Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43857   clinical trials with a EudraCT protocol, of which   7284   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    Huntington's Disease Rilmenidine Safety Trial

    Summary
    EudraCT number
    		 2009-018119-14
    Trial protocol
    		 GB  
    Global end of trial date
    30 Jun 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    16 Jul 2016
    First version publication date
    16 Jul 2016
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    A091758
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Cambridge University Hospitals NHS Foundation Trust
    Sponsor organisation address
    Hills Road, Cambridge, United Kingdom, CB2 2PY
    Public contact
    Stephen Kelleher, Cambridge University NHS Foundation Trust, 01223 217418, stephen.kelleher@addenbrookes.nhs.uk
    Scientific contact
    Stephen Kelleher, Cambridge University NHS Foundation Trust, 01223 217418, stephen.kelleher@addenbrookes.nhs.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
    13 Jun 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    30 Jun 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Jun 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To investigate whether Rilmenidine (oral preparation) can safely be taken and is well tolerated by patients suffering from Huntington’s Disease (HD). This will be achieved by regular, periodic assessments of the patients’ physical and mental health monitoring for adverse effects and disease progression.
    Protection of trial subjects
    The patients were recruited from our normal NHS HD clinic, and on completion of the trial came back to this clinic. They are well known to us and the trial itself was straightforward with no invasive procedures, but simple assessments, blood tests and imaging. The only special measure was the monitoring of blood pressure given the agent being trialled is normally used as an anti-hypertensive.
    Background therapy
    		 Patients were trialled with Rilmenidine 1mg for 6 months and 2mg for 18 month, taken once per day. No placebo arm.
    Evidence for comparator
    		 N/A.
    Actual start date of recruitment
    03 Sep 2012
    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: 16
    Worldwide total number of subjects
    16
    EEA total number of subjects
    16
    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)
    15
    From 65 to 84 years
    1
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 All patients have been recruited from Cambridge University Hospital NHS FoundationTrust Huntington's disease clinic, which is run weekly at the Cambridge centre for Brain Repair. All patients have been recruited from Cambridge (single centre study) within one year of recruitment starting.

    Pre-assignment
    Screening details
    		 Known to have Huntington's disease, with a mild disease. Able to do MRI scan, which happened before and after medication was administered. Stable medication. no other ongoing medical or psychiatric problems and self caring. Not on hypertensive medication. Able to understand English.

    Period 1
    Period 1 title
    Overall Trial Period
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    Not applicable

    Arms
    Arm title
    		 Active Treatment
    Arm description
    		 -
    Arm type
    		 Open Label drug repurposing

    Investigational medicinal product name
    Rilmenidine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1mg for 6 months and 2 mg for following 18 months.

    Number of subjects in period 1
    		Active Treatment
    Started
    16
    None
    16
    Completed
    16
    Period 2
    Period 2 title
    Post intervention
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Active Treatment
    Arm description
    		 -
    Arm type
    		 Open Label drug repurposing

    Investigational medicinal product name
    Rilmenidine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1mg for 6 months and 2 mg for following 18 months.

    Number of subjects in period 2
    		Active Treatment
    Started
    16
    Completed
    16

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Overall Trial Period
    Reporting group description
    		 -

    Reporting group values
    		 Overall Trial Period Total
    Number of subjects
    		 16 16
    Age categorical
    Ambulant and able to self care independently. Males and Females, aged between 18 and 70. Women of childbearing age who are neither pregnant nor planning to conceive during the period of the study. Women will be required to use two forms of contraception, at least one of which to be a barrier method. English speaking and able to give written, informed consent.
    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)
    		 15 15
        From 65-84 years
    		 1 1
        85 years and over
    		 0 0
        Study Subject
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (full range (min-max))
    		 53 (37.8 to 69.9) -
    Gender categorical
    Males and Females with no selected gender bias for the trial
    Units: Subjects
        Female
    		 5 5
        Male
    		 11 11
    Demographics
    Age, gender, disease duration
    Units: Subjects
        Demographics
    		 16 16
    Clinical Assessments
    UHDRS - Clinical scoring
    Units: out of 144
        arithmetic mean (full range (min-max))
    		 24.2 (4 to 79) -
    Cognitive Assessment
    Mini Mental State
    Units: out of 30
        arithmetic mean (full range (min-max))
    		 27.5 (21 to 30) -
    Total Functional Capacity
    Units: 0-13
        arithmetic mean (full range (min-max))
    		 9.6 (5 to 13) -
    Trail A
    Units: Seconds
        arithmetic mean (full range (min-max))
    		 53.3 (30 to 221) -
    Trail B
    Units: seconds
        arithmetic mean (full range (min-max))
    		 162 (33 to 497) -

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Active Treatment
    Reporting group description
    		 -
    Reporting group title
    Active Treatment
    Reporting group description
    		 -

    Subject analysis set title
    Safety Popultion
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Any patients who received IMP

    Primary: Number of Serious Adverse Events

    		 Close Top of page
    End point title
    		 Number of Serious Adverse Events
    End point description
    End point type
    Primary
    End point timeframe
    27 months
    End point values
    		 Active Treatment Active Treatment Safety Popultion
    Number of subjects analysed
    16
    16
    16
    Units: Participants
    3
    3
    3
    Statistical analysis title
    		 Primary Analysis
    Statistical analysis description
    Comparison of SAE rate to a reference value of 5%
    Comparison groups
    Active Treatment v Active Treatment v Safety Popultion
    Number of subjects included in analysis
    48
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.04
    Method
    		 exact binomial test, one-sided
    Parameter type
    		 Incidence rate of SAEs
    Point estimate
    0.18
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.053
         upper limit
    		 0.348

    Secondary: MRI Volumetric Change

    		 Close Top of page
    End point title
    		 MRI Volumetric Change
    End point description
    End point type
    Secondary
    End point timeframe
    27 months - trial duration
    End point values
    		 Active Treatment
    Number of subjects analysed
    16
    Units: ML
    arithmetic mean (standard deviation)
        MRI
    13000 ± 10000
    No statistical analyses for this end point

    Secondary: Mini Mental State Examination

    		 Close Top of page
    End point title
    		 Mini Mental State Examination
    End point description
    End point type
    Secondary
    End point timeframe
    Collection over 27 months and collected at Baseline, 3, 6, 9 , 12, 18, 24 and 27 Months
    End point values
    		 Active Treatment
    Number of subjects analysed
    16
    Units: 30
    number (not applicable)
        MMSE
    16
    No statistical analyses for this end point

    Secondary: UHDRS motor score

    		 Close Top of page
    End point title
    		 UHDRS motor score
    End point description
    End point type
    Secondary
    End point timeframe
    at all time points as specified in trial protocol.
    End point values
    		 Active Treatment
    Number of subjects analysed
    16
    Units: 0-144
        number (not applicable)
    16
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    27 months
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 None
    Dictionary version
    1
    Reporting groups
    Reporting group title
    Active Treatment
    Reporting group description
    		 -

    Serious adverse events
    		 Active Treatment
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 16 (18.75%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Nervous system disorders
    Migraine
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Psychiatric disorders
    Depressive delusion
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal and connective tissue disorders
    Fracture
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Active Treatment
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    14 / 16 (87.50%)
    Injury, poisoning and procedural complications
    Thumb Injury
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    1
    Cardiac disorders
    Arrhythmia
         subjects affected / exposed
    4 / 16 (25.00%)
         occurrences all number
    4
    Nervous system disorders
    Head discomfort
    Additional description: Headache
         subjects affected / exposed
    3 / 16 (18.75%)
         occurrences all number
    3
    Dizziness
         subjects affected / exposed
    2 / 16 (12.50%)
         occurrences all number
    2
    Fall
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    1
    Insomnia related to another mental condition
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    1
    Paraesthesia
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    1
    Pain in extremity
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    1
    Blood and lymphatic system disorders
    Raised CPK
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    1
    Gastrointestinal disorders
    weight gain
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    1
    nausea
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    1
    Hepatobiliary disorders
    Alanine aminotransferase increased
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    1
    Alkaline Phosphatase Increased
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    1
    Psychiatric disorders
    Increased irritability
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    1
    Low Mood
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    1

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    02 Aug 2011
    Addition of patient ID card to the study.
    18 Aug 2011
    Update the Clinical Trials Authorisation with details of the company manufacturing and importing IMP.
    10 Dec 2012
    Increase the dose of the IMP that the patients take from 1mg to 2mg per day from 6 months for the remaining 18 months on the trial until month 24. Updates to the Patient Information sheets, protocol and patient Identification card and update to the original REC application form to correctly catagorise the trial as a phase II and not a phase IV as previously listed.

    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.
    Technical issues prevented saccadometer data from being recorded. NeuroPsychiatry Inventory could not be analysed as subjects attended with different or no caregiver. Hand tapping was collected over different time periods so couldn't be analysed.
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Wed Apr 24 13:42:51 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA