A Phase 1/2 interventional study of Ketamine in Cluster Headache, sponsored by CCH Pharmaceuticals. Completed at 1 site in Denmark. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2021-02-24.
Sponsored by CCH Pharmaceuticals · Phase 1/2, Interventional, and Treatment
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
116 studies on the registry are indexed under Cluster Headache; 27 are open to participants now.
This study's enrollment of 23 is below the median of 42 across 86 interventional studies indexed under Cluster Headache.
Browse Cluster Headache studies →This is the only study on the registry with CCH Pharmaceuticals as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
One Cluster headache attack is treated with intranasal ketamine
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 .
Time frame: 15 minutes
Effect on pain intensity at 30 min
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.
Time frame: 30 minutes
Effect on pain intensity at 15 min (25% reduction)
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.
Time frame: 15 minutes
Proportion of patients achieving NRS less than 4 at 15 minutes
Proportion of patients achieving NRS less than 4 at 15 minutes
Time frame: 15 minutes
Proportion of patients achieving NRS less than 4 at 30 minutes
Proportion of patients achieving NRS less than 4 at 30 minutes
Time frame: 30 minutes
Proportion of patients receiving rescue medication at 15 minutes
Proportion of patients receiving rescue medication at 15 minutes
Time frame: 15 minutes
Proportion of patients preferring ketamine treatment compared to oxygen or injectable sumatriptan.
Proportion of patients preferring ketamine treatment compared to oxygen or injectable sumatriptan.
Time frame: 180 minutes (entire attack)
Proportion of patients experiencing serious side effects during treatment
Proportion of patients experiencing serious side effects during treatment
Time frame: one week follow-up.
Plan to share: No — Do to GDPR rules individual data will not be shared. Group data will be presented in publication. By request by other researcher other data will be presented if the request lines within the out approval from the The Danish Data Protection Agency
No publications or documents are linked to this record.
This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
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