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    The EU Clinical Trials Register currently displays   42330   clinical trials with a EudraCT protocol, of which   6971   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2015-000904-24
    Sponsor's Protocol Code Number:TV7820-CNS-20016
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-08-18
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2015-000904-24
    A.3Full title of the trial
    A Multi-Center, Open-Label Study Evaluating the Safety, Tolerability, and Efficacy of Pridopidine in Patients with Huntington’s Disease
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study testing if pridopidine is safe and efficacious in patients with Huntington's Disease
    A.3.2Name or abbreviated title of the trial where available
    Open PRIDE-HD
    A.4.1Sponsor's protocol code numberTV7820-CNS-20016
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorTeva Branded Pharmaceutical Products R&D, Inc
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportTeva Branded Pharmaceutical Products R&D, Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTeva GmbH
    B.5.2Functional name of contact pointClinical Trial Information Desk
    B.5.3 Address:
    B.5.3.1Street AddressGraf-Arco-Str. 3
    B.5.3.2Town/ cityUlm
    B.5.3.3Post code89079
    B.5.3.4CountryGermany
    B.5.4Telephone number00000000
    B.5.5Fax number00000000
    B.5.6E-mailInfo.era-clinical@teva.de
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/05/288
    D.3 Description of the IMP
    D.3.1Product namePridopidine
    D.3.2Product code TV-7820
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNpridopidine
    D.3.9.1CAS number 346688-38-8
    D.3.9.2Current sponsor codeTV-7820
    D.3.9.3Other descriptive nameACR16 hydrochloride, ASP2314 hydrochloride, FR310826
    D.3.9.4EV Substance CodeSUB47886
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number22.5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/05/288
    D.3 Description of the IMP
    D.3.1Product namePridopidine
    D.3.2Product code TV-7820
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNpridopidine
    D.3.9.1CAS number 346688-38-8
    D.3.9.2Current sponsor codeTV-7820
    D.3.9.3Other descriptive nameACR16 hydrochloride, ASP2314 hydrochloride, FR310826
    D.3.9.4EV Substance CodeSUB47886
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number45
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Huntington's disease
    E.1.1.1Medical condition in easily understood language
    An hereditary disorder of the central nervous system that affects muscle coordination and leads to cognitive decline and psychiatric problems.
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10070668
    E.1.2Term Huntington's disease
    E.1.2System Organ Class 10010331 - Congenital, familial and genetic disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to evaluate safety and tolerability of pridopidine in patients with HD.
    E.2.2Secondary objectives of the trial
    The secondary objectives of the study are to assess the effects of long-term, open-label dosing with pridopidine on motor symptom severity, overall patient function, physical performance, and healthrelated quality of life.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Sub-study title: Objective quantification of chorea using a wearable sensor-mobile application tool (Digital Health)
    Sub-study Protocol Date: 10 October 2016
    Version: included in main Clinical Study Protocol Amendment 02
    Objective: To test the hypothesis of using wearable sensor data to estimate clinically relevant measures of HD in patients while on their medication regimen. The aim is to develop algorithms to objectively quantify chorea by analyzing the data from the wearable sensors.
    E.3Principal inclusion criteria
    a.Patient has completed the PRIDE-HD study (including the follow-up period), or exited from Open PRIDE-HD global or local amendments, all within the last 6 months, or transitioned from Open-HART.
    For patients that have failed to complete the PRIDE-HD study or those who exited or completed the above mentioned studies over 6 months prior to the screening visit, and meet all other inclusion criteria, eligibility should be discussed with the Open-PRIDE-HD medical monitor and clinician on a case-by-case basis.
    b. For patients that experienced a drug-related serious adverse event during PRIDE-HD, Open-HART, or Open PRIDE-HD global or local amendments, eligibility approval should be discussed with the Open PRIDE-HD medical monitor and clinician. Patients that experienced an adverse event/serious adverse event of active suicidal ideation/behavior will be excluded without discussion.
    c. Able and willing to provide written informed consent prior to any study related procedure being performed. Patients with a legal guardian should be consented according to local requirements.
    d. Females of child bearing potential have to be compliant in using adequate birth control throughout the duration of the study. Adequate birth control is defined as consistent practice of an effective and accepted method of contraception according to local regulations (hormone-based, intrauterine device, or double barrier contraception, ie, condom and diaphragm). Abstinence is an acceptable method of contraception only when this is the preferred and usual lifestyle of the subject. Periodic abstinence (calendar, symptothermal, post-ovulation methods), withdrawal (coitus interruptus), and lactational amenorrhea method (LAM) are not acceptable methods of contraception. Male study participants have to be compliant in using adequate birth control with their partners (as defined above) throughout the duration
    of the study.
    f. Willing and able to take oral medication and able to comply with the study specific procedures.
    g. Ambulatory, being able to travel to the study center, and judged by the investigator as likely to be able to continue to travel for the duration of the study.
    h. The patient is in good health as determined by medical examination, ECG, serum chemistry, hematology, and urinalysis.
    i. The patient must be willing and able to comply with study restrictions and to remain at the investigational center for the required duration during the study period, and willing to return to the investigational center for further visits, as applicable, and the follow up procedures and assessments as specified in this protocol.
    E.4Principal exclusion criteria
    a. A prolonged QTcF interval (defined as a QTcF interval of >450 msec) at the screening visit. ECGs will be performed in triplicate during the screening visit, and the mean of the 3 QTcF measurements will be used to determine whether or not the patient is suitable for inclusion in the study.
    b. Patients with clinically significant heart disease at the screening visit, defined as follows: (i) significant cardiac event (eg, myocardial infarction), angina pectoris or episode of congestive heart failure with symptoms >Grade 2 New York Heart Association classification within 12 weeks before randomization, or presence of cardiac disease that in the opinion of the investigator increased the risk of ventricular arrhythmia, (ii) history of arrhythmia (multifocal premature ventricular contractions, bigeminy, trigeminy, ventricular tachycardia) that was symptomatic or required treatment (Common Terminology Criteria for Adverse Events Grade 3), symptomatic or uncontrolled atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia, (iii) presence of left bundle branch block.
    c. Patients with serum potassium, magnesium, and/or calcium levels outside of the central laboratory’s reference range at the screening visit and considered clinically significantly abnormal by the investigator. Repeat testing is allowed (up to a maximum of 3 tests) if required to establish whether values are within normal range or clinically significantly abnormal.
    d. Patients receiving medications (within the last 6 weeks prior to baseline) other than pridopidine that have been proven to prolong QT interval or who may require such medications during the course of the study such as but not limited to non-allowed anti-psychotic medications, tricyclic antidepressants, and/or Class I antiarrhythmics.
    e. Patients receiving medications (within the last 6 weeks prior to baseline) other than pridopidine that are metabolized by CYP2D6 and have the potential of reducing seizure threshold.
    f. Patients with a history of epilepsy or of seizures within the last 5 years or the history of seizures currently treated with antiepileptic drugs.
    g. Creatinine clearance <60 mL/min at screening, calculated using the Cockcroft-Gault equation: (140 - age) × mass (kg) × [0.85 if female] / 72 × serum creatinine (mg/ dL). It is allowed to repeat the test once, if clinically appropriate.
    h. Any clinically significant, abnormal, screening laboratory result which in the opinion of the investigator, affects the patients’ suitability for the study or puts the patient at risk if he/she enters the study.
    i.Patients with adverse events of suicidal ideation or attempt at any time in the past or as measured by suicide ideation score of ≥3on the C-SSRS, or PBA-s or patients who answer “Yes” on any of the 5 C-SSRS Suicidal Behavior Items (actual attempt, interrupted attempt, aborted attempt, preparatory acts, or behavior) if the attempt or acts were performed at any time in the past, or patients who, in the opinion of the investigator, present a risk of suicide.
    j. Females who are pregnant or breastfeeding.
    k. Treatment with any investigational product other than pridopidine within 6 weeks of screening or patients planning to participate in another clinical study assessing any investigational product during the study.
    E.5 End points
    E.5.1Primary end point(s)
    The safety endpoints for this study are as follows:
    - adverse events
    - vital signs assessments
    - concomitant medication usage throughout the study
    - physical examination findings
    - clinical laboratory evaluations (hematology, clinical chemistry, and urinalysis)
    - ECG findings
    - Suicidality [using the Columbia-Suicide Severity Rating Scale (C-SSRS)] and Problem Behaviors Assessment-Short form (PBA-s)

    The tolerability endpoints for this study are as follows:
    - Proportion of patients (%) who prematurely discontinued from the study
    - Proportion of patients (%) who prematurely discontinued from the study due to AEs
    E.5.1.1Timepoint(s) of evaluation of this end point
    The following safety and tolerability measures will be assessed during the study:
    - AEs – monitored at every study visit.
    - Vital signs assessments – monitored at every study visit.
    - Concomitant medication usage - monitored at every study visit.
    - Physical examination findings – brief physical examination will be performed at every study visit.
    - Clinical laboratory evaluations (hematology, clin. chemistry, urinalysis) - at each study visit
    - ECG findings – ECG will be performed at every study visit
    - Suicidality (C-SSRS,PBA-s) will be assessed throughout the study.

    Tolerability endpoints:
    - Proportion of patients (%) who prematurely discontinued from the study
    - Proportion of patients (%) who prematurely discontinued from the study due to AEs
    E.5.2Secondary end point(s)
    Long-term efficacy evaluations are the secondary objective of this study. Efficacy endpoints include the following:
    - Unified Huntington’s Disease Rating Scale – Total Motor Score (UHDRS-TMS)
    - Modified Physical Performance Test (mPPT)
    -Unified Huntington’s Disease Rating Scale - Total Functional Capacity (UHDRSTFC)
    - Short Form 12 (SF-12) questionnaire (acute version)
    - Problem Behaviors Assessment-Short form (PBA-s) (also part of safety assessments)
    -Quantitative motor (Q-motor) assessment (up to 104 weeks; not applicable for newly enrolled patients after global Amendment 02)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Efficacy analyses will be considered exploratory. Comparisons will generally be made to baseline, as appropriate. Efficacy endpoints include the following:
    - UHDRS-TMS - will be performed on site at all visits during the study.
    - mPPT - will be performed at baseline, week 12, 26, 52, 78, 104, 130 and visit 26 weeks thereafter
    - UHDRS-TFC will be performed at baseline, week 26, 52, 78, 104, 130 and every visit 26 weeks thereafter,
    - SF-12 evaluation will be performed at baseline, week 26, 52, 78, 104, 130 and every visit 26 weeks thereafter,
    - PBA-s – a full scale will be performed at all on site visits an abbreviated PBA-s will be performed at all safety evaluation TCs
    - Q-motor – will be performed at baseline and at weeks 52, 78, and 104.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA33
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Austria
    Canada
    France
    Germany
    Italy
    Netherlands
    Poland
    Russian Federation
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months1
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 276
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 24
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state28
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 210
    F.4.2.2In the whole clinical trial 300
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-08-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-11-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-01-12
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