Proof of concept study for evaluation of the effect of ketamine intranasal spray in treatment of chronic Cluster Headache (CCH)

This open-label trial (n=20) conducted in Denmark by CCH Pharmaceuticals, with the protocol code CCH01, aimed to assess the efficacy of ketamine intranasal spray in treating chronic Cluster Headache (CCH). The trial, part of an EEA CTA, was initiated on June 12, 2019, and completed on May 25, 2020.

The study enrolled adults aged 18 to 60 diagnosed with chronic cluster headaches according to ICHD-3 criteria. The primary objective was to evaluate the effectiveness of ketamine administered as an intranasal spray in sub-anesthetic doses in reducing pain. The trial employed an open design with no randomization or placebo control. Key exclusion criteria included conditions preventing participants from completing the experiment and a history of severe medical conditions.

The primary endpoint was a 50% or more reduction in pain on a ten-point NRS scale at 15 minutes from baseline. Secondary endpoints included various pain reduction measures, patient preferences, and the proportion of patients experiencing serious side effects. The trial concluded with an authorized Competent Authority Decision on August 16, 2019, and a favourable Ethics Committee Opinion on September 10, 2019.

Note to self, results: https://www.clinicaltrialsregister.eu/ctr-search/trial/2019-001260-29/DK

Topic Headache Disorders
Compound Ketamine
Country Denmark
Visit trial
Status Completed
Results Published Yes
Start date 16 August 2019
End date 25 May 2020
Phase Phase II
Design Open
Type Interventional
Generation First
Participants 20
Sex All
Age 18- 60
Therapy No

Trial Details

This open-label trial (n=20), sponsored by CCH Pharmaceuticals in Denmark, aimed to evaluate the efficacy of ketamine intranasal spray in treating chronic Cluster Headache. Conducted as part of an EEA CTA, the trial enrolled adults aged 18 to 60 with the primary endpoint being a 50% or more reduction in pain at 15 minutes. The study, initiated on June 12, 2019, concluded on May 25, 2020, with an authorized Competent Authority Decision on August 16, 2019, and a favorable Ethics Committee Opinion on September 10, 2019.

NCT Number 2019-001260-29

Papers

Intranasal ketamine for acute cluster headache attacks—Results from a proof-of-concept open-label trial
This open-label pilot study (n=20) investigated the safety and efficacy of intranasal ketamine for treating a single cluster headache (CH) attack. While the primary endpoint of a 50% reduction in pain intensity within 15 minutes was not met, at 30 minutes post-treatment, pain intensity was significantly reduced by 59% on an 11-point scale, with no serious adverse events reported.

Data attribution

A large set of the trials in our database are sourced from ClinicalTrials.gov (CTG). We have modified these post to display the information in a more clear format or to correct spelling mistakes. Our database in actively updated and may show a different status (e.g. completed) if we have knowledge of this update (e.g. a published paper on the study) which isn't reflected yet on CTG. If a trial is not sourced from CTG, this is indicated on this page and you can follow the link to the alternative source of information.