Boston, MANCT06700811Now EnrollingIRB Ready

Developmental and Epileptic Encephalopathies Clinical Trial in Boston, MA

Access cutting-edge developmental and epileptic encephalopathies treatment through this clinical trial at a research site in Boston. Study-provided care at no cost to qualified participants.

Sponsored by Heather Olson

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Expert Care in Boston

Access developmental and epileptic encephalopathies specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related developmental and epileptic encephalopathies treatment provided free

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Check if you qualify for this developmental and epileptic encephalopathies clinical trial in Boston, MA

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Why Participate?

  • No-Cost Study Care

  • Local to Boston

    Convenient for MA 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 Boston site if eligible
  4. 4Begin participation

About This Developmental and Epileptic Encephalopathies Study in Boston

Epileptic spasms (ES) are a predominantly infantile seizure type observed frequently in certain genetic disorders. Ketogenic diet (high ratio of fat to carbohydrate/protein) is an established non-medication treatment for difficult to control seizures, including ES. Because ES are associated with worse developmental and cognitive outcomes if not detected or treated quickly and effectively, this trial aims to test the ketogenic diet to prevent ES in this high-risk population. This trial is a single-center pilot study of 10 infants with suspected or confirmed genetic seizure disorders to establish if the protocol of early ketogenic diet administration and ES evaluation is safe and feasible.

Sponsor: Heather Olson

Who Can Participate

Inclusion Criteria

Plan for initiation of ketogenic diet by clinical team for treatment of epilepsy
The clinical team initiating the ketogenic diet agrees that the use of the KetoVie formula is appropriate for the subject, as all study subjects need to receive the same formula
Male or female, age 0 to less than 9 months (including neonates per investigator's judgment)
Epilepsy onset at less than 6 months of age
Abnormal development (any sub score of the Bayley-4 less than 1 standard deviation below the mean) and/or neurologic exam (microcephaly, macrocephaly, strabismus, abnormal vision/CVI, hypotonia, spasticity, dystonia, movement disorder), per investigators judgment
Suspected or confirmed genetic diagnosis as a cause for epilepsy
Weight adequate to complete required study laboratory testing without exceeding maximum allowable blood draws per draw or in a 30 day period per BCH policy

Exclusion Criteria

Epileptic spams prior to enrollment
Tuberous sclerosis complex, trisomy 21 (based on differential response to ES treatment)
Metabolic diagnosis with targeted treatment (including specific indication for ketogenic diet such as glucose transporter disorder, vitamin dependent epilepsies, and others) or exclusion for the ketogenic diet
Ongoing treatment with vigabatrin, ACTH, corticosteroids, topiramate or zonisamide. Other anti-seizure medications are permitted.

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 Boston?

Yes, this clinical trial (NCT06700811) has an active research site in Boston, MA 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.

Developmental and Epileptic Encephalopathies Treatment Options in Boston, MA

If you're searching for developmental and epileptic encephalopathies treatment options in Boston, MA, this clinical trial (NCT06700811) 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 Boston research site is actively enrolling participants for this clinical trial. You'll receive care from experienced developmental and epileptic encephalopathies 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 developmental and epileptic encephalopathies clinical trials near you to find additional studies recruiting in your area.

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