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      ["post_title"]=>
      string(134) "NCT00253175 - A Comparison Of The Efficacy And Safety Of Topamax® (Topiramate) Tablets Versus Placebo For The Prophylaxis Of Migraine"
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  ["project_date_type"]=>
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  ["property_scientific_abstract"]=>
  string(1304) "Background: Topiramate is the classical first-line treatment for migraine prophylaxis. Gepants are small molecules that block the CGRP docking station or CGRP receptor, which provide preventive effects for migraine attacks. Recently, oral gepants are approved by FDA for the preventive treatment of migraine or proved to be effective. However, the comparative effectiveness between topiramate and oral gepants is unknown.

Objective: To perform a systematic review of topiramate and oral gepants for the preventive treatment of migraine and to conduct a matching adjusted indirect comparison of topiramate versus oral oral gepants.

Study design: Matching adjusted indirect comparison

Participants: diagnosed with migraine.

Main outcome measure: Change in mean monthly migraine days

Statistical analysis: We will use a matching adjusted indirect comparison model, built based on the propensity score matching method, to compare the difference in the change of mean monthly migraine days between topiramate and oral gepants. We will calculate weights for the study population from topiramate trials, and use the weights to adjust for baseline imbalance among the treatment arms. Weighted t test will be used to compare the treatment effects of topiramate and oral gepants."
  ["project_brief_bg"]=>
  string(502) "Topiramate is the classical first-line treatment for migraine prophylaxis. Oral gepants, a new class of drugs approved for the treatment of migraine, show promising treatment effects for migraine prevention. Patients with migraine, clinicians, and policymakers will be interested in the comparative effectiveness between topiramate and oral gepants which facilitates clinical decision making. Regarding the high prevalence of migraine, the general population will also be interested in this comparison."
  ["project_specific_aims"]=>
  string(197) "Hypotheses to be evaluated:

1. Oral gepants reduce more monthly migraine days than topiramate.

2. Oral gepants cause fewer adverse events than topiramate in the treatment of migraine."
  ["project_study_design"]=>
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  ["project_research_methods"]=>
  string(490) "Data source

1. A search for studies published in MEDLINE, EMBASE, CENTRAL, and Web of Science;

2. Participant-level data from YODA project will be acquired for the topiramate group;

3. Summary-level data will be acquired from the randomized controlled trials assessing the effect of oral gepants.

Inclusion/Exclusion Criteria

1. Diagnosed with migraine (with or without aura);

2. Received at least one-month treatment of topiramate or oral gepants."
  ["project_main_outcome_measure"]=>
  string(309) "Change in monthly migraine days.

The number of migraine days is an outcome that was the most frequently used in trials studying migraine prevention. The assessment period of migraine days is normally one month. The primary outcome of our study will be the change from baseline in monthly migraine days."
  ["project_main_predictor_indep"]=>
  string(570) "Main predictors.

1. Age (years). This variable will be used as a continuous outcome.

2. Proportion of females (%). The variable will be used as a number with 2 digits. For example, a trial recruiting 100 participants (70 female participants) will be recorded as 70/100=0.7.

3. Baseline migraine days (no. of days). The variable will be used as a continuous outcome, for example, 15 days/per month.

4. Previous treatments (no. of treatments). The variable will be a binary outcome (yes/no), and it will be transformed into a proportion number."
  ["project_other_variables_interest"]=>
  string(203) "1. Duration of migraine. The variable will be a continuous outcome, preferably presented as months (eg, 12 months).

2. The body mass index(BMI). The BMI index will be used as a continuous outcome."
  ["project_stat_analysis_plan"]=>
  string(1586) "1. Descriptive analysis. We will describe the distribution of the main outcome measure using mean, standard deviation, and 95%CI. We will also describe and compare the baseline characteristics of the two study populations: mean age, proportion of females, baseline migraine days, and the number of previous treatments.

2. Hypothesis testing. The hypothesis testing will have two steps, the first we will perform matching-adjusted indirect treatment comparison (MAIC), and the second we will perform multilevel network meta-regression models to incorporate data from both individual-level and summary-level datasets.

For the MAIC study, we will compare the inclusion criteria and baseline characteristics from topiramate trials and the oral gepant trials, and we will select one topiramate trial and one gepant trial in pairs.  We will use the MAIC model, developed on the basis of the propensity score matching method, to calculate the propensity scores for each participant assigned to receive topiramate. We then use the propensity scores as weights and adjust baseline imbalance, and we will perform a weighted t-test to compare the effect of topiramate versus oral gepants.

For the multi-level multilevel network meta-regression (ML-NMR) models, we will include all trials (including summary-level data from gepants trial and individual-level data from topiramate trials). We will consider running a ML-NMR model adjusting for effect-modifying covariates (the 6 predictors). The analysis will be performed in the multinma package in the R environment (R 4.1.1)."
  ["project_timeline"]=>
  string(261) "Anticipated project start date: 1 July 2022

Analysis completion date: 31 December 2022

Manuscript drafted date: 31 March 2022

First submitted for publication: 30 Apirl 2022

Date results reported back to the YODA project: 30 June 2022"
  ["project_dissemination_plan"]=>
  string(204) "The results will be submitted to a peer-reviewed journal, and if possible, be presented at a conference. Potentially suitable journals might be JAMA Neurology, Neurology, or European Journal of Neurology."
  ["project_bibliography"]=>
  string(1018) "
1. Robbins MS. Diagnosis and Management of Headache: A Review. JAMA. 2021;325(18):1874-1885. doi:10.1001/jama.2021.1640

2. Croop R, Lipton RB, Kudrow D, et al. Oral rimegepant for preventive treatment of migraine: a phase 2/3, randomised, double-blind, placebo-controlled trial. Lancet. 2021;397(10268):51-60. doi:10.1016/S0140-6736(20)32544-7

3. Ailani J, Lipton RB, Goadsby PJ, et al. Atogepant for the Preventive Treatment of Migraine. N Engl J Med. 2021;385(8):695-706. doi:10.1056/NEJMoa2035908

4. Negro A, Martelletti P. Rimegepant for the treatment of migraine. Drugs Today (Barc). 2020;56(12):769-780. doi:10.1358/dot.2020.56.12.3211624

5. Lipton RB, Croop R, Stock EG, et al. Rimegepant, an Oral Calcitonin Gene-Related Peptide Receptor Antagonist, for Migraine. N Engl J Med. 2019;381(2):142-149. doi:10.1056/NEJMoa1811090

6. Dodick DW, Lipton RB, Ailani J, et al. Ubrogepant for the Treatment of Migraine. N Engl J Med. 2019;381(23):2230-2241. doi:10.1056/NEJMoa1813049
"
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  ["project_year_access"]=>
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data partner
array(1) {
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pi country
array(1) {
  [0]=>
  string(5) "China"
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pi affil
array(1) {
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  string(8) "Academia"
}


products
array(1) {
  [0]=>
  string(7) "topamax"
}


num of trials
array(1) {
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res
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