EpilepsyNCT03254680
Turmeric as Treatment in Epilepsy
A study testing Turmeric in people with Epilepsy and Dravet Syndrome, run by NYU Langone Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 70 years
- Conditions the study is for
- Epilepsy, Dravet Syndrome, Lennox-Gastaut Syndrome
- What is being tested?
- Turmeric
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2018to Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- liver function
- renal function
- absorption
- absorption
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
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.
- Being tested
- Turmeric
- Keywords
- Turmeric Oil, antiseizure medications, ar-turmerone
- Medical subject headings
- Epilepsy, Epilepsies, Myoclonic, Lennox Gastaut Syndrome, Tuberous Sclerosis, Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TurmericDietary supplement
Twenty patients will be enrolled and treated with a stable dose of orally administered turmeric oil daily for 3 months.
| Study group | Role | What they receive |
|---|---|---|
| Turmeric Oil | Experimental | stable dose of orally administered turmeric oil Receives: Dietary Supplement: Turmeric |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (1)
Number of epilepsy seizures post epilepsy treatment with turmeric
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2017
- Study startMar 2018 (estimated)
- Primary completionNov 2018 (estimated)
- Study completionNov 2018 (estimated)
Why it stopped: Funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Manisha Holmes, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03254680
- Sponsor's protocol ID
- 17-00750
- Status last verified
- Apr 2018
- First submitted
- 15 Aug 2017
- Last updated
- 30 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Turmeric as Treatment in Epilepsy
- ClinicalTrials.gov ID
- NCT03254680
- Acronym / sponsor ID
- 17-00750
- Keywords
- Turmeric Oil, antiseizure medications, ar-turmerone
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- Mar 2018 (estimated)
- Primary completion
- Nov 2018 (estimated)
- Study completion
- Nov 2018 (estimated)
- First posted
- 18 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Turmeric Oil | Experimental | Dietary Supplement: Turmericstable dose of orally administered turmeric oil |
Who may qualify
- Ages
- 1 year to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TurmericTwenty patients will be enrolled and treated with a stable dose of orally administered turmeric oil daily for 3 months. | Dietary supplement | Turmeric Oil |
Primary outcome
Number of epilepsy patients enrolled in study
Time frame: 3 months
feasibility of recruiting patients into a prospective study designed to evaluate the effect of orally ingested turmeric oil on seizures.
1 secondary outcome
Number of epilepsy seizures post epilepsy treatment with turmeric
Time frame: 3 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manisha Holmes, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Turmeric in people with Epilepsy and Dravet Syndrome, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 30 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of epilepsy patients enrolled in study (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2018.