E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Postherpetic neuralgia (PHN) |
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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 |
Demonstrate the efficacy of SAB378 in patients with PHN by testing the hypothesis that SAB378 15mag t.i.d. is superior to placebo on reduction in pain intensity as measured by an 11-point numerical rating scale (NRS) during the last week of double-blind treatment compared to baseline. |
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E.2.2 | Secondary objectives of the trial |
To evaluate the safety of SAB378 in patients with PHN by comparing the frequency of AEs and of treatment-emergent laboratory, ECG and vital sign abnormalities on SAB378 15mg t.i.d. with those on placebo. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
1. Male and female outpatients 50 year old or older. 2. History of PHN for 3 months after healing of a herpes zoster skin rash. 3. Pain due to PHN at least 5 on 11-point NRS in 24 hours preceding Visit 1 4. Average pain due to PHN must be at least 5 on 11-point NRS during pre-randomization phase. 5. Pain intensity due to PHN at least 50 mm on 100 mm visual analogue scale (VAS) in the last 7 days prior to randomization. 6. Patients must have completed NRS ratings at least 4 days in diary in last 7 days prior to randomization. 7. Post-menopausal women defined as 24 months of natural (spontaneous) amenorrhea or at least 6 months of spontaneous amenorrhea with serum FSH levels >40 mIU/m or 6 weeks post surgical bilateral oophroectomy with or without hysterectomy. Premenopausal women must have been surgically sterilised at least six months prior to screening. Surgical sterilisation procedures must be supported with clinical documentation made available to sponsor and noted Relevant Medical History/ Current Medical Conditions sections of the electronic Case eport Forms (eCRFs). 8. Male patients must be either surgically incapable of bearing children or practicing at minimum, a combination of double barrier method such as male or female condom with spermicical gel, diaphragm, sponge or cervical cap. A male patient and his partner must comply with an acceptable contraception method. Abstinence will be considered as an acceptable method of contraception. In addition, if female partners of male patients meet the criteria of the female patients entering the trial, male patients will be considered to enter the study, without practising contraception. 9. Patients must not receive conconimitant medication for PHN, or must be maintained on a stable dose of one allowable concomitant PHN medication (e.g. pregabalin, gabapentin, tricyclic antidepressants) for at least 1 month prior to randomization. 10. Patients must be willing to give informed consent according to the legal requirements for their respective countries. |
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E.4 | Principal exclusion criteria |
1. Patients who have other pain that could confound the assessment neuropathic pin to PHN. 2. Patients with skin conditions in are area affected by neuralgia that could alter sensation. 3. Patients with neurolytic or neurosurgical treatment for PHN. 4. Patients, who are in an immunocomprised state, e.g. have known or suspected chronic infectous disease including HIV or hepatitis B or C. 5. Patients with clinically significant psychiatric diagnosis, in particular depression, that would impair their reliable participation in this trial, or patients with significant psychosocial problems that can be related to pain complaints. 6. Women with child bearing potential, defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partners have been sterlised by vasectomy or other means. 7. Patients with Body Mass Index >35Kg/m2. 8. Patients with low blood pressure (systolic blood pressure <90 mm Hg and/or diastolic blood pressure <60 mm Hg), or orthostatic hypotension (defined as supine-standing systolic BP drop >20 mm Hg or a suprine-standing diastolic BP drop >10 mm Hg) at baseline. 9. Patients with history of cerebrovascular disease (confirmed treatment ischaemic attacks, reversible ischemic neurolgic deficits, and/ or stroke). 10. Patients with symptomatic coronary disease or history of heart failure. 11. An advanced, severe, or unstable disease of any type that may interfere with primary and secondary variable evaluations, including any medical conditions that could be expected to progress, recur, or change to such an extent that it may bias the assessment of the clinical status of the patient to a significant degree ot put the patient at special risk. 12. Patients receiving moderate/strong opioids (e.g. morphine, tramadol, oxycontine), carbamazepine and lidoderm patech during 1 month prior to randomisation. 13. Patients who have a history of alcohol or drug abuse within the past year, or evidence of abuse through positive urine drug screen, if not proven to be derived from previously stopped intake of opiates. 14. Patients who have used cannibis or derivatives within the past 6 months, unless these products were used successfully for pain relief, in which case they will need to be discontinued one month prior to randomisation. 15. Patients known to be hypersensitive to the inredients of the SAB378 capsule, or to cannabinoid agonists. 16. Patient who have received an experimental treatment within the past month. 17. Patients who have a history of poor compliance or are unlikely to comply with medical regimens or study requirements. 18. History of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, including localised basal cell carcinoma of the skin. 19. Patients who foresee intensive UV exposure during the study (such as solar exposure on the beach, mountain sports, UV radiation by suntan lamps) or those with inherent sensitivity to sun.
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E.5 End points |
E.5.1 | Primary end point(s) |
11-point Numerical Rating Scale |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Yes |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Information not present in EudraCT |
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 | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | Information not present in EudraCT |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
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 | 0 |
E.8.9.2 | In all countries concerned by the trial months | 7 |