E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 7.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10036376 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate the efficacy of each dose of ucb 34714 (200 mg/day and 400 mg/day) compared with placebo, in the treatment of Post-herpetic Neuralgia. |
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E.2.2 | Secondary objectives of the trial |
To explore the safety and tolerability of ucb 34714 in the same indication.
Exploratory objectives To explore the impact on subject’s self-reported health status. To collect data on pain free days and on medical resources used during the study. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
• Written informed consent signed and dated by the subject. • Male/female subject aged 18 years or older. • Pain present for at least 6 months after healing of the acute herpes zoster skin rash. • Pain intensity score assessed on an 11-point numerical pain rating scale with a score of at least 4 at the screening visit (to assess pain intensity during the past 24 hours) and with an average weekly score of at least 4 on an 11-point numerical pain rating scale during baseline period as evaluated on a minimum of 4 days. • If the subject is female, the subject must be post-menopausal for at least two years, or surgically sterile (hysterectomy, bilateral tubal ligation, bilateral salpingectomy, congenital sterility or bilateral oophorectomy), or using a medically acceptable method of birth control for the duration of trial participation (intrauterine device, diaphragm plus spermicide, male condom plus spermicide, female condom) or must have a monogamous relationship with a vasectomized partner. Subjects using hormonal contraceptive can be included in the trial if taking OCs containing ≥ 30µg ethinylestradiol. Abstinence will be considered as an acceptable method of contraception on a case-by-case basis upon discussion between the Investigator and UCB or its representative. The subject must understand the consequences and potential risks of inadequately protected sexual activity, be educated about and understand the proper use of contraceptive methods, and undertake to inform the Investigator of any potential change in status. • Be considered as reliable and capable of adhering to the protocol, according to the judgement of the Investigator, e.g. able to understand and complete diaries and questionnaires.
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E.4 | Principal exclusion criteria |
• Subject getting any kind of psychological support to help cope with pain such as biofeedback or behavioral cognitive therapy. Subjects being followed by a psychologist as part of their multidisciplinary care off can be included, provided that this support started at least 6 months before the screening visit. • Subject who had undergone or who is scheduled for neurolytic or neurosurgical therapy for PHN or who receives TENS (trans-electrical neural stimulation). • TCAs or non-steroidal anti-inflammatory drug (NSAIDs) or permitted opioid analgesics, that started less than 30 days and/or not stabilized prior to screening and/or not expected to be kept at stable dose over the trial period. • Intake of more than two pain treatments at trial entry (screening visit) including TCAs, NSAIDs or permitted opioid analgesics, started at least 30 days and stabilized prior to the screening visit. • Subject being treated with Carbamazepine for any indication. • Subject with history of severe adverse hematologic reaction to any drug. • Subject with history of bone marrow depression. • Presence of any sign (clinical or paraclinical) suggesting rapidly progressing brain disorder, dementia or brain tumor. • Known significant neurological disorder or a condition that can mimic stroke with distal neurological deficit, amyotrophy, radiculopathy, history of transient ischemic attacks, multiple sclerosis, or any amputations. • Subject with conditions known to be associated with immunodepressive states (e.g. HIV subject if known by the Investigator). • Clinically significant ECG abnormalities. • Any significant clinical and/or medical conditions (acute or chronic illness such as but not restricted to: severe cardiac dysfunction, bone marrow depression, severe hepatic disease and/or moderate to severe renal impairment) which may contraindicate the use of ucb 34714, impair reliable participation in the trial or necessitate the use of medication not allowed by protocol. • Known coexistent source of painful peripheral neuropathy such as paraproteinemia, untreated hypoparathyroidism, vitamin B12 deficiency, amyloidosis, connective tissue disease, porphyria, diabetic peripheral neuropathy, complex regional pain syndrome, alcoholism, uremia, syphilis, myeloma, malignancy (less than 5 years in remission), peripheral nerve trauma (including surgery), drug induced peripheral neuropathy (e.g. vinca alkaloids, taxols, etc.) or other systemic disease associated with a secondary painful neuropathy. • Subject having clinically significant deviations from reference range values for laboratory parameters, such as hepatic markers (ALAT/SGPT, ASAT/SGOT, alkaline phosphatase, γGT) > 3 x UNL, platelets < 100,000/µl, leukocyte count < 3500 / mm3 or neutrophil cells < 1,800/µl. The non-clinically significant abnormalities for hepatic markers (< 3 x UNL) have to be documented as stable for at least 6 months. • Subject having a creatinine clearance < 50 mL/min or a history of significantly impaired renal function. • Subject being treated in the four weeks prior to screening visit with “strong” opioid analgesics (e.g. morphine, hydromorphone, oxymorphone, methadone, levomethadyl acetate, meperidine, fentanyl group, levorphanol, bezitramide, buprenorphine, butorphanol, dextromoramide, piritramide). • Subject being treated in the two weeks prior to screening visit with: skeletal musclerelaxants, AEDs, mexiletine, anesthetics, topical analgesics, antiviral agents. • Subject being treated in the week prior to screening visit with: any other treatment considered efficacious in the treatment of post-herpetic neuralgia. Aspirin ≤ 300 mg/day may be taken for the prophylaxis of myocardial infarction or transient ischemic attacks. • Subject treated with over-the-counter and/or homeopathy analgesics. • Pregnant, lactating or sexually active woman with childbearing potential who is not using a medically accepted birth control method or who is using an OC containing < 30µg ethinylestradiol, in case she is taking hormonal contraception. • Known psychiatric condition (including suicidal ideation in past three months or history of attempted suicide in the past ten years). • Subject having a past history (within the past year) or is currently abusing alcohol or any other drug according to the DSM-IV criteria for drug and alcohol abuse. • Contraindication to any component of the treatments in the trial (ucb 34714 or placebo) or known allergic reaction to or intolerance of pyrrolidine derivates and/or other excipients (principally lactose, cornstarch, cellulose). • Subject currently participating or having participated within the last 30 days in another clinical trial. • Investigators, co-investigators, their spouses or children or any trial collaborator may not be included as subjects in the trial. • Subject having been blood donator during the previous 3 months or planning to be blood donator during the trial.
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary efficacy variable is the percent change in the average pain intensity score on an 11-point numerical pain rating scale from the Baseline Period to the last week of the Treatment Period. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | Yes |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | Information not present in EudraCT |
E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Information not present in EudraCT |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
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
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The end of the trial is defined as the date of database lock as, at that time, interactions between the sponsor and the investigator(s) with possible impact on subjects data have ended |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 10 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 7 |