Overview

A Phase IIa Withdrawal Study of CNV1014802 in Patients With Trigeminal Neuralgia

Status:
Completed
Trial end date:
2014-06-30
Target enrollment:
0
Participant gender:
All
Summary
This is a double-blind, randomized withdrawal study comparing CNV1014802 with placebo in patients with trigeminal neuralgia who have successfully responded to CNV1014802 in an initial open-label phase. Patients will participate in an initial open-label treatment period of 21 days of CNV1014802 150mg three times a day (tid). Responders will be randomized to 28 days of CNV1014802 150mg tid or placebo. Following an interim analysis after 10 evaluable patients have completed the open-label phase, the dose regimen may be increased to 350mg twice a day (bid) for the remainder of the trial if the responder rate is less than 60%.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Biogen
Convergence Pharmaceuticals
Criteria
Inclusion Criteria:

- Male or female aged between 18 and 70 years, with a diagnosis of trigeminal neuralgia;
IHS criteria to be used.

- Female patients must be of non-child bearing potential or agree to use an approved
form of contraception

- Male patients must agree to use an approved form of contraception

- Body weight > 50 kg for men and > 45 kg for women.

- BMI ≤ 34.9

- Capable of giving written informed consent. Informed consent must be obtained prior to
the commencement of any study related procedures.

- QTcB either/or QTcF < 450 msec in two of three ECGs conducted at screening

- AST and ALT < 2xULN; alkaline phosphatase and bilirubin < 1.5xULN.

- Approved concomitant medications must have been stable for at least 3 weeks prior to
day 0.

Exclusion Criteria:

- 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 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 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.