Thank you for your interest in RESUME.
RESUME is a Phase 3 clinical research study involving an oral, non-opioid, investigational medication in people with pain due to acute back muscle spasms.
Back pain is a condition that affects millions of people in the United States every year. When a person suffers from sudden onset (acute) of back muscle spasms (involuntary tensing of the muscles), it can result in short-term pain that may last a few weeks.
The purpose of RESUME is to determine if the investigational medication is safe and effective in study participants suffering from recent pain caused by acute back muscle spasms.
RESUME is sponsored by Neurana Pharmaceuticals, Inc.
RESUME will take up to 24 days for each study participant to complete and will consist of the following:
This will be your first visit to the study center. During the Screening visit, you will provide your informed consent and undergo assessments to determine if you are eligible to participate in RESUME.
If you are eligible to participate in RESUME, you will progress to the Treatment period for 14 days. During this period, you will visit the study center 2 additional times and will be asked to keep a daily dosing diary and to inform us about your daily back pain.
A telephone consultation will take place 7 days after your Treatment period. The purpose of the call is to assess your health and well-being.
Please use the map below to find a study center near you. Study centers will be added as they begin enrolling participants. If there is no study center near you, please check back at a later time.
A clinical research study is a medical research study involving human participants. It tests the use of a medical procedure, medical device, drug, or potential treatment, and is led by researchers and study doctors. Clinical research studies provide valuable information, and may help researchers to understand a condition better and learn how best to treat it, or may lead to new or better treatments being made available.
A study drug must pass three phases of clinical testing before it is approved by a country’s regulatory authority and made available to the public. RESUME is a Phase 3 study.
Phase 1: The study drug is given to a small group of healthy volunteers or study participants. Researchers look to see how much is safe to take and how the human body responds when it receives the drug.
Phase 2: The study drug is given to a small group of people with the target disease or condition it is intended to treat. In this phase, researchers evaluate what dose is appropriate and begin to learn more about how safe the drug is and how well it works.
Phase 3: Researchers test the safety and effectiveness of the study drug in a larger group of study participants over a longer period of time. Sometimes, comparisons are made between the study drug and other medications that are already approved for the same purpose.
Phase 4: A Phase 4 study is conducted after a study drug has been approved for public use. The approved drug may be compared with other drugs on the market or researchers may monitor the drug’s long-term effectiveness and impact on the study participant’s quality of life.
Before you take part in a clinical research study, it is important that you are aware of all aspects of it, including what will happen at the study visits, how you will take the investigational medication, what is expected of you when you participate, any potential risks and benefits involved. Before you agree to participate, the study doctor will meet with you to tell you everything you need to know. You will be given written information to read that you can discuss with your family and friends, and you will be given time to ask any questions you may have.
When you understand what is involved in the clinical research study and you decide to take part, you will be given an Informed Consent Form (ICF) to sign, which documents that you voluntarily consent to taking part in the clinical research study. Even if you provide informed consent, you are free to leave the study at any time and for any reason.
Your participation in RESUME will last for approximately 24 days. However, participation is voluntary and you are free to leave the study at any time.
You are free to leave the study at any time, and this will not affect your future care in any way.
Copy and paste the link below to tell a friend or family member about RESUME.http://resume-study.com/