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Erenumab For Treatment of Hemicrania Continua

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04303845
Recruitment Status : Not yet recruiting
First Posted : March 11, 2020
Last Update Posted : August 17, 2020
Sponsor:
Information provided by (Responsible Party):
Rashmi B. Halker Singh, Mayo Clinic

Brief Summary:
This research is being conducting to learn if the study drug erenumab is successful in treating hemicrania continua. The study is also evaluating the safety and tolerability of erenumab in individuals being treated for hemicrania continua.

Condition or disease Intervention/treatment Phase
Hemicrania Continua Drug: Erenumab Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Erenumab For Treatment of Hemicrania Continua
Estimated Study Start Date : November 10, 2020
Estimated Primary Completion Date : November 10, 2021
Estimated Study Completion Date : November 10, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment with Erenumab
Subjects diagnosed with hemicrania continua will receive single dose of Erenumab
Drug: Erenumab
140 mg of erenumab via subcutaneous injection




Primary Outcome Measures :
  1. Total number of participants to have a response rate of 50% or greater reduction of headache frequency after treatment [ Time Frame: 4 weeks post erenumab treatment ]

Secondary Outcome Measures :
  1. Change in number of headaches experienced by participants [ Time Frame: Baseline, 4 weeks post erenumab treatment ]
  2. Change in the amount of total headache hours (with moderate or severe pain) experienced by participants [ Time Frame: Baseline, 4 weeks post erenumab treatment ]
  3. Remission rate [ Time Frame: 4 weeks post erenumab treatment ]
    Number of participants who do not have any occurrence of headache



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 66 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • Adults over the age of 18-66
  • At least a 12 month history of hemicrania continua (unremitting subtype) according to International Classification of Headache Disorders, 3rd Edition (ICHD-3)1
  • Previous or current complete response to indomethacin
  • Stable preventive treatment for at least 2 months and no anticipated need to adjust/add current headache prevention treatment

Exclusion Criteria

  • Nonresponse to a therapeutic dose of indomethacin for hemicrania continua when used for at least 1 week
  • Pregnant or lactating subjects
  • Use of barbiturate or opioid >6 days per month; history of chronic migraine
  • History of previous trigeminal-autonomic cephalalgia
  • History within previous 2 months of interventional procedure for headache (occipital or other extracranial nerve block, sphenopalatine ganglion block, cervical facet block, facet rhizotomy)
  • History of cranial nerve/rhizolysis
  • Botulinumtoxin injection with previous 4 months
  • Parenteral infusion of or oral corticosteroid use for more than 3 days within 4 weeks prior to screening phase

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04303845


Locations
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United States, Arizona
Mayo Clinic in Arizona
Scottsdale, Arizona, United States, 85259
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Rashmi Halker Singh, MD Mayo Clinic
Additional Information:
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Responsible Party: Rashmi B. Halker Singh, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT04303845    
Other Study ID Numbers: 19-007088
First Posted: March 11, 2020    Key Record Dates
Last Update Posted: August 17, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Anencephaly
Headache
Pain
Neurologic Manifestations
Neural Tube Defects
Nervous System Malformations
Nervous System Diseases
Abnormalities, Severe Teratoid
Congenital Abnormalities
Erenumab
Calcitonin Gene-Related Peptide Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs