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    Summary
    EudraCT Number:2008-002108-24
    Sponsor's Protocol Code Number:SLC022/201
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-01-05
    Trial 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 ConcernedGermany - BfArM
    A.2EudraCT number2008-002108-24
    A.3Full title of the trial
    A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study Evaluating the Efficacy and Tolerability of Oral SLC022 300 mg TID, a Glial Cell Modulating Agent,
    Versus Placebo in the Treatment of Post Herpetic Neuralgia
    A.4.1Sponsor's protocol code numberSLC022/201
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorSolace Pharmaceuticals 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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 namepropentofylline
    D.3.2Product code SLC022
    D.3.4Pharmaceutical form Capsule*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNpropentofylline
    D.3.9.1CAS number 55242-55-2
    D.3.9.2Current sponsor codeSLC022
    D.3.9.3Other descriptive nameHWA-285
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 placeboCapsule*
    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
    Post herpetic neuralgia
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10036376
    E.1.2Term Post herpetic neuralgia
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the efficacy of SLC022 300 mg three times daily (TID) versus placebo TID over 28 days of treatment in subjects with PHN (postherpetic neuralgia).
    E.2.2Secondary objectives of the trial
    -- To determine the safety and tolerability of SLC022 300 mg three times daily (TID) compared to placebo TID over 28 days of treatment in subjects with PHN (postherpetic neuralgia).

    -- To establish a population-based pharmacokinetic (PK) model for comparing inter-subject variances in exposure.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female age 18 years or older.

    2. A history of cutaneous herpes zoster infection and sustained pain associated with the site of the herpes zoster skin rash for >6 months, after onset of the herpes zoster skin rash.

    3. Pain intensity score of ≥4 on an 11-point numerical rating scale for at least 5 of 7 days immediately prior to randomization.

    4. Mean pain intensity of ≥4 on an 11-point numerical rating scale during the Baseline Phase.

    5. Completion of at least 5 out of 7 daily pain reports during the Baseline Phase.

    6. Completed a washout period of 7 days for any of the following medications: α2-δ
    antagonists (e.g., gabapentin), opiate analgesics, topical lidocaine, anticonvulsants, TCAs, serotonin-norepinephrine reuptake inhibitors (SNRIs) (e.g., duloxetine), skeletal muscle relaxants, orally administered steroids, capsaicin, mexiletene, and centrally acting analgesics (dextromethorphan, tramadol).

    7. Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.

    8. A willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
    E.4Principal exclusion criteria
    1. Pregnant or breast feeding.

    2. Female subjects who are not surgically sterile (hysterectomy or bilateral tubal ligation), postmenopausal for at least one year, or are not willing to practice adequate methods of contraception if of childbearing potential (defined as consistent use of combined effective methods of contraception [including at least 1 barrier method], unless sexually abstinent).

    3. Previous neurolytic or neurosurgical therapy for PHN.

    4. Treatment with local anesthetic nerve blocks within the last 30 days.

    5. Failure of an adequate dose of 3 or more first line drug treatments for PHN-related pain due to efficacy. First line drug treatments include α2-δ antagonists (gabapentin or pregabalin), SNRIs (e.g., duloxetine), the 5% lidocaine patch, opioid analgesics, tramadol hydrochloride, and TCAs.

    6. Any other type of pain which may impair the self assessment of the pain due to PHN.

    7. Skin conditions in the affected dermatome that could alter sensation.

    8. Participation in other studies within 30 days before the current study begins and/or during study participation.

    9. Taking CYP1A2 inhibitors such as fluvoxamine, certain fluoroquinolones (e.g. ciprofloxacin, enoxacin, pefloxacin, etc), mexiletine, and zileuton.

    10. History of drug or alcohol abuse during the last 5 years.

    11. Creatinine clearance <50 mL/min.

    12. History of malignancy (< 5 years since diagnosis) other than basal cell carcinoma and carcinoma in situ.

    14. History of chronic hepatitis B or C, or human immunodeficiency virus (HIV) infection.

    15. Clinically significant hepatic, respiratory, hematological, cardiovascular or neurological disease.

    16. Immunocompromised state.

    17. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint of this study is the reduction of PHN-related pain as reported on an 11-point numerical pain rating scale via the electronic subject diary. Actual values and change from baseline will be summarized by visit. The mean pain score at the end of the Treatment Phase (last 5 pain scores reported during treatment) will be compared to the mean pain score from baseline (last 5 pain scores reported prior to randomization). An Analysis of Covariance (ANCOVA) with baseline pain as a covariate will be performed on the difference in mean pain from baseline to end of treatment. Primary efficacy analysis will utilize the last observation carried forward (LOCF) imputation methodology outlined below. An observed case analysis using mixed model repeated measures (MMRM) will also be presented as a secondary sensitivity analysis.
    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 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 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 Yes
    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.8.3 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 concerned9
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA9
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    Last patient's last visit in the trial
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    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.1.3Elderly (>=65 years) Yes
    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 state70
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 70
    F.4.2.2In the whole clinical trial 154
    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)
    After the subject has ended his/her participation in the trial, they are supposed to receive a standard treatment for post herpetic neuralgia
    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 Decision2009-02-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-03-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-09-09
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