Migraine Headache Clinical Trial
Official title:
A Double-Blind Placebo-Controlled Trial of Rozerem in Migraine Headaches
To study the effect of Rozerem, a high affinity MT1 and MT2, low affinity 5-HT2B receptor agonist used for insomnia, as a migraine prophylactic agent.
In a recent, large study of migraineurs, over half reported difficulties with sleep
initiation or maintenance. Those who had shorter average sleep times reported more severe
headaches. Poor sleep has been associated with increased frequency and severity of
migraines. The improvement of migraine frequency with improved sleep hygiene has been
documented.
PET imaging has shown increased regional cerebral blood flow to neural structures involved
in the sleep wake cycle during migraine headaches. Polysomnography has shown specific
headache types to occur in specific sleep stages.
Melatonin has been effective primarily in headache due to delayed sleep phase syndrome.
Recent studies support the efficacy of melatonin in treating migraine. The purpose of this
study is to examine the efficacy of Rozerem as a prophylactic migraine medication. If
effective, the benefits of the drug as a prophylactic agent for migraine include the
tolerability of the drug and the possible secondary benefit of improvement in sleep.
Hypothesis: Rozerem will decrease migraine frequency due to the improvement in sleep and
possibly due to the shared neurophysiology of sleep and migraine affected by melatonin.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04084314 -
Assessment of Prolonged Safety and tOLerability of in Migraine Patients in a Long-term OpeN-label Study
|
Phase 4 | |
| Not yet recruiting |
NCT05943457 -
Vitamin K2 Supplementation in Adult Episodic Migraine
|
N/A | |
| Completed |
NCT01211145 -
Zomig - Treatment of Acute Migraine Headache in Adolescents
|
Phase 4 | |
| Completed |
NCT00530517 -
A Study on the Usability of the Needle-free Intraject® System in Adult Patients During Acute Migraine Attack
|
Phase 2 | |
| Completed |
NCT00898677 -
Rizatriptan 5 mg and 10 mg, Sumatriptan 100 mg, and Placebo Comparison Study (0462-030)
|
Phase 3 | |
| Completed |
NCT03971071 -
A Study to Evaluate the Efficacy and Safety of Erenumab in Adults With Medication Overuse Headache
|
Phase 4 | |
| Withdrawn |
NCT02706015 -
Cefaliv® Compared to Neosaldina® in the Treatment of Migraine Attacks
|
Phase 3 | |
| Terminated |
NCT02375789 -
Intranasal Cooling for Symptomatic Relief of Migraine
|
N/A | |
| Completed |
NCT02518464 -
Ticagrelor Therapy for RefrACTORy Migraine Study
|
Phase 4 | |
| Completed |
NCT03401346 -
Bioavailability of DHE Administered by I123 POD Device, IV Injection, and Migranal Nasal Spray in Healthy Adults
|
Phase 1 | |
| Completed |
NCT05085483 -
Ketone for Migraine Prevention
|
N/A | |
| Completed |
NCT01604785 -
Low-dose Propofol for Pediatric Migraine
|
Phase 2/Phase 3 | |
| Terminated |
NCT00804973 -
Study in Participants With Acute Migraines Headaches
|
Phase 2 | |
| Completed |
NCT03341689 -
Psilocybin for the Treatment of Migraine Headache
|
Phase 1 | |
| Completed |
NCT01630044 -
Neurostimulation Device for Treatment of Migraine Headache
|
N/A | |
| Active, not recruiting |
NCT00285402 -
Efficacy and Safety Clinical Trial of Intranasal AST-726 for the Prevention of Migraine
|
Phase 2 | |
| Completed |
NCT00203255 -
Clinical Study Examining Use of an Over-the-Counter Supplement for the Prevention of Menstrually-Associated Migraine Headache
|
N/A | |
| Recruiting |
NCT06046508 -
Migraine With Aura and Patent Foramen Ovale: Identification of Biomarkers to Select Patients In Whom Intervention Would Be Beneficial (MANET)
|
||
| Active, not recruiting |
NCT04584762 -
Automated Variable Pattern Insufflator Device (AVPI) for the Acute Treatment of Migraine
|
N/A | |
| Terminated |
NCT03099070 -
Acute Stress Response in Migraine Sufferers
|
N/A |