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Cluster HeadachePhase 1/2NCT04179266

Effect of Ketamine Intranasal Spray in Treatment of Chronic Cluster Headache

A Phase 1/2 study testing Ketamine in people with Cluster Headache, run by CCH Pharmaceuticals at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Cluster Headache
What is being tested?
Ketamine
How many people
23 participants
Where
1 siteDenmark
Study dates
20 Nov 2019to 25 May 2020
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 13Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • Danish Headache Center

    Glostrup Municipality, DK-2600

Other trials in Denmark

About this study

Official title: Proof of Concept Study for Evaluation of the Effect of Ketamine Intranasal Spray in Treatment of Chronic Cluster Headache

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

Being tested
Ketamine
Medical subject headings
Cluster Headache

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • KetamineDrug

    One Cluster headache attack is treated with intranasal ketamine

What is being measured

The primary outcome is the main question the study is designed to answer.

  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 .

    Measured: 15 minutes

Secondary outcomes (7)

  1. 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.

    Measured: 30 minutes

  2. 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.

    Measured: 15 minutes

  3. Proportion of patients achieving NRS less than 4 at 15 minutes

    Proportion of patients achieving NRS less than 4 at 15 minutes

    Measured: 15 minutes

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

    Proportion of patients achieving NRS less than 4 at 30 minutes

    Measured: 30 minutes

  5. Proportion of patients receiving rescue medication at 15 minutes

    Proportion of patients receiving rescue medication at 15 minutes

    Measured: 15 minutes

  6. Proportion of patients preferring ketamine treatment compared to oxygen or injectable sumatriptan.

    Proportion of patients preferring ketamine treatment compared to oxygen or injectable sumatriptan.

    Measured: 180 minutes (entire attack)

  7. Proportion of patients experiencing serious side effects during treatment

    Proportion of patients experiencing serious side effects during treatment

    Measured: one week follow-up.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Nov 2019
  2. Study start20 Nov 2019
  3. Primary completion12 May 2020
  4. Study completion25 May 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
open label - proof of concept study
Masking
None (open label)
Enrolment
23 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04179266
Sponsor's protocol ID
2019-001260-29
Other IDs
2019
Status last verified
Feb 2021
First submitted
25 Nov 2019
Last updated
24 Feb 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Ketamine in people with Cluster Headache, run by CCH Pharmaceuticals at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Effect on pain intensity at 15 min (50% reduction) (time frame: 15 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04179266.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2021.

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