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    Summary
    EudraCT Number:2018-004750-21
    Sponsor's Protocol Code Number:TAK-935-2008
    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:2019-04-05
    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 number2018-004750-21
    A.3Full title of the trial
    A Phase 2a, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of TAK-935 as an Adjunctive Therapy in Adult Subjects With Chronic Complex Regional Pain Syndrome
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of TAK-935 as an Adjunctive Therapy in Adult Subjects With Complex Regional Pain Syndrome
    A.4.1Sponsor's protocol code numberTAK-935-2008
    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 SponsorMillennium Pharmaceuticals, a wholly owned subsidiary of Takeda
    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 supportMillennium Pharmaceuticals
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTakeda
    B.5.2Functional name of contact pointTakeda Study Registration Call Cent
    B.5.3 Address:
    B.5.3.1Street Addressunknown
    B.5.3.2Town/ cityunknown
    B.5.3.3Post codeunknown
    B.5.3.4CountryUnited States
    B.5.4Telephone number0018778253327
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameTAK-935
    D.3.2Product code TAK-935
    D.3.4Pharmaceutical form Tablet
    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 INNNone at this time
    D.3.9.1CAS number 1429505-03-2
    D.3.9.2Current sponsor codeTAK-935
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Complex Regional Pain Syndrome (CRPS)
    E.1.1.1Medical condition in easily understood language
    Complex Regional Pain Syndrome (CRPS)
    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 21.1
    E.1.2Level LLT
    E.1.2Classification code 10064334
    E.1.2Term Complex regional pain syndrome Type I
    E.1.2System Organ Class 100000004852
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10064335
    E.1.2Term Complex regional pain syndrome Type II
    E.1.2System Organ Class 100000004852
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To investigate the effect of TAK-935 on calculated 24-hour average pain intensity by the Numeric Pain Scale (NPS)
    E.2.2Secondary objectives of the trial
    To investigate the effect of TAK-935 on overall function using the Patient Global Impression of Change (PGIC) and the Patient-Reported Outcomes Measurement Information System (PROMIS-29) scale.

    To investigate the effect of TAK-935 on the CRPS Severity Score (CSS).

    To investigate the effect of TAK-935 on responder rate (responder is defined as ≥30% improvement in the 24-hour pain intensity).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. In the opinion of the investigator, the subject is capable of understanding and complying with protocol requirements.
    2. The subject signs and dates a written, informed consent form (ICF) and any required privacy authorization prior to the initiation of any study procedures, including requesting that a subject fast for any clinical laboratory evaluations.
    3. The subject is a male or female aged ≥18 to 75 years inclusive at the time of informed consent.
    4. The subject meets the Budapest clinical diagnosis of CRPS at the screening visit, and is at least 6 months since onset of symptoms.
    The Budapest/International Association for the Study of Pain clinical criteria:
    a. Continuing pain, which is disproportionate to any inciting event.
    b. Must report at least 1 symptom in 3 of the following symptom categories:
    i. Sensory: Reports of hyperalgesia and/or allodynia.
    ii. Vasomotor: Reports of temperature asymmetry and/or skin color changes and/or skin color asymmetries.
    iii. Sudomotor/Edema: Reports of edema and/or sweating changes and/or sweating asymmetry.
    iv. Motor/trophic: Reports of decreased range of motion and/or motor dysfunction (weakness, tremor, dystonia) and/or trophic changes (hair, nail, skin).
    c. Must display at least 1 sign (observed at evaluation) in 2 or more sign categories:
    i. Sensory: Evidence of hyperalgesia (to pinprick) and/or allodynia (to light touch and/or temperature sensation and/or deep somatic pressure and/or joint movement).
    ii. Vasomotor: Evidence of temperature asymmetry (>1.0°C) and/or skin color changes and/or sweating asymmetry.
    iii. Sudomotor/Edema: Evidence of edema and/or sweating changes and/or sweating asymmetry.
    iv. Motor/Trophic: Evidence of decreased range of motion and/or motor dysfunction (weakness, tremor, dystonia) and/or trophic changes (hair, nail, skin).
    d. No other diagnosis that better explains the signs and symptoms.
    5. The subject has a history of failure of one or more standard of care therapies for the treatment of CRPS as judged by the investigator.
    6. The subject’s pain medications and nondrug treatments must be stable (regimented per prescription) for 1 month prior to screening and remain stable throughout Part A.
    7. The subject agrees to use a single previously prescribed rescue medication within the prescribed dose during Part A of the study and to record the daily use of these medications.
    8. The subject must have an average 24-hour pain intensity score ≥4 and ≤9 on the 24-hour average pain intensity NPS during screening/baseline. This score will be calculated by averaging the daily 24-hour pain intensity scores for the past seven days prior to randomization. The subject must have daily 24-hour pain intensity scores recorded for at least 6 of the past 7 days.
    9. The subject is not involved in active litigation related to CRPS.
    10. A male subject who is nonsterilized and sexually active with a female partner of childbearing potential agrees to use adequate contraception from signing of informed consent throughout the duration of the study and for 90 days after last dose.
    11. A female subject of childbearing potential who is sexually active with a nonsterilized male partner agrees to use a highly effective method of contraception from signing of informed consent throughout the duration of the study and for 30 days after the last dose.
    12. The subject must agree to never post any personal medical data related to the study or information related to the study on any web site or social media site (eg, Facebook, Twitter).
    E.4Principal exclusion criteria
    1. Currently receiving intravenous (IV) or oral ketamine, history of IV or oral ketamine use within the past 6 weeks prior to screening, or planned use of IV or oral ketamine during this study.
    2. The subject has received any excluded medications, procedures, or treatments during the time periods listed in the protocol.
    3. The subject has any unstable, clinically significant neurologic (other than the disease being studied), psychiatric, cardiovascular, ophthalmologic, pulmonary, hepatic, renal, metabolic, gastrointestinal, urologic, immunologic, hematopoietic, or endocrine disease or other abnormality which may impact the ability to participate in the study or that may potentially confound the study results. It is the responsibility of the investigator to assess the clinical significance.
    4. The subject has any history of convulsions (excluding febrile seizures in childhood) or is at an increased risk for convulsions.
    5. The subject has any history of alcohol, opioid, or moderate to severe substance use disorder (except nicotine and cannabis), as per the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, within the 2 years immediately prior to the screening visit (Visit 1).
    6. Subject is receiving chronic opioid treatment at a dose that has not been stable 28 days prior to screening.
    7. Subjects is receiving chronic opioid treatment >160 mg of morphine equivalent per day.
    8. The subject has a positive drug screen for phencyclidine, amphetamine/ methamphetamine, or cocaine at screening. Cannabis is allowed.
    9. The subject is considered by the investigator to be at imminent risk of suicide or injury to self,
    others, or property, or the subject has attempted suicide within the past year prior to screening. Subjects who have positive answers on item number 4 or 5 on the C-SSRS (based on the past year) prior to randomization are excluded.
    10. The subject has or any first-degree family members have a history of psychosis, bipolar disorder, or schizophrenia.
    11. The subject has cataracts based on investigator opinion.
    12. The subject is positive for hepatitis B or hepatitis C infection at screening. (Note that subjects who have been vaccinated against hepatitis B [hepatitis B surface antibody {Ab}-positive] who are negative for other markers of prior hepatitis B infection [eg, negative for hepatitis B core Ab] are eligible. Also, note that subjects who are positive for hepatitis C Ab are eligible if they have a negative hepatitis C viral load by quantitative polymerase chain reaction).
    13. The subject has abnormal and clinically significant ECG abnormality at screening as determined by the investigator. Subject has a QT interval with Fridericia’s correction method(QTcF) >450 ms (males) or >470 ms (females), confirmed with 1 repeat testing, at screening.
    14. The subject has abnormal clinical laboratory test results at screening that suggest a clinically significant underlying disease that would compromise the well-being of the subject (if the subject has alanine aminotransferase [ALT] and/or aspartate aminotransferase [AST] >2.5 × the upper limit of normal [ULN], the medical monitor should be consulted).
    15. The subject has a known hypersensitivity to any component of the formulation of TAK-935.
    16. The subject has been part of a clinical study involving another investigational product in the previous 3 months prior to screening or subject is currently receiving an investigational product.
    17. The subject has received TAK-935 in a previous clinical study or as a therapeutic agent.
    18. The subject is an immediate family member, study site employee, or is in a dependent relationship with a study site employee who is involved in conduct of this study (eg, spouse, parent, child, sibling) or may consent under duress.
    19. If female, the subject is pregnant or lactating or intending to become pregnant before, during, or within 30 days after participating in this study; or intending to donate ova during such time period.
    20. If male, the subject intends to donate sperm during the course of the study or within 90 days after the last dose of study drug.
    E.5 End points
    E.5.1Primary end point(s)
    Change in mean 24-hour pain intensity NPS from baseline to the end of Part A (Week 15)
    E.5.1.1Timepoint(s) of evaluation of this end point
    End of Part A (week 15)
    E.5.2Secondary end point(s)
    - Percent change in mean 24-hour pain intensity NPS score from baseline to the end of Part A (Week 15).

    - Percent of responders (defined as ≥30% improvement on the 24-hour pain intensity NPS) by the end of Part A (Week 15).

    - Change and percent change from baseline of mean total score of the PROMIS 29 version 2 to the end of Part A (Week 15).

    - Change and percent change from baseline of mean PGIC to the end of Part A (Week 15).

    - Change and percent change from baseline of mean CSS in subjects to the end of Part A (Week 15).
    E.5.2.1Timepoint(s) of evaluation of this end point
    End of Part A (week 15)
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 concerned3
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    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 years1
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days16
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days16
    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: 22
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 2
    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 Yes
    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 state24
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 24
    F.4.2.2In the whole clinical trial 24
    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 Decision2019-05-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-06-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-10-28
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