Calcitonin Gene-related Peptide Levels in Chronic Migraine
Condition: Chronic Migraine
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 4

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 .
    

Detailed description: 
      This double-blind study will evaluate reduction in number of headache days following
      treatment with OnabotulinumtoxinA versus Saline. Additionally, CGRP levels in saliva will be
      correlated with a reduction in headache attacks.

      At Visit 1, eligible subjects will be randomized 1:1 to receive injections of
      OnabotulinumtoxinA or Saline in an identical manner. Subjects will collect 3 saliva samples
      during each month of the 7 month study: 1 collection at Baseline headache level, 1 collection
      at onset of headache that is one degree worse than Baseline level that will be treated with
      acute therapy, and 1 collection at 2 hours following treatment. Subjects will document
      headache and headache symptoms in a daily diary and return to the clinic with diary and
      saliva samples at monthly visits.

      Following 4 months (including a 1 month washout after Visit 4), subjects will return at Visit
      5 and receive cross-over injections. Subjects randomized to OnabotulinumtoxinA at Visit 1
      will receive injections of Saline. Subjects randomized to saline at Visit 1 will receive
      injections of OnabotulinumtoxinA. Subjects will document headache and headache symptoms in a
      daily diary and return to the clinic with diary and saliva samples at monthly visits.

      At Visit 8, 3 months following re-injection at Visit 5, subjects will exit the study.
    

Intervention name(s): OnabotulinumtoxinA; Saline
Intervention type(s): Drug; Drug
Intervention description(s): Minimum dose of 155 U OnabotulinumtoxinA Purified Neurotoxin Complex administered at 31 fixed-site, fixed-dose injections across seven specific head/neck muscle areas. Subjects will continue to monitor headache symptoms with a headache diary and collect saliva samples as instructed.
At investigator's discretion, additional 40 U OnabotulinumtoxinA Purified Neurotoxin Complex may be administered unilaterally or bilaterally, using follow-the-pain paradigm.; 155 U Saline administered at 31 fixed-site, fixed-dose injections across seven specific head/neck muscle areas. Subjects will continue to monitor headache using a headache diary and collect saliva samples as instructed.
At investigator's discretion, additional Saline may be administered unilaterally or bilaterally, using follow-the-pain paradigm.
Other intervention name(s): Botulinum Toxin Type A Purified Neurotoxin Complex; Botox; Placebo
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Botox; OnabotulinumtoxinA; Chronic Migraine; Calcitonin Gene-Related Peptide; Saliva