Axsome Therapeutics Announces Acceleration of MOMENTUM Phase 3 Trial of AXS-07 in Migraine
Topline results now anticipated in 2H 2019
Trial enriched with only patients with history of inadequate response to prior migraine treatments
Trial compares AXS-07 to placebo and active comparator
Trial being conducted under FDA Special Protocol Assessment (SPA)
Company to discuss development on the conference call scheduled today at
The MOMENTUM (Maximizing Outcomes in Treating Acute Migraine) Phase 3 trial is a randomized, double-blind, placebo- and active-controlled study of AXS-07 for the acute treatment of migraine, in which patients are randomized to treatment with AXS-07, rizatriptan, meloxicam, or placebo. Rizatriptan, the active comparator in the trial, is considered to be one of the most efficacious oral medications currently available for the acute treatment of migraine .
Patients enrolled in the MOMENTUM trial must have a history of inadequate response to prior acute migraine treatments, assessed using the Migraine Treatment Optimization Questionnaire (mTOQ-4). The mTOQ-4 is a validated questionnaire that assesses efficacy response to prior acute treatments based on four aspects (two-hour pain freedom, efficacy for at least 24 hours with one dose, ability to plan daily activities, and disruption of daily activities) . In addition to having a history of inadequate response, the majority of patients randomized to date in the MOMENTUM trial also report allodynia with their migraine attacks. Allodynia, which is pain from normally non-painful stimuli (such as brushing hair, wearing glasses, taking a shower, etc.), has been shown to be strongly associated with worse outcomes for pain freedom and pain relief after treatment with triptan medications [3,4].
The MOMENTUM trial is being enriched with difficult-to-treat patients because they represent a population for whom superior medicines are urgently needed. The rapid absorption and distinct dual mechanisms of action of AXS-07 provide a scientific rationale for potential success in providing relief for this more treatment resistant population. AXS-07 consists of MoSEIC™ meloxicam and rizatriptan. Meloxicam, a COX-2 preferential non-steroidal anti-inflammatory drug, is a new molecular entity for migraine enabled by Axsome’s MoSEIC™ (
“The stringent design of the MOMENTUM trial, which is enrolling a difficult-to-treat patient population and utilizing a potent active comparator, sets a high bar for the demonstration of efficacy of AXS-07,” said
Elements of the MOMENTUM Trial:
- Eligible patients are randomized in a 2:2:2:1 ratio to treatment with AXS-07, rizatriptan, meloxicam, or placebo. The target number of patients is approximately 875.
- Eligible patients must have a history of inadequate response to prior acute migraine treatments, assessed using the mTOQ-4 questionnaire.
- Co-primary endpoints are freedom from headache pain two hours after dosing, and freedom from the most bothersome migraine-associated symptom (nausea, photophobia, or phonophobia) two hours after dosing, for AXS-07 as compared to placebo.
- Superiority of AXS-07 to the rizatriptan and meloxicam arms (component contribution) will be established based on sustained freedom from headache pain from two to 24 hours after dosing.
The MOMENTUM study is being conducted pursuant to an SPA with the
Conference Call Information
Axsome will host a conference call and webcast today at
About the MOMENTUM Trial
MOMENTUM is a Phase 3, randomized, double-blind, multicenter, controlled trial to assess the efficacy and safety of AXS-07 in the acute treatment of migraine. Approximately 875 patients, with a history of inadequate response to prior migraine treatments, will be randomized in a 2:2:2:1 ratio to treatment with AXS-07, rizatriptan, meloxicam, or placebo. The two co-primary endpoints of the trial are the proportion of patients who are free from headache pain two hours after dosing, and the proportion of patients who no longer suffer from their most bothersome migraine-associated symptom (nausea, photophobia, or phonophobia) two hours after dosing, for AXS-07 as compared to placebo.
Over 37 million Americans suffer from migraine according to the
AXS-07 is a novel, oral, investigational medicine with distinct dual mechanisms of action under development for the acute treatment of migraine. AXS-07 consists of MoSEIC™ meloxicam and rizatriptan. Meloxicam is a new molecular entity for migraine enabled by Axsome’s MoSEIC (
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Forward Looking Statements
Certain matters discussed in this press release are “forward-looking statements”. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. In particular, the Company’s statements regarding trends and potential future results are examples of such forward-looking statements. The forward-looking statements include risks and uncertainties, including, but not limited to, the success, timing and cost of our ongoing clinical trials and anticipated clinical trials for our current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials, futility analyses and receipt of interim results, which are not necessarily indicative of the final results of our ongoing clinical trials, and the number or type of studies or nature of results necessary to support the filing of a new drug application (“NDA”) for any of our current product candidates; our ability to fund additional clinical trials to continue the advancement of our product candidates; the timing of and our ability to obtain and maintain
Senior Vice President, Operations
Source: Axsome Therapeutics, Inc.