Symptoms and General Pathology

All Conditions

Nervous System Diseases

Diseases and Abnormalities at or Before Birth

Neoplasms

Skin and Connective Tissue Diseases

Rare Diseases

Sclerosis

Syndrome

Epilepsy

Seizures

Lennox Gastaut Syndrome

Tuberous Sclerosis

Epilepsies, Myoclonic

Brain Diseases

Central Nervous System Diseases

Neurologic Manifestations

Hamartoma

Neoplasms, Multiple Primary

Neoplastic Syndromes, Hereditary

Congenital Abnormalities

Malformations of Cortical Development

Nervous System Malformations

Neurocutaneous Syndromes

Heredodegenerative Disorders, Nervous System

Neurodegenerative Diseases

Genetic Diseases, Inborn

Epilepsy, Generalized

Epileptic Syndromes

Dravet Syndrome

CDKL5 Deficiency Disorder

Lennox-Gastaut Syndrome

Tuberous Sclerosis Complex

All Drugs and Chemicals

Herbal and Botanical

Turmeric extract

Turmeric

stable dose of orally administered turmeric oil

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

Manisha Holmes, MD

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.

Turmeric as Treatment in Epilepsy

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

NYU Langone Health

Immune System Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Heart and Blood Diseases

Nutritional and Metabolic Diseases

Gland and Hormone Related Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Behaviors and Mental Disorders

Eye Diseases

Blood and Lymph Conditions

Musculoskeletal Diseases

Digestive System Diseases

Infections

Mouth and Tooth Diseases

Dermatitis, Atopic

Dermatitis

Eczema

Multiple Sclerosis

Kidney Diseases

Stroke

Diabetes Mellitus

Myasthenia Gravis

Asthma

Alzheimer Disease

Macular Degeneration

Lymphoma

Leukemia

Scleroderma, Systemic

Scleroderma, Diffuse

Heart Diseases

Anemia, Sickle Cell

Thalassemia

beta-Thalassemia

Psoriasis

Arthritis

Crohn Disease

Spondylitis

Parkinson Disease

Thyroid Diseases

Hepatitis A

Hepatitis

Liver Cirrhosis

Fibrosis

Schizophrenia

Hypersensitivity

Cystic Fibrosis

Autistic Disorder

Amyloidosis

Graves Disease

Colitis

Fibromyalgia

Myofascial Pain Syndromes

Colitis, Ulcerative

Ulcer

Spondylarthritis

Vasculitis

Hidradenitis Suppurativa

Hidradenitis

Vitiligo

Alopecia

Alopecia Areata

Celiac Disease

Spondylitis, Ankylosing

Behcet Syndrome

Hepatitis, Autoimmune

Pemphigus

Anemia

Liver Diseases

Gastrointestinal Diseases

Hepatitis, Viral, Human

Virus Diseases

Communicable Diseases

Enterovirus Infections

Picornaviridae Infections

RNA Virus Infections

Joint Diseases

Parkinsonian Disorders

Ganglion Cysts

Synovial Cyst

Basal Ganglia Diseases

Movement Disorders

Synucleinopathies

Mental Disorders

Psychotic Disorders

Schizophrenia Spectrum and Other Psychotic Disorders

Autoimmune Diseases

Demyelinating Autoimmune Diseases, CNS

Autoimmune Diseases of the Nervous System

Demyelinating Diseases

Dementia

Tauopathies

Neurocognitive Disorders

Urologic Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Male Urogenital Diseases

Skin Diseases

Pancreatic Diseases

Lung Diseases

Respiratory Tract Diseases

The study may require a tissue collection and/or a participant survey for participation. Most tissue collected will come from a blood draw; up to 100mL for the health condition group, 60mL for the exceptive condition group, and up to 180mL for the control group (if determined safe for the participant). Participant surveys may involve participant reported outcomes (PROs) or custom participant surveys.

Specimen sample

Carolyn Bidwell

Houman Hemmati, MD

To collect, preserve, and/or distribute annotated biospecimens and associated medical data to institutionally approved, investigator-directed biomedical research to discover and develop new treatments, diagnostics, and preventative methods for specific and complex conditions.

Tissue Repository Providing Annotated Biospecimens for Approved Investigator-directed Biomedical Research Initiatives

A Single-Site Tissue Repository Providing Annotated Biospecimens for Approved Investigator-directed Biomedical Research Initiatives

To collect enough biospecimens and associated clinical data to allow researchers to come to statistically relevant scientific results

Sanguine Biosciences

Chronic Graft Versus Host Disease

Pharmaceutical Solutions

Anticonvulsants

Hematinics

Cannabidiol

Liver Extracts

Cannabidiol solution 100 milligrams per milliliter (mg/mL) will be administered orally at a dose level of 5 mg/kg/day for 1 week, then increase to 10 mg/kg/day by the participant or their caregiver twice each day (morning and evening).

This study will monitor for potential chronic liver injury and liver fibrosis, in participants treated with cannabidiol oral solution.

Assessment of Potential for Chronic Liver Injury in Participants Treated With Epidiolex (Cannabidiol) Oral Solution

A Long-term Safety Study to Assess the Potential for Chronic Liver Injury in Participants Treated With Epidiolex (Cannabidiol) Oral Solution

Jazz Pharmaceuticals

Muscle Cramp

Spasm

Spasms, Infantile

West Syndrome

The 52-week treatment period includes a fixed 2-week titration schedule followed by flexible dose optimization.

Day 1: 5 mg/kg/day (2.5 mg/kg twice daily (b.i.d.))

Day 8: 10 mg/kg/day (5 mg/kg b.i.d.)

Day 15 to Week 52: Flexible dosing based on the participant's observed efficacy, safety, and tolerability per the investigator's clinical judgement. Up to a maximum of 20 mg/kg/day (10 mg/kg b.i.d.) for LGS and DS or 25 mg/kg/day (12.5 mg/kg b.i.d.) for TSC, in maximum weekly increments of 5 mg/kg/day (≤ 2.5 mg/kg b.i.d.).

GWP42003-P

Clinical Trial Disclosure & Transparency

This study will be conducted to evaluate the safety, pharmacokinetics (PK), and efficacy of adjunctive GWP42003-P in participants \< 2 years of age with tuberous sclerosis complex (TSC), Lennox-Gastaut syndrome (LGS), or Dravet syndrome (DS).

The study duration will be up to approximately 62 weeks, including a 4-week screening/baseline period, a 52-week dose optimization treatment period (which includes a fixed 2-week titration period followed by flexible dose optimization), a 10-day taper period, and a safety follow-up period (4 weeks after the end-of-taper visit).

Assessment of Adjunctive Cannabidiol Oral Solution (GWP42003-P) in Children With Tuberous Sclerosis Complex (TSC), Dravet Syndrome (DS), or Lennox-Gastaut Syndrome (LGS) Who Experience Inadequately-controlled Seizures

An Open-label, Single-arm Study to Assess the Safety, Pharmacokinetics, and Efficacy of Adjunctive Cannabidiol Oral Solution (GWP42003-P) in Participants With Tuberous Sclerosis Complex (Age 1 Month to < 2 Years of Age), Dravet Syndrome (1 Year to < 2 Years of Age), or Lennox-Gastaut Syndrome (1 Year to < 2 Years of Age) Who Experience Inadequately-controlled Seizures

The CGIC/S is a comprehensive neurodevelopmental assessment that covers the following domains: sensory, motor, cognition, emotional/behavioral health, communication, social, and adaptive functioning. This assessment is a 2-question survey per domain to be completed by the clinician. Individual domain scores will be summed and the total will be reported. Higher scores indicate poor clinical outcome.

The Infant and Toddler Quality of Life Questionnaire Short Form 47 (ITQOL-47) was developed for use in infants and toddlers from 12-months-to-5 years of age and assesses levels of health and well-being. The caregiver will complete the assessment on an electronic device. For each concept, item responses are scored, summed, and transformed on a scale from 0 (worst health) to 100 (best health). Higher scores indicate better clinical outcome.

Treatment Responders are defined as participants with ≥ 50% reduction from baseline in caregiver-reported total countable seizures

This endpoint includes the following changes in percentage of seizures:

* \> 25% (increase);
* ≥ 0% to ≤ 25% (increase);
* \> -25% to \< 0% (reduction);
* \> -50% to ≤ -25% (reduction);
* \> -75% to ≤ -50% (reduction);
* ≤ -75% (reduction).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Turmeric as Treatment in Epilepsy	NCT03254680	Epilepsy Dravet Syndrome Lennox-Gastaut ... Tuberous Sclero... Focal Seizures	Turmeric	1 Year - 70 Years	NYU Langone Health
Tissue Repository Providing Annotated Biospecimens for Approved Investigator-directed Biomedical Research Initiatives	NCT05635266	Age-Related Mac... Allergies Alpha-Gal Syndr... Alzheimer Disea... Amyloidosis Ankylosing Spon... Arthritis Alopecia Areata Asthma Atopic Dermatit... Autism Autoimmune Hepa... Behcet's Diseas... Beta-Thalassemi... Cancer Celiac Disease Kidney Diseases COPD Crohn Disease Cystic Fibrosis Diabetes Dravet Syndrome DMD Fibromyalgia Graves Disease Thyroid Disease... Hepatitis Hidradenitis Su... ITP Leukemia ALS Lupus or SLE Lymphoma Multiple Sclero... Myasthenia Grav... Heart Diseases Parkinson Disea... Pemphigus Vulga... Cirrhosis Psoriasis Schizophrenia Scleroderma Sickle Cell Dis... Stroke Ulcerative Coli... Vasculitis Vitiligo	Specimen sample	18 Years - 85 Years	Sanguine Biosciences
Assessment of Potential for Chronic Liver Injury in Participants Treated With Epidiolex (Cannabidiol) Oral Solution	NCT05044819	Lennox Gastaut ... Dravet Syndrome Tuberous Sclero...	Cannabidiol	1 Year -	Jazz Pharmaceuticals
Turmeric as Treatment in Epilepsy	NCT03254680	Epilepsy Dravet Syndrome Lennox-Gastaut ... Tuberous Sclero... Focal Seizures	Turmeric	1 Year - 70 Years	NYU Langone Health
Turmeric as Treatment in Epilepsy	NCT03254680	Epilepsy Dravet Syndrome Lennox-Gastaut ... Tuberous Sclero... Focal Seizures	Turmeric	1 Year - 70 Years	NYU Langone Health
Assessment of Adjunctive Cannabidiol Oral Solution (GWP42003-P) in Children With Tuberous Sclerosis Complex (TSC), Dravet Syndrome (DS), or Lennox-Gastaut Syndrome (LGS) Who Experience Inadequately-controlled Seizures	NCT04485104	Seizure in Part... Seizure in Part... Seizure in Part...	GWP42003-P	1 Month - 23 Months	Jazz Pharmaceuticals

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