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Safety, Efficacy and Pharmacokinetics of ALD403

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01772524
Recruitment Status : Completed
First Posted : January 21, 2013
Last Update Posted : January 8, 2016
Sponsor:
Information provided by (Responsible Party):
Alder Biopharmaceuticals, Inc.

Tracking Information
First Submitted Date  ICMJE January 17, 2013
First Posted Date  ICMJE January 21, 2013
Last Update Posted Date January 8, 2016
Study Start Date  ICMJE January 2013
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 21, 2013)
Safety of ALD403: laboratory variables, ECG and adverse events [ Time Frame: 24 weeks ]
  • Physical Examination
  • Vital signs
  • 12-lead ECG (electrocardiogram)
  • Clinical laboratory tests (hematology, chemistry)
  • Number of participants with Adverse Events
Original Primary Outcome Measures  ICMJE
 (submitted: January 17, 2013)
Safety and efficacy of ALD403: laboratory variables, ECG and adverse events [ Time Frame: 24 weeks ]
  • Physical Examination
  • Vital signs
  • 12-lead ECG (electrocardiogram)
  • Clinical laboratory tests (hematology, chemistry)
  • Number of participants with Adverse Events
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 21, 2013)
  • Evaluation of Pharmacokinetics of ALD403 [ Time Frame: 24 weeks ]
    • 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 ]
    • Change in frequency of migraine days compared to baseline
    • Responder rate
    • Migraine hours
    • Migraine episodes
    • Migraine severity
    • Use of acute migraine medications
Original Secondary Outcome Measures  ICMJE
 (submitted: January 17, 2013)
Evaluation of Pharmacokinetics of ALD403 [ Time Frame: 24 weeks ]
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety, Efficacy and Pharmacokinetics of ALD403
Official Title  ICMJE 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
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Migraine
Intervention  ICMJE
  • Biological: ALD403
  • Drug: Placebo
Study Arms  ICMJE
  • Experimental: ALD403
    Single IV Dose on Day 0
    Intervention: Biological: ALD403
  • Placebo Comparator: Saline
    Single IV infusion on Day 0
    Intervention: Drug: Placebo
Publications * Dodick DW, Goadsby PJ, Silberstein SD, Lipton RB, Olesen J, Ashina M, Wilks K, Kudrow D, Kroll R, Kohrman B, Bargar R, Hirman J, Smith J; ALD403 study investigators. Safety and efficacy of ALD403, an antibody to calcitonin gene-related peptide, for the prevention of frequent episodic migraine: a randomised, double-blind, placebo-controlled, exploratory phase 2 trial. Lancet Neurol. 2014 Nov;13(11):1100-1107. doi: 10.1016/S1474-4422(14)70209-1. Epub 2014 Oct 5.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 16, 2014)
163
Original Estimated Enrollment  ICMJE
 (submitted: January 17, 2013)
160
Actual Study Completion Date  ICMJE February 2014
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01772524
Other Study ID Numbers  ICMJE ALD403-CLIN-002
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Alder Biopharmaceuticals, Inc.
Study Sponsor  ICMJE Alder Biopharmaceuticals, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Jeff Smith, MD Alder Biopharmaceuticals
PRS Account Alder Biopharmaceuticals, Inc.
Verification Date January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP