Calcitonin Gene-related Peptide Levels in Chronic Migraine

• Status: Completed
• Trial end date: 2011-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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 .

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cady, Roger, M.D.
• Collaborator: Allergan
• Treatments: abobotulinumtoxinA; Botulinum Toxins; Botulinum Toxins, Type A; Calcitonin; Calcitonin Gene-Related Peptide; incobotulinumtoxinA; onabotulinumtoxinA; Salmon calcitonin

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.