Multiple Sclerosis MedDRA version: 14.1 Level: PT Classification code 10028245 Term: Multiple sclerosis System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Product Name: Namisol
Product Code: ECP002A
Pharmaceutical Form: Tablet
INN or Proposed INN: dronabinol
CAS Number: 1972-08-03
Current Sponsor code: ECP002A
Other descriptive name: Namisol
Concentrati
Sponsors
Echo Pharmaceuticals B.V.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subject is legally competent; 2. Subject is eighteen years of age or older; 3. Subject is able to speak, read and understand the local language of the investigational site, is familiar with the procedures of the study, and agrees to participate in the study program by giving oral and written informed consent prior to screening evaluations; 4. Subject has a diagnosis of progressive (primary or secondary) Multiple Sclerosis according to the revised McDonald criteria; 5. Subject has a disease duration of more than 1 year as defined by a diagnosis of MS at least one year prior to inclusion in the trial; 6. Subject has clinically stable disease > 30 days. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 24 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 24
Exclusion criteria
Exclusion criteria: 1. Baseline Expanded Disability Status Scale (EDSS) score 7.5; 2. Subject does not have spasticity in at least one of the lower limbs as defined by an Ashworth score = 2; 3. Subject has a body mass index (BMI) below 18 or above 28.5 kg/m2; 4. Subject has a presence or a significant history of any cardiac or vascular disorder, asthma or other pulmonary disease, major gastrointestinal abnormalities, peptic ulceration, hepatic, psychiatric, haematological (including bleeding disorders), endocrine, renal, or major genitourinary disease or neurological disease other than MS or uses any kind of concomitant medication that - in the opinion of the investigator - may interfere with the study; 5. Subject has a (history of) a significant medical disorder that may pose a risk for the subject or jeopardize the aims of the study, based on medical history, physical examination, ECG and safety laboratory parameters; 6. Subject has a presence or history of clinically significant psychiatric illness in first degree relatives; 7. History of sensitivity / idiosyncrasy to THC, compounds chemically related to these compounds, or excipients which may be employed in the study or to any other drug used in the past; 8. Irregular use of any drug or substance that is known to induce or inhibit (study) drug-metabolizing enzymes within one month prior to the first dose; 9. Subject is currently a regular user (including “recreational uses”) of any illicit drugs, except for cannabis, or has (a history of) drug or alcohol abuse (alcohol consumption > 40 grams/day or 4 units/day); 10. Subject smokes more than 10 cigarettes or 2 cigars or 2 pipes per day and/or not able or not willing to refrain from smoking on study days; 11. Subject is a habitual and heavy consumer of caffeinated beverages (more than 6 cups of coffee or equivalent/day) at the time of the study and/or is not able to refrain from use of (methyl) xanthines (e.g. coffee, tea, cola, chocolate) from 12 hours prior to dosing until the end of the study day; 12. Unable/unwilling to refrain from all use of grapefruit from 2 weeks prior to the first dose until the last study day and/or unable/unwilling to refrain from all use of quinine containing products from 2 days prior to the first dose until discharge; 13. Positive alcohol breath test at screening or admission and/or unable/unwilling to refrain from alcohol use from 48 hours before each study day until the last blood sample has been drawn; 14. Positive urine screen at screening for other drugs than THC, i.e., cocaine, opioids, MDMA, methamphetamine and amphetamines; 15. Positive urine drug test, including THC prior to first dosing; 16. Positive test result on hepatitis B surface antigen, hepatitis C antibody or HIV antibody test; 17. Participation in an investigational drug study within 90 days prior to the first dose and during the entire study period; 18. Donation of blood/plasma outside limits of Sanquin Blood Supply Foundation guidelines; 19. Premenopausal women not using one of the monophasic oral contraceptives (including Diane-35), who are unable or unwilling to also skip the pill/ring-free week, from the screening until the end of the first study phase and during the second study phase; 20. Pregnant and/or breastfeeding subjects; 21. Clinically significant history of use of CNS medication as judged by the investigator. 22. Unable to stay in the Netherlands for more than four weeks.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: ?Evaluation of the efficacy of ECP002A (?9-THC) on spasticity in patients with MS;Secondary Objective: ?Evaluation of the efficacy of ECP002A (?9-THC) on pain in patients with MS; ?Evaluation of the tolerability of ECP002A (?9-THC) in patients with MS; ?Establishment of a PK-PD model for the effect of ECP002A (?9-THC) on spasticity in patients with MS ;Timepoint(s) of evaluation of this end point: o Dose finding phase - day 1 (T=-30 min, T=100 min, T=200 min, T=300 min) o Dose finding phase - day 15 (T=-30 min, T=100 min, T=200 min, T=300 min) o Treatment phase - Baseline (T=100 min) o Treatment phase - 14 days post start treatment (T=100 min) o Treatment phase - 28 days post start treatment (T=100 min);Primary end point(s): The difference in the severity of spasticity: defined by the H-reflex/M-wave amplitude ratio. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Dose Finding - Pharmacokinetics: o Cmax, AUC0-last, AUC0-?, tmax, t1/2ß - Pharmacodynamics: o severity of spasticity on numerical rating scale (NRS) o visual analogue scale (VAS) as described by Bowdle (feeling high, internal perceptions, external perceptions) o VAS as described by Bond & Lader (alertness, mood and calmness) o body sway o heart rate Treatment phase: o the difference in the severity of spasticity based on a daily diary assessment by the subject on a spasticity numerical rating scale (NRS), between the subjects who received ECP002A (?9-THC) and the subjects who received placebo o the difference in the severity of spasticity as measured by the modified Ashworth scale in lower limb muscles affected by spasticity between the subjects who received ECP002A (?9-THC) and the subjects who received placebo o the difference in the severity of patient disability in multiple sclerosis as measured by the Kurtzke expanded disability status scale (EDSS), between the subjects who received ECP002A (?9-THC) and the subjects who received placebo o the difference in the severity of spasms based on a daily diary assessment by the subject on a spasm frequency scale, between the subjects who received ECP002A (?9-THC) and the subjects who received placebo o the difference in the severity of pain based on the short form McGill pain questionnaire (SF-MPQ), between the subjects who received ECP002A (?9-THC) and the subjects who received placebo o the difference in the patient’s global impression of change (PGIC) in their disease between the subjects who received ECP002A (?9-THC) and the subjects who received placebo o the difference in the quality of sleep as determined by the Pittsburgh sleep quality index (PSQI), between the subjects who received ECP002A (?9-THC) and the subjects who received placebo o the difference in the walking distance as determined by the timed 25 feet walk test (T25FW) between the subjects who received ECP002A (?9-THC) and the | — |
Countries
Netherlands
Contacts
Public ContactClinical Research Centre
Echo Pharmaceuticals B.V.
Outcome results
None listed