Effect of Ketamine Intranasal Spray in Treatment of Chronic Cluster Headache

NCT04179266 | Completed Phase 1 DMC

• 1 other identifier: 2019-001260-29
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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

Conditions

Cluster Headache

Outcome Measures

Primary Outcomes (1)

• Effect on pain intensity at 15 min (50% reduction)

  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 .

  15 minutes

Secondary Outcomes (7)

• Effect on pain intensity at 30 min

  30 minutes

• Effect on pain intensity at 15 min (25% reduction)

  15 minutes

• Proportion of patients achieving NRS less than 4 at 15 minutes

  15 minutes

• Proportion of patients achieving NRS less than 4 at 30 minutes

  30 minutes

• Proportion of patients receiving rescue medication at 15 minutes

  15 minutes

Interventions

Ketamine DRUG

One Cluster headache attack is treated with intranasal ketamine

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• CCH Pharmaceuticals: lead
• Danish Headache Center: collaborator

Study Sites (1)

Danish Headache Center

Glostrup Municipality, DK-2600, Denmark

Location

MeSH Terms

Conditions

Cluster Headache

Interventions

Ketamine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: open label - proof of concept study

Study Record Dates

• First Submitted: November 25, 2019
• First Posted: November 27, 2019
• Study Start: November 20, 2019
• Primary Completion: May 12, 2020
• Study Completion: May 25, 2020
• Last Updated: February 24, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)