i-NEED: NEw migrainE Drugs Database

Condition(s) studied

Investigational drug(s) / intervention(s)

anti-CGRP monoclonal antibodies: erenumab, fremanezumab, galcanezumab, eptinezumab

gepants: atogepant, rimegepant

combination of sumatriptan and naproxen: combination of sumatriptan and naproxen

ditan: lasmiditan

Study summary

Approved by the Food and Drug Administration (FDA) and the European Medicine Agency (EMA) starting in 2018, anti-CGRP monoclonal antibodies (anti-CGRP mAbs) represent the first true revolution in the preventive treatment of migraine due to their selectivity and specificity. To date, four anti-CGRP mAbs have been developed for the preventive treatment of migraine: eptinezumab, erenumab, fremanezumab, and galcanezumab.Anti-CGRP mAbs constitute not only the first specific and selective treatment for the prevention of migraine but also the most extensively studied pharmacological category in this field, considering the vast and complex populations examined. The clinical effects of the various mAbs are substantially comparable and are characterized by several fundamental aspects:

* High efficacy in both episodic and chronic migraine, with the presence of super-responders who experience a reduction in the average monthly number of migraine days of \>75% (or even 100%) compared to before treatment.
* Efficacy that is independent of the clinical form of migraine - with or without aura - and regardless of whether there is analgesic overuse.
* Efficacy maintained even in the presence of depressive or anxious comorbidities.
* Rapid onset of action (even more pronounced with eptinezumab), with the therapeutic effect appearing within the first week in most cases.
* Excellent tolerability with an absence of class-specific adverse events.
* Outstanding treatment adherence and a very low rate of treatment discontinuation in the long term. It should also be noted that the development of anti-drug antibodies or neutralizing antibodies to anti-CGRP mAbs is rare and does not significantly impact the efficacy or tolerability of treatment. Future clinical practice will need to clarify several additional aspects, such as: 1) whether treatment with anti-CGRP mAbs can modify the course of migraine; 2) the appropriate approach regarding any traditional preventive treatment (whether to continue or discontinue it); 3) the definition of the characteristics of non-responders; 4) the definition of patients with a delayed response to treatment.

Gepants are oral antagonists of the CGRP receptor. Among the four gepants synthesized so far (atogepant, rimegepant, ubrogepant, zavegepant), atogepant and rimegepant are currently available in Italy. Atogepant has proven to be an effective and well-tolerated option for the prevention of episodic and chronic migraines. Rimegepant is effective for both acute treatment and prevention of migraines, with a favorable safety profile and flexible oral administration. Lasmiditan is the first ditan effective for migraine attack and it represents a new therapeutic option for patients with contraindications to triptans, due to the presence of vascular risk factors, or for patients who experience undesirable side effects with these, thus increasing the therapeutic possibilities for the symptomatic treatment of migraine. The combination of sumatriptan 85 mg and naproxen sodium 500 mg is indicated for the acute treatment of migraine attacks in adult patients for whom sumatriptan monotherapy is insufficient.

Eligibility

Primary outcome measure(s)

• effectiveness of innovative drugs as migraine prophylaxis — the assessment will be conducted at 4 weeks from treatment initiation
  reduction in the number of monthly migraine days compared to the baseline average recorded in the three months preceding treatment
• effectiveness of innovative drugs as migraine prophylaxis — the assessment will be conducted at 8 weeks from treatment initiation
  reduction in the number of monthly migraine days compared to the baseline average recorded in the three months preceding treatment
• effectiveness of innovative drug as migraine prophylaxis — the assessment will be conducted at 12 weeks from treatment initiation
  reduction in the number of monthly migraine days compared to the baseline average recorded in the three months preceding treatment
• effectiveness of innovative drugs as migraine prophylaxis — the assessment will be conducted at 24 weeks from treatment initiation
  reduction in the number of monthly migraine days compared to the baseline average recorded in the three months preceding treatment
• effectiveness of innovative drugs as migraine prophylaxis — the assessment will be conducted at 48 weeks from treatment initiation
  reduction in the number of monthly migraine days compared to the baseline average recorded in the three months preceding treatment
• 2 hour-pain freedom — 2 hours
  Percentage of patients reporting complete pain relief within 2 hours after taking the innovative drug for migraine attack

Trial sites (2)

More IRCCS San Raffaele Roma trials in Italy

Other trials for the same condition