Ketamine for Refractory Chronic Migraine: a Pilot Study
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|ClinicalTrials.gov Identifier: NCT03896256|
Recruitment Status : Completed
First Posted : March 29, 2019
Last Update Posted : March 11, 2020
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|Condition or disease||Intervention/treatment||Phase|
|Migraine Headache With Intractable Migraine||Drug: ketamine infusion||Early Phase 1|
This study is a comparison between ketamine, used in the standard fashion at Thomas Jefferson University Hospital (TJUH) for 5 days, and past data collected from inpatient treatment at Methodist Hospital. The collection of blood samples is the only experimental part of the study.
Eligible patients will be identified by a study team member at the end of inpatient treatment at Methodist Hospital. The study will be explained to patients at that time. Patients who express interest in participation will be given a consent packet to take home and bring to their office visit at Jefferson Headache Center prior to admission to TJUH for ketamine infusions. Patients will be given the time to read over the study information and have all questions answered to their satisfaction. The will provide informed consent at the end of the office visit if they choose to participate. Baseline demographic information and past medical history including current medications and medications previously tried will be collected. Patients and assessors will not be blinded to treatment.
When the patient is admitted to the hospital for treatment, the neurology team will be the admitting team and will consult the Acute Pain Service (APS) for assistance with management of ketamine, which is standard practice when ketamine is used for headache treatment at TJUH. Patients will be admitted for a total of 5 full days from the time of admission until discharge. Adjustments to ketamine infusion will be made according to standard APS protocol and data will be collected by the research coordinator or other study team personnel. A standard 11-point numeric rating scale (NRS) will be used to obtain pain ratings and they will be collected twice daily. A 4-point pain assessment scale (0=none, 1=mild, 2=moderate, 3=severe) will also be used. Blood samples will be collected at baseline and at 24 hours, 72 hours, and the final day of treatment. They will be performed at external laboratories. A daily headache diary will be used for all patients and they will be given instructions how to use one prior to discharge. A depression screening will be performed on day of admission to TJUH.
Follow-up office visits at approximately 2 weeks and 2 months will be used for collection of pain ratings and medication use. Headache diaries will be collected. If telephone visits occur, assessments will be done over the phone in place of an office visit.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Masking Description:||No masking|
|Official Title:||Ketamine for Refractory Chronic Migraine: a Pilot Study|
|Actual Study Start Date :||March 22, 2019|
|Actual Primary Completion Date :||January 1, 2020|
|Actual Study Completion Date :||January 1, 2020|
Experimental: Treatment Arm
Patients will be admitted to the hospital for a total of 5 full days from the time of admission until discharge. Ketamine infusion will be started on day 1. Adjustments to ketamine infusion will be made according to standard acute pain service protocol.
Drug: ketamine infusion
Ketamine will be used in subanesthetic doses for patients with refractory chronic migraine to see if it improves pain after a 5-day continuous infusion.
Other Name: Ketalar
- The improvement in pain after ketamine (0 to 10 numerical rating scale) will be compared to improvement after initial inpatient treatment. [ Time Frame: 1 year ]Each patient will serve as his or her own control.
- Improvement in a 0-3 qualitative scale where 0=none, 1=mild, 2=moderate, 3=severe pain will be used comparing change from beginning to end of ketamine treatment to change after initial inpatient treatment. [ Time Frame: 1 year ]Each patient will serve as his or her own control.
- Incidence of adverse effects [ Time Frame: 1 year ]The number and severity of adverse effects, including hallucinations, nightmares, nausea/vomiting, blurry vision, sedation, and changes in liver function tests, will be recorded.
- Ketamine metabolite levels [ Time Frame: 1 year ]Levels of ketamine metabolites, including norketamine, hydroxynorketamines, hydroxyketamines, and dehydronorketamines, will be measured at baseline, 24 h, 48 h, 72 h, and just before infusion is stopped.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- All adult patients (age 18 years and older) who meet the criteria of refractory chronic migraine as defined by the International Classification of Headache Disorders-II definition who present to the Jefferson Headache Center after failing an inpatient course of treatment at Methodist.
- active psychosis
- poorly controlled cardiovascular disease
- previous treatment with intravenous ketamine
These criteria are all consistent with the 2018 Consensus Guidelines for Ketamine. Patients who are deemed poor candidates for ketamine by a study team member for any reason, such as intolerance of prior neuroleptic medications, may be excluded.
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): NCT03896256
|United States, Pennsylvania|
|Thomas Jefferson University Hospital|
|Philadelphia, Pennsylvania, United States, 19107|
|Responsible Party:||Eric Schwenk, Associate Professor, Thomas Jefferson University|
|Other Study ID Numbers:||
|First Posted:||March 29, 2019 Key Record Dates|
|Last Update Posted:||March 11, 2020|
|Last Verified:||March 2020|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
|Product Manufactured in and Exported from the U.S.:||No|
Headache Disorders, Primary
Central Nervous System Diseases
Nervous System Diseases
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Molecular Mechanisms of Pharmacological Action