E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
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) copared with placebo, in the treatment of post-herpetic neuralgia |
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E.2.2 | Secondary objectives of the trial |
Secondary objective: To explore the safety and tolerability of ucb 34714 in the same indication
Exploratory objective: To explore the impact on subject´s self-reported health status To collect data on painfree 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 the healing of the acute herpes zoster skin rash. - Pain intensity score assessed on a 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. - Female chilbearing potential must use medically acceptable method of birth control. - Be considered as reliable and capable of adhering to the protocol. |
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E.4 | Principal exclusion criteria |
- Subject getting psychological support to help cope with pain. - Subject who had undergone or who is scheduled for neurolytic or neurosurgical therapy for PHN or who receives TENS. - TCAs or non-steroidal anti-inflamatory drug or permitted opioid analgesics that started less than 30 days and /or stabilized prior to screening and/or not expected to be kept at stable dose over the trial period. - Patient treated with Carbamazepine. - Subject with history of severe advers hematologic reaction to any drug - Subject with history of bone marrow depression - Any sign suggesting repidly pregressing brain disorder, dementia or brain tumor. - Known significant neurological disorder or a condition that can mimic stroke with distal neurological deficit, amyotrophy, radiculopathy, histori of transient ischemic attacks, multiple sclerosis, or any amputations. -Subject with immunidepresion - Clinically significant ECG abnormalities. - Subject with clinically significant deviations from reference range values. - Known coexistent source of pinful peripheral neuropathy. - Subjects having creatinine clearance< 50mL/min or a history of singificant impaired renal function. -Subjects treated in the four weeks prior to screening visit with strong opioids analgesics. - Subjects being treated in the two weeks prior to screening visit with: skeletal muscle-relaxants, AEDs, mexiletine, anesthetics, topical analgesics, antiviral agents - Subjects treated in the week prior to the 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. - Subject having a past history or is currently abusing alcohol or any other drug according to the DSM-IV criteria. -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<30ug ethinylestradiol, in case she is taking hormonal contraception. - Known psychiatric condition (inluding suicidal ideation in past three months or history of attempted suicide in the past ten years). -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, theri 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. -Presence of any sign suggestign rapidly progressing brain disorder, dementia or brain tumor. - Any significant clinical and/or medical contidions (acute or chronic illness such as but not restricted to: severe cardiac dysfunction, bone marrow depression, severe hepatic disease and /or moderate to severe rena impairment) with may contraindicate the use of ucb 34714, impair reliable participation in the trial or necessitate the use of medication not allowed. |
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E.5 End points |
E.5.1 | Primary end point(s) |
- to evaluate the efficacy of each dose of ucb 34714 (200mg/day and 400mg/day) compared with placebo, in the treatment of Post-herpetic Neuralgia. |
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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) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
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
| No |
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 | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
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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- whether the subject completed (final visit performed) or discontinued the trial; - whether there is still an unresolved adverse event at the end of the trial- If an AE is still present, Investigators must attempt to follow up the subject until complete resolution/stabilization of the condition with sequelae (the AE is resolved but residual effects are still present), and to report all pertinent information to UCB or dcision not to follow-up with justification.
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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 | 1 |
E.8.9.1 | In the Member State concerned months | 7 |
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 |