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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.
This study will be conducted at our clinical trials unit in London Bridge and will involve healthy male and female volunteers.
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You will need to attend a screening appointment within 27 days of admission. If successful, you will need to attend our unit for 2 in-house stay of 3 nights and 3.5 days as well as an outpatient appointment 6 days after being given with the study medication. You will also need to be available for 1 follow up telephone call 30 days after receiving the drug for the second time.
- Screening period: January 17th-January 26th 2018
- In-house period: January 29th-February 1st 2018
- Outpatient visit: February 5th 2018
- In-house period: February 8th-February 11th 2018
- Outpatient visit: February 15th 2018
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)
- 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.
In recognition of the time involved in taking part in this study, you will receive £1,632 on completion of the study provided you comply fully with all 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: email@example.com
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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