A Study to Evaluate the Efficacy and Safety of VX-765 in Subjects With Treatment-Resistant Partial Epilepsy

• Conditions: Partial epilepsy; MedDRA version: 14.1Level: LLTClassification code 10065336Term: Partial epilepsySystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2011-004156-19-FI
• Lead Sponsor: Vertex Pharmaceuticals Incorporated

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05-31
• Last Update Posted: 27 January 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• Males or females aged 18 to 64 (inclusive) years with a BMI between 18 and 35 (kg/m2)
• Subjects must agree to use acceptable contraceptive methods as described in Section 12.7.5. of the study protocol
• Subjects who have completed the assigned study treatment in Part A
may enter Part B if eligible per protocol
• Must have a diagnosis and hx of treatment-resistant partial-onset epilepsy (as defined in protocol) and are taking 1 to 4 stable doses of concomitant AEDs at the time of Screening Period
• Subjects must have had at least 1 EEG consistent with partial epilepsy
• Must have had at least 6 partial-onset seizures and a seizure free period of no more than 3 weeks during Baseline
• Subjects with stable medical conditions as determiend by Principal investigator
• Must understand and comply with the protocol requirements and be willing to provide written informed consent to participate
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 500
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• Subjects who are pregnant or lactating or do not agree to use medically approved methods of contraception as outlined in the protocol – for the duration od the study and for 90 days after last dose of study drug
• Subjects who are male and have a female partner who is pregnant, nursing, or is planning to become pregnant during the study period, or within 90 days of the last dose of study drug
• Subjects with a history of nonepileptic, transient alterations in consciousness (e.g., metabolic, structural, and post traumatic or pseudo seizures)
• Those who have a history of status epilepticus in the past 12 months before the Screening Visit
• Subjects whose seizure frequency cannot be quantified
• Subjects who have a significant medical illness including kidney, liver, pulmonary, or gastrointestinal disease; or unstable or poorly controlled conditions such as hypertension, diabetes, or angina pectoris, as judged by the investigator
• Subjects with clinically significant psychiatric illness or had an active suicidal plan/intent, thoughts, or attempt as defined in the study protocol
• Subjects with clinically significant laboratory abnormalities during the Screening Visit/Baseline Period, as judged by the investigator
• Subjects who have had serious adverse events (SAEs) thought to be
related to study drug that led to discontinuation during Part A may not
participate in part B
• Subjects with active hepatitis B, hepatitis C, or human immunodeficiency virus (HIV)
• Subjects with positive drug screen at screening or during the Baseline Period (excluding any allowed prescribed medications) and/or a history of alcoholism or drug addiction within past 2 years
• Subjects on felbamate with fewer than 18 month of continuous felbamate exposure at the time of the Screening Visit or with significant adverse reactions to felbamate
• Subjects treated with vigabatrin fewer than 2 years prior to the Screening Visit or who have a prior history of treatment with vigabatrin without a documented stable examination by an ophthalmologist or neuroophthalmologist of the visual field within the 2 years prior to the Screening Visit
• Subjects using prohibited medications (Section 10.3 and Table 10 1) or treated with any systemic immunosuppressant as defined in the protocol
• Subjects who experienced a symptomatic viral, fungal, or bacterial infection requiring systemic treatment within 7 days prior to the first dose of study drug
• Subjects with a current or prior history of illness precluding them from immunomodulatory therapy
• Subjects who have donated any blood or have had a significant loss of blood (500 mL) as defined in the protocol
• Subjects who participated in any other clinical studies involving an investigational product or device and have received the last dose of the study drug associated with that clinical study within 30 days or 5 half lives (whichever is longer) of the Screening Visit
• Subjects who have participated in earlier VX-765 clinical studies and received at least one dose of study drug
• Subjects who have no completed the full 13-week Treatment Period in
part A may not participate in Part B
• Any subject judged by the investigator or sponsor (or designee) to be inappropriate for the study

Study & Design

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