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    Summary
    EudraCT Number:2016-001306-41
    Sponsor's Protocol Code Number:ALD403-CLIN-011
    National Competent Authority:Slovakia - SIDC (Slovak)
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-12-14
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSlovakia - SIDC (Slovak)
    A.2EudraCT number2016-001306-41
    A.3Full title of the trial
    A Parallel Group, Double-Blind, Randomized, Placebo Controlled Phase 3 Trial to Evaluate the Efficacy and Safety of ALD403 Administered Intravenously in Patients with Chronic Migraine
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to determine how safe and effective ALD403 is in patients with chronic migraine.
    A.4.1Sponsor's protocol code numberALD403-CLIN-011
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAlder BioPharmaceuticals, Inc.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportAlder BioPharmaceuticals, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAlder BioPharmaceuticals, Inc.
    B.5.2Functional name of contact point Alder Clinical Trials
    B.5.3 Address:
    B.5.3.1Street Address11804 North Creek Parkway South
    B.5.3.2Town/ cityBothell
    B.5.3.3Post code98011
    B.5.3.4CountryUnited States
    B.5.4Telephone number1425205-2900
    B.5.5Fax number1425205-2883
    B.5.6E-mailclinicaltrials@alderbio.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.2Product code ALD403
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNeptinezumab
    D.3.9.1CAS number 1644539-04-7
    D.3.9.2Current sponsor codeALD403
    D.3.9.3Other descriptive nameALD403 MONOCLONAL ANTIBODY
    D.3.9.4EV Substance CodeSUB184929
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Chronic Migraine
    E.1.1.1Medical condition in easily understood language
    Migraine headaches
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10027599
    E.1.2Term Migraine
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of repeat doses of ALD403 administered intravenously (IV) compared to placebo in patients with chronic migraine.
    E.2.2Secondary objectives of the trial
    To evaluate the safety of repeat doses of ALD403 administered IV compared to placebo in patients with chronic migraine.
    To evaluate the pharmacokinetics (PK) and immunogenicity of repeat doses of ALD403 administered IV to patients with chronic migraine.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Willing and able to read, understand, and sign the Informed Consent Form (ICF) for the clinical trial approved by the Investigator’s local Review Board or a central Institutional Review Board (IRB) or Ethics Committee (EC).
    2.Has adequate venous access for administration of investigational product and collection of blood samples.
    3.Male or female 18-65 years of age, inclusive, at time of informed consent.
    4.Diagnosis of migraine at ≤ 50 years of age with history of chronic migraine ≥ 1 year prior to screening.
    5.Prescription or over-the-counter medication for acute and/or prophylactic treatment of migraine has been prescribed or recommended by a healthcare professional.
    6.During the 28 day screening period, must have ≥ 15 to ≤ 26 headache days, of which ≥ 8 days were assessed as migraine days as documented in the eDiary (ICHD-III beta
    version, 2013 Section 1.3).
    7.Women of child-bearing potential, and males with partners of child-bearing potential, must agree to use adequate contraception for the duration of the study (from screening through Week 32) and for 6 months after the last dose of study drug. The following types of contraception are considered adequate provided they are locally authorised for use: oral, transdermal, or injectable (depot) estrogen and/or progestogen, selective estrogen receptor modulator therapy, intrauterine contraceptive device, double barrier method (e.g., condom and diaphragm or spermicidal gel) or vasectomy. Non-childbearing potential is defined as post-menopausal for at least 1 year, or surgical sterilization or hysterectomy at least 3 months before screening.
    8.Any hormonal therapy (e.g., contraceptives, hormone replacement therapy) use is stable and ongoing for at least 3 months prior to screening .
    9.Willing, committed, and able to comply with scheduled clinic visits and complete all trial-related procedures.
    10.Headache eDiary was completed on at least 24 of the 28 days prior to randomization.
    11.Any prophylactic use of medications for headaches must be stable for at least 3 months prior to screening.
    12.Limited use of barbiturates (including Fiorinal®, Fioricet®, or any other combination containing butalbital) or prescription opiates ( including single ingredient or combinations containing opiates, opioids, tramadol or tapentadol) by maintaining a stable dose for 2 months prior to screening and dosing is not expected to exceed 4 days per month through Week 24.
    13.Subject agrees not to post any personal medical data or information related to the trial
    on any website or social media site (e.g., Facebook, Twitter) during the trial.
    14.Subject is willing to complete the daily eDiary for the duration of the study and agrees to use the eDiary devices for the sole purpose of the ALD403-CLIN-011 study without alteration.
    E.4Principal exclusion criteria
    1.Confounding and clinically significant pain syndromes (e.g. fibromyalgia, chronic low back pain, complex
    regional pain syndrome).
    2.Psychiatric conditions that are uncontrolled and/or untreated, including conditions that are not controlled for a minimum of 6 months prior to screening. Patients with a lifetime history of psychosis, mania, or dementia are excluded.
    3.Diagnosis of acute or active temporomandibular disorders (TMD).
    4.History or diagnosis of chronic tension-type headache, hypnic headache, cluster headache, hemicrania continua, new daily persistent headache, or unusual migraine subtypes such as hemiplegic migraine (sporadic and familial), opthalmoplegic migraine and migraine with neurological accompaniments that are not typical of migraine aura (eg. diplopia, altered consciousness or long duration).
    5.Any use of approved devices, neuromodulation, neurostimulation or injectable therapy (trigger point injections, extracranial nerve blocks, facet joint injections) are prohibited 2 months prior to screening and during the screening period.
    6.Any use of botulinum toxin for migraine or for any other medical/cosmetic reasons requiring injections within 4 months prior to screening and during the screening period.
    7.Any use of monoamine oxidase inhibitors (MAOIs), ketamine, methysergide,
    methylergonovine, or nimesulide within 3 months prior to screening or during the
    screening period.
    8.Have present or previous malignancies, except:
    Squamous or basal skin cell carcinoma with excision without evidence of
    recurrence
    Malignancy ≥ 10 years since diagnosis/treatment without evidence of recurrence
    9.Subject with known history or evidence of arteriosclerosis,cardiomyopathy, coronary artery disease, serious heart rhythm abnormalities, cerebrovascular disease, diabetes, Raynaud’s disease, hereditary fructose intolerance, lifethreatening allergy (e.g, anaphylaxis) or any active, progressive or unstable cardiovascular, neurological or autoimmune disorder. If questions arise, the Investigator should contact the Medical Monitor for guidance.
    10.Clinically significant abnormal ECG during the screening period or on Day 0.
    11.Any clinically significant concurrent medical condition or clinically significant
    laboratory abnormality during the screening period or on Day 0.
    12.Body Mass Index (BMI) ≥ 39 kg/m2 at screening.
    13.Primary hypertension that is uncontrolled or newly diagnosed (systolic BP of > 139 mm Hg or diastolic BP of >89 mm Hg) at screening or secondary hypertension. Mild primary hypertension that is well-controlled for ≥ 6 months prior to screening is allowed.
    14.The subject is at risk of self-harm or harm to others in the Investigator’s opinion, based on clinical interview and responses provided on the Columbia-Suicide Severity Rating Scale (C-SSRS). Subjects must be excluded if they have a lifetime history of a serious suicide attempt or multiple suicide attempts (i.e., actual, interrupted, or aborted attempts), have had any suicidal behavior in the past 5 years (i.e., preparatory acts or behavior), or have had suicidal ideation of Type 3, 4, or 5 (i.e., suicidal ideation with any method without intent to act or suicidal ideation with intent to act, with or without a plan) in the past 6 months, as measured by the C-SSRS at Screening or on Day 0.
    15.Any history or evidence of substance abuse or dependence (e.g., alcohol, opiates, amphetamines and barbiturates) within the past 2 years according to the International Classification of Diseases (ICD) 10: F10-1912
    16.Pregnant, breastfeeding, or planning to become pregnant during the trial.
    17.Receipt of any experimental, unregistered therapy (within or outside a clinical trial) within 30 days or 5 plasma half-lives (whichever is longer) before screening.
    18.Receipt of any monoclonal antibody treatment (within or outside a clinical trial) within 6 months before screening.
    19.Previously dosed with ALD403 or any monoclonal antibody targeting the CGRP
    pathway.
    20.Planned or current participation in any other clinical trial during the duration of this clinical trial, or within 6 months before screening.
    21.Recent or planned surgery, requiring general anesthesia, within 8 weeks prior to screening and during the duration of this clinical trial.
    22.Positive for HIV, hepatitis B surface antigen, or hepatitis C antibody at screening.
    23.Any condition that, in the opinion of the Investigator, would make the subject
    unsuitable for the clinical trial.
    24.Employees of the Sponsor, CRO, or any clinical trial site involved in this trial and their immediate family members (i.e., parents, spouse, siblings, children).
    E.5 End points
    E.5.1Primary end point(s)
    Change in frequency of migraine days
    E.5.1.1Timepoint(s) of evaluation of this end point
    Weeks 1-12
    E.5.2Secondary end point(s)
    75% migraine responder rate
    50% migraine responder rate
    Percentage of subjects with a migraine on the day after dosing
    Reduction in migraine prevalence from baseline to Week 4
    E.5.2.1Timepoint(s) of evaluation of this end point
    Weeks 1-4 and Weeks 1-12
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA50
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Belgium
    Czech Republic
    Denmark
    Georgia
    Germany
    Hungary
    Italy
    Russian Federation
    Slovakia
    Spain
    Ukraine
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days15
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 1040
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state72
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 467
    F.4.2.2In the whole clinical trial 1050
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2017-02-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-11-29
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-09-18
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