Patients with multiple sclerosis associated with central neuropathic pain MedDRA version: 16.0 Level: LLT Classification code 10054095 Term: Neuropathic pain System Organ Class: 100000004852
Conditions
Interventions
Product Name: dronabinol
Product Code: cnp-MS-0601
Pharmaceutical Form: Oral solution
INN or Proposed INN: dronabinol
CAS Number: 1972-08-3
Current Sponsor code: cnp-MS-0601
Other descriptive name: (-
Sponsors
Bionorica research GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Outpatients aged 18 to 70 years • Patients who meet the McDonald diagnostic criteria for definite MS • Patients with an EDSS score =3 and =8 • Patients who are in a stable phase of MS • Patients with MS associated with central neuropathic pain for at least 3 months • Patients with central neuropathic pain characterized by pain in a body territory with abnormal sensation to pinprick, touch, or temperature evaluated by the bedside • Patients with moderate to severe pain (= pain intensity score of at least ?4 on the 11-point Likert Numerical Rating Scale (NRS) at the maximal pain site) Inclusion criteria for follow-up phase 3: • Complete participation in main study, from visit E1 to visit E20 • Termination of study phase 2 with visit E20a taking place not more than 7 days later. Exception for all patients with E20 before implementation of Amendment No 11: Termination of study phase 2 with visit E20a taking place not more than 1 month later Exception for all patients with E20 taking place after 31.07.2008 and E20a taking place between December 1st and December 17th, 2008. • Treatment is still indicated as per the investigator’s discretion • Negative pregnancy test for female patients of childbearing potential at visit E20 or E20a respectively • Willingness and capability to pass all required examinations over the entire time of the follow-up phase 3 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Patients experiencing a relapse - within 30 days prior to screening, or - during the run-in phase, or - at randomization • Patients with mania or bipolar affective disorder • Schizoid symptoms or history of schizophrenia or schizophrenia in the family anamneses • Patients with epilepsy • Patients with trigeminal neuralgia • Patients with severe cardiac diseases • Advanced renal insufficiency (creatinine >2,2mg/100ml) • Advanced hepatic insufficiency (SGOT/ASAT; SGPT/ALAT >2,5 x upper normal value) • Treatment with dronabinol within the last 12 months • Use of marihuana within the last 4 weeks and unwillingness to abstain from the use of marihuana for the duration of the study • Known hypersensitivity to tramadol and excipients of Tramal® (in Germany and Austria) or Nobligan® (in Denmark) capsules Exclusion criteria for follow-up phase 3: • Critical adverse events during time interval between E20 and E20a including: - Schizoid symptoms - Mania or bipolar affective disorder - Epilepsy • Abuse of or dependence on Dronabinol • Reevaluation of main criteria such as - Advanced renal insufficiency (creatinine >2,2mg/100ml) - Advanced hepatic insuffiency (SGOT/ASAT; SGPT/ALAT >2,5 x upper normal value) - Known severe cardiac diseases (e.g. cardiac insufficiency NYHA IV, severe arrhythmia, severe CHD, myocardial infarction within the last 6 months) - Known HIV-infection - Known alcohol, narcotics or drug abuse - Unwillingness to abstain from use of marihuana - Concurrent participation in other studies - Patients with major peripheral pain syndromes - Legal incompetence or limited legal competence - Patients who do not sign a consent form after thorough medical consultation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of this study is to examine whether the long-term administration of dronabinol leads to a statistically and clinically significant reduction of the chronic pain in patients with MS associated with central neuropathic pain.;Secondary Objective: • Distribution of frequency, duration, and intensity of episodes with acute pain attacks • Distribution of responder at visits E6, E7, E8 and E9 • Distribution of responder at visits E6, E7, E8 and E9 by dosage group • NRS pain relief • Pain- related sleep interference • Length of treatment period • Time to first response • SF-36 (QOL-questionnaire) • Clinical global impression • Intake of rescue medication • Adverse Events • Safety laboratory parameters • Vital parameters / weigh Criteria in follow-up phase 3: • Retrospective pain assessment for the past 4 weeks (11-NRS) • Pain-related sleep interference • SF-36 (QOL-questionnaire) • CGI, Item A • Adverse events • Assessment of dependence • Safety laboratory • Vital parameters • Global assessment of tolerability • ECG • EDSS;Primary end point(s): The primary endpoint of efficacy will be the mean change of baseline pain severity score taken from the initial patient assessment and the daily patient recordings of his/her average chronic pain on the 11-point NRS within a maximum of 16 weeks | — |
Countries
Austria, Germany
Outcome results
None listed