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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

Tracking Information
First Submitted Date  ICMJE November 25, 2019
First Posted Date  ICMJE November 27, 2019
Last Update Posted Date February 24, 2021
Actual Study Start Date  ICMJE November 20, 2019
Actual Primary Completion Date May 12, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 26, 2019)
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 .
Original Primary Outcome Measures  ICMJE
 (submitted: November 26, 2019)
Effect on pain intensity at 15 min (50% reduction) [ Time Frame: 15 min ]
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 .
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 26, 2019)
  • 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.
  • 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.
  • 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
  • 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
  • Proportion of patients receiving rescue medication at 15 minutes [ Time Frame: 15 minutes ]
    Proportion of patients receiving rescue medication at 15 minutes
  • 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.
  • Proportion of patients experiencing serious side effects during treatment [ Time Frame: one week follow-up. ]
    Proportion of patients experiencing serious side effects during treatment
Original Secondary Outcome Measures  ICMJE
 (submitted: November 26, 2019)
  • Effect on pain intensity at 30 min [ Time Frame: 30 min ]
    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.
  • Effect on pain intensity at 15 min (25% reduction) [ Time Frame: 15 min ]
    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.
  • Proportion of patients achieving NRS less than 4 at 15 minutes [ Time Frame: 15 min ]
    Proportion of patients achieving NRS less than 4 at 15 minutes
  • Proportion of patients achieving NRS less than 4 at 30 minutes [ Time Frame: 30 min ]
    Proportion of patients achieving NRS less than 4 at 30 minutes
  • Proportion of patients receiving rescue medication at 15 minutes [ Time Frame: 15 min ]
    Proportion of patients receiving rescue medication at 15 minutes
  • Proportion of patients preferring ketamine treatment compared to oxygen or injectable sumatriptan. [ Time Frame: 180 min (entire attack) ]
    Proportion of patients preferring ketamine treatment compared to oxygen or injectable sumatriptan.
  • Proportion of patients experiencing serious side effects during treatment [ Time Frame: one week follow-up. ]
    Proportion of patients experiencing serious side effects during treatment
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Ketamine Intranasal Spray in Treatment of Chronic Cluster Headache
Official Title  ICMJE Proof of Concept Study for Evaluation of the Effect of Ketamine Intranasal Spray in Treatment of Chronic Cluster Headache
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

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
open label - proof of concept study
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Cluster Headache
Intervention  ICMJE Drug: Ketamine
One Cluster headache attack is treated with intranasal ketamine
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 23, 2021)
23
Original Estimated Enrollment  ICMJE
 (submitted: November 26, 2019)
20
Actual Study Completion Date  ICMJE May 25, 2020
Actual Primary Completion Date May 12, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04179266
Other Study ID Numbers  ICMJE 2019-001260-29
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
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
Responsible Party CCH Pharmaceuticals
Study Sponsor  ICMJE CCH Pharmaceuticals
Collaborators  ICMJE Danish Headache Center
Investigators  ICMJE Not Provided
PRS Account CCH Pharmaceuticals
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP