Migraine Clinical Trial
Official title:
A Single-Center, Open Label Pilot Study Examining The Use Of Duloxetine In The Prevention Of Episodic Migraine
This is a single-center, open-label, pilot trial to collect and evaluate data on the safety and efficacy of duloxetine in the preventive treatment of subjects experiencing episodic migraine headaches. Following a 28-day baseline period, qualifying subjects will be entered into an 84-day treatment period. Subjects will be titrated over the first four weeks to a dose of 120mg or their maximally tolerated dose (MTD). The dose adjustments will be based on individual subject response and/or subject's tolerability. Subjects will maintain a daily diary capturing detailed information on migraine headache days.
Pharmacologic therapy of migraine headaches can be divided into two types: acute treatment
and prophylactic treatment. Acute headache medication is intended to relieve the pain and
disability of an acute attack and stop its progression. Prophylactic (preventive) headache
therapy is generally given daily, even in the absence of headache, to reduce the frequency
and perhaps the severity of anticipated attacks. Subjects who experience recurring migraine
attacks which significantly interfere with the subject's daily routine despite acute
treatment, may warrant chronic prophylactic treatment.
Duloxetine may be an important treatment option for millions of unsuccessfully treated
migraine patients and therefore warrants further study. Considering this, we propose a
single-center, open-label pilot trial to collect and evaluate data on the safety and
efficacy of duloxetine in the preventive treatment of subjects with episodic migraine
headaches. The results of this pilot trial will provide preliminary insight into the
clinical role duloxetine may play in the treatment of headache, as well as provide a basis
for future well-controlled trials of this medication.
This is a single-center, open-label, pilot trial to collect and evaluate data on the safety
and efficacy of duloxetine in the preventive treatment of subjects experiencing episodic
migraine headaches. Following a 28-day baseline period, qualifying subjects will be entered
into an 84-day treatment period. Subjects will be titrated over the first four weeks to a
dose of 120mg or their maximally tolerated dose (MTD). The dose adjustments will be based on
individual subject response and/or subject's tolerability. Subjects will maintain a daily
diary capturing detailed information on migraine headache days.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
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