Trajectory of treatment response in the child and adolescent migraine prevention (CHAMP) study: A randomized clinical trial

Reidy, Brooke L; Peugh, James; Hershey, Andrew D.; Coffey, Christopher S.; Chamberlin, Leigh A.; Ecklund, Dixie; Klingner, Elizabeth; Yankey, Jon; Korbee, Leslie; Porter, Linda; Kabbouche, Marielle A.; Kacperski, Joanne; Powers, Scott W.

doi:10.1177/03331024211033551

Cited by 4 publications

(5 citation statements)

References 26 publications

(30 reference statements)

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“…In addition, acknowledging the limitations of missing data, we observed that the proportion of participants reporting at least 1 headache day per week continued to decline each week over the 8-week placebo run-in period. This is consistent with the trajectory of improvement in placebo-controlled trials in this age group, 1,14,17 hence the data here support the design of having used an 8-week placebo run-in period; however, knowing that many participants dropped out during this phase, future studies (utilizing diaries with higher adherence) could examine whether a shorter duration placebo run-in phase would improve power during the randomized phase.…”

Section: A Outcome Data For Placebo Versus Melatonin Groups Combinedsupporting

confidence: 82%

“…Approximately 60%–70% of those treated with placebo can be expected to have a ≥50% reduction in their headache frequency 1 . Generally, a duration of 6–8 weeks of treatment is needed to determine whether a preventive will be effective for a child or adolescent with migraine 14 . Hence, the current study was designed with an 8‐week single‐blind placebo run‐in period with the aim of removing placebo responders before randomization.…”

Section: Discussionmentioning

confidence: 99%

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Melatonin for migraine prevention in children and adolescents: A randomized, double‐blind, placebo‐controlled trial after single‐blind placebo lead‐in

et al. 2023

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BackgroundMelatonin is effective for migraine prevention in adults. We hypothesized that melatonin would also be effective for migraine prevention in children and adolescents.MethodsThis was a randomized, double‐blind trial of melatonin (3 mg or 6 mg) versus placebo for migraine prevention in 10–17 year‐olds with 4–28/28 headache days at baseline. Participants were recruited from the UCSF Child & Adolescent Headache Program, UCSF child neurology clinic, and social media advertisements. Migraine diagnosis was confirmed by a headache specialist. Participants completed an 8‐week single‐blind placebo run‐in. Those meeting randomization criteria (≥4 headache days and ≥23/28 electronic diary entries during weeks 5–8) were randomized 1:1:1 to placebo:melatonin 3 mg:melatonin 6 mg nightly for 8 weeks. The primary outcome measure was migraine days in weeks 5–8 of randomized treatment between melatonin (combined 6 mg + 3 mg) versus placebo. We aimed to enroll n = 210.ResultsThe study closed early due to slow enrollment (n = 72). Two participants were in the single‐blind phase when the study closed, therefore the meaningful n = 70. Sixteen percent (11/70) were lost to follow‐up during the single‐blind phase. An additional 21% (15/70) did not meet randomization criteria (<4 headache days: n = 5, <23/28 diary days: n = 7, both: n = 3). Sixty‐three percent (44/70) were eligible to randomize, of whom 42 randomized (n = 14 per arm). Taking another preventive at enrollment (OR 8.3, 95% CI 1.01 to 68.9) was the only variable associated with meeting randomization criteria. Of those randomized, 91% (38/42) provided diary data in the final 4‐weeks. However, given the amount of missing data, only those with ≥21/28 diary days were analyzed—7/14 (50%) in the placebo group, and 20/28 (71%) in the melatonin groups combined. Median (IQR) migraine/migrainous days in weeks 5–8 of double‐blind treatment was 2 (1–7) in the placebo group versus 2 (1–12) in the melatonin groups combined; the difference in medians (95% CI for the difference) was 0 days (−9 to 3). There were no differences in adverse events between groups.ConclusionsWhen compared to recall at enrollment, headache days decreased across the single‐blind placebo phase and the double‐blind phase. There was no suggestion of superiority of melatonin; however, given the substantial portion of missing data, numerically higher in the placebo arm, and underpowering, this should not be interpreted as proof of inefficacy. Melatonin was generally well tolerated with no serious adverse events. Future migraine preventive trials in this age group may find this trial helpful for anticipating enrollment needs if using a single‐blind placebo run‐in. Enriching for those already on a migraine preventive may improve randomization rates in future trials, though would change the generalizability of results.

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Section: A Outcome Data For Placebo Versus Melatonin Groups Combinedsupporting

confidence: 82%

Section: Discussionmentioning

confidence: 99%

Melatonin for migraine prevention in children and adolescents: A randomized, double‐blind, placebo‐controlled trial after single‐blind placebo lead‐in

et al. 2023

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“…Eighty children and adolescents with primary headache disorders [51 females, 29 males, mean age (range) = 13.1 (6)(7)(8)(9)(10)(11)(12)(13)(14)(15)(16)(17)(18)(19) years] participated in the study. The mean age in the olfactory training group was 13.83 years and in the control group was 12.38 years (p = 0.048).…”

Section: Resultsmentioning

confidence: 99%

“…Importantly, active pharmacological treatments show more side effects, which in turn lead to restrictions in daily life, compared to placebo. Response trajectories for therapy of children and adolescents with headaches show quick improvements ( 13 ). This positive aspect regarding the therapy of young headache patients should be taken into account in treatment.…”

Section: Introductionmentioning

confidence: 99%

Olfactory training reduces pain sensitivity in children and adolescents with primary headaches

Goßrau

Zaranek²,

Klimová³

et al. 2023

Front. Pain Res.

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ObjectiveHeadache prevalence among children and adolescents has increased over the last few years. Evidence-based treatment options for pediatric headaches remain limited. Research suggests a positive influence of odors on pain and mood. We investigated the effect of repeated exposure to odors on pain perception, headache-related disability, and olfactory function in children and adolescents with primary headaches.MethodsEighty patients with migraine or tension-type headache (mean 13.1 ± 3.29 years) participated, of whom 40 underwent daily olfactory training with individually selected pleasant odors for 3 months and 40 received state-of-the-art outpatient therapy as a control group. At baseline and after a 3-month follow-up, olfactory function [odor threshold; odor discrimination; odor identification; comprehensive Threshold, Discrimination, Identification (TDI) score], mechanical detection and pain threshold (quantitative sensory testing), electrical pain threshold, patient-reported outcomes on headache-related disability [Pediatric Migraine Disability Assessment (PedMIDAS)], pain disability [Pediatric Pain Disability Index (P-PDI)], and headache frequency were assessed.ResultsTraining with odors significantly increased the electrical pain threshold compared to the control group (U = 470.000; z = −3.177; p = 0.001). Additionally, olfactory training significantly increased the olfactory function (TDI score [t(39) = −2.851; p = 0.007], in particular, olfactory threshold, compared to controls (U = 530.500; z = −2.647; p = 0.008). Headache frequency, PedMIDAS, and P-PDI decreased significantly in both groups without a group difference.ConclusionsExposure to odors has a positive effect on olfactory function and pain threshold in children and adolescents with primary headaches. Increased electrical pain thresholds might reduce sensitization for pain in patients with frequent headaches. The additional favorable effect on headache disability without relevant side effects underlines the potential of olfactory training as valuable nonpharmacological therapy in pediatric headaches.

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“…Interessanterweise gibt es in verschiedenen klinischen Studien zur Migräneprophylaxe bei Kindern und Jugendlichen ähnliche Entwicklungen der Kopfschmerzhäufigkeit. Dabei zeigt sich eine relativ zügige Reduktion der Kopfschmerzfrequenz, unabhängig von der Intervention [ 58 ]. Bisher sind die Mechanismen dieser klinisch relevanten Verbesserung noch nicht ausreichend untersucht.…”

Section: Diskussionunclassified

Gender-specific results of the Dresden children and adolescents headache program DreKiP

Zaranek,

Sobe,

Richter

et al. 2023

Schmerz

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Zusammenfassung Hintergrund Mädchen und Frauen sind häufiger von Kopfschmerzen betroffen als Jungen und Männer. Der Einfluss des Geschlechts auf die Wirksamkeit von Kopfschmerztherapien ist bisher kaum untersucht. Wir prüften geschlechterspezifische Unterschiede im ambulanten multimodalen Dresdner Kinder- und Jugendkopfschmerzprogramm DreKiP. Methoden 140 Patienten mit primären Kopfschmerzen wurden in einem 15-stündigen strukturiertem Gruppenprogramm behandelt. Zu Beginn des Programms (T0) sowie 6 (T1) und 12 Monate (T2) nach dem Ende wurden Daten zu kopfschmerzbedingter Einschränkung der Alltagsfähigkeit (PedMIDAS), Kopfschmerzfrequenz, -intensität und schmerzbedingter Alltagseinschränkung (P-PDI) erhoben. Retrospektiv wurden diese Daten für Mädchen und Jungen getrennt analysiert. Ergebnisse Von 91 Patienten (9–19 Jahre, Median = 15; 71,4 % weiblich) lagen Daten für mindestens zwei Messzeitpunkte vor. Mädchen zeigten zu allen Zeitpunkten eine signifikant höhere Kopfschmerzfrequenz als Jungen (Mediane Kopfschmerztage/letzte 3 Monate zu T0: ♀ 43, ♂ 20; T1: ♀ 32, ♂ 12; T2: ♀ 28, ♂ 9) sowie eine numerisch höhere kopfschmerzbedingte Alltagseinschränkung. Es zeigten sich signifikante Effekte über die Zeit mit Abnahme der Kopfschmerzfrequenz (F (2,88) = 5,862; p = 0,004) und Verbesserung der Alltagsfunktion (F (2,92) = 5,340; p = 0,006). Eine geschlechtsspezifische Therapieantwort zeigte sich nicht. Diskussion Therapieinhalte des DreKiP zeigten bei Mädchen und Jungen mit primären Kopfschmerzen Effekte. Höhere Kopfschmerzfrequenzen und Alltagseinschränkung bei Mädchen können vor allem hormonelle, aber auch psychosoziale Ursachen haben und sollten in Edukationsmaßnahmen aufgegriffen werden.

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Trajectory of treatment response in the child and adolescent migraine prevention (CHAMP) study: A randomized clinical trial

Cited by 4 publications

References 26 publications

Melatonin for migraine prevention in children and adolescents: A randomized, double‐blind, placebo‐controlled trial after single‐blind placebo lead‐in

Melatonin for migraine prevention in children and adolescents: A randomized, double‐blind, placebo‐controlled trial after single‐blind placebo lead‐in

Olfactory training reduces pain sensitivity in children and adolescents with primary headaches

Gender-specific results of the Dresden children and adolescents headache program DreKiP

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