Safety, Efficacy and Pharmacokinetics of ALD403

Migraine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01772524
• Other study ID #: ALD403-CLIN-002
• Status: Completed
• Phase: Phase 1
• First received: January 17, 2013
• Last updated: January 6, 2016
• Start date: January 2013
• Est. completion date: February 2014

Study information

• Verified date: January 2016
• Source: Alder Biopharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 163
• Est. completion date: February 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

Biological:
• ALD403

Drug:
• Placebo

Locations

Country	Name	City	State
United States	ACT Trials	Anaheim	California
United States	Michigan Headache & Neurological Institute	Ann Arbor	Michigan
United States	Neurology Associates of Arlington	Arlington	Texas
United States	Premiere Research	Austin	Texas
United States	SPRI	Brooklyn	New York
United States	ClinSearch	Chattanooga	Tennessee
United States	Community Research	Cincinnati	Ohio
United States	MD Clinical	Hallandale Beach	Florida
United States	Collaborative Neuroscience Network, Inc.	Long Beach	California
United States	Miami Research	Miami	Florida
United States	Coastal Carolina Research Center	Mt. Pleasant	South Carolina
United States	Segal Institute for Clinical Research	North Miami	Florida
United States	Premiere Research	Phoenix	Arizona
United States	Wake Research	Raleigh	North Carolina
United States	Rochester Clinical Research, Inc.	Rochester	New York
United States	Boston Clinical Trials	Roslindale	Massachusetts
United States	CRI Lifetree	Salt Lake City	Utah
United States	Medical Center for Clinical Research	San Diego	California
United States	San Francisco Clinical Research	San Francisco	California
United States	CA Medical Clinic for Headache	Santa Monica	California
United States	Seattle Women's: Health, Research, Gynecology	Seattle	Washington
United States	Clinvest	Springfield	Missouri
United States	Tidewater Integrated Medical Research	Virginia Beach	Virginia
United States	Diablo Clinical Research, Inc.	Walnut Creek	California
United States	MedVadis Research	Watertown	Massachusetts
United States	Palm Beach Research Center	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Alder Biopharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	No
Secondary	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	No