine characteristics. Methods Forty episodic and 39 chronic migraine patients who completed this randomized double-blind controlled trial received two capsules of multispecies probiotic or placebo. The migraine severity was assessed by visual analog scale (VAS). The number of abortive drugs consumed, migraine days, frequency and duration of attacks were recorded on paper-based headache diaries. Serum tumor necrosis factor alpha (TNF-α) and C- reactive protein (CRP) levels were measured at baseline and the end of the intervention. Results After a 10-week intervention, among episodic migraineurs the mean frequency of migraine attacks significantly reduced in the probiotic group compare to the placebo group (mean change: −2.64 vs. 0.06; respectively, p < 0.001). A significant reduction was also evident in the migraine severity (mean decrease: −2.14 in the probiotic group and 0.11 in the placebo group; p < 0.001). Episodic migraineurs who received the probiotic also showed significant reduction in abortive drug usage per week (mean change: −0.72; p < 0.001) compare to baseline, while there was no significant changes within the placebo group. In chronic migraine patients, after an 8-week intervention, the mean frequency of migraine attacks significantly reduced in the probiotic compared to the placebo group (mean change: −9.67 vs. −0.22; p ≤ 0.001). In contrast to the placebo, probiotic supplementation significantly decreased the severity (mean changes: −2.69; p ≤ 0.001), duration (mean changes: −0.59; p ≤ 0.034) of attacks and the number of abortive drugs taken per day (mean changes: −1.02; p < 0.001), in chronic migraine patients. We failed to detect any significant differences in the serum levels of inflammatory markers at the end of the study either in chronic or in episodic migraineurs. Discussion The results of this study showed that the 14-strain probiotic mixture could be an effective and beneficial supplement to improve migraine headache in both chronic and episodic migraineurs. Further research is required to confirm our observations.

scholarly journals Therapeutic Effect of Electrical Stimulation on Chronic Tinnitus: A Double Blind Randomized Controlled Trial

2020 ◽  
Author(s):  
Vahid Zand ◽  
Abolfazl Mollasadeghi ◽  
Mohammad Ansari ◽  
Mohammad Hossein Baradaranfar ◽  
Amir Houshang Mehrparvar
Keyword(s):  
Electrical Stimulation ◽  
Therapeutic Effect ◽  
Controlled Trial ◽  
Chronic Tinnitus ◽  
Control Group ◽  
Case Group ◽  
Medical Sciences ◽  
Double Blind ◽  
Significant Difference ◽  
The Mean

Chronic tinnitus is a disturbing condition that may affect different aspects of life. In this study, the therapeutic effect of electrical stimulation on chronic tinnitus was assessed. This was a clinical trial on 49 patients with persistent tinnitus for more than 6 months without a proper response to routine treatments. They were randomly allocated into two groups: the case group was treated with electrical stimulation for 6 sessions over 6 consecutive days, and the control group received a placebo. Before the intervention, one week and three months after the treatment sessions, patients were evaluated by comprehensive audiological assessments and hearing tests. The mean age of the participants was 40.37±9.32 and 41.35±9.24 in treatment and placebo groups, respectively. Tinnitus intensity was significantly decreased in the case group one week and three months after the treatment (P<0.05). Tinnitus handicap inventory score significantly decreased in the treatment group one week and three months after the treatment (P<0.05). There was no significant difference in tinnitus intensity after treatment, considering gender, age, tinnitus duration, and tinnitus type. Electrical stimulation could significantly reduce the severity of the tinnitus regardless of age, gender, duration, and type of tinnitus. © 2020 Tehran University of Medical Sciences. All rights reserved. Acta Med Iran 2020;58(1):4-8.

Transcranial Direct Current Stimulation for Treatment-Resistant Major Depression: A Double-Blind Randomized Sham-Controlled Trial

2019 ◽  
Vol 50 (6) ◽  
pp. 375-382 ◽  
Author(s):  
Elham Sharafi ◽  
Arsia Taghva ◽  
Mohammad Arbabi ◽  
Afsaneh Dadarkhah ◽  
Jamshid Ghaderi
Keyword(s):  
Major Depression ◽  
Direct Current ◽  
Transcranial Direct Current Stimulation ◽  
Controlled Trial ◽  
Active Group ◽  
Treatment Resistant ◽  
Double Blind ◽  
Direct Current Stimulation ◽  
Significant Difference ◽  
The Mean

In the current study, we tried to evaluate the effect of transcranial direct current stimulation (tDCS) on treatment-resistant major depression. We carried out a double-blind randomized sham-controlled trial was conducted in University Hospitals. Individuals with less than 50% decrease in the intensity of depression after 8 weeks of treatment with selective serotonin reuptake inhibitors were recruited. Thirty patients (16 women) with a mean (SD) age of 47.2 (12.0) years were randomly allocated to 2 groups. For the active group we administered 2-mA stimulation 20 minutes for each session, with 30 seconds ramp-up from 0 and 30 seconds ramp-down. For the sham group we administered 30 seconds ramp-up to 2 mA, 10 seconds stimulation, 30 seconds ramp-down, and 20 minutes no current. The anode was fixed on the center of F3, and the cathode on F4, over the dorsolateral prefrontal cortex. We assessed the Hamilton Depression Rating Scale at the baseline (mean difference = 1.0, P = .630), at the last session of tDCS, and at 1-month postintervention. There were statistically significant differences in the mean Hamilton scores after the intervention, and 1 month later in favor of active group; P < .001, and P = .003, respectively. Mixed analysis of variance showed a significant difference in the mean scores for active group P = .010 and pattern of change during the study P < .001 in favor of active intervention. We concluded that tDCS is an efficient therapy for patients with resistant major depression, and the benefits would remain at least for 1 month.

scholarly journals Efficacy of Ginger in Ameliorating Acute and Delayed Chemotherapy-Induced Nausea and Vomiting Among Patients With Lung Cancer Receiving Cisplatin-Based Regimens: A Randomized Controlled Trial

2018 ◽  
Vol 17 (3) ◽  
pp. 747-754 ◽  
Author(s):  
Xiangfeng Li ◽  
Ying Qin ◽  
Wei Liu ◽  
Xiao-yu Zhou ◽  
Ya-nan Li ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Adverse Events ◽  
Patient Adherence ◽  
Controlled Trial ◽  
Nausea And Vomiting ◽  
Antiemetic Therapy ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Significant Difference ◽  
Delayed Nausea

Nausea and vomiting are among the most common and distressing side effects of chemotherapy. Additional antiemetic drugs are urgently needed to effectively manage and ameliorate chemotherapy-induced nausea and vomiting (CINV). The efficacy of ginger as an antiemetic modality for ameliorating CINV has not been established in previous studies. The aim of this study was to examine the efficacy of ginger, as an adjuvant drug to standard antiemetic therapy, in ameliorating acute and delayed CINV in patients with lung cancer receiving cisplatin-based regimens. In this randomized, double-blind, placebo-controlled clinical trial, 140 patients with lung cancer receiving cisplatin-based regimens were enrolled and allocated to receive either ginger root powder or a placebo. Ginger root powder was administered orally (0.5 g, 2 capsules per day, 0.25 g per capsule, every 12 hours) for 5 days beginning on the first day of chemotherapy. The incidence and severity of acute and delayed nausea and vomiting were assessed using the MASCC (Multinational Association for Supportive Care in Cancer) Antiemesis Tool (MAT). Adverse effects and patient adherence were also assessed in this study. No significant difference was observed between the ginger and control groups in the reduction of the incidence and severity of nausea and vomiting ( P > .05). No significant difference in adverse events was observed between the 2 groups ( P > .05). No study-treatment-related adverse events were observed in this study. As an adjuvant drug to standard antiemetic therapy, ginger had no additional efficacy in ameliorating CINV in patients with lung cancer receiving cisplatin-based regimens.

scholarly journals Cyclamen europaeum nasal spray, a novel phytotherapeutic product for the management of acute rhinosinusitis: a randomized double-blind, placebo-controlled trial

2012 ◽  
Vol 50 (1) ◽  
pp. 37-44
Author(s):  
O. Pfaar ◽  
J. Mullol ◽  
C. Anders ◽  
K. Hörmann ◽  
L. Klimek
Keyword(s):  
Adverse Events ◽  
Nasal Spray ◽  
Facial Pain ◽  
Controlled Trial ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Acute Rhinosinusitis ◽  
Significant Difference ◽  
Symptom Scores ◽  
Change In Mean

Aim: To evaluate the efficacy and safety of a phytotherapeutic nasal spray containing Cyclamen europaeum (CE) in the treatment of acute rhinosinusitis (ARS). Material/methods: We performed a randomized, double-blind, placebo-controlled trial of CE nasal spray once daily for 15 days in 99 adult patients with moderate-to-severe ARS who also received amoxicillin 500 mg three times daily for the first 8 days. The primary endpoint was the change in mean total symptom scores (TSS) on day 7. Secondary endpoints included individual symptom scores (nasal congestion, mucus secretion, facial pain, impairment of smell) and endoscopic findings on days 7 and 15 and others. Results: No statistically significant difference in TSS was noted for CE versus placebo on day 7. Moreover, the individual scores were not statistically different between the groups for the ITT-population on day 7. However, both a reduction in facial pain and an improvement in endoscopically-assessed mucosal obstruction significantly favoured CE on day 7. The most common adverse events were nasal burning and mild epistaxis, but no severe adverse events were documented. Conclusion: In summary, this is the first randomized controlled trial on phytotherapy in patients with moderate-to-severe ARS demonstrating clinical safety and some encouraging effects of CE which merit to investigate phytotherapeutic products in further large-scale clinical trials.

scholarly journals Escitalopram add-on in stable Schizophrenia with subsyndromal depression

2020 ◽  
Vol 7 (2) ◽  
pp. 211
Author(s):  
Anil Nischal ◽  
Pooja Singh ◽  
Manu Agarwal ◽  
Anuradha Nischal ◽  
Bandna Gupta ◽  
...  
Keyword(s):  
Mental Illness ◽  
Placebo Group ◽  
Depressive Symptoms ◽  
Adverse Events ◽  
Controlled Trial ◽  
Significant Proportion ◽  
Anti Psychotic ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Significant Difference

Background: Significant proportion of the patients of schizophrenia suffer from subsyndromal symptomatic depressive symptoms (SSD) which not only add to the burden of disease but also to the already pre-existing challenges of living with this serious mental illness. Many psychiatrists prescribe antidepressants to patients with schizophrenia who have subsyndromal symptomatic depressive symptoms but data regarding SSD in schizophrenia is meagre. Aim was to study the effect of addition of Escitalopram on psychopathology, cognition and functioning in patients with stable schizophrenia having subsyndromal depressive symptoms and to compare these parameters with patients treated with antipsychotics alone.Methods: The study was a prospective, 8-week randomized double-blind placebo-controlled trial. Seventy four patients who fulfilled the diagnostic criteria of Schizophrenia on the basis of the ICD10-DCR, adjudged to be stable clinically and not requiring any increase in dose of antipsychotic medication over the last eight weeks were recruited into the study. The patients randomly received either Antipsychotics with add-on Escitalopram (10 mg/day) or Antipsychotics with placebo for 8 weeks. The patients were assessed using the HAM-D, CDRS, PANSS, SCoRS, SOFAS and CGI scores at the end of 8 weeks. Patients were also assessed for adverse events at baseline, week 4 and week 8.Results: A total of sixty-six patients who completed the study were analyzed. The HAM-D, CDRS and PANSS score  showed significantly better cognition and functioning in the patients of add-on Escitalopram group when compared with the placebo group. There was no significant difference between the two groups in terms of observed side effects.Conclusions: Escitalopram addition to the standard anti-psychotic treatment of schizophrenia, in patients having subsyndromal depressive symptoms, results in better cognition and improved functioning.

scholarly journals Efficacy and safety of fremanezumab in clinical trial participants aged ≥60 years with episodic or chronic migraine: pooled results from 3 randomized, double-blind, placebo-controlled phase 3 studies

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Stephanie J. Nahas ◽  
Steffen Naegel ◽  
Joshua M. Cohen ◽  
Xiaoping Ning ◽  
Lindsay Janka ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Adverse Events ◽  
Chronic Migraine ◽  
Preventive Treatment ◽  
Efficacy And Safety ◽  
Phase 3 ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Link Type ◽  
Trial Participants

Abstract Background Although migraine is less common in older people, preventive treatment of migraine in these individuals may be more challenging due to the presence of multiple comorbidities and polypharmacy. Additionally, evidence for migraine treatment efficacy, safety, and tolerability is limited in this population. We evaluated efficacy, safety, and tolerability of fremanezumab, a fully humanized monoclonal antibody (IgG2Δa) that selectively targets calcitonin gene–related peptide (CGRP), in clinical trial participants aged ≥60 years with episodic migraine (EM) or chronic migraine (CM). Methods This analysis included data from 3 randomized, double-blind, placebo-controlled phase 3 studies: the HALO EM study, HALO CM study, and FOCUS study in participants with EM or CM and prior inadequate response to 2–4 migraine preventive medication classes. Participants in all studies were randomized 1:1:1 to receive 12 weeks of subcutaneous treatment with quarterly fremanezumab (Months 1/2/3: EM/CM, 675 mg/placebo/placebo), monthly fremanezumab (Months 1/2/3: EM, 225 mg/225 mg/225 mg; CM, 675 mg/225 mg/225 mg), or matched monthly placebo. Results These pooled analyses included 246 participants aged ≥60 years. Reductions in monthly migraine days from baseline over 12 weeks were significantly greater with fremanezumab (least-squares mean change from baseline [standard error]: quarterly fremanezumab, − 4.3 [0.59]; monthly fremanezumab, − 4.6 [0.54]) versus placebo (placebo, − 2.3 [0.57]; both P < 0.01 vs placebo). As early as Week 1, significant reductions from baseline in weekly migraine days were observed with fremanezumab versus placebo (both P < 0.01). With fremanezumab treatment versus placebo, a significantly higher proportion of participants achieved ≥50% reduction in monthly migraine days, and significant improvements in disability and quality-of-life outcomes were observed (P < 0.05). Proportions of participants experiencing serious adverse events and adverse events leading to discontinuation were low and similar in the fremanezumab and placebo groups. Efficacy and safety results were comparable to the overall pooled population (N = 2843). Conclusions This pooled subgroup analysis demonstrates that fremanezumab treatment is efficacious and well-tolerated over 12 weeks in participants aged ≥60 years with EM or CM. These data may help healthcare providers with clinical decision making and preventive treatment selection for older patients with migraine. Trial registration ClinicalTrials.gov identifiers: HALO CM: NCT02621931; HALO EM: NCT02629861; FOCUS: NCT03308968.

Sign in / Sign up

Export Citation Format

Share Document