Calcitonin Gene-related Peptide Levels in Chronic Migraine

Completed · Phase 4 · Has a placebo group

Conditions studied: Chronic Migraine

In brief

Twenty patients will be enrolled in a 2-site, 7-month, double-blind study conducted to evaluate a reduction in headache days and attacks and calcitonin gene-related peptide (CGRP) levels in saliva following treatment with OnabotulinumtoxinA versus saline. Eligible patients will be randomized and receive injections of OnabotulinumtoxinA or Saline at Visit 1. Following 3 months plus a 1 month wash out, patients will receive cross-over injections at Visit 5. Patients will return for monthly visits and exit the study at Visit 8. Patients will collect saliva at monthly intervals and document in a daily headache diary throughout the study .

Key facts

Study ID

NCT01071096

Run by

Cady, Roger, M.D.

People needed

20

Starts

2010-06-01

Expected to finish

2011-06-01

Last updated by the study team

2013-02-12

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• must be outpatient, male or female, of any race, between 18 and 65 years of age.
• if female of childbearing potential must have negative pregnancy test result at Screening Visit and practice reliable method of contraception.
• A female is considered of childbearing potential unless she is post menopausal for at least 12 months prior to administration of study drug, without a uterus and/or both ovaries or has been surgically sterilized for at least 6 months prior to study drug administration.
• Reliable methods of contraception are: Complete abstinence from intercourse from 2 weeks prior to administration of the investigational product, throughout the study, and for a time interval (5 days) after completion or premature discontinuation from the study; or, History of bilateral tubal ligation; or, Sterilization of male partner; or, Implants of levonorgestrel; or, Injectable progestogen; or, Oral contraceptive (combination therapy with ethinyl estradiol plus a progestin) with a placebo week every 1-3 months; or, Any intrauterine device (IUD) with published data showing that the highest expected failure rate is less than 1% per year (not all IUD's meet this criterion) in use at least 30 days prior to study drug administration; or, Spermicide plus a mechanical barrier (e.g., spermicide plus a male condom or a female diaphragm); or, Any other barrier methods (only is used in combination with any of the above acceptable methods) in use at least 14 days prior to study drug administration; or, Any other methods with published data showing that the highest expected failure rate for that methods is less than 1% per year.
• must have history of chronic migraine (with or without aura) according to the criteria proposed by the Headache Classification Committee of the International Headache Society (IHS) for at least 3 months prior to enrollment.
• must be able to understand the requirements of the study including maintaining a headache Diary, and signing informed consent.
• must be in good general health as determined by investigator.
• if taking migraine preventive, must be on a stable dose of preventive medication for at least 3 months prior to screening.

You may not qualify if…

• if female, is pregnant, planning to become pregnant during the study period, is breast feeding, or is of childbearing potential and not practicing a reliable form of birth control.
• has headache disorders outside IHS-defined chronic migraine definition.
• has evidence of underlying pathology contributing to their headaches.
• has any pathology of the salivary glands such as sialadenitis (e.g. Sjogren's syndrome, viral or bacterial sialadenitis) or condition or symptom that would alter the content of saliva.
• has any medical condition that may increase their risk with exposure to OnabotulinumtoxinA including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other significant disease that might interfere with neuromuscular function.
• has profound atrophy or weakness of muscles in the target areas of injection.
• has skin conditions or infections at any of the injection sites.
• has allergy or sensitivities to any component of the test medication.
• who in the opinion of the investigator, has active major psychiatric or depressive disorders including alcohol/drug abuse.
• meets International Headache Society criteria for Medication Overuse with opioid or butalbital containing products.
• is planning or requiring surgery during the study.
• has a history of poor compliance with medical treatment.
• is currently participating in an investigational drug study or has participated in an investigational drug study within the previous 30 days of the screening visit.

Where it is running

• Clinvest — Springfield, Missouri, United States
• Island Neurological Associates, P.C. — Plainview, New York, United States

Full record on ClinicalTrials.gov

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