Safety, Efficacy and Pharmacokinetics of ALD403

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alder Biopharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01772524
First received: January 17, 2013
Last updated: April 16, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Migraine
Biological: ALD403
Phase 1

Study Type: Interventional
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
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

Resource links provided by NLM:


Further study details as provided by Alder Biopharmaceuticals, Inc.:

Primary Outcome Measures:
  • Safety of ALD403: laboratory variables, ECG and adverse events [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
    • Physical Examination
    • Vital signs
    • 12-lead ECG (electrocardiogram)
    • Clinical laboratory tests (hematology, chemistry)
    • Number of participants with Adverse Events


Secondary Outcome Measures:
  • Evaluation of Pharmacokinetics of ALD403 [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    • 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

  • Efficacy of ALD403 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    • Change in frequency of migraine days compared to baseline
    • Responder rate
    • Migraine hours
    • Migraine episodes
    • Migraine severity
    • Use of acute migraine medications


Enrollment: 163
Study Start Date: January 2013
Study Completion Date: February 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ALD403
Single IV Dose on Day 0
Biological: ALD403
Placebo Comparator: Saline
Single IV infusion on Day 0

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01772524

  Show 26 Study Locations
Sponsors and Collaborators
Alder Biopharmaceuticals, Inc.
Investigators
Study Director: Jeff Smith, MD Alder Biopharmaceuticals
  More Information

No publications provided

Responsible Party: Alder Biopharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01772524     History of Changes
Other Study ID Numbers: ALD403-CLIN-002
Study First Received: January 17, 2013
Last Updated: April 16, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Alder Biopharmaceuticals, Inc.:
Migraine Disorders
Phase 1
ALD403

Additional relevant MeSH terms:
Migraine Disorders
Brain Diseases
Central Nervous System Diseases
Headache Disorders
Headache Disorders, Primary
Nervous System Diseases

ClinicalTrials.gov processed this record on October 23, 2014