MigrainePhase 1NCT01772524
Safety, Efficacy and Pharmacokinetics of ALD403
A Phase 1 study testing ALD403 in people with Migraine, run by Alder Biopharmaceuticals, Inc. at 26 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Migraine
- What is being tested?
- ALD403
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 163 participants
- Where
- 26 sitesUnited States
- Study dates
- Jan 2013to Feb 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
26 sites in 1 country.
26 sites in 1 country
United States26 sites
ACT Trials
Anaheim, California, 92801
Michigan Headache & Neurological Institute
Ann Arbor, Michigan, 48104
Neurology Associates of Arlington
Arlington, Texas, 76017
Premiere Research
Austin, Texas, 78705
SPRI
Brooklyn, New York, 11235
ClinSearch
Chattanooga, Tennessee, 37421
Community Research
Cincinnati, Ohio, 45255
MD Clinical
Hallandale, Florida, 33009
Collaborative Neuroscience Network, Inc.
Long Beach, California, 90806
Miami Research
Miami, Florida, 33143
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, 29464
Segal Institute for Clinical Research
North Miami, Florida, 33161
Premiere Research
Phoenix, Arizona, 85027
Wake Research
Raleigh, North Carolina, 27612
Rochester Clinical Research, Inc.
Rochester, New York, 14609
Boston Clinical Trials
Roslindale, Massachusetts, 02131
CRI Lifetree
Salt Lake City, Utah, 84106
Medical Center for Clinical Research
San Diego, California, 92108
San Francisco Clinical Research
San Francisco, California, 94109
CA Medical Clinic for Headache
Santa Monica, California, 90404
Seattle Women's: Health, Research, Gynecology
Seattle, Washington, 98105
Clinvest
Springfield, Missouri, 65807
Tidewater Integrated Medical Research
Virginia Beach, Virginia, 23454
Diablo Clinical Research, Inc.
Walnut Creek, California, 94598
MedVadis Research
Watertown, Massachusetts, 02472
Palm Beach Research Center
West Palm Beach, Florida, 33409
About this study
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
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.
- Conditions
- Migraine
- Being tested
- ALD403, Placebo
- Keywords
- Migraine Disorders, Phase 1, ALD403
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALD403Biological
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| ALD403 | Experimental | Single IV Dose on Day 0 Receives: Biological: ALD403 |
| Saline | Placebo comparator | Single IV infusion on Day 0 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of ALD403: laboratory variables, ECG and adverse events
- Physical Examination
- Vital signs
- 12-lead ECG (electrocardiogram)
- Clinical laboratory tests (hematology, chemistry)
- Number of participants with Adverse Events
Measured: 24 weeks
Secondary outcomes (2)
Evaluation of Pharmacokinetics of ALD403
- 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
Measured: 24 weeks
Efficacy of ALD403
- Change in frequency of migraine days compared to baseline
- Responder rate
- Migraine hours
- Migraine episodes
- Migraine severity
- Use of acute migraine medications
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionDec 2013
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 163 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alder Biopharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jeff Smith, MD, Study director, Alder Biopharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01772524
- Sponsor's protocol ID
- ALD403-CLIN-002
- Status last verified
- Jan 2016
- First submitted
- 17 Jan 2013
- Last updated
- 8 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Smith TR, Spierings ELH, Cady R, Hirman J, Ettrup A, Shen V. Cardiovascular outcomes in adults with migraine treated with eptinezumab for migraine prevention: pooled data from four randomized, double-blind, placebo-controlled studies. J Headache Pain. 2021 Nov 25;22(1):143. doi: 10.1186/s10194-021-01360-1.
PubMed 34823467Smith TR, Spierings ELH, Cady R, Hirman J, Schaeffler B, Shen V, Sperling B, Brevig T, Josiassen MK, Brunner E, Honeywell L, Mehta L. Safety and tolerability of eptinezumab in patients with migraine: a pooled analysis of 5 clinical trials. J Headache Pain. 2021 Mar 30;22(1):16. doi: 10.1186/s10194-021-01227-5.
PubMed 33781209Dodick 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.
PubMed 25297013
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01772524
- Acronym / sponsor ID
- ALD403-CLIN-002
- Conditions
- Migraine
- Keywords
- Migraine Disorders, Phase 1, ALD403
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 163 participants (actual)
- Lead sponsor
- Alder Biopharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 21 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ALD403 | Experimental | Biological: ALD403Single IV Dose on Day 0 |
| Saline | Placebo comparator | Drug: PlaceboSingle IV infusion on Day 0 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Diagnosis of migraine at ≤ 50 years of age (ICHD-II, 2004 Section 1)
- History of migraine ≥ 12 months with
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ALD403 | Biological | ALD403 |
| Placebo | Drug | Saline |
Primary outcome
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
2 secondary outcomes
Evaluation of Pharmacokinetics of ALD403
Time frame: 24 weeks
Efficacy of ALD403
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2016.
- Derived from this study: PubMed 34823467Smith TR, Spierings ELH, Cady R, Hirman J, Ettrup A, Shen V. Cardiovascular outcomes in adults with migraine treated with eptinezumab for migraine prevention: pooled data from four randomized, double-blind, placebo-controlled studies. J Headache Pain. 2021 Nov 25;22(1):143. doi: 10.1186/s10194-021-01360-1.
- Derived from this study: PubMed 33781209Smith TR, Spierings ELH, Cady R, Hirman J, Schaeffler B, Shen V, Sperling B, Brevig T, Josiassen MK, Brunner E, Honeywell L, Mehta L. Safety and tolerability of eptinezumab in patients with migraine: a pooled analysis of 5 clinical trials. J Headache Pain. 2021 Mar 30;22(1):16. doi: 10.1186/s10194-021-01227-5.
- Derived from this study: PubMed 25297013Dodick 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeff Smith, MD study director
Alder Biopharmaceuticals
26 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ALD403 in people with Migraine, run by Alder Biopharmaceuticals, Inc. at 26 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of ALD403: laboratory variables, ECG and adverse events (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01772524, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2016.