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    Clinical Trial Results:
    Open-label Pilot Study of Memantine in Chronic Cough Patients Attending a Specialist Clinic

    Summary
    EudraCT number
    		 2011-005151-13
    Trial protocol
    		 GB  
    Global end of trial date
    14 Aug 2013

    Results information
    Results version number
    		 v1(current)
    This version publication date
    11 Apr 2020
    First version publication date
    11 Apr 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    MEM-COUGH-01
    Additional study identifiers
    ISRCTN number
    		 ISRCTN99941214
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 REC reference: 11/NW/0840
    Sponsors
    Sponsor organisation name
    Manchester University NHS Foundation Trust
    Sponsor organisation address
    29 Grafton Street, Manchester, United Kingdom, M13 9WU
    Public contact
    Dr. Jacky Smith, 11/NW/0840, +44 1612915879, jacky.smith@manchester.ac.uk
    Scientific contact
    Dr. Jacky Smith, 11/NW/0840, +44 1612915879, jacky.smith@manchester.ac.uk
    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
    14 Aug 2013
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    14 Aug 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the change in cough frequency in chronic cough patients after treatment with Memantine by assessing 24 hour cough frequency.
    Protection of trial subjects
    All potential adverse effects and risks associated with taking part in the trial were fully explained to patients before they decided whether to participate. It was made clear to patients at the beginning of the trial that although Memantine is a licensed medication it may not be possible for it to be prescribed for them "off-label" once the trial had ended and that treatment would be discontinued at the end of the study even if they had felt some benefit from taking it. Objective cough monitoring involves patients wearing a digital recording device to capture how much they cough over a 24 hour period. The device records patient's conversations as well as cough sounds which could be heard by trained cough analysis staff. Any conversation recorded in this manner was treated in accordance with the GMC Confidentiality Booklet and the Data Protection Act. This was explained in detail to patients prior to their participation.
    Background therapy
    		 No background therapy.
    Evidence for comparator
    		 This was an open-label study, no comparators were tested.
    Actual start date of recruitment
    17 Jan 2013
    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
    United Kingdom: 14
    Worldwide total number of subjects
    14
    EEA total number of subjects
    14
    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)
    8
    From 65 to 84 years
    6
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 All patients were recruited from the specialist cough clinic held at University Hospital of South Manchester NHS Foundation Trust between February 2013 and August 2013. All patients were required to read the participant information sheet thoroughly prior to providing written consent.

    Pre-assignment
    Screening details
    		 17 patients were screened and 14 enrolled. Reasons for 3 screen failures were; uncontrolled hypertension, use of systemic anticholinergic and clinically significant abnormal blood result. Main criteria for inclusion were diagnosis of idiopathic chronic cough of >8 weeks duration, aged 18 years or over, normal chest x-ray and normal spirometry.

    Period 1
    Period 1 title
    Baseline
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Baseline
    Arm description
    		 -
    Arm type
    		 Enrolled

    Investigational medicinal product name
    No treatment
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Unknown use
    Dosage and administration details
    N/A

    Number of subjects in period 1
    		Baseline
    Started
    14
    Completed
    14
    Period 2
    Period 2 title
    Treatment Period
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Memantine
    Arm description
    		 Escalating doses of memantine 10-40mg
    Arm type
    		 Experimental

    Investigational medicinal product name
    Memantine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    10-40mg OD doses escalating weekly if tolerated. Maximum tolerated dose continued for 4 weeks.

    Number of subjects in period 2
    		Memantine
    Started
    14
    Dosed
    14
    Completed
    12
    Not completed
    2
         Adverse event, non-fatal
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Baseline
    Reporting group description
    		 -

    Reporting group values
    		 Baseline Total
    Number of subjects
    		 14 14
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 57.9 ± 11.8 -
    Gender categorical
    Units: Subjects
        Female
    		 13 13
        Male
    		 1 1
    Smoking Status
    Units: Subjects
        Never smoked
    		 11 11
        Ex smoker
    		 3 3
    Cough Type
    Units: Subjects
        Dry
    		 11 11
        Productive
    		 3 3
    Cough Duration
    Units: Years
        arithmetic mean (standard deviation)
    		 13.7 ± 6.8 -

    End points

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    End points reporting groups
    Reporting group title
    Baseline
    Reporting group description
    		 -
    Reporting group title
    Memantine
    Reporting group description
    		 Escalating doses of memantine 10-40mg

    Primary: Awake cough frequency

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    End point title
    		 Awake cough frequency [1]
    End point description
    End point type
    Primary
    End point timeframe
    From baseline to end of treatment
    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: Details of the statistical analysis have not been inputted to the database as the fields are not tailored to this type of study. Two sided paired-sample t-tests were performed to compare post treatment measurements to baseline. There were no statistically significant differences with the p values for daytime cough frequency and total CQLQ score being p=0.141 and p=0.366 respectively.
    End point values
    		 Memantine Baseline
    Number of subjects analysed
    11 [2]
    13 [3]
    Units: coughs per hour
        geometric mean (confidence interval 95%)
    30.9 (15.6 to 61.2)
    41.1 (22.9 to 73.8)
    Notes
    [2] - 2 participants withdrew, 1 attended final visit with URTI so cough recording was not carried out
    [3] - 1 participant did not complete cough recording
    No statistical analyses for this end point

    Secondary: CQLQ Score

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    End point title
    		 CQLQ Score
    End point description
    End point type
    Secondary
    End point timeframe
    From baseline to end of treatment
    End point values
    		 Memantine Baseline
    Number of subjects analysed
    13 [4]
    13 [5]
    Units: number score
        arithmetic mean (confidence interval 95%)
    62.0 (54.3 to 69.7)
    64.6 (58.4 to 70.8)
    Notes
    [4] - 1 missing due to questionnaire being completed incorrectly
    [5] - 1 missing due to questionnaire being completed incorrectly
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From start of treatment to end of treatment
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16
    Reporting groups
    Reporting group title
    Memantine
    Reporting group description
    		 Single arm - escalating memantine treatment

    Serious adverse events
    		 Memantine
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 14 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Memantine
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    14 / 14 (100.00%)
    Nervous system disorders
    Sedation
         subjects affected / exposed
    3 / 14 (21.43%)
         occurrences all number
    3
    Dysarthria
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Paraesthesia
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    General disorders and administration site conditions
    Dizziness
         subjects affected / exposed
    10 / 14 (71.43%)
         occurrences all number
    10
    Fatigue
         subjects affected / exposed
    6 / 14 (42.86%)
         occurrences all number
    6
    Somnolence
         subjects affected / exposed
    5 / 14 (35.71%)
         occurrences all number
    5
    Headache
         subjects affected / exposed
    5 / 14 (35.71%)
         occurrences all number
    5
    Viral upper respiratory tract infection
         subjects affected / exposed
    4 / 14 (28.57%)
         occurrences all number
    4
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    3 / 14 (21.43%)
         occurrences all number
    3
    Constipation
         subjects affected / exposed
    2 / 14 (14.29%)
         occurrences all number
    2
    Diarrhoea
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Haemoptysis
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Cough
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Lung infection
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    11 May 2012
    Substantial Amendment 1.0: At the request of the MHRA, a section was added to the protocol (6.7) to describe and cover concomitant therapies.
    26 Nov 2012
    Substantial Amendment 2.0: Changes were 1. The IMP brand was changed from Ebixa to Axura due to sourcing difficulties. 2. Alterations to eligibility wording around definition of child bearing potential and acceptable methods of contraception. 3. Altered eligibility criteria for uncontrolled hypertension with an increase in acceptable limit. 4. Altered wording to eligibility criteria with regards to history of seizures. 5. Altered wording for eligibility with regards to the use of tricyclic antidepressants.

    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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