A study looking at the effects of a new drug called CNV2197944 against a placebo treatment in diabetic patients who have neuropathic pain.

• Conditions: europathic pain associated with diabetic peripheral neuropathy; MedDRA version: 14.1Level: LLTClassification code 10067547Term: Diabetic peripheral neuropathic painSystem Organ Class: 100000004852; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2013-000407-16-PL
• Lead Sponsor: Convergence Pharmaceuticals Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09-10
• Last Update Posted: 7 October 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 165

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 at screening.
5. Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
6. Diabetes mellitus (Type I or II) that is documented to be under stable glycaemic control over a period of 3 months as indicated by a HgA1c of =9%. Diabetes should be controlled by diet, hypoglycaemics or insulin for 3 months prior to starting study medication, and no significant change in diabetic medication should be planned for the duration of the study.
7. Evidence of symmetrical, bilateral pain in the lower extremities due to DPN, which is defined as pain in the legs or feet with decreased sensation in the feet or decreased/absent ankle jerk deep tendon reflexes.
8. Presence of daily pain due to DPN for at least 6 months, but less than 5 years.
9. Score of = 3 on the physical examination section of the Michigan Neuropathy Screening Instrument at screening.
10. Patient’s baseline average daily pain score for neuropathic pain due to DPN on the PI-NRS, calculated as the average of their daily PI-NRS scores over the first baseline period (study baseline - the 5 days immediately prior to randomisation), is greater than or equal to 4 and not greater than 9 on the PI-NRS, 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 that the entry requirement of the average PI-NRS is at least 4, in order not to bias their pain intensity score.

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 110
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 55

Exclusion Criteria

1. Patients having other severe pain, which may impair the self-assessment of the pain due to DPN.
2. Diabetic related medical conditions that might impair the assessment of pain due to DPN. This would include amputations, major skin ulcers, physical injury to the affected limb, or any planned surgeries during the course of the study.
3. Patients who have received nerve blocks for neuropathic pain within 4 weeks prior to the start of the single-blind placebo run-in (Day 1).
4. Certain medications used to relieve the pain of DPN such as gabapentanoids, tricyclic antidepressants, SNRIs, anticonvulsants/antiepileptics, opioids, topical analgesics, capsaicin products, mexiletine, dextromethorphan, tramadol, cannabinoids, ketamine and oral/injectable corticosteroids are prohibited during the study and must be washed out prior to the start of the run-in period (Day 1).
5. Patients with a documented failure to respond to a maximum tolerated dose regimen of gabapentin or pregabalin. The dose should fall within the approved regulatory labelling for DPN for this exclusion to apply. In case of uncertainty the case should be discussed with the medical monitor.
6. Use of other prohibited medications.
7. History or presence of significant cardiovascular or gastro-intestinal 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. In case of uncertainty the case should be discussed with the medical monitor.
8. A positive pre-study HIV, Hepatitis B surface antigen or positive Hepatitis C antibody result.
9. 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.
10. 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.
11. 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.
12. 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.
13. At the screening and baseline visit both QTcB and QTcF must be <450msec on two out of three ECG recordings taken at 5 minute intervals.
14. A history of any significant liver or renal disease during the twelve months prior to screening. In case of uncertainty the case should be discussed with the medical monitor.
15. AST, ALT and/or GGT >2x upper limit of normal. Alkaline phosphatase or bilirubin >1.5x upper limit of normal.
16. Creatinine cleara

Study & Design

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