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

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 650

Inclusion Criteria

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

Exclusion Criteria

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
11.Psychiatric problems that, in the investigator’s opinion, are severe enough to interfere with study participation or results (eg, bipolar disorder)
12.Infection or skin disorder at anticipated injection sites
13.Females who are pregnant, nursing, or planning a pregnancy during the study
14.Females of childbearing potential, not using a reliable means of contraception
15.Previous treatment with botulinum toxin therapy of any serotype for any reason, or immunization to any botulinum toxin serotype
16.Anticipated need for botulinum toxin treatment for any reason during the study (other than study treatment)
17.Known allergy or sensitivity to the study medication or its components
18.Acupuncture, TENS (transcutaneous electrical nerve stimulation), cranial traction, nociceptive trigeminal inhibition or occipital nerve block treatments, or injection of anesthetics or steroids into the study target muscles within 4 weeks prior to Week -4 or , on or after Week -4
19.Previous participation in any botulinum toxin clinical trial
20.Concurrent enrollment in an investigational drug or device study or participation in such a study in the 30 days immediately prior to Week -4 or, on or after Week -4
21.Patient has a condition or is in a situation which in the investigator's opinion may put the patient at significant risk, may confound the study results, or may interfere significantly with the patient's participation in the study
22.The patient is not in the baseline phase (Week -4 to Day 0) for at least 28 days or does not record a minimum of 20 days worth of diary data

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the efficacy and safety of Botulinum Toxin Type A Purified Neurotoxin Complex compared with placebo as headache prophylaxis in migraine patients with 15 or more headache days per 4-week period.;Secondary Objective: To evaluate the long term safety of Botulinum Toxin Type A Purified Neurotoxin Complex as headache prophylaxis in migraine patients with 15 or more headache days per 4-week period.;Primary end point(s): The change from baseline in the frequency of headache episodes per 4 weeks to Week 24

Secondary Outcome Measures

Name	Time	Method

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