Post-herpetic Neuralgia MedDRA version: 15.1 Level: PT Classification code 10036376 Term: Post herpetic neuralgia System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Product Name: CNV2197944
Product Code: CNV2197944
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: CNV2197944
CAS Number: 1204535-44-3
Other descriptive name: CNV2197944C
Concentration unit: mg
Sponsors
Convergence Pharmaceuticals Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
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 /= 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
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 2x upper limit of normal. Alkaline phosphatase or bilirubin >1.5x upper limi
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the effect of repeat oral dosing of CNV2197944 75 mg three times daily on the pain experienced in post-herpetic neuralgia (PHN) as measured by changes in pain intensity numerical rating scale after three weeks of treatment compared to the baseline period.;Secondary Objective: To investigate the effects of repeat oral dosing of CNV2197944 on pain in patients with PHN. To investigate the safety and tolerability of CNV2197944 in patients with PHN. To assess the plasma concentrations and exposures of CNV2197944.;Primary end point(s): • Change in average daily neuropathic pain score between the third week of treatment and baseline based on the 11 point Pain Intensity Numerical Rating Scale (PI-NRS) (0=no pain, 10=maximum pain imaginable). Subjects should specifically rate the pain intensity for the neuropathic pain associated with PHN and not pain from other causes. ;Timepoint(s) of evaluation of this end point: Daily from Day 1 to Day 76 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Efficacy: The following endpoints specifically refer to the neuropathic pain from PHN. -Change in average daily pain score from baseline over time (weeks 1, 2 and 3 of treatment). -Change in Neuropathic Pain Symptom Inventory total score and sub-scales from baseline to week 3 of treatment. - = 30% reduction in PI-NRS score after 3 weeks of treatment. - = 50% reduction in PI-NRS score after 3 weeks of treatment. -Improved Patient Global Impression of Change (PGIC) after 3 weeks of treatment. -Improved Clinician Global Impression of Change (CGIC) after 3 weeks of treatment. -Use of rescue medication. Safety: -Incidence, severity, seriousness and relatedness of adverse events. -Changes in vital signs. -Changes in ECG parameters. -Changes in laboratory safety test results (clinical chemistry, haematology, urinalysis) and the incidence of abnormal laboratory test results. Pharmacokinetics: -Pre-dose and post-dose blood CNV2197944 concentrations – AUC(0-24)-ss, Cmin-ss and Cmax-ss.;Timepoint(s) of evaluation of this end point: The timepoints are detailed in the study protocol, Section 10. For example, PI-NRS is recorded daily from Day 1 to Day 76. Vital signs and ECGs is assessed pre-dose and 1h post dose on Days 1, 15, 22, 36, 50, 57, 71. PK samples are taken pre-dose at visits 3 and 6, pre-dose and between 0-1h post-dose at visits 4 and 7, pre-dose and between 2- 3 h post-dose on visits 6 and 8. | — |
Countries
Bulgaria, Georgia, South Africa, Ukraine
Contacts
Public ContactClinical Trials Information
Convergence Pharmaceuticals Ltd
Outcome results
None listed