Migraine Clinical Trial
Official title:
A Randomized, Open Label, Crossover, Bioavailability Study to Compare Omexa Sumatriptan Transmucosal Sublingual Tablet Versus Commercial Imitrex® Sumatriptan Oral Tablet in Healthy Volunteers
the trial is a randomized, open label, crossover, single-administration bioavailability study to compare the pharmacokinetic parameters of Omexa sumatriptan transmucosal sublingual tablet versus commercial Imitrex® sumatriptan oral tablet in 14 healthy volunteers.
Volunteers will randomly receive either the commercial oral tablet 100 mg Imitrex® or 75 mg
Omexa sublingual tablet under fasted conditions. One week following the first
administration, the volunteers will receive the alternative treatment.
Blood samples will be collected at each visit before drug administration and at 5, 15, 30,
45, 60, 90, 120, 240, 360 and 480 min after drug administration, in order to characterize
the drug's absorption and pharmacokinetics, as well as to evaluate Omexa formulation safety.
;
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT06192173 -
Patent Foramen Ovale Closure in Migraine
|
||
| Completed |
NCT05525611 -
Cabergoline as a Preventive Treatment for Chronic Migraine
|
N/A | |
| Recruiting |
NCT03832998 -
Efficacy and Safety of Erenumab in Pediatric Subjects With Chronic Migraine
|
Phase 3 | |
| Enrolling by invitation |
NCT04196933 -
Analysis of Vestibular Compensation Following Clinical Intervention for Vestibular Schwannoma
|
N/A | |
| Not yet recruiting |
NCT06428838 -
Eptinezumab as an Adjunct to Standard of Care for Migraine in an Acute Emergency Context
|
Phase 3 | |
| Completed |
NCT06304675 -
Manageable Environmental Factors in Migraine
|
||
| Completed |
NCT04084314 -
Assessment of Prolonged Safety and tOLerability of in Migraine Patients in a Long-term OpeN-label Study
|
Phase 4 | |
| Recruiting |
NCT05517200 -
Pilot Study for a Machine Learning Test for Migraine
|
||
| Completed |
NCT04179474 -
Safety, Tolerability and Drug- Drug Interaction Study of Ubrogepant With Erenumab or Galcanezumab in Participants With Migraine
|
Phase 1 | |
| Recruiting |
NCT04603976 -
Registry for Migraine - Clinical Core
|
Phase 4 | |
| Completed |
NCT03597529 -
CHOCOlate MeLatonin for AdolescenT MigrainE
|
Phase 2 | |
| Completed |
NCT04197349 -
Safety, Tolerability and Pharmacokinetics of ALD1910 in Healthy Men and Woman
|
Phase 1 | |
| Recruiting |
NCT05891808 -
miR-155 Expression in Episodic and Chronic Migraine
|
||
| Active, not recruiting |
NCT05064371 -
Long-Term Extension Study With Eptinezumab as Preventive Treatment in Participants With Migraine in Japan
|
Phase 3 | |
| Suspended |
NCT04069572 -
Vibratory Stimulation for the Treatment of Chronic Pain
|
N/A | |
| Not yet recruiting |
NCT04859374 -
Chronic Pain and Conditioned Pain Modulation After on Line-behavioral Approach
|
N/A | |
| Not yet recruiting |
NCT03083860 -
Evaluation of Migraine Management Mobile App Combined With Electrophysiological Measurements for Identification of Migraine Attack Risk and Beneficial Preventive Actions.
|
N/A | |
| Completed |
NCT02905227 -
A Study of the Pulmonary Safety and Pharmacokinetics of Zolmitriptan Inhalation Powder
|
Phase 1 | |
| Enrolling by invitation |
NCT02532023 -
The Combined Effects of omega3 Fatty Acids and Curcumin Supplementation on Inflammatory and Endothelial Factors in Migraine Patients
|
Phase 4 | |
| Completed |
NCT02108678 -
One-Day Intervention for Depression and Impairment in Migraine Patients
|
N/A |