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

    Summary
    EudraCT number
    		 2019-001260-29
    Trial protocol
    		 DK  
    Global end of trial date
    01 Jul 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    28 Jul 2021
    First version publication date
    28 Jul 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CCH01
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Lionheart Pharmaceuticals ApS
    Sponsor organisation address
    Groendals Parkvej 54, Vanloese, Denmark, 2720
    Public contact
    Chief Scientific Officer, CCH Pharmaceuticals, 45 27772988,
    Scientific contact
    Chief Scientific Officer, CCH Pharmaceuticals, 45 27772988,
    Sponsor organisation name
    Lionheart Pharmaceuticals ApS
    Sponsor organisation address
    Groendals Parkvej 54, Vanloese, Denmark, 2720
    Public contact
    CEO, Lionheart Pharmaceuticals ApS, 45 27772988, ph@lionheart-pharmaceuticals.com
    Scientific contact
    CEO, Lionheart Pharmaceuticals ApS, 45 27772988, ph@lionheart-pharmaceuticals.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    01 Jun 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 Jul 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Jul 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    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
    Protection of trial subjects
    Rescue medication ready and patients allowed to withdrawn from the study if desired or if severe adverse effects are observed
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Dec 2019
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Denmark: 23
    Worldwide total number of subjects
    23
    EEA total number of subjects
    23
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    23
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 According to inclusion/exclusion criteria

    Pre-assignment period milestones
    Number of subjects started
    		 23
    Number of subjects completed
    		 23

    Period 1
    Period 1 title
    Overall trial (intervention) (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Intervention
    Arm description
    		 The treatment is initiated under a cluster headache attack when the headache pain 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 with a maximum of 5 times (maximum total dose of 75 mg).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ketamine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nasal spray, solution
    Routes of administration
    Intranasal use
    Dosage and administration details
    15 mg R,S ketamine base per intranasal spray (100 microliter). Dosed in one nose nostril at intervals of 6 minutes (15 mg per dose), maximal 5 times (total of 75 mg).

    Number of subjects in period 1
    		Intervention
    Started
    23
    IMP administration
    20
    Completed
    20
    Not completed
    3
         No attack during admission
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial (intervention)
    Reporting group description
    		 -

    Reporting group values
    		 Overall trial (intervention) Total
    Number of subjects
    		 23 23
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 23 23
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
        Adults
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 7 7
        Male
    		 16 16

    End points

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    End points reporting groups
    Reporting group title
    Intervention
    Reporting group description
    		 The treatment is initiated under a cluster headache attack when the headache pain 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 with a maximum of 5 times (maximum total dose of 75 mg).

    Primary: Reduction in pain from time point 0 minutes to time point 15 minutes

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    End point title
    		 Reduction in pain from time point 0 minutes to time point 15 minutes [1]
    End point description
    End point type
    Primary
    End point timeframe
    15 minutes
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The endpoint looked at the mean percent difference from baseline (timepoint 0 min) to Timepoint 15. No statistical analysis was performed on this percent change. Analyzing the the difference in actual numbers from t0 to t15 with a paired t test resulted in a p value of 0.188. Primary endpoint was not met in the study.
    End point values
    		 Intervention
    Number of subjects analysed
    20
    Units: percent
        arithmetic mean (standard deviation)
    11.8 ( 46.2 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From first drug administration and for the 3 following hours. Further there was a follow up conversation with the patient via telephone a week after treatment.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.0
    Reporting groups
    Reporting group title
    Reporting group
    Reporting group description
    		 -

    Serious adverse events
    		 Reporting group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 20 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Reporting group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    20 / 20 (100.00%)
    Injury, poisoning and procedural complications
    Intoxication
         subjects affected / exposed
    20 / 20 (100.00%)
         occurrences all number
    7
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    20 / 20 (100.00%)
         occurrences all number
    1
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    20 / 20 (100.00%)
         occurrences all number
    12
    Parasthesia
         subjects affected / exposed
    20 / 20 (100.00%)
         occurrences all number
    4
    Lethargy
         subjects affected / exposed
    20 / 20 (100.00%)
         occurrences all number
    1
    Aphasia
         subjects affected / exposed
    20 / 20 (100.00%)
         occurrences all number
    1
    tension headache
         subjects affected / exposed
    20 / 20 (100.00%)
         occurrences all number
    1
    headache
         subjects affected / exposed
    20 / 20 (100.00%)
         occurrences all number
    1
    General disorders and administration site conditions
    Hangover
         subjects affected / exposed
    20 / 20 (100.00%)
         occurrences all number
    1
    Asthenia
         subjects affected / exposed
    20 / 20 (100.00%)
         occurrences all number
    1
    Fatigue
         subjects affected / exposed
    20 / 20 (100.00%)
         occurrences all number
    1
    Feeling of relaxation
         subjects affected / exposed
    20 / 20 (100.00%)
         occurrences all number
    1
    Eye disorders
    Ocular discomfort
         subjects affected / exposed
    20 / 20 (100.00%)
         occurrences all number
    1
    Visual impairment
         subjects affected / exposed
    20 / 20 (100.00%)
         occurrences all number
    1
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    20 / 20 (100.00%)
         occurrences all number
    4
    Vomiting
         subjects affected / exposed
    20 / 20 (100.00%)
         occurrences all number
    2
    Abdominal pain
         subjects affected / exposed
    20 / 20 (100.00%)
         occurrences all number
    2
    Dry mouth
         subjects affected / exposed
    20 / 20 (100.00%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Nasopharyngitis
         subjects affected / exposed
    20 / 20 (100.00%)
         occurrences all number
    2
    Epistaxis
         subjects affected / exposed
    20 / 20 (100.00%)
         occurrences all number
    1
    Rhinalgia
         subjects affected / exposed
    20 / 20 (100.00%)
         occurrences all number
    1
    Respiration abnormal
         subjects affected / exposed
    20 / 20 (100.00%)
         occurrences all number
    1
    Psychiatric disorders
    Euphoric mood
         subjects affected / exposed
    20 / 20 (100.00%)
         occurrences all number
    3
    Confusional state
         subjects affected / exposed
    20 / 20 (100.00%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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