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

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-001260-29-DK

Enrollment

Registered

2019-06-12

Start date

2019-09-10

Completion date

Unknown

Last updated

2021-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Cluster Headache MedDRA version: 20.0 Level: PT Classification code 10059133 Term: Cluster headache System Organ Class: 10029205 - Nervous system disorders

Interventions

Product Name: Ketaminhydrochlorid intranasal spray Product Code: Ketamin Pharmaceutical Form: Nasal spray INN or Proposed INN: Ketamine hydrochloride CAS Number: 1867-66-9 Current Sponsor code: ketami

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

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Secondary

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

Measure

Time frame

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

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Countries

Denmark

Contacts

Public ContactChief Scientific Officer

CCH Pharmaceuticals

4527772988

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026