A clinical trial to investigate the effect of a drug called CNV1014802 onintense face pain and how safe the drug is
- Conditions
- Trigeminal neuralgiaMedDRA version: 14.1Level: LLTClassification code 10029227Term: Neuralgia trigeminalSystem Organ Class: 10029205 - Nervous system disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2010-023963-16-IT
- Lead Sponsor
- CONVERGENCE PHARMACEUTICALS LTD.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 40
A patient will be eligible for inclusion in this study only if all of the
following criteria apply:
1. IHS criteria for trigeminal neuralgia to be used. The diagnosis must be
verified by a member of the diagnostic sub-committee of the DMC 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
2. 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.
3. Male or female between 18 and 70 years of age inclusive, at the time
of signing the informed consent.
4. 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 in Section 7.5 if they wish to continue their HRT during the
study.
• Child-bearing potential and agrees to use one of the contraception
methods listed in Section 0 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.
5. Male patients must agree to use one of the contraception methods
listed in Section 7.5. This criterion must be followed from the time of the
first dose of study medication until 14 days post-last dose.
6. Body weight = 50 kg for men and = 45 kg for women.
7. BMI =34.9.
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.
9. Three ECGs
• Patients who are known non-responders to sodium channel blockers at
therapeutic doses.
• 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 Cantibody 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, gastrointestinal, 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 or lactating females.
• History or presence of any clinically significant
abnormality in vital signs / ECG / laboratory tests or have any medical
or psychiatric condition, which, in the opinion of the Investigator may
interfere with the study
procedures or compromise patient safety.
• History of suicidal ideation and/or suicide attempts or clinical evidence
of recent major depression.
• Patients who are unable to maintain approved
medications for their trigeminal neuralgia at a stable dose during the
study.
• Unable to refrain from excessive use of sedatives.
• Unable to comply with the prohibited concomitant medication
restrictions as detailed in the protocol. This includes but is not limited to
sodium channel blockers or drugs that adversely interact with a
monoamine oxidase-
B inhibitor: MAOI's, antidepressants, opioids and sympathomimetic
agents.
• History of hypersensitivity to CNV1014802.
• The patient has participated in a clinical trial and has received an
investigational product within 5 half-lives or twice the duration of the
biological effect of the investigational product (whichever is longer)
prior to the start of this study.
• Exposure to more than four new chemical entities (medications for
which no marketing authorization has been obtained) within 12 months
prior to the first dosing day.
• Where participation in the study would result in total donation of blood
or blood products in excess of 500mL within a 56 day period.
• Patient is mentally or legally incapacitated.
• Unwillingness or inability to follow the procedures outlined in the
protocol.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method