Turmeric as Treatment in Epilepsy

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.

Study Overview

• Status: Withdrawn
• Conditions: Epilepsy; Tuberous Sclerosis; Dravet Syndrome; Focal Seizures; Lennox-Gastaut Syndrome
• Intervention / Treatment: Dietary supplement: Turmeric

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • New York University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 70 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Turmeric Oil; stable dose of orally administered turmeric oil	Dietary supplement: Turmeric; Twenty patients will be enrolled and treated with a stable dose of orally administered turmeric oil daily for 3 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
Number of epilepsy seizures post epilepsy treatment with turmeric	3 months

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Manisha Holmes, MD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2018
• Primary Completion (Anticipated): November 1, 2018
• Study Completion (Anticipated): November 1, 2018

Study Registration Dates

• First Submitted: August 15, 2017
• First Submitted That Met QC Criteria: August 16, 2017
• First Posted (Actual): August 18, 2017

Study Record Updates

• Last Update Posted (Actual): April 30, 2018
• Last Update Submitted That Met QC Criteria: April 26, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: Turmeric Oil; antiseizure medications; ar-turmerone
• Additional Relevant MeSH Terms: Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy, Generalized; Epileptic Syndromes; Neoplasms; Neurologic Manifestations; Disease; Congenital Abnormalities; Genetic Diseases, Inborn; Neurodegenerative Diseases; Heredodegenerative Disorders, Nervous System; Neoplastic Syndromes, Hereditary; Malformations of Cortical Development, Group I; Malformations of Cortical Development; Nervous System Malformations; Neurocutaneous Syndromes; Hamartoma; Neoplasms, Multiple Primary; Epilepsy; Epilepsies, Myoclonic; Syndrome; Seizures; Tuberous Sclerosis; Lennox Gastaut Syndrome
• Other Study ID Numbers: 17-00750

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No