Turmeric as Treatment in Epilepsy

NCT03254680 | Withdrawn

• 1 other identifier: 17-00750
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single center open-label pilot clinical trial of patients 1-70 years of age with greater than 6 seizures per month diagnosed with Dravet Syndrome, Lennox-Gastaut Syndrome, Tuberous Sclerosis, or focal seizures. Twenty patients will be enrolled and treated with a stable dose of orally administered turmeric oil daily for 3 months. Patients and caregivers will be asked to keep a seizure diary logging all clinical events during the course of the study. Serum comprehensive metabolic panel, complete blood count with differential, and antiseizure medication levels, will be monitored at baseline, 1.5 months, and at the end of 3 months.

Conditions

Epilepsy; Dravet Syndrome; Lennox-Gastaut Syndrome; Tuberous Sclerosis; Focal Seizures

Keywords

Turmeric Oil; antiseizure medications; ar-turmerone

Outcome Measures

Primary Outcomes (1)

• Number of epilepsy patients enrolled in study

  feasibility of recruiting patients into a prospective study designed to evaluate the effect of orally ingested turmeric oil on seizures.

  3 months

Secondary Outcomes (1)

• Number of epilepsy seizures post epilepsy treatment with turmeric

  3 months

Study Arms (1)

Turmeric Oil

EXPERIMENTAL

stable dose of orally administered turmeric oil

Dietary Supplement: Turmeric

Interventions

Turmeric DIETARY_SUPPLEMENT

Twenty patients will be enrolled and treated with a stable dose of orally administered turmeric oil daily for 3 months.

Turmeric Oil

Eligibility Criteria

• Age: 1 Year - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with greater than greater than six seizures per month diagnosed with Dravet Syndrome, Lennox-Gastaut Syndrome, Tuberous Sclerosis, or focal seizures followed at NYU CEC.

You may not qualify if:

• Patients expected to have changes to any medications or supplements during study period
• exposure to any investigational agent in the month prior to study entry
• pregnant or breast feeding women, positive pregnancy test
• history of non-compliance
• known drug or alcohol dependence
• known baseline hematologic
• liver function
• renal function
• absorption
• absorption

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Epilepsy; Epilepsies, Myoclonic; Lennox Gastaut Syndrome; Tuberous Sclerosis; Seizures

Interventions

Curcumin

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy, Generalized; Epileptic Syndromes; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hamartoma; Neoplasms; Neoplasms, Multiple Primary; Neoplastic Syndromes, Hereditary; Malformations of Cortical Development, Group I; Malformations of Cortical Development; Nervous System Malformations; Neurocutaneous Syndromes; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Congenital Abnormalities; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diarylheptanoids; Heptanes; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic

Study Officials

• Manisha Holmes, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2017
• First Posted: August 18, 2017
• Study Start: March 1, 2018
• Primary Completion: November 1, 2018
• Study Completion: November 1, 2018
• Last Updated: April 30, 2018

Record last verified: 2018-04

Locations

US (1)