Clinical pilot study for evaluation of the effect of ketamine intranasal spray in treatment of chronic Cluster Headache

Phase 1

• Conditions: Chronic Cluster Headache; MedDRA version: 20.0Level: PTClassification code 10059133Term: Cluster headacheSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2019-001260-29-DK
• Lead Sponsor: CCH Pharmaceuticals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-06-12
• Last Update Posted: 19 April 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Signed informed consent
Age between 18 and 60 years
Diagnose: Chronic cluster headache according to ICHD-3 criteria
Body weight =50 kg and BMI =30
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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 no breastfeeding
•Known hypersensitivity to ketamine

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The objective of this open pilot study is to evaluate whether ketamine administered as an intranasal spray in sub-anesthetic doses is effective in treatment of chronic CH;Secondary Objective: Not applicable;Primary end point(s): 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 . ;Timepoint(s) of evaluation of this end point: T=15 min

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): • 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.<br> • 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. <br>• Proportion of patients achieving NRS less than 4 at 15 minutes <br>• Proportion of patients achieving NRS less than 4 at 30 minutes <br>• Proportion of patients receiving rescue medication at 15 minutes <br>• Proportion of patients preferring ketamine treatment compared to oxygen or injectable sumatriptan. <br>• Proportion of patients experiencing serious side effects during treatment ;Timepoint(s) of evaluation of this end point: T=15 and T=30