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    Clinical Trial Results:
    A Multi-Center, Open-Label Study Evaluating the Safety, Tolerability, and Efficacy of Pridopidine in Patients with Huntington’s Disease (Open PRIDE-HD) (Open PRIdopidine Dose Evaluation in Huntington’s Disease)

    Summary
    EudraCT number
    2015-000904-24
    Trial protocol
    DE   GB   AT   NL   IT  
    Global end of trial date
    12 Jan 2018

    Results information
    Results version number
    v2(current)
    This version publication date
    26 Aug 2021
    First version publication date
    11 Mar 2021
    Other versions
    v1
    Version creation reason
    • Correction of full data set
    alignment with CT.gov

    Trial information

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    Trial identification
    Sponsor protocol code
    TV7820-CNS-20016
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02494778
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Prilenia Neurotherapeutics Ltd.
    Sponsor organisation address
    Hamenofim 10, Herzliya, Israel, 4672561
    Public contact
    Michal Geva, Prilenia Neurotherapeutics Ltd., clinicaltrialseu@prilenia.com
    Scientific contact
    Michal Geva, Prilenia Neurotherapeutics Ltd., clinicaltrialseu@prilenia.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
    10 Jul 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    12 Jan 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    12 Jan 2018
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary objective of this study is to evaluate safety and tolerability of pridopidine in patients with Huntington’s Disease (HD).
    Protection of trial subjects
    Not applicable
    Background therapy
    -
    Evidence for comparator
    No comparison drug was used in this open-label study.
    Actual start date of recruitment
    24 Sep 2015
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Netherlands: 9
    Country: Number of subjects enrolled
    Poland: 28
    Country: Number of subjects enrolled
    United Kingdom: 28
    Country: Number of subjects enrolled
    Austria: 18
    Country: Number of subjects enrolled
    France: 18
    Country: Number of subjects enrolled
    Germany: 32
    Country: Number of subjects enrolled
    Italy: 34
    Country: Number of subjects enrolled
    Australia: 9
    Country: Number of subjects enrolled
    Canada: 4
    Country: Number of subjects enrolled
    Russian Federation: 34
    Country: Number of subjects enrolled
    United States: 34
    Worldwide total number of subjects
    248
    EEA total number of subjects
    167
    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)
    215
    From 65 to 84 years
    33
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    248 patients, ≥21 years of age, with a body weight of ≥50 kg, with a diagnosis of HD who completed the double-blind, randomized phase in PRIDE-HD study, including the follow-up period, or who participated in the open-label ACR16C015 (Open-HART) extension study, were scheduled to be included in this study.

    Pre-assignment
    Screening details
    The study consisted of a screening period/baseline visit of up to 2 weeks.

    Period 1
    Period 1 title
    Overall trial (78 weeks) (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Not applicable
    Blinding used
    Not blinded
    Blinding implementation details
    This was an open-label study with no blinding.

    Arms
    Arm title
    Pridopidine 45 mg bid
    Arm description
    Pridopidine (45 mg) was administered as oral capsules, taken twice daily (bid).
    Arm type
    Experimental

    Investigational medicinal product name
    Pridopidine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    Pridopidine (45 mg) was administered as oral capsules, taken twice a day (bid).

    Number of subjects in period 1
    Pridopidine 45 mg bid
    Started
    248
    Completed
    27
    Not completed
    221
         Consent withdrawn by subject
    20
         Adverse event, non-fatal
    18
         Other
    173
         Death
    3
         Noncompliance with study drug administration
    1
         Lost to follow-up
    2
         Lack of efficacy
    4

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial (78 weeks)
    Reporting group description
    -

    Reporting group values
    Overall trial (78 weeks) Total
    Number of subjects
    248 248
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    215 215
        From 65-84 years
    33 33
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    50.6 ± 11.61 -
    Gender categorical
    Units: Subjects
        Female
    129 129
        Male
    119 119

    End points

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    End points reporting groups
    Reporting group title
    Pridopidine 45 mg bid
    Reporting group description
    Pridopidine (45 mg) was administered as oral capsules, taken twice daily (bid).

    Primary: Percentage of Participants With Adverse Events

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    End point title
    Percentage of Participants With Adverse Events [1]
    End point description
    End point type
    Primary
    End point timeframe
    78 weeks
    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: No statistical analyses have been specified for this primary end point.
    End point values
    Pridopidine 45 mg bid
    Number of subjects analysed
    248
    Units: Patients
    193
    No statistical analyses for this end point

    Secondary: Change From Baseline in Quantitative Motor (Q-motor) Measurements, Pro-Sup-Inter-Onset-interval-SD-Hand

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    End point title
    Change From Baseline in Quantitative Motor (Q-motor) Measurements, Pro-Sup-Inter-Onset-interval-SD-Hand
    End point description
    Q-motor assessments were based on the application of force transducers and 3-dimensional position sensors. The reported parameter is the Pro-Sup-Inter-Onset-interval-SD-Hand, measured in seconds. Positive change from baseline indicates worsening.
    End point type
    Secondary
    End point timeframe
    Week 52, end of treatment (EOT)
    End point values
    Pridopidine 45 mg bid
    Number of subjects analysed
    146
    Units: Score on a scale
    arithmetic mean (standard deviation)
        Change from baseline to Week 52
    0.0 ± 0.05
        Change from baseline to EOT
    -0.1 ± 0.01
    No statistical analyses for this end point

    Secondary: Change From Baseline in Quantitative Motor (Q-motor) Measurements, Pro-Sup-Peak-Force-CV-Hand

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    End point title
    Change From Baseline in Quantitative Motor (Q-motor) Measurements, Pro-Sup-Peak-Force-CV-Hand
    End point description
    Q-motor assessments were based on the application of force transducers and 3-dimensional position sensors. The reported parameter is the Pro-Sup-Peak-Force-CV-Hand, measured in %. Positive change from baseline indicates worsening.
    End point type
    Secondary
    End point timeframe
    Week 52, end of treatment (EOT)
    End point values
    Pridopidine 45 mg bid
    Number of subjects analysed
    146
    Units: Score on a scale
    arithmetic mean (standard deviation)
        Change from baseline to Week 52
    -2.9 ± 9.31
        Change from baseline to EOT
    -5.9 ± 8.05
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    78 weeks
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    17.0
    Reporting groups
    Reporting group title
    Pridopidine 45 mg bid
    Reporting group description
    -

    Serious adverse events
    Pridopidine 45 mg bid
    Total subjects affected by serious adverse events
         subjects affected / exposed
    31 / 248 (12.50%)
         number of deaths (all causes)
    3
         number of deaths resulting from adverse events
    3
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Basal cell carcinoma
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 248 (0.40%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Malignant melanoma in situ
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 248 (0.40%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Prostate cancer
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 248 (0.40%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Squamous cell carcinoma
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 248 (0.40%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Death
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 248 (0.40%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    1 / 1
    Gait disturbance
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 248 (0.40%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pneumonia aspiration
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 248 (0.40%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pulmonary embolism
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 248 (0.40%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Psychiatric disorders
    Suicidal ideation
    alternative assessment type: Systematic
         subjects affected / exposed
    3 / 248 (1.21%)
         occurrences causally related to treatment / all
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    Depression
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 248 (0.40%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hallucination, auditory
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 248 (0.40%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Paranoia
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 248 (0.40%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Investigations
    Weight decreased
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 248 (0.40%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Injury, poisoning and procedural complications
    Fall
    alternative assessment type: Systematic
         subjects affected / exposed
    4 / 248 (1.61%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    Subdural haematoma
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 248 (0.81%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Ankle fracture
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 248 (0.40%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Brain contusion
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 248 (0.40%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Contusion
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 248 (0.40%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Craniocerebral injury
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 248 (0.40%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Extradural haematoma
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 248 (0.40%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Facial bones fracture
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 248 (0.40%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Head injury
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 248 (0.40%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Skull fracture
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 248 (0.40%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Skull fractured base
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 248 (0.40%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Tibia fracture
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 248 (0.40%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Toxicity to various agents
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 248 (0.40%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Congenital, familial and genetic disorders
    Huntington’s disease
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 248 (0.40%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Chorea
    alternative assessment type: Systematic
         subjects affected / exposed
    3 / 248 (1.21%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Dystonia
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 248 (0.40%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Haemorrhage intracranial
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 248 (0.40%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Peripheral nerve palsy
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 248 (0.40%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Subarachnoid haemorrhage
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 248 (0.40%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Syncope
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 248 (0.40%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Transient ischaemic attack
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 248 (0.40%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 248 (0.40%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 1
    Gastrointestinal disorders
    Dysphagia
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 248 (0.40%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal polyp haemorrhage
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 248 (0.40%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hepatobiliary disorders
    Drug-induced liver injury
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 248 (0.40%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal and connective tissue disorders
    Musculoskeletal pain
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 248 (0.40%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pain in extremity
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 248 (0.40%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Pneumonia
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 248 (0.81%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Diverticulitis
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 248 (0.40%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Urinary tract infection
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 248 (0.40%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Urosepsis
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 248 (0.40%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Metabolism and nutrition disorders
    Cachexia
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 248 (0.40%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Pridopidine 45 mg bid
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    191 / 248 (77.02%)
    Investigations
    Weight decreased
    alternative assessment type: Systematic
         subjects affected / exposed
    13 / 248 (5.24%)
         occurrences all number
    13
    Injury, poisoning and procedural complications
    Fall
    alternative assessment type: Systematic
         subjects affected / exposed
    74 / 248 (29.84%)
         occurrences all number
    163
    Contusion
    alternative assessment type: Systematic
         subjects affected / exposed
    13 / 248 (5.24%)
         occurrences all number
    20
    Nervous system disorders
    Chorea
    alternative assessment type: Systematic
         subjects affected / exposed
    23 / 248 (9.27%)
         occurrences all number
    30
    Headache
    alternative assessment type: Systematic
         subjects affected / exposed
    14 / 248 (5.65%)
         occurrences all number
    19
    Psychiatric disorders
    Insomnia
    alternative assessment type: Systematic
         subjects affected / exposed
    20 / 248 (8.06%)
         occurrences all number
    27
    Anxiety
    alternative assessment type: Systematic
         subjects affected / exposed
    16 / 248 (6.45%)
         occurrences all number
    17
    Musculoskeletal and connective tissue disorders
    Back pain
    alternative assessment type: Systematic
         subjects affected / exposed
    14 / 248 (5.65%)
         occurrences all number
    15
    Infections and infestations
    Nasopharyngitis
    alternative assessment type: Systematic
         subjects affected / exposed
    29 / 248 (11.69%)
         occurrences all number
    36

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    30 Jun 2015
    Amendment 1 to the protocol was issued before any patients were enrolled into the study. Following the voluntary harmonization procedure protocol assessment, the primary reasons for this amendment were to limit the duration of treatment with study drug to 52 weeks and to clarify the use of permitted medications and prohibited tricyclic antidepressants. The following major procedural changes were made to the protocol: • Treatment with study drug was limited to 52 weeks. • Butriptyline and mianserin were removed from the list of allowed antidepressants, and trimipramine and mirtazapine were removed to clarify the use of the permitted medications and prohibited tricyclic and tetracyclic antidepressants. • Clarification of the assessment time points following the limitation of the study drug treatment duration to 52 weeks.
    31 Mar 2016
    Amendment 2 to the protocol was issued after 94 patients were enrolled into the study. Changes to the protocol were considered to have no negative impact on the safety of patients already enrolled into the study. The primary reason for this global amendment was to implement the following major procedural changes made to the protocol: • The 2 telephone calls for safety evaluation at weeks 18 and 38 were added, including C-SSRS and an abbreviated PBA-s assessment. • The treatment duration in the study was extended by an additional period of 52 weeks (for a total of 104 weeks). • Q-Motor assessments were added to the protocol as an efficacy measure. • Suicidal thoughts and ideations were defined as protocol-defined adverse events for expedited reporting.

    Interruptions (globally)

    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    10 Nov 2017
    This was an open-label extension of study TV7820-CNS-20002. It was terminated on 10 Nov 2017, as it was considered by the sponsor to have served its purpose in providing long-term safety data. Study termination was not based on safety concerns.
    -

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
    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.

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