ALLEGRO Study FAQs

How can the ALLEGRO clinical study potentially help people with RRMS?

The currently available treatments for RRMS require patients to administer injections or infusions. ALLEGRO is a Phase III clinical study, which is exploring the efficacy, safety and tolerability of laquinimod, a new once daily oral experimental drug currently being studied in RRMS. It is hoped that if the new drug laquinimod proves to be effective in people with MS, then the choice to be able to take an oral drug may be more convenient for patients.

Perhaps most importantly, participating in this clinical study may not only enable you to help yourself, but also future patients with RRMS by contributing to medical knowledge about a potential new treatment option being studied.

Are there any risks associated with participating in this clinical study?

As with any drug, there is a possibility that you may experience unpleasant or potentially serious side effects, some which may be unknown, while participating in this clinical study, or that the study drug or placebo may not be effective for you. However, the study team will review the potential risks and side effects with you, both before you agree to participate in the study and throughout the study at all of your visits. In addition, you may find that study participation requires more time and attention than your regular multiple sclerosis treatment. We encourage you to ask questions and be sure you fully understand any potential risks or side effects before agreeing to participate.

What will happen if I decide to participate in this clinical study?

Eligible participants will be asked to attend an initial screening appointment and up to 11 additional appointments at their designated study site over 24 months. During these appointments, the study doctor and nurse may ask you questions about your experience on the study drug, perform laboratory tests and/or conduct a physical examination. The appointments also will be an excellent opportunity to ask whatever questions you may have about the study or your experience as a participant.

As a study participant, you must agree to take the study drug as directed every day for two years, and attend all scheduled appointments. Your commitment to these requirements is extremely important to the success of the study.

Who has reviewed the clinical trial protocol?

All clinical trial protocols are reviewed by a research ethics committee and the Regulatory Agency. The National Research Ethics Committee is an independent group of people, composed of for example, doctors, nurses and members of the public. This committee ensures that the rights of the participants will be respected, that any risks have been reduced to a minimum and balanced against possible benefits and that the study information to be given to the participant is clear and thorough. The research ethics committee must give all clinical trial protocols a favourable ethical opinion before they can go ahead.

For more information, please view http://www.nres.npsa.nhs.uk/patients-and-the-public/

Who has reviewed the scientific content of the clinical trial protocol?

In the UK, the government regulatory agency called the Medicines and Healthcare products Regulatory Agency (MHRA), is responsible for reviewing the clinical trial protocols. They ensure that the benefits of the proposed new clinical trial justify the risks to the participants. At the end of the clinical trial testing, once positive and conclusive results have been obtained, it is the responsibility of the MHRA to review all the results and conclude whether or not the new treatment/ drug gains a marketing application.

For more information, please view http://www.mhra.gov.uk/index.htm