Frequently Asked Questions

Signs of spasticity may include:^1.

• Muscle spasms (which can be quick or continuous)
• Involuntary muscle contractions
• Increased muscle tone, known as hypertonia
• Abnormal posture
• Contracture (a long-lasting structural change, shortening of muscles, tendons, or other soft tissue, from prolonged spasticity, immobility)
• Difficulty performing daily activities, such as dressing and bathing
• Disruption in sleep (often due to muscle spasms, pain, or tightness)
• Muscle, joint and/or bone deformities

1. Source: https://my.clevelandclinic.org/health/symptoms/14346-spasticity

You should consider applying for a clinical study if you or a loved one:

• Are 18 years of age or older
• Have been diagnosed with a neurological condition (affecting the brain or spinal cord) that causes spasticity in the arm and shoulder
• If taking a spasticity medication (e.g., baclofen) orally, have been on a stable dose for at least 4 weeks, or 6 months in the case of an intrathecal baclofen pump
• Have not had Botulinum-based neurotoxin injections (e.g. Botox, Dysport, etc.) in the last three months

The information gleaned from clinical studies may help identify new treatment options in the future for people living with spasticity. Study participants are often connected to specialists who understand their situation and can help answer questions from patients or their loved ones. Participants in research studies should expect to experience a professional clinical environment, be treated with compassion and respect, and have access to top quality care during the trial.

Most clinical trials will involve frontline screening to confirm that a potential patient is, in fact, a match for that study’s criteria. Once verified and the patient has signed an Informed Consent Form, which clearly provides the details and purpose of the study to that individual and what it involves, participants can expect to attend scheduled appointments at a clinician’s office. They will also receive an investigational treatment or a placebo, and undergo additional screening and regular follow-up monitoring from a clinician and/or research staff. Throughout the study, participants should expect to enjoy a safe, professional clinical environment, and be treated with compassion and respect.

In almost all instances, there is no cost to participate in a clinical trial. Participants receive all study-related medical care and medications for the duration of the study at no cost. Likewise in certain instances, patients may also receive reimbursement for study-related time and travel.

As all drugs and medical procedures carry a risk of side effects, the possibility that participants may experience some discomfort or other reactions during or after a clinical trial does exist. The study staff for that trial should explain these potential risks before participants decide whether to participate, and help address any concerns.

No. Requirements or eligibility criteria vary by clinical trial, and sponsors/clinical sites are constantly looking for patient populations in order to test the efficacy of their investigational drugs. Further screening will determine whether a patient is eligible to participate in an active clinical study, but if not, they will likely be a candidate for one in the future, in which case that person may expect to be contacted. At that point, and before a potential participant decides whether to take part in the study, the study staff will review the informed consent form with them and answer any questions. Once the consent form has been signed by the participant, the screening period of the study begins.

Yes. Participation in clinical trials is entirely voluntary. Even if a participant is already involved in a study, they may change their mind at any time, for any reason.

If you are interested in learning more, please contact us at any time. You may email us at help@clinicalenrollment.com.