INTERCEPT: Initiating Early Control of Migraine Pain and Associated Symptoms
Sponsor
Axsome Therapeutics, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT04163185
Collaborator
(none)
302
41
2
5.5
7.4
1.3
Study Details
Study Description
Brief Summary
AXS-07 is an oral, investigational medicine consisting of MoSEIC meloxicam and rizatriptan, which is being developed for the acute treatment of migraine with or without aura in adults. AXS-07 tablets are formulated to provide an enhanced rate of absorption of meloxicam. This study is designed to evaluate the efficacy and safety of AXS-07 compared to placebo.
This is a randomized, double-blind, single-dose, placebo-controlled trial. Subjects who successfully complete the screening period and continue to meet all entry criteria will be randomly assigned to take one dose of either AXS-07 or placebo upon the earliest onset of migraine pain.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
302 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Randomized, Double-blind, Single-dose, Placebo-controlled Study to Assess the Efficacy and Safety of AXS-07 (Meloxicam and Rizatriptan) for the Acute Treatment of Migraine in Adults
Actual Study Start Date
:
Oct 8, 2019
Actual Primary Completion Date
:
Mar 23, 2020
Actual Study Completion Date
:
Mar 23, 2020
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: AXS-07 Taken once upon migraine |
Drug: AXS-07 (MoSEIC meloxicam and rizatriptan)
AXS-07 tablet taken once upon the earliest onset of migraine pain.
|
| Placebo Comparator: Placebo Taken once upon migraine |
Drug: Placebo
Placebo tablet taken once upon the earliest onset of migraine pain.
|
Outcome Measures
Primary Outcome Measures
- Percentage of subjects reporting headache pain freedom [Hour 2]
Absence of headache pain
- Percentage of subjects with absence of Most Bothersome Symptom [Hour 2]
Absence of Most Bothersome Symptom, defined at the onset of migraine
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Key Inclusion Criteria:
• Has an established diagnosis of migraine with or without aura.
Key Exclusion Criteria:
-
Has previously received any investigational drug or device or investigational therapy within 30 days before Screening.
-
Pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Clinical Research Site | Birmingham | Alabama | United States | 35205 |
| 2 | Clinical Research Site | Birmingham | Alabama | United States | 35216 |
| 3 | Clinical Research Site | Mobile | Alabama | United States | 36608 |
| 4 | Clinical Research Site | Colton | California | United States | 92399 |
| 5 | Clinical Research Site | Encino | California | United States | 91316 |
| 6 | Clinical Research Site | Los Alamitos | California | United States | 90720 |
| 7 | Clinical Research Site | Los Angeles | California | United States | 90017 |
| 8 | Clinical Research Site | Redlands | California | United States | 92374 |
| 9 | Clinical Research Site | Santa Monica | California | United States | 90404 |
| 10 | Clinical Research Site | Spring Valley | California | United States | 91978 |
| 11 | Clinical Research Site | Walnut Creek | California | United States | 94598 |
| 12 | Clinical Research Site | Hallandale Beach | Florida | United States | 33009 |
| 13 | Clinical Research Site | Jacksonville | Florida | United States | 32256 |
| 14 | Clinical Research Site | Lake City | Florida | United States | 32055 |
| 15 | Clinical Research Site | Lake Worth | Florida | United States | 33467 |
| 16 | Clinical Research Site | Ocoee | Florida | United States | 34761 |
| 17 | Clinical Research Site | Orlando | Florida | United States | 32801 |
| 18 | Clinical Research Site | Ormond Beach | Florida | United States | 32174 |
| 19 | Clinical Research Site | South Miami | Florida | United States | 33143 |
| 20 | Clinical Research Site | Sunrise | Florida | United States | 33351 |
| 21 | Clinical Research Site | Tampa | Florida | United States | 33634 |
| 22 | Clinical Research Site | Stockbridge | Georgia | United States | 30281 |
| 23 | Clinical Research Site | Evanston | Illinois | United States | 60201 |
| 24 | Clinical Research Site | Louisville | Kentucky | United States | 40213 |
| 25 | Clinical Research Site | Boston | Massachusetts | United States | 02131 |
| 26 | Clinical Research Site | Waltham | Massachusetts | United States | 02451 |
| 27 | Clinical Research Site | Ann Arbor | Michigan | United States | 48104 |
| 28 | Clinical Research Site | Springfield | Missouri | United States | 65810 |
| 29 | Clinical Research Site | Albuquerque | New Mexico | United States | 87102 |
| 30 | Clinical Research Site | Manlius | New York | United States | 13104 |
| 31 | Clinical Research Site | Williamsville | New York | United States | 14221 |
| 32 | Clinical Research Site | High Point | North Carolina | United States | 27262 |
| 33 | Clinical Research Site | Oklahoma City | Oklahoma | United States | 73106 |
| 34 | Clinical Research Site | Philadelphia | Pennsylvania | United States | 19114 |
| 35 | Clinical Research Site | Charleston | South Carolina | United States | 29406 |
| 36 | Clinical Research Site | Mount Pleasant | South Carolina | United States | 29464 |
| 37 | Clinical Research Site | Memphis | Tennessee | United States | 38119 |
| 38 | Clinical Research Site | Nashville | Tennessee | United States | 37203 |
| 39 | Clinical Research Site | Austin | Texas | United States | 78731 |
| 40 | Clinical Research Site | Salt Lake City | Utah | United States | 84107 |
| 41 | Clinical Research Site | Charlottesville | Virginia | United States | 22911 |
Sponsors and Collaborators
- Axsome Therapeutics, Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Axsome Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT04163185
Other Study ID Numbers:
- AXS-07-303
First Posted:
Nov 14, 2019
Last Update Posted:
Apr 30, 2021
Last Verified:
Apr 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Axsome Therapeutics, Inc.
Additional relevant MeSH terms: