Trial record 2 of 2 for:    ald403

Safety, Efficacy and Pharmacokinetics of ALD403

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Alder Biopharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01772524
First received: January 17, 2013
Last updated: July 25, 2013
Last verified: June 2013

January 17, 2013
July 25, 2013
January 2013
November 2013   (final data collection date for primary outcome measure)
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
Safety and efficacy 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
Complete list of historical versions of study NCT01772524 on ClinicalTrials.gov Archive Site
  • 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
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
Not Provided
Not Provided
 
Safety, Efficacy and Pharmacokinetics of ALD403
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

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Migraine
Biological: ALD403
  • Experimental: ALD403
    Single IV Dose on Day 0
    Intervention: Biological: ALD403
  • Placebo Comparator: Saline
    Single IV infusion on Day 0
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
160
Not Provided
November 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01772524
ALD403-CLIN-002
No
Alder Biopharmaceuticals, Inc.
Alder Biopharmaceuticals, Inc.
Not Provided
Study Director: Jeff Smith, MD Alder Biopharmaceuticals
Alder Biopharmaceuticals, Inc.
June 2013

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