Chronic Migraine Clinical Trial
Official title:
Calcitonin Gene-related Peptide (CGRP) Levels in the Pathogenesis of Chronic Migraine
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 .
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05720819 -
Biofeedback-VR for Treatment of Chronic Migraine
|
N/A | |
Not yet recruiting |
NCT06428838 -
Eptinezumab as an Adjunct to Standard of Care for Migraine in an Acute Emergency Context
|
Phase 3 | |
Recruiting |
NCT05517200 -
Pilot Study for a Machine Learning Test for Migraine
|
||
Recruiting |
NCT05891808 -
miR-155 Expression in Episodic and Chronic Migraine
|
||
Completed |
NCT02514148 -
Biobehavioral Physical Therapy Strategies Based on Therapeutic Exercise Applied to Chronic Migraine Patients
|
N/A | |
Enrolling by invitation |
NCT02291380 -
A Study to Evaluate Botulinum Toxin Type A for Injection(HengLi®)for Prophylactic Treatment of Chronic Migraine
|
Phase 3 | |
Withdrawn |
NCT02122744 -
RCT Versus Placebo of rTMSQP Over Visual Cortex for the Prevention of Chronic Migraine
|
N/A | |
Completed |
NCT02122237 -
Cathodal tDCS in Chronic Migraine: Neurophysiological Study and Pilot Therapeutic Trial
|
Phase 3 | |
Recruiting |
NCT02202486 -
Investigation of the Blood-brain and Blood-dura Barrier Durin Migraine Attacks Using MRI
|
N/A | |
Completed |
NCT01709708 -
Use of the Tx360 Nasal Applicator in the Treatment of Chronic Migraine
|
Phase 4 | |
Completed |
NCT01741246 -
Neuroimaging Studies of Chronic Primary Headaches Using Positron Emission Tomography and Magnetic Resonance Imaging
|
N/A | |
Completed |
NCT01090050 -
Treximet in the Treatment of Chronic Migraine
|
Phase 4 | |
Recruiting |
NCT03507400 -
Introvision for Migraine and Headaches
|
N/A | |
Completed |
NCT04161807 -
Efficacy and Safety of Nerivio™ for Acute Treatment of Migraine in People With Chronic Migraine
|
N/A | |
Completed |
NCT03175263 -
OnabotulinumtoxinA Injections in Chronic Migraine, Targeted to Sites of Pericranial Myofascial Pain
|
N/A | |
Withdrawn |
NCT04353505 -
Intra-arterial Sphenopalatine Ganglion Block for Patients With Refractory Headache
|
Phase 1 | |
Completed |
NCT01667250 -
Non-Invasive Neurostimulation for the Prevention of Chronic Migraine
|
N/A | |
Completed |
NCT01700387 -
A Study to Evaluate the Tolerability of Botox and Topiramate or Botox and Placebo and Effect on Cognitive Efficiency
|
Phase 4 | |
Not yet recruiting |
NCT01135784 -
Study of MIGRA-ZEN RELIEF PLUS In the Treatment of Chronic Migraine Headache
|
Phase 2 | |
Completed |
NCT00772031 -
NINDS CRC Chronic Migraine Treatment Trial
|
Phase 3 |