Clinical Trial Page

Summary
EudraCT Number:2006-004545-42
Sponsor's Protocol Code Number:TRO19622 CLEQ 1104-1
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:2007-01-10
Trial results
A. Protocol Information
A.1Member State ConcernedGermany - BfArM
A.2EudraCT number2006-004545-42
A.3Full title of the trial
A double-blind, randomized, multi-center study with 500 mg QD of TRO19622 versus placebo in patients with painful peripheral diabetic neuropathy
A.4.1Sponsor's protocol code numberTRO19622 CLEQ 1104-1
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 SponsorTROPHOS
B.1.3.4CountryFrance
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.3.2Product code TRO19622
D.3.4Pharmaceutical form Capsule, hard
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.3.9.1CAS number 22033-87-0
D.3.9.2Current sponsor codeTRO19622
D.3.10 Strength
D.3.10.1Concentration unit mg milligram(s)
D.3.10.2Concentration typeequal
D.3.10.3Concentration number to 125
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 Yes
D.3.11.13.1Other medicinal product typecholest-4-en-3-one, oxime Derived from a natural metabolite of cholesterol.
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, hard
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
Painful peripheral diabetic neuropathy
MedDRA Classification
E.1.2 Medical condition or disease under investigation
E.1.2Version 8.1
E.1.2Level LLT
E.1.2Classification code 10012680
E.1.2Term Diabetic neuropathy
E.1.3Condition being studied is a rare disease No
E.2 Objective of the trial
E.2.1Main objective of the trial
The primary objective of the study is to compare the effect of TRO19622 versus placebo on the 24h neuropathic pain scores during the last 7 days of the 6-week treatment period.
Therefore, the mean pain score during the last 7 days of the treatment period will be compared to the mean baseline pain during the last 7 days of the screening period
E.2.2Secondary objectives of the trial
Secondary objectives are to compare the efficacy on neuropathic pain, impact on emotional functioning, safety profile, pain time course, and response rate of TRO19622 versus placebo. Additionally, the pharmacokinetics of TRO19622 will be assessed.
E.2.3Trial contains a sub-study No
E.3Principal inclusion criteria
1.Be a male >18 years or a post-menopausal female (>60 years of age and at least 1 year of amenorrhea).
2.Have painful diabetic neuropathy of >6 months duration and have had a documented response to their neuropathic pain treatment (if not pain treatment naive).
3.Be on current pain medication (prescribed analgesics), stable for at least 3 months before study entry (± 25% dosage of basic pain medication, top-up rescue medication allowed), or pain treatment naive.
4.Have stable diabetes, defined as HbA1c <10%, no changes in medication in the previous 3 months, and no new symptoms associated with diabetes in the previous 3 months.
5.Have scored >2 points on the Michigan Neuropathy Screening Instrument (MNSI), part B-physical assessment by health professional.
6.Have a normal electrocardiogram (ECG)

The following inclusion criteria should be ascertained at the baseline visit:
7.Have measurable pain perception (previous 24h) on the Likert numerical rating scale with a mean ≥4.0 points calculated from at least 4 daily measurements over the 7 days immediately prior to the Baseline Visit.
8.Have stopped current pain medication at least 14 days prior to the Baseline Visit (except rescue medication).
E.4Principal exclusion criteria
1.Be pregnant female, lactating female, or female of child bearing potential (≤60 years of age).
2.Have a documented neuropathy of any cause other than those mentioned in the inclusion criteria which might interfere with the assessment of the severity of pain (eg, including, but not limited to, alcoholic, uremic, B12, TSH, chemotherapy, HIV, post surgical, or post-traumatic neuropathy).
3.Have other neurological diseases that may produce weakness, sensory loss, or autonomic symptoms, or laboratory test abnormality.
4.Have been on pain treatment with strong opioids, more than
4 different drug regimens in the previous year, or a current combination of more than 3 drugs.
5.Have a current medication of lipid lowering agents other than statins.
6.Have a body mass index (BMI) >40 kg/m2 (obesity grade III).
7.Had any surgery within the previous 2 months.
8.Have concurrent serious neurological disease (eg, dementia, multiple sclerosis, or any other disease that would impact the ability of the patient to provide consent for study participation).
9.Have a recent history (within the previous 6 months) or current evidence of alcohol or drug abuse.
10.Have concurrent unstable disease involving any system (eg, advanced carcinoma, acute myocardial infarction, renal failure, or any other condition that in the opinion of the Investigator would make the patient unsuitable for study participation).
11.Participated in any other investigational drug or therapy study within the previous 3 months.
12.Changed or interrupted current well-tolerated medication during the previous 3 months.
13.Lack of ability or willingness to give informed consent.
14.Be possibly dependent on the Investigator or the Sponsor (eg, including, but not limited to, affiliated employee).
15.Have hemostasis disorders or a current treatment of anticoagulants.
16.Have non-adequate renal and/or hepatic function as follows:
•Renal – blood creatinine >1.5 × upper limit of normal (ULN)
•Hepatic – liver enzymes (ALT and AST) >2 × ULN
E.5 End points
E.5.1Primary end point(s)
The primary efficacy endpoint is the mean pain score during the last 7 days of the treatment period.
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 concerned5
E.8.5The trial involves multiple Member States Yes
E.8.5.1Number of sites anticipated in the EEA12
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
E.8.9 Initial estimate of the duration of the trial
E.8.9.1In the Member State concerned years0
E.8.9.1In the Member State concerned months8
E.8.9.1In the Member State concerned days0
E.8.9.2In all countries concerned by the trial years0
E.8.9.2In all countries concerned by the trial months8
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.1.3Elderly (>=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 No
F.3.3.1Women of childbearing potential not using contraception No
F.3.3.2Women of child-bearing potential using contraception No
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 state50
F.4.2 For a multinational trial
F.4.2.1In the EEA 120
F.4.2.2In the whole clinical trial 180
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 Decision2007-04-25
N.Ethics Committee Opinion of the trial applicationFavourable
N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
N.Date of Ethics Committee Opinion
P. End of Trial
P.End of Trial StatusCompleted
P.Date of the global end of the trial2009-03-31
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