Amherst, NYNCT07051629Now EnrollingIRB Ready

Epilepsy Clinical Trial in Amherst, NY

Access cutting-edge epilepsy treatment through this clinical trial at a research site in Amherst. Study-provided care at no cost to qualified participants.

Sponsored by Suninflam Inc

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Expert Care in Amherst

Access epilepsy specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related epilepsy treatment provided free

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Check if you qualify for this epilepsy clinical trial in Amherst, NY

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Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Local to Amherst

    Convenient for NY residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Amherst site if eligible
  4. 4Begin participation

About This Epilepsy Study in Amherst

This is a dose escalation study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of SIF001, a monoclonal antibody with the potential to treat epilespy

Sponsor: Suninflam Inc

Who Can Participate

Inclusion Criteria

\- Healthy Volunteers Only (Stage I and II (Phase 1a and 1b)):
Male or female 18 to 55 years of age at the time of signing the informed consent.
In good health as determined by the Investigator, based on medical history and screening evaluations.
Body weight of ≥ 50 kg and BMI within the range 18-30 kg/m2 (inclusive) Patients with Epilepsy Only (Stage II (Phase 1b)):
Male or female 18 to 70 years of age at the time of signing the informed consent.
A clinical diagnosis of focal or generalized epilepsy. Subjects must have motor seizures, with or without impaired awareness.
Has a minimum of 4 seizures per 4-week period while taking 1 to 3 anti-seizure medications
All medications and epilepsy interventions must be stable for 8 weeks before screening and are expected to remain stable during the study All Subjects:
Negative serum pregnancy test at screening and urine pregnancy test on Day -1 before starting study treatment in all pre-menopausal women and women \< 12 months after the onset of menopause.
Female participants of child-bearing potential and male participants must agree to use adequate contraception for the duration of the protocol.
Able to sign informed consent and comply with the protocol.

Exclusion Criteria

Healthy Volunteers (Stage I and II (Phase 1a and 1b)):
Subjects with any unresolved history of clinically significant disease, in the opinion of the investigator.
Past or intended use of over-the-counter (OTC) or prescription medication (other than ≤ 2 g/day paracetamol \[acetaminophen\] or ≤ 800-mg/day ibuprofen), vitamins, and dietary or herbal supplements within 7 days or 5 half-lives of the respective drug, if known (whichever is longer), prior to dosing. Patients with Epilepsy (Stage II (Phase 1b)):
Acute precipitant of seizure within the past 3 months prior to screening such as major trauma, hypoglycemia, hyperglycemia, cardiac arrest, or post-anoxia All Subjects:
Any uncontrolled medical or psychiatric condition (e.g., hypertension, diabetes, chronic obstructive pulmonary disorder, asthma, depression) as judged by the investigator.
Any clinically significant findings in medical examination, including physical examination, 12-lead ECG, vital signs, clinical laboratory tests. Specifically:
alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 3 × upper limit of normal (ULN), Total bilirubin ≥ 2 × ULN
QT interval corrected by Fridericia's formula (QTcF) \> 450 msec (male) or \> 470 msec (female)
Undergone major surgery ≤ 2 months prior to Day -1.
Received any investigational drug within 30 days or 5 half-lives (whichever is longer, if known) before screening.
Received any vaccine within 6 weeks before planned SIF001 administration.
Loss of more than 100 mL blood (e.g., a blood donation) within 2 months before Day -1, or has received any blood, plasma, or platelet transfusions within 3 months before admission.
Active liver disease or severe renal impairment, including serum creatinine ≥ 1.5 × ULN or estimated glomerular filtration rate of \< 60 mL/min/1.73m2.
Known history of substance use disorder.
History of active human immunodeficiency virus (HIV), active hepatitis C virus (HCV), or active hepatitis B virus (HBV)
Recent (2 weeks) history of a positive COVID-19 test result or disease symptoms of COVID-19 disease such as shortness of breath, cough, rhinorrhea, sore throat etc.
Known history of hypersensitivity or anaphylactic reaction to intravenous medications, biologicals, or fluids.
History of any clinically significant disease or disorder which, in the opinion of the investigators, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.
History of status epilepticus within 2 years of screening
Known history of suicidality within 2 years of screening, or answering "yes" to questions 4 and 5 of the Columbia Suicide Severity Rating Scale (C-SSRS)
Unable to complete this study for other reasons or the investigator believes that the subject should be excluded.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Amherst?

Yes, this clinical trial (NCT07051629) has an active research site in Amherst, NY that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Epilepsy Treatment Options in Amherst, NY

If you're searching for epilepsy treatment options in Amherst, NY, this clinical trial (NCT07051629) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Amherst research site is actively enrolling participants for this clinical trial. You'll receive care from experienced epilepsy specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all epilepsy clinical trials near you to find additional studies recruiting in your area.

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