NEW clinical trial for healthy volunteers aged 18 to 55. Get paid for your time!

Screening now available!

 

We are carrying out a clinical trial with an investigational drug that is being developed for the treatment of epilepsy. Epilepsy affects approximately one in every 100 people in the UK. People suffering from epilepsy experience seizures, varying from a loss of awareness to loss of consciousness and uncontrollable shaking, resulting in a lower quality of life. Epilepsy can be very difficult to treat, with existing anti-epileptic drugs having side effects such as dizziness and drowsiness. The information gathered during this clinical trial may support further drug development, including larger trials in patients with epilepsy.

Register your interest in this clinical trial

Study summary

This study will be conducted at our clinical trials unit in London Bridge and will involve healthy male and female volunteers.

Part Ia

You will need to attend a screening appointment within 27 days of admission. If successful, you will be required to be in our unit for 1 in-house stay of 3 days/2 nights. There will be 1 follow up visit 7 days after receiving the drug. There will also be 1 follow up telephone call 30 days after receiving the drug (Part Ia only).

Part Ib

Right handed male volunteers, who have successfully completed Part Ia of the study and are found eligible, will progress onto Part Ib where we will be testing the effects of the study drug on the body using Transcranial Magnetic Stimulation (TMS). You will be required to be in the TMS unit (located in King’s College London) for 1 in-house stay of 2 days/1 night following Day 7 of Part Ia. There will be 1 follow up visit 7 days after receiving the drug for the second time. There will also be 1 follow up telephone call 30 days after receiving the drug for the second time.

Study dates

Details of dates for the first three cohorts can be seen below:

Cohort 2a

  • Screening period: October 2nd-20th (excluding weekends) 
  • In-house period: October 24th-26th
  • Outpatient visits: Sunday 31st October

Cohort 2b

  • Screening period: October 2nd-23rd (excluding weekends) 
  • In-house period: October 25th-27th
  • Outpatient visits: Monday 1st November

Cohort 2c

  • Screening period: October 2nd-24th (excluding weekends)
  • In-house period: October 26th-28th
  • Outpatient visits: Tuesday 02nd November

The study dates for Part IB of the study will commence from mid-November. Further details of this will be discussed during your telephone screening process.

Who can take part?
To be eligible to take part in this study you must fit the following criteria

  • Healthy males or females aged between 18 and 55 (inclusive)
  • You must weigh between 50.0-100.0 kg (inclusive) and have a Body Mass Index (BMI) within the range 18.5-30.0 kg/m² (inclusive)
  • If you are male, you must be right handed (Part Ia and Ib)
  • You must not consume beverages containing caffeine 48 hours prior to dosing up until you are discharged from the study unit
  • You must not have used tobacco in any form (e.g. smoking or chewing) or other nicotine-containing products in any form (e.g. gum, patch and electronic cigarettes) within 60 days prior to admission onto the study
  • You must not test positive for hepatitis B/C, HIV, alcohol or drugs or show any evidence of drug or alcohol abuse within the last 12 months. (Alcohol abuse is defined as a regular weekly intake of more than 14 units)
  • You must be healthy with no underlying medical conditions that may either interfere with participation in the clinical study, and/or put you at any significant risk
  • You must not be on any regular medications, including over the counter medications
  • You must not have donated blood within 30 days prior to first dosing
  • You must not have any history of heart-related diseases or abnormalities that show up on your ECGs
  • You must not be pregnant or breastfeeding
  • Female volunteers of childbearing potential, if heterosexually active, must agree to the use of highly effective contraception starting at least one menstrual cycle before the drug administration and continuing for at least 3 months after the final study drug dose.
  • Male subjects must be willing to use appropriate contraception throughout the study and for three months after the last dose of study medication. They must also agree not to donate sperm for three months following the final administration of the study drug.

A full list of acceptable contraceptive methods will be discussed in full by a member of the recruitment team and a study doctor during screening.

Study payment

In recognition of the time involved in taking part in this study, you will receive a payment. The payments for the various parts of the study are as follows:

  • Volunteers who successfully complete Part Ia will receive £816 (£245 bonus and £571 study payment).
  • Right handed male volunteers who complete Part Ia and are willing to participate, but NOT selected for the TMS section (Part IB) of the study will receive a total £941 (£282 bonus and £659 study payment).
  • Right handed male volunteers who successfully complete both Parts (Ia & Ib) of the study will receive £1,191 (£357 bonus and £834 study payment).

All payments are subject to volunteers successfully completing and fully complying with the study requirements.

Get in touch
Call our team for more information: +44 (0) 20 7042 5800 (opt 1)
We are open weekdays 9am-5pm
or email us: volunteer@richmondpharmacology.com

Ref: XEN_October 2017 (email_website_advert text)

The contents of this page have been approved by an ethics committee. Any response to this advertisement will be recorded. Your response will not place you under any obligation to participate in this trial.

You may be required to remain resident in the unit until resolution of any safety issues, after which you will be discharged from the unit.

Register your interest in this clinical trial