A Multicenter Study Evaluating the Efficacy and Safety of BOTOX® (Botulinum Toxin Type A) Purified Neurotoxin Complex as Headache Prophylaxis in Migraine Patients with 15 or More Headache Days per 4-Week Period in a 24-Week, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Phase Followed by a 32-Week Open-Label Extension Phase

ALLERGAN LTD0 sites650 target enrollmentAugust 29, 2006

Overview

No summary available.

Registry

who.int

Start Date

August 29, 2006

End Date

TBD

Last Updated

12 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

ALLERGAN LTD

•Male or female, 18 to 65 years old; history of migraine disorder as classified in ICHD\-11 (2004\) Section 1 \[with the exception of hemiplegic migraine (1\.2\.4, 1\.2\.5\) basilar migraine (1\.2\.6\), ophthalmoplegic migraine (13\.17\) or migrainous infarction (1\.5\.4]; four or more headache episodes with a duration of at least 4 hours during the 4\-week baseline period; fifteen or more headache days during the 4\-week baseline period with each day consisting of at least 4 hours of continuous headache; written informed consent and data protection consent. Negative pregnancy test in females of childbearing potential
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes
•F.1\.2\.1 Number of subjects for this age range
•F.1\.3 Elderly (\>\=65 years) no
•F.1\.3\.1 Number of subjects for this age range

•1\.Uncontrolled clinically significant medical condition other than the condition under evaluation (including alcohol/illicit substance abuse)
•2\.Any medical condition that may put the patient at increased risk with exposure to Botulinum Toxin Type A Purified Neurotoxin Complex, including diagnosed myasthenia gravis, Eaton\-Lambert syndrome, amyotrophic lateral sclerosis, or any other significant disease that might interfere with neuromuscular function
•3\.Patients who have been diagnosed with the following headache disorders, as listed in ICHD\-II (2004\) section 1: complicated migraine (eg, hemiplegic migraine \[1\.2\.4, 1\.2\.5], basilar migraine \[1\.2\.6], ophthalmoplegic migraine \[13\.17] or migrainous infarction \[1\.5\.4])
•4\.Use of any headache prophylactic medication within 28 days prior to Week \-4
•5\.Headache diagnosis of chronic tension\-type headache (ICHD\-II 2\.3\), hypnic headache (ICHD\-II 4\.5\), hemicrania continua (ICHD\-II 4\.7\) or new daily persistent headache (ICHD\-II 4\.8\)
•6\.Headache attributed to another disorder (eg, cervical dystonia, craniotomy, head/neck trauma)
•7\.Unremitting headache lasting continuously throughout the 4\-week baseline period
•8\.Patients with a known or suspected Temporomandibular Disorder (TMD), including pain in or around the Temporomandibular Joint (TMJ)
•9\.Patients with a concurrent diagnosis of fibromyalgia
•10\.Beck Depression Inventory score \> 24 at Week \-4