A study to compare the safety and efficacy of CNV2197944 in patients with post-herpetic neuralgia

• Conditions: Post-herpetic Neuralgia; MedDRA version: 15.1Level: PTClassification code 10036376Term: Post herpetic neuralgiaSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Body processes [G] - Bones and nerves physological processes [G11]

• Registration Number: EUCTR2012-002903-16-BG
• Lead Sponsor: Convergence Pharmaceuticals Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-02-12
• Last Update Posted: 24 November 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

1. Male or female between 18 and 85 years of age inclusive, at the time of signing the informed consent.
2. A female patient is eligible to participate if she is of:
• Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea [in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) > 40 MlU/mL and estradiol < 40 pg/mL (<140 pmol/L) is confirmatory]. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the contraception methods in the protocol if they wish to continue their HRT during the study.
• Child-bearing potential and agrees to use one of the contraception methods listed in the protocol for an appropriate period of time (as determined by the product label or investigator) prior to the start of dosing to sufficiently minimize the risk of pregnancy at that point. Female patients must agree to use contraception until the follow-up visit.
3. Male patients must agree to use one of the contraception methods listed in the protocol. This criterion must be followed from the time of the first dose of study medication until the follow-up visit.
4. Body weight >/= 50 kg for men and >/= 45 kg for women.
5. Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
6. Patients with post-herpetic neuralgia (PHN) with pain at screening present for more than 3 months after healing of the herpes zoster skin rash. The maximum duration of PHN will be no longer than 5 years.
7. Patient’s baseline average daily pain score for neuropathic pain due to PHN on the PI-NRS, calculated as the average of their daily PI-NRS scores over the baseline period (Day 10 to Day 14), is greater than or equal to 4 on the PI-NRSs and no greater than 9, and to have no individual daily score less than 3. Subjects will need to have recorded their daily PI-NRS for a minimum of 4 days during the baseline period. Subjects will not be told what the pain inclusion criteria are.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 48
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 62

Exclusion Criteria

1. Patients having other severe pain, which may impair the self-assessment of the pain due to PHN. Any question regarding the acceptability of aetiology of the neuropathic pain should be discussed with the medical monitor.
2. Skin conditions in the affected dermatome that could alter sensation, other than PHN.
3. Patients who have undergone neurolytic or neurosurgical therapy including skin excisions for PHN.
4. Patients who have received nerve blocks for neuropathic pain within 4 weeks prior to the start of Day 1.
5. Certain medications used to relieve the pain of PHN, specifically gabapentinoids (gabapentin and pregabalin), carbamazepine and topical agents (eg capsaicin, lidocaine), are prohibited during the study and must be washed out prior to Day 1. The minimum washout period is 3 days for gabapentanoids; the minimum washout period for carbamazepine is 7 days and the washout period for other prohibited drugs will be calculated as 5-half-lives.
6. Patients with a documented failure to respond to a maximally tolerated dose regimen of gabapentin or pregabalin. The dose should fall within the approved regulatory labeling for PHN for this exclusion to apply.
7. Patients taking more than one medication to treat the PHN pain (paracetamol is permitted as a 2nd medication).
8. Use of other prohibited medications, as defined in section 9.12 of the study protocol.
9. History or presence of significant cardiovascular, gastro-intestinal, or renal disease or other condition known to interfere with the absorption, distribution, metabolism, or excretion of drugs which, in the opinion of the Investigator may interfere with the study procedures or compromise patient safety.
10. A positive pre-study HIV, Hepatitis B surface antigen or positive Hepatitis C antibody result.
11. History of regular alcohol consumption during the 6 months prior to screening, defined as an average weekly intake of greater than 21 units or an average daily intake of greater than 3 units for male patients and of greater than 14 units weekly or an average daily intake of greater than 2 units for female patients. One unit is equivalent to a half-pint (280 mL) of beer or 1 (25 mL) measure of spirits or 1 glass (125 mL) of wine.
12. A significant medical history of recurrent syncope or symptomatic orthostatic hypotension, blackouts, fainting or vaso-vagal attacks during the twelve months prior to screening, or evidence of low blood pressure at screening or baseline (systolic BP < 90 mmHg or diastolic BP < 50 mmHg, mean of triplicate readings) after repeated measurements.
13. Patients with a history of uncontrolled or poorly controlled hypertension during the twelve months prior to screening, with a systolic BP frequently exceeding 160 mmHg and/or diastolic BP frequently exceeding 100 mmHg, or with evidence of BP greater than 160 mmHg and/or greater than 100 mmHg diastolic, mean of triplicate readings, at screening and baseline after repeated measurement.
14. A history of second or third degree heart block during the twelve months prior to screening, or evidence of second or third degree heart block on ECG’s recorded at screening and baseline.
15. At the screening and baseline visit QTcB and QTcF must be <450msec on two out of three ECG recordings taken at 5 minute intervals.
16. A history of any liver or renal disease during the 12 months prior to screening.
17. AST, ALT and/or GGT >2x upper limit of normal. Alkaline phosphatase or bilirubin >1.5x upper limi

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified