Multi-centre, randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of the pain relieving effect of Dronabinol in patients with multiple sclerosis associated with central neuropathic pai

• Conditions: Patients with multiple sclerosis associated with central neuropathic pain; MedDRA version: 16.0Level: LLTClassification code 10054095Term: Neuropathic painSystem Organ Class: 100000004852

• Registration Number: EUCTR2006-004255-38-AT
• Lead Sponsor: Bionorica research GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-11-06
• Last Update Posted: 20 May 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 240

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

•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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified