A clinical trial to investigate the effect of a drug called CNV1014802 on intense face pain and how safe the drug is.

• Conditions: Trigeminal Neuralgia; MedDRA version: 16.0Level: LLTClassification code 10029227Term: Neuralgia trigeminalSystem Organ Class: 100000004852; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2010-023963-16-ES
• Lead Sponsor: Convergence Pharmaceuticals Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-02-04
• Last Update Posted: 2 June 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

-IHS criteria for trigeminal neuralgia to be used. The diagnosis must be verified by a member of the diagnostic sub-committee of the Data Monitoring Committee before the patient is entered into the study.
-A diagnosis of trigeminal neuralgia - Pain must be unilateral, and characterized by brief electric shock-like pains, abrupt in onset and termination, limited to the distribution of one or more divisions of the trigeminal nerve. Pain is commonly evoked by trivial stimuli including washing, shaving, smoking, talking and/or brushing the teeth(trigger factors), and frequently occurs spontaneously. The attacks start and end rapidly. There is often no pain between each bout of pain and many bouts can occur every day. There is often a refractory period between attacks. Some patients may report some after pain after the severe pain for a few minutes. Pain remissions occur where there can be weeks or months of no pain even when medications are stopped.
-The following diagnostic criteria for trigeminal neuralgia must be met:
-Paroxysmal attacks of pain lasting from a fraction of a second to 2 minutes, affecting one or more divisions of the trigeminal nerve and fulfilling criteria b and c.
-Pain has at least one of the following characteristics:
i. Intense, sharp, superficial or stabbing
ii. Precipitated from trigger areas or by trigger factors
-Attacks are stereotyped in the individual patient
-There is no clinically evident neurological deficit
-Not attributed to another disorder
-Frequency criteria for numbers of paroxysms:
-Patients must have suffered a minimum of 3 or more paroxysms of pain per day, rated at an intensity of 4 or more on the pain NRS, on at least 4 days during the last 7 days prior to entry into the open-label treatment period.
-Male or female between 18 and 80 years of age inclusive, at the time of signing the informed consent.
-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) >/= 25.8 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 if they wish to continue their HRT during the study.
-Child-bearing potential and agrees to use one of the contraception methods listed 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 3 days post-last dose.
-Male patients must agree to use one of the contraception methods listed.
This criterion must be followed from the time of the first dose of study medication until 14 days post-last dose.
-Body weight >/=50 kg for men and >/=45 kg for women.
-BMI -Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form. Informed consent must be obtained prior to the commencement of any study related procedures.
-Three ECGs taken at least 5 min apart should be performed at Screening. QTcF < 450 msec in at least two of the three ECGs .
-AST and ALT < 2xULN; alkaline phosphatase and bilirubin </=1.5x

Exclusion Criteria

-Patients who are known non-responders to sodium channel blockers at therapeutic doses.
-Patients taking the following medication: carbamazepine, lamotrigine, mexiletine, valproate, lidocaine, lacosamide, amitriptyline, topiramate or other known or hypothesised sodium channel blockers.
-Patients with causes for their facial pain other than that specified in Inclusion Criterion
-A positive pre-study drug screen.
-A positive history of HIV.
-A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening.
-History of any liver disease within the last 6 months, with the exception of known Gilbert's disease.
-History of excessive regular alcohol consumption within 6 months of the study
-Patients with a history or risk of seizures or a history of epilepsy, head injury or related neurological disorders.
-Patients with a history of uncontrolled or poorly controlled hypertension, with systolic BP frequently exceeding 160mmHg and/or diastolic BP frequently exceeding 100mmHg, or patients who have BP greater than or equal to 160mmHg systolic and/or greater than or equal to 100mmHg diastolic at screening after repeated measurements.
-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.
-Patients with conditions known to affect cardiac conduction or a personal or familial history of Brugada syndrome.
-Pregnant females as determined by positive urine or serum hCG test at screening or prior to dosing.
-Lactating females.
-History or presence of any clinically significant abnormality in vital signs/ECG/ laboratory tests or have any medical or psychiatric condition, which may interfere with the study procedures or compromise patient safety.
-Patient has a history of suicidal ideation and/or suicide attempts.
-Patient has clinical evidence of recent major depression.
-Changes to medications for the treatment of neuropathic pain that are permitted within the study within 3 weeks of the start of open-label (Day 0), including dose adjustment, withdrawal of medications or initiation of new medications. Patients must be able to maintain the medications at stable dose during the study
-Unable to refrain from excessive use of sedative medications
-Use of other prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John,s Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of open-label study medication (Day 0) or during the study, that may interfere with the study procedures or compromise patient safety or introduce a risk of drug-drug interactions. This includes but is not limited to:

-Patients taking the following medication: lamotrigine, carbamazepine, mexiletine, valproate, lidocaine, lacosamide, amitriptyline, topiramate or other known or hypothesised sodium channel blockers.
-Patients taking medications that may adversely interact with a monoamine oxidase-B inhibitor: Antidepressants such as the tricyclics, selective serotonin reuptake inhibitors (SSRIs), serotonin and noradrenaline reuptake inhibitors (SNRIs), trazodone, lithium, tryptophan, opioids, and sympathomimetic agents. Concomitant use with all monoamine oxidase inhibitors is prohibited
-History of hypersensitivity to CNV1014802
-The patient has participated in a cl

Study & Design

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