Ketamine for Refractory Chronic Migraine: a Pilot Study

NCT03896256 | Completed Early Phase 1 FDA Drug

• 1 other identifier: 19D0.99
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

Ketamine is a drug used for anesthesia but at low doses it is a very effective pain reliever in several chronic conditions. Preliminary studies have shown that ketamine might be effective for patients with refractory chronic migraine, which is a severe type of headache for which patients usually have tried and failed many medications and can cause severe disability to their lives. This study will evaluate ketamine prospectively when given to patients who have "failed" an initial inpatient treatment.

Conditions

Migraine Headache With Intractable Migraine

Outcome Measures

Primary Outcomes (2)

• The improvement in pain after ketamine (0 to 10 numerical rating scale) will be compared to improvement after initial inpatient treatment.

  Each patient will serve as his or her own control.

  1 year

• 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.

  Each patient will serve as his or her own control.

  1 year

Secondary Outcomes (2)

• Incidence of adverse effects

  1 year

• Ketamine metabolite levels

  1 year

Study Arms (1)

Treatment Arm

EXPERIMENTAL

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

Interventions

ketamine infusion DRUG

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.

Also known as: Ketalar

Treatment Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Schizophrenia
• active psychosis
• pregnancy
• poorly controlled cardiovascular disease
• cirrhosis
• 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.

Sponsors & Collaborators

• Thomas Jefferson University: lead

Study Sites (1)

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

Related Publications (6)

• Schwenk ES, Dayan AC, Rangavajjula A, Torjman MC, Hernandez MG, Lauritsen CG, Silberstein SD, Young W, Viscusi ER. Ketamine for Refractory Headache: A Retrospective Analysis. Reg Anesth Pain Med. 2018 Nov;43(8):875-879. doi: 10.1097/AAP.0000000000000827.

  PMID: 29923953 BACKGROUND

• Cohen SP, Bhatia A, Buvanendran A, Schwenk ES, Wasan AD, Hurley RW, Viscusi ER, Narouze S, Davis FN, Ritchie EC, Lubenow TR, Hooten WM. Consensus Guidelines on the Use of Intravenous Ketamine Infusions for Chronic Pain From the American Society of Regional Anesthesia and Pain Medicine, the American Academy of Pain Medicine, and the American Society of Anesthesiologists. Reg Anesth Pain Med. 2018 Jul;43(5):521-546. doi: 10.1097/AAP.0000000000000808.

  PMID: 29870458 BACKGROUND

• Schwenk ES, Viscusi ER, Buvanendran A, Hurley RW, Wasan AD, Narouze S, Bhatia A, Davis FN, Hooten WM, Cohen SP. Consensus Guidelines on the Use of Intravenous Ketamine Infusions for Acute Pain Management From the American Society of Regional Anesthesia and Pain Medicine, the American Academy of Pain Medicine, and the American Society of Anesthesiologists. Reg Anesth Pain Med. 2018 Jul;43(5):456-466. doi: 10.1097/AAP.0000000000000806.

  PMID: 29870457 BACKGROUND

• Schulman E. Refractory migraine - a review. Headache. 2013 Apr;53(4):599-613. doi: 10.1111/head.12047. Epub 2013 Feb 13.

  PMID: 23405959 BACKGROUND

• Afridi SK, Giffin NJ, Kaube H, Goadsby PJ. A randomized controlled trial of intranasal ketamine in migraine with prolonged aura. Neurology. 2013 Feb 12;80(7):642-7. doi: 10.1212/WNL.0b013e3182824e66. Epub 2013 Jan 30.

  PMID: 23365053 BACKGROUND

• Pomeroy JL, Marmura MJ, Nahas SJ, Viscusi ER. Ketamine Infusions for Treatment Refractory Headache. Headache. 2017 Feb;57(2):276-282. doi: 10.1111/head.13013. Epub 2016 Dec 27.

  PMID: 28025837 BACKGROUND

MeSH Terms

Interventions

Ketamine

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Masking Details: No masking
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 26, 2019
• First Posted: March 29, 2019
• Study Start: March 22, 2019
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2020
• Last Updated: March 11, 2020

Record last verified: 2020-03

Locations

US (1)