Nausea Clinical Trial
Official title:
The Safety , Tolerability and Efficacy of Dronabinol, a Synthetic Endocannabinoid Receptor Agonist, for the Treatment of Nausea and Vomiting in Patients With Familial Dysautonomia
Verified date | June 2019 |
Source | NYU Langone Health |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a pilot clinical trial of dronabinol to treat disabling attacks of nausea and vomiting in patients with familial dysautonomia (FD, also known as Riley Day syndrome or hereditary sensory and autonomic neuropathy type III). FD is a rare autosomal recessive disease in which the growth and development of selective nerves is impaired. Patients with FD suffer recurrent uncontrollable nausea and vomiting crises accompanied by skin flushing, tachycardia and arterial hypertension. Current treatments of nausea are ineffective or have intolerable side sides. Our long-term goal is to treat nausea effectively and without side effects, a therapeutic intervention that would markedly improve the quality of life of patients with FD.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | March 22, 2019 |
Est. primary completion date | March 22, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility |
Inclusion Criteria: 1. Male or female patients aged 18-60. 2. Confirmed diagnosis of familial dysautonomia by genetic testing. 3. Symptoms of severe nausea. 4. Able to swallow the capsules. 5. Written informed consent or ascent to participate in the pilot trial and understanding that they can withdraw consent or accent at anytime without affecting their future care. 6. Ability to comply with the requirements of the study procedures, including taking blood pressure measurements at home Exclusion Criteria: 1. Patients with a history of hypersensitivity to any cannabinoid or sesame oil. 2. Cannabinoid use in the previous 4 weeks (a urinary cannabinoid test will be performed before study entry). 3. Patients with a history of substance abuse, including alcohol abuse or dependence, or marijuana. 4. Seizure disorder with at least one epileptic seizure in the last 3 years or abnormal epileptic discharge in electroencephalography 5. Patients with history of bipolar disorder, severe depression or schizophrenia. 6. Patients that require driving, operating machinery, or engaging in hazardous activities. 7. Patients taking medications thought, in the investigator's opinion, to be unsafe when used with dronabinol. 8. Patients with atrial fibrillation, angina or an electrocardiogram documenting a significant abnormality that may jeopardize the patient's health. 9. Patients with significant pulmonary, liver, renal (creatinine > 2.0 mg/ml), or cardiac illness that may, in the investigators opinion jeopardize their health by participating in this pilot trial. 10. Patients with severe cognitive impairment or pervasive developmental disorders, or patients who are unable to clearly identify and rate their symptoms of nausea. 11. Women who are pregnant or lactating. 12. Patients who have a significant abnormality on clinical examination that may, in the investigator's opinion, jeopardize their health by participating in this pilot trial. |
Country | Name | City | State |
---|---|---|---|
United States | NYU Medical Center | New York | New York |
Lead Sponsor | Collaborator |
---|---|
NYU Langone Health |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of adverse effects | number of AEs during 4 weeks active drug phase vs. 4 weeks placebo phase | 8 weeks | |
Primary | Change in nausea scores | nausea scores during 4 weeks active drug phase vs. 4 weeks placebo phase | 8 weeks | |
Secondary | Change in weight. | change in weight (kgs) during 4 weeks active drug phase vs. 4 weeks placebo phase | 8 weeks | |
Secondary | Change in anxiety scores | change in anxiety scale scores during 4 weeks active drug phase vs. 4 weeks placebo | 8 Weeks |
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