Allegro Clinical Trial
A clinical research study of a new investigational drug for RRMS that is taken by mouth
What is the ALLEGRO clinical trial?
ALLEGRO is the name given to a global clinical research trial designed to explore how effective, how safe and how tolerable a new investigational drug, called laquinimod, is in patients who have relapsing-remitting multiple sclerosis (RRMS).
Why is the ALLEGRO clinical trial taking place?
As you may know, the currently available medications for RRMS are Avonex®, Rebif®, Betaferon®, Novantrone®, Tysabri®, and Copaxone®. Studies have shown that these medications are effective in decreasing the rate and severity of relapses (as well as, in some cases, decreasing the risk that a disability caused by MS may progress).
However, all of the current RRMS medications are injected – either under the skin, into the muscle, or into the vein – this may cause pain and discomfort to some people and potentially can cause reactions on the body where they are injected.
As such, medical researchers are conducting clinical research studies in an effort to help develop oral treatments, which are medications that are taken by mouth.
One of these studies is the ALLEGRO study.
What type of clinical trial is the ALLEGRO study?
The ALLEGRO study is a Phase III clinical trial. This study is comparing the effect of daily treatment of laquinimod at a dose of 0.6mg compared to placebo (dummy drug), in people with RR-MS. In total, approximately 1000 patients from 26 countries across the world will be invited to participate in this study some of these patients will come from the UK. Allegro is a privately funded study. The study sponsor is called Teva Pharmaceuticals.
What is Relapsing Remitting Multiple Sclerosis (RR-MS)?
Multiple Sclerosis (MS) is an inflammatory disease that affects the body’s central nervous system and causes the cells there to break down. MS is a complex and unpredictable condition that varies from person to person and does not follow a set pattern. There are different types of MS, this clinical trial is focussed on people who have been diagnosed with Relapsing Remitting MS or RR-MS. For more information please view www.mstrust.org.uk.
What is the new investigational drug that is being tested?
Laquinimod is a man-made chemical compound that has been developed for the treatment of RR-MS. Laqunimod has previously been tested in Phase I (healthy volunteer) and Phase II clinical trials (testing in people with MS). Laquinimod is an oral (given by mouth) drug and is supplied as white capsules. In the ALLEGRO clinical trial, one capsule containing laquinimod at a dose of 0.6mg, will be taken by mouth with water, once a day.
Will everyone recieve the new investigational drug called laquinimod?
No, only half of the participants who participate in the study will receive the new experimental drug laquinimod. The other half of participants will receive dummy capsules (or placebo) that does not contain any active ingredient. Therefore, you will have a 50% chance of receiving active drug. The treatment that you will receive is decided randomly by a computer programme, in a similar way to tossing a coin. Neither you nor your study doctor will know what treatment you are receiving during the study (this is called a double-blind study). However, should it need to be known, for example, if you experience a serious side effect to the study medication, your study doctor can find out what you are receiving.
What do we know about the safety of laquinimod from clinical trials performed to date?
In previous clinical trials, laquinimod was found to be well tolerated. The most common side effects and discomforts reported by participants were: insomnia (difficulty sleeping), chest pain, stomach pain, back pain, sinus infection, tonsillitis (throat infection), sore throat, urinary tract infection, menstrual (period) pain, headaches, dizziness, fast heart beat, nausea and vomiting, upper respiratory tract infection, joint pain and herpes virus infections. Some changes in the blood tests, which can be early signs of inflammation (swelling) or potential liver problems and a decrease in haemoglobin (the oxygen carrier in the blood), sometimes leading to mild anaemia were also reported. In general, these changes did not require the experimental drug to be stopped.
It is important to remember that these side effects are only the most common ones reported to date, and individual participants may suffer from additional and different side-effects. It is important that you ask your study doctor questions about the potential risks and disadvantages before agreeing to participate in this study.
What do I have to do if I am interested in participating in the study?
The first thing you need to do is read the Patient Information Leaflet very carefully. This leaflet will explain all of the details about the study (including possible side effects and risks), however, please ask questions about anything you don’t understand. If you agree to participate and before you enter the study, you will be asked to sign two consent forms. One copy will be given to you to keep and your study doctor will keep the other. The informed consent form is not a contract – please remember that you have the right to leave the study at any time, for any reason.
How long will my participation in the study last?
The study is scheduled to last 25 months. This is made up of a screening phase of one month followed by a 24 months of treatment with either active study drug (laquinimod 0.6mg/ daily) or placebo. However, during the study, a mathematical calculation will be performed to see if the data generated by this study will answer a scientific question about the change in disability due to MS in the people taking part. Depending on the results of this mathematical calculation, the study may be extended by an additional 6 months. In this case, the study will last 31 months. This is made up of a screening phase of one month followed by a 30 months of treatment with either active study drug or placebo.
What is the screening visit?
If you agree to take part in this study, you will be asked to attend the hospital for your first visit, what is known as a screening visit. The aim of the screening visit is to see whether you are eligible to take part in the study. The study doctor will discuss all entry criteria with you and inform you about all aspects of the study. The screening visit may take up to 4 hours and will include a variety of assessments, including, having an ECG, possibly having a chest X-ray, giving blood and urine samples, a timed 25 foot walk, a peg test (placing small pegs in holes and removing them by hand) and a number counting exercise.
If all your medical examinations and blood results obtained at the screening visit are suitable, you may be invited to attend another visit about four weeks later called the baseline visit. If you are invited to this visit, you will be booked in for an MRI scan 7-13 days before the baseline visit date.
What is the baseline visit?
If you are eligible and wish to enter the study, you will be asked to return to the clinic for a baseline visit. This visit is expected to last up to 4 hours. At this visit, your blood pressure, temperature and pulse measurements will be taken before you are given the study drug. The neurological examination, physical examination, ECG and some of the blood tests will also be repeated. You will be asked to fill in 3 general health questionnaires to provide information on your general heath status. If the test measurements made during the baseline visit are acceptable, you will then receive your first dose of study drug and your blood pressure, temperature and pulse measurements will be taken 30 and 60 minutes after taking the medication. You will need to remain in the hospital during this time so that the study doctor may check on your well-being.
What will I have to do during subsequent study visits?
At the study visits your study doctor will check how you are getting on with your study medication, perform the study related assessments and will review your general health and well-being. The assessments performed at each visit vary slightly, however, may include MRI scans, neurological examinations, chest X-rays, ECGs, testing of blood and urine samples and having physical examinations.
What happens if I experience a relapse whilst participating in this study?
If you experience a symptom or group or symptoms that suggest that you are having a relapse, it is very important that you contact your study doctor immediately.
You will be asked to attend the clinic within 7 days from when you noticed the start of your symptoms, so that a neurological examination may be performed. Your study doctor will discuss your symptoms with you and he/she may give you treatment for them which may take the form of steroid injection treatment. It is not permissible to have oral steroids in this study, however, you will be reminded by the doctor of the options available for the treatment of MS and given the opportunity to withdraw from the trial.
If you do have a relapse, you may remain in the study unless you do not wish to do so. If you chose to remain in the study you will be asked to sign a re-consent form. If you decide that you do not want to be in the trial, then your doctor will discuss the treatment options available to you.
What happens at the end of the study?
If you discontinue with the study, either you have decided that you don’t want to be in the study anymore, or the study doctor has decided that you should not be in the trial anymore, you will be asked to attend for a termination visit to end your participation in the study.
If, you complete the 25 or 31 month study, you will be invited to enter a separate study called an open label extension study. This means that you would receive 0.6mg of active laquinimod drug. Open label means that both your study doctor and you know what medication you are taking. This open label extension phase is planned for 12 months. If, after discussing the separate study with your study doctor, and you decide that you would like to take part, you will be asked to sign a separate informed consent form.
In all instances, your study doctor will discuss alternative treatment and care options with you when you complete the study.