Migraine Clinical Trial
Official title:
A Comparison of the Efficacy and Safety of ULTRACET® (Tramadol HCl/Acetaminophen) Versus Placebo for the Acute Treatment of Migraine Headache Pain
The purpose of this study is to evaluate the effectiveness and safety of tramadol HCl/acetaminophen as a pain medication compared with placebo in the treatment of acute pain from a migraine headache. Although tramadol HCl/acetaminophen is approved to treat acute pain, it is not approved for the treatment of acute pain associated with migraine headache. The study hypothesis is that tramadol HCl/acetaminophen is safe and effective as a pain medication in the treatment of acute pain associated with a migraine headache.
Although new drugs and procedures are available to treat acute migraine pain, inadequacies
in treatment still exist. The ingredients in tramadol HCl/acetaminophen tablet and the way
it works may be effective in the treatment of the pain of acute migraine headache. The
combination of tramadol HCl/ acetaminophen works faster than tramadol alone and lasts longer
than acetaminophen alone. This is a multicenter, single-dose, outpatient, randomized (study
with two groups one in treatment and one control group), double-blind (neither patient nor
investigator knows which patient is receiving study drug or control treatment),
placebo-controlled, parallel-group (each group receives only one type of treatment) study of
adult patients who experience at least moderate pain from migraine headaches. After being
randomly assigned to a group patients will leave the study center with one dose (2 tablets)
of study medication, either active treatment or placebo. The next time the patient has a
migraine headache of at least moderate pain, the patient will take the study medication and
start to answer questions about their headache pain and pain relief in a study diary.
Patients should return to the study center within 72 hours of taking this dose. The study
hypothesis is that tramadol HCl/acetaminophen is safe and effective as a pain medication in
the treatment of acute pain associated with a migraine headache.
2 tramadol HCl (37.5 milligrams)/acetaminophen (325 milligrams) combination tablets or 2
matching placebo (inactive substance) tablets for tramadol HCl/acetaminophen taken one time
orally
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT05525611 -
Cabergoline as a Preventive Treatment for Chronic Migraine
|
N/A | |
| Completed |
NCT06192173 -
Patent Foramen Ovale Closure in Migraine
|
||
| 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 |