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Effect of Ketamine Intranasal Spray in Treatment of Chronic Cluster Headache

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ClinicalTrials.gov Identifier: NCT04179266
Recruitment Status : Completed
First Posted : November 27, 2019
Last Update Posted : February 24, 2021
Sponsor:
Collaborator:
Danish Headache Center
Information provided by (Responsible Party):
CCH Pharmaceuticals

Brief Summary:

Ketamine has been used clinically IV in a very safe manner by a very small number of clinicians, to treat migraines and CH, and various other rarer pain disorders, including mixed headache and neuropathic pain clinical syndromes. In 5 cases taken from Krusz J.C. headache clinic data in Dallas, Texas US, an intranasal spray of ketamine aqueous solution of 100 µL in one nostril were dosed in treatment of patients with refractory chronic cluster headache as an alternative to IV-treatment (data not published).The net conclusion, at this point, is that intranasal ketamine is a legitimate pharmacologic treatment and is safe and has in one case series proven effective for CH rescue.

The CCH patients will be dosed with an intranasal spray containing 172.5 mg ketamine hydrochloride (150 mg ketamine base) per ml in an aqueous solution. The individual dosing includes 15 mg ketamine in an intranasal sprayed volume of 100 µL given in one nose nostril under supervision of a nurse. The treatment is initiated at T0 under a CH attack when the headache pain exceeds NRS = 6 on an NRS pain scale. The first intranasal dose of 15 mg is given at time 0 and at time intervals of 6 minutes. At 15 minutes after 3 doses (45 mg) it is decided to evaluate whether the patient is sufficiently pain relieved (e.g. NRS < 4) or wants to receive rescue medications instead or if pain is not sufficiently relieved wants to continue until 5 dosing's (75 mg) are received at timepoints T24. The final evaluation of the treatment is performed at T30. Participants are followed up after 1-2 weeks by telehone


Condition or disease Intervention/treatment Phase
Cluster Headache Drug: Ketamine Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: open label - proof of concept study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Proof of Concept Study for Evaluation of the Effect of Ketamine Intranasal Spray in Treatment of Chronic Cluster Headache
Actual Study Start Date : November 20, 2019
Actual Primary Completion Date : May 12, 2020
Actual Study Completion Date : May 25, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache
Drug Information available for: Ketamine


Intervention Details:
  • Drug: Ketamine
    One Cluster headache attack is treated with intranasal ketamine


Primary Outcome Measures :
  1. Effect on pain intensity at 15 min (50% reduction) [ Time Frame: 15 minutes ]
    A 50% or more reduction in pain on a ten-point NRS scale (0: no pain, 10: worst imaginable pain) at T15 from pain intensity at T=0 .


Secondary Outcome Measures :
  1. Effect on pain intensity at 30 min [ Time Frame: 30 minutes ]
    A 50% or more reduction in pain on a ten-point NRS scale (0: no pain, 10: worst imaginable pain) at T30 from pain intensity at T=0.

  2. Effect on pain intensity at 15 min (25% reduction) [ Time Frame: 15 minutes ]
    A 25% reduction in pain on a ten-point NRS scale (0: no pain, 10: worst imaginable in) at T15 from pain intensity at T=0.

  3. Proportion of patients achieving NRS less than 4 at 15 minutes [ Time Frame: 15 minutes ]
    Proportion of patients achieving NRS less than 4 at 15 minutes

  4. Proportion of patients achieving NRS less than 4 at 30 minutes [ Time Frame: 30 minutes ]
    Proportion of patients achieving NRS less than 4 at 30 minutes

  5. Proportion of patients receiving rescue medication at 15 minutes [ Time Frame: 15 minutes ]
    Proportion of patients receiving rescue medication at 15 minutes

  6. Proportion of patients preferring ketamine treatment compared to oxygen or injectable sumatriptan. [ Time Frame: 180 minutes (entire attack) ]
    Proportion of patients preferring ketamine treatment compared to oxygen or injectable sumatriptan.

  7. Proportion of patients experiencing serious side effects during treatment [ Time Frame: one week follow-up. ]
    Proportion of patients experiencing serious side effects during treatment



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed informed consent
  • Age between 18 and 60 years
  • Diagnose: Chronic cluster headache according to ICHD-3 criteria (1)
  • Body weight ≥50 kg and BMI ≤30

Exclusion Criteria:

  • Conditions that result in the participant being unable to complete the experiment
  • Medical history with elevated intraocular pressure (e.g. glaucoma)
  • Medical history with severe heart or liver disease
  • Aneurysmal vascular disease or arteriovenous malformations
  • Medical history with severe neurological disease except of headache
  • BP measured at baseline before CH attack (Systolic> 140 mmHg or / and diastolic blood pressure> 90 mm Hg)
  • Medical history with severe depression or psychosis
  • A previous history of drug abuse
  • Consumption of illegal drugs within the last 6 months
  • Medical history of nasal abnormality or dysfunction (e.g. rhinitis)
  • High disposition for larynges or apnea
  • Positive pregnancy test before treatment and breastfeeding
  • Known hypersensitivity to ketamine

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): NCT04179266


Locations
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Denmark
Danish Headache Center
Glostrup, Denmark, DK-2600
Sponsors and Collaborators
CCH Pharmaceuticals
Danish Headache Center
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Responsible Party: CCH Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04179266    
Other Study ID Numbers: 2019-001260-29
First Posted: November 27, 2019    Key Record Dates
Last Update Posted: February 24, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Do to GDPR rules individual data will not be shared. Group data will be presented in publication. By request by other researcher other data will be presented if the request lines within the out approval from the The Danish Data Protection Agency

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Cluster Headache
Headache
Pain
Neurologic Manifestations
Trigeminal Autonomic Cephalalgias
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action