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Safety, Efficacy and Pharmacokinetics of ALD403

6. januar 2016 opdateret af: Alder Biopharmaceuticals, Inc.

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

163

Fase

  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Arizona
      • Phoenix, Arizona, Forenede Stater, 85027
        • Premiere Research
    • California
      • Anaheim, California, Forenede Stater, 92801
        • ACT Trials
      • Long Beach, California, Forenede Stater, 90806
        • Collaborative Neuroscience Network, Inc.
      • San Diego, California, Forenede Stater, 92108
        • Medical Center for Clinical Research
      • San Francisco, California, Forenede Stater, 94109
        • San Francisco Clinical Research
      • Santa Monica, California, Forenede Stater, 90404
        • CA Medical Clinic for Headache
      • Walnut Creek, California, Forenede Stater, 94598
        • Diablo Clinical Research, Inc.
    • Florida
      • Hallandale Beach, Florida, Forenede Stater, 33009
        • MD Clinical
      • Miami, Florida, Forenede Stater, 33143
        • Miami Research
      • North Miami, Florida, Forenede Stater, 33161
        • Segal Institute for Clinical Research
      • West Palm Beach, Florida, Forenede Stater, 33409
        • Palm Beach Research Center
    • Massachusetts
      • Roslindale, Massachusetts, Forenede Stater, 02131
        • Boston Clinical Trials
      • Watertown, Massachusetts, Forenede Stater, 02472
        • MedVadis Research
    • Michigan
      • Ann Arbor, Michigan, Forenede Stater, 48104
        • Michigan Headache & Neurological Institute
    • Missouri
      • Springfield, Missouri, Forenede Stater, 65807
        • Clinvest
    • New York
      • Brooklyn, New York, Forenede Stater, 11235
        • SPRI
      • Rochester, New York, Forenede Stater, 14609
        • Rochester Clinical Research, Inc.
    • North Carolina
      • Raleigh, North Carolina, Forenede Stater, 27612
        • Wake Research
    • Ohio
      • Cincinnati, Ohio, Forenede Stater, 45255
        • Community Research
    • South Carolina
      • Mt. Pleasant, South Carolina, Forenede Stater, 29464
        • Coastal Carolina Research Center
    • Tennessee
      • Chattanooga, Tennessee, Forenede Stater, 37421
        • ClinSearch
    • Texas
      • Arlington, Texas, Forenede Stater, 76017
        • Neurology Associates of Arlington
      • Austin, Texas, Forenede Stater, 78705
        • Premiere Research
    • Utah
      • Salt Lake City, Utah, Forenede Stater, 84106
        • CRI Lifetree
    • Virginia
      • Virginia Beach, Virginia, Forenede Stater, 23454
        • Tidewater Integrated Medical Research
    • Washington
      • Seattle, Washington, Forenede Stater, 98105
        • Seattle Women's: Health, Research, Gynecology

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 55 år (Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: ALD403
Single IV Dose on Day 0
Biologisk: ALD403
Placebo komparator: Saline
Single IV infusion on Day 0
Medicin: Placebo

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Safety of ALD403: laboratory variables, ECG and adverse events
Tidsramme: 24 weeks
  • Physical Examination
  • Vital signs
  • 12-lead ECG (electrocardiogram)
  • Clinical laboratory tests (hematology, chemistry)
  • Number of participants with Adverse Events
24 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Evaluation of Pharmacokinetics of ALD403
Tidsramme: 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
24 weeks
Efficacy of ALD403
Tidsramme: 12 weeks
  • Change in frequency of migraine days compared to baseline
  • Responder rate
  • Migraine hours
  • Migraine episodes
  • Migraine severity
  • Use of acute migraine medications
12 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Alder Biopharmaceuticals, Inc.

Efterforskere

  • Studieleder: Jeff Smith, MD, Alder Biopharmaceuticals

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. januar 2013

Primær færdiggørelse (Faktiske)

1. december 2013

Studieafslutning (Faktiske)

1. februar 2014

Datoer for studieregistrering

Først indsendt

17. januar 2013

Først indsendt, der opfyldte QC-kriterier

17. januar 2013

Først opslået (Skøn)

21. januar 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

8. januar 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

6. januar 2016

Sidst verificeret

1. januar 2016

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • ALD403-CLIN-002

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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