Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00055484
Status:
COMPLETED
Last Update Posted:
2015-12-14
First Post:
2003-03-03
Brief Title:
A Study to Measure the Safety and Effectiveness of Zonisamide in Subjects With Migraine Headache
Sponsor:
Elan Pharmaceuticals
Organization:
Elan Pharmaceuticals
Study Overview
Official Title:
A Double-Blind Randomized Multicenter Parallel Dose Study to Evaluate the Safety and Efficacy of Zonisamide 150 mg and 300 mg Per Day and Placebo in Subjects With Migraine Headache
Status:
COMPLETED
Status Verified Date:
2015-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine if zonisamide is effective as a preventative medication for individuals with migraine headache
Detailed Description:
The pharmacologic treatment of migraine may be acute abortive symptomatic or preventive prophylactic Preventive medication is usually given daily for months or years however treatment may also be given in an intermittent regimen Most migraine prophylactic medications were designed to treat other disorders and they can be divided into three groups
1 Serotonergic or monoaminergic agents such as methysergide which have demonstrated high degrees of effectiveness
2 Non-serotonergic drugs such as beta-blockers tricyclic antidepressants valproate and
3 Drugs with lesser demonstrated effectiveness such as selective serotonin reuptake inhibitors calcium channel antagonists and non-steroidal anti-inflammatory drugs
The choice of treatment must be individualized and is influenced by contraindications potential side effects the need to treat associated symptoms like tension-type headache and insomnia and drug cost
Anticonvulsants such as valproate have shown significant degrees of efficacy in migraine prophylaxis when used in low doses Considering the differences in proposed mechanisms of action of these agents it is likely that a novel anticonvulsant such as zonisamide may also be an effective prophylactic treatment for migraine
1 Serotonergic or monoaminergic agents such as methysergide which have demonstrated high degrees of effectiveness
2 Non-serotonergic drugs such as beta-blockers tricyclic antidepressants valproate and
3 Drugs with lesser demonstrated effectiveness such as selective serotonin reuptake inhibitors calcium channel antagonists and non-steroidal anti-inflammatory drugs
The choice of treatment must be individualized and is influenced by contraindications potential side effects the need to treat associated symptoms like tension-type headache and insomnia and drug cost
Anticonvulsants such as valproate have shown significant degrees of efficacy in migraine prophylaxis when used in low doses Considering the differences in proposed mechanisms of action of these agents it is likely that a novel anticonvulsant such as zonisamide may also be an effective prophylactic treatment for migraine
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None