Safety, Efficacy and Pharmacokinetics of ALD403

Study Overview
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Brief Summary
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The purpose of this study is to assess the safety, pharmacokinetics and efficacy of a single dose of ALD403 in the prevention of migraine headache in frequent episodic migraineurs for 24 weeks.

Official Title
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A Parallel Group, Double-Blind, Randomized, Placebo Controlled Phase 1b Trial to Evaluate the Safety, Pharmacokinetics, and Efficacy of a Single Dose of ALD403 Administered Intravenously in Patients With Frequent Episodic Migraines

Conditions
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Migraine

Intervention / Treatment
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* Biological: ALD403
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Diagnosis of migraine at ≤ 50 years of age (ICHD-II, 2004 Section 1) History of migraine ≥ 12 months with ≥ 5 and ≤ 14 migraine days in each 28 day period in the 3 months prior to screening use of acute migraine medications ≤ 14 days per 28 day period and, within those days, ≤ 10 days of triptan use per 28 day period in the 3 months prior to screening and the 28 day period of completion of eDiary prior to randomization Women of child-bearing potential and males with partners of child-bearing potential must agree to use adequate contraception (oral or injectable [depot] estrogen, and/or progestogen, or selective estrogen receptor modulator contraceptive therapeutic, intrauterine contraceptive device, or double barrier method [e.g., condom and diaphragm or spermicidal gel]). Non-childbearing potential is defined as post-menopausal for at least 1 year or surgical sterilization or hysterectomy at least 3 months before screening Any hormonal therapy (e.g., oral contraceptives, hormone replacement therapy) use is stable and ongoing for at least 3 months prior to screening and during the 28 day period from screening to randomization Agree not to post any personal medical data related to the trial or information related to the trial on any website or social media site (e.g., Facebook, Twitter) until the trial has been completed Exclusion Criteria Confounding pain syndromes including fibromyalgia, chronic musculoskeletal (e.g., low back pain), psychiatric conditions, dementia, or major neurological disorders other than migraine that interfere with the participation in the trial Diagnosis of complicated migraine, chronic tension-type headache, hypnic headache, hemicrania continua, new daily persistent headache, basilar, hemiplegic, or familial hemiplegic migraine Regular use (greater than 7 days) of prophylactic headache medication (any preventive medication or supplement with evidence of efficacy from at least 1 placebo-controlled trial) within 3 months, or onabotulinumtoxin A within 6 months prior to screening or during the 28 day period prior to randomization Cardiac surgery or cardiac symptoms within 3 months of screening and during the 28 day period prior to randomization Suspected or diagnosis of hypertension with or without antihypertensive treatment Any ongoing co-morbidity that in the opinion of the Investigator will interfere with the participation in the trial Body Mass Index (BMI) > 39 at screening Pregnant, breast-feeding, or planning to become pregnant during the trial Patients who have used opioids > 5 days for the treatment of pain in more than 2 of the 6 months prior to screening or in the 28 day period prior to randomization

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ALD403<br>Single IV Dose on Day 0 | Biological: ALD403<br> <br> |
| Placebo Comparator: Saline<br>Single IV infusion on Day 0 | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of ALD403: laboratory variables, ECG and adverse events | Physical Examination Vital signs 12-lead ECG (electrocardiogram) Clinical laboratory tests (hematology, chemistry) Number of participants with Adverse Events | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of Pharmacokinetics of ALD403 | Cmax - maximum plasma concentration Tmax - Time to achieve maximum plasma concentration AUC - Area under the plasma concentration-time curve T1/2 - Elimination half-life Vz - Volume of distribution CL - Clearance Bioavailability Plasma levels of unbound ALD403 | 24 weeks | 
| Efficacy of ALD403 | Change in frequency of migraine days compared to baseline Responder rate Migraine hours Migraine episodes Migraine severity Use of acute migraine medications | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Migraine Disorders, Phase 1, ALD403