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 pai

Phase 1

• Conditions: Patients with multiple sclerosis associated with central neuropathic pain; MedDRA version: 8.1Level: LLTClassification code 10054095Term: Neuropathic pain

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-12-18
• Last Update Posted: 21 August 2017

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
•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)

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

Study & Design

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