Table 1 CNV1014802 in patients with trigeminal neuralgia inclusion and exclusion criteria

A patient will be eligible for inclusion in this study only if all of the following criteria apply:

A patient will not be eligible for inclusion in this study if any of the following criteria apply:

1. The following diagnostic criteria for trigeminal neuralgia must be met:

1. Patients who are known non-responders to sodium channel blockers at therapeutic doses. If patients have previously been unable to tolerate sodium channel blockers and therefore has not been able to take doses within the therapeutic dose range, they may still be included.

Paroxysmal attacks of pain lasting from a fraction of a second to 2 min affecting one or more divisions of the trigeminal nerve

Pain has at least one of the following characteristics:

i. Intense, sharp, superficial or stabbing

ii. Precipitated from trigger areas or by trigger factors

iii. Attacks are stereotyped in the individual patient

There is no clinically evident neurological deficit

Not attributed to another disorder

2. Frequency criteria for numbers of paroxysms:

2. A positive history of HIV.

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.

3. Male or female between 18 and 80 years of age inclusive at the time of signing the informed consent.

3. A positive pre-study hepatitis B surface antigen or positive hepatitis C antibody result within 3 months of screening.

4. A female patient is eligible to participate if she is of non-childbearing or child-bearing potential and agrees to use one of the contraception methods listed.

4. History of any liver disease within the last 6 months, with the exception of known Gilbert’s disease.

5. Male patients must agree to use one of the contraception methods.

5. History of excessive regular alcohol consumption within 6 months of the study defined as: an average weekly intake of >28 units or average daily intake >4 units for males; an average weekly intake >21 units or average daily intake >3 units for females. One unit is equivalent to 8 g of alcohol: a half-pint (~240 ml) of beer, 1 glass (125 ml) of wine or 1 (25 ml) measure of spirits.

6. Body weight ≥ 50 kg for men and ≥  45 kg for women.

6. Patients with a history or risk of seizures or a history of epilepsy, head injury or related neurological disorders.

7. BMI ≤34.9.

7. Patients with a history of uncontrolled or poorly controlled hypertension.

8. 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.

8. History or presence of significant cardiovascular, gastrointestinal, 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.

9. Patients with conditions known to affect cardiac conduction or a personal or familial history of Brugada syndrome.

10. Females of child-bearing potential only: pregnant females as determined by positive urine or serum hCG test at screening or prior to dosing.

11. Lactating females.

12. History or presence of any clinically significant abnormality in vital signs/ECG/laboratory tests, or any medical or psychiatric condition, which, in the opinion of the investigator, may interfere with the study procedures or compromise patient safety.

13. The patient has a history of suicidal ideation and/or suicide attempts.

14. The patient has clinical evidence of recent major depression (by patient’s medical history).