CLINICAL TRIALS PROFILE FOR ADVIL MIGRAINE LIQUI-GELS
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505(b)(2) Clinical Trials for Advil Migraine Liqui-gels
| Trial Type | Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|---|
| OTC | NCT01687101 ↗ | STOPAIN in the Treatment of a Single Migraine Attack | Completed | Thomas Jefferson University | N/A | 2012-05-01 | This is an open label pilot study of 25 subjects with a diagnosis of episodic migraine with or without aura. STOPAIN is an over-the-counter product that is used for the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises and sprains. We plan to have subjects apply the product during a single migraine attack to see if it will alleviate the headache pain and associated symptoms. |
| >Trial Type | >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
All Clinical Trials for Advil Migraine Liqui-gels
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00004654 ↗ | Phase III Randomized, Placebo-Controlled, Crossover Study of Soy Protein Isolate for Hereditary Hemorrhagic Telangiectasia | Completed | Yale University | Phase 3 | 1996-01-01 | OBJECTIVES: I. Evaluate migraine prophylaxis with soy protein isolate in patients with hereditary hemorrhagic telangiectasia. II. Assess whether soy protein isolate reduces the frequency and severity of epistaxis and gastrointestinal bleeding in these patients. |
| NCT00004654 ↗ | Phase III Randomized, Placebo-Controlled, Crossover Study of Soy Protein Isolate for Hereditary Hemorrhagic Telangiectasia | Completed | National Center for Research Resources (NCRR) | Phase 3 | 1996-01-01 | OBJECTIVES: I. Evaluate migraine prophylaxis with soy protein isolate in patients with hereditary hemorrhagic telangiectasia. II. Assess whether soy protein isolate reduces the frequency and severity of epistaxis and gastrointestinal bleeding in these patients. |
| NCT00055484 ↗ | A Study to Measure the Safety and Effectiveness of Zonisamide in Subjects With Migraine Headache | Completed | Elan Pharmaceuticals | Phase 2 | 2002-03-01 | The purpose of this study is to determine if zonisamide is effective as a preventative medication for individuals with migraine headache. |
| NCT00069355 ↗ | Propranolol for the Treatment of Acute Stress Disorder | Completed | National Institute of Mental Health (NIMH) | Phase 2 | 2003-09-01 | This 10-week study will examine whether propranolol, a medication that blocks the activity of the stress hormones adrenaline and noradrenaline, can relieve acute stress disorder (ASD) and symptoms from persisting long-term. ASD is a condition that some people develop soon after exposure to trauma. They may be anxious, depressed, have trouble sleeping, startle easily, have difficulties concentrating, and feel as though the event is happening again. Propranolol has been used for many years to treat high blood pressure and heart disease, and has been found useful in treating anxiety states such as social phobia and migraine. Men and women between 18 and 65 years of age who were recently exposed to trauma (between 1 and 3 weeks of evaluation in this study) may be eligible for this study. Candidates must be diagnosed with ASD and must have been mentally healthy before the traumatic event. They will be screened for the study with a medical and psychiatric interview, physical examination, electrocardiogram (EKG), and blood and urine tests. Participants will be evaluated with the following procedures: - Neuropsychological tests using pen-and-paper and computer tests to evaluate cognitive function, particularly memory, learning, attention and concentration, and vocabulary and naming. - Emotion-related performance tasks to determine if the study medication can weaken emotionally arousing information by blocking the activity of adrenaline and noradrenaline. Subjects perform emotion-related and neutral tasks, such as looking at pictures with neutral, pleasant, or unpleasant content, both before and after treatment with the study medication (see below). - Traumatic script exposure: Subjects recount the traumatic event that caused them to develop ASD. The description is summarized, recorded, and played back to the subject. During the playback, physiological responses, such as heart rate and skin conductance (sweating), are recorded using electrodes taped to the hand and chest. - Fear conditioning to evaluate the response to an unpleasant stimulus: Several mild electrical shocks are delivered to the wrists while the subject looks at colored squares. Heart rate and skin conductance are measured. - Magnetic resonance imaging (MRI) to examine brain structure. The subject lies on a table that is moved into the MRI scanner (a narrow cylinder containing a strong magnetic field) and must remain still during the actual scanning. Earplugs are worn to muffle loud noises caused by electrical switching of radio frequency circuits used in the scanning process. After the evaluation, participants are randomly assigned to receive either propranolol or placebo (a look-alike pill with no active ingredient) for 8 weeks During this time they are seen by a doctor once a week for 4 weeks and then once every other week for the rest of the study. At the end of the 8-week treatment period, participants undergo the same evaluation they had before beginning treatment (see above). The decision to continue treatment will then be decided based on the individual's clinical condition and whether he or she received propranolol or placebo. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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