A multiple dose study of ZYN002 (transdermal gel) in Healthy Volunteers and Patients with Epilepsy
- Conditions
- EpilepsyNeurological - Epilepsy
- Registration Number
- ACTRN12616000104459
- Lead Sponsor
- Zynerba Pharmaceuticals Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 36
1.Healthy male or female adults, 18-55 years of age, inclusive, at the time of screening for subjects enrolling in Periods 1 and 2; and male or female patients having a diagnosis of epilepsy with partial onset seizures, 18 – 55 years of age, inclusive, at the time of screening for patients enrolling in Period 3.
2.Judged by the investigator to be in generally good health at screening based upon the results of a medical history, physical examination, 12-lead ECG, and clinical laboratory test results. Laboratory results outside of the reference range, but acceptable must be documented as not clinically significant (NCS) at the discretion of the investigator.
3.Patients enrolled for Period 3 must have a diagnosis of epilepsy with partial onset seizures with or without associated generalized tonic-clonic seizures (so called secondarily generalized seizures). Patients having ONLY generalized tonic-clonic seizures may be included ONLY if these seizures are considered to be a manifestation of partial onset seizures. The Patient’s epilepsy should be stable, i.e., currently seizure-free OR controlled by one or two antiepileptic drugs [AEDs] with an average monthly seizure frequency of less than 5 seizures per month.
4.The patient should have a confirmed epilepsy diagnosis for at least one year, with a history of assessments, such as electroencephalogram (EEG), scan (either computed tomography [CT] or magnetic resonance imaging [MRI]), and narrative, including detailed descriptions of each seizure type from the physician who manages the patient’s epilepsy. The historical baseline of seizures over the previous 8 weeks should show a reasonably stable pattern of seizure occurrence without clustering of seizures.
5.Patients enrolled in Period 3 must be on a stable dose (no changes in AED regimen for the 4 weeks preceding study enrollment) of no more than two approved AEDs limited to: carbamazepine, clonazepam, gabapentin, lacosamide, lamotrigine, levetiracetam, pregabalin, topiramate, valproate, valproic acid, or zonisamide. Patients must remain on a stable AED dose regimen throughout the study.
6.Subjects in Periods 1-2 have a body mass index between 18-30 kg/m2. Patients in Period 3 have a body mass index between 18-32 kg/m2.
7.Females of childbearing potential must have a negative pregnancy test at the Screening Visit and on Day -1.
8.Subject/patient agrees to abide by all study restrictions and comply with all study procedures.
9.Subject/patient must be adequately informed of the nature and risks of the study and give written informed consent prior to screening.
10.In the investigator’s opinion, the subject/patient is reliable and is willing and able to comply with all protocol requirements and procedures (including keeping an accurate seizure diary, scheduled visits and confinement periods).
1.Females who are pregnant, nursing or planning a pregnancy; females of childbearing potential who are unwilling or unable to use an acceptable method of contraception as outlined in this protocol from at least 21 days prior to the first dose of study medication and for 28 days after the last dose of study medication.
a.Standard acceptable methods include abstinence or the use of a highly effective method of contraception, including; hormonal contraception, diaphragm, cervical cap, vaginal sponge, condom, vasectomy, intrauterine device.
2.Patients with epilepsy enrolled in Period 3 cannot have a history of status epilepticus or the occurrence of seizure clusters (bouts of seizures so close together that an accurate seizure counts are not possible).
3.Use of tobacco/nicotine-containing products within one month of Screening Visit or during study.
4.Use of the following AEDs: clobazam, ethosuximide, oxcarbazepine, phenytoin, phenobarbital, tiagabine, or vigabatrin.
5.For subjects in Period 1 and 2 use of any prescription drugs except hormonal contraception or herbal supplements within four weeks prior to the Screening Visit or any OTC drugs/vitamins within 72 hours prior to first dose of study medication.
6.For patients in Period 3 use of any prescription drugs except hormonal contraception, AEDs, antidepressants (except citalopram, vilazodone, and trazodone) or herbal supplements within four weeks prior to the Screening Visitor any OTC drugs/vitamins within 72 hours prior to first dose of study medication.
7.Use of cannabis or any CBD-containing product within 4 weeks of Screening Visit or during the study.
8.Positive result for the presence of HBsAg, HCAb, or HIV antibodies.
9.Positive drug screen for ethanol, cocaine, delta-9-tetrahydrocannabinol (THC), barbiturates, amphetamines, benzodiazepines (except clonazepam when prescribed as an AED medication), and opiates.
10.Any clinically significant condition or abnormal findings at the Screening Visit that would, in the opinion of the investigator, preclude study participation or interfere with the evaluation of the study treatment.
11.Any skin disease or condition, including eczema, psoriasis, melanoma, acne or contact dermatitis, scarring, imperfections, lesions, tattoos, or discoloration that may affect treatment application, application site assessments, or affect absorption of the study drug.
12.Use of cosmetics or lotions on the shoulder/upper arms during the study.
13.History of significant allergic condition, significant drug-related hypersensitivity, or allergic reaction to any adhesives, compound, or chemical class related to ZYN002 or its excipients.
14.Has taken grapefruit products within the last four weeks or during the study.
15.History of treatment for, or evidence of alcohol or drug abuse within the past year or regular alcohol consumption exceeding an average of two units of alcohol per day.
16.History or current diagnosis of a significant psychiatric disorder that would, in the opinion of the investigator, affect the subject’s ability to comply with the study requirements.
17.Has suspected or confirmed cardiovascular disease.
18.Participation in any investigational product or device study within 30 days prior to Screening Visit (except ZYN2-CL-01 study), or is scheduled to participate in an investigational device or another investigational drug study during the course of this study.
19.Demonstrates behavior indicating unreliabilit
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method