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NCT Number: NCT04179266

Effect of Ketamine Intranasal Spray in Treatment of Chronic Cluster Headache

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

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Key information

Conditions

Cluster Headache Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Nervous System Diseases Trigeminal Autonomic Cephalalgias

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Danish Headache Center

Glostrup Municipality, DK-2600, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ketamine

Drug

One Cluster headache attack is treated with intranasal ketamine

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

CCH Pharmaceuticals

Industry

Collaborators

  • Danish Headache Center

Registry information

Official study title

Proof of Concept Study for Evaluation of the Effect of Ketamine Intranasal Spray in Treatment of Chronic Cluster Headache

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Nov 27, 2019
Registry last updated
Feb 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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