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Clinical Trials/EUCTR2006-004255-38-DK
EUCTR2006-004255-38-DKActive, not recruitingPhase 1

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 pain

Bionorica research GmbH0 sites240 target enrollmentStarted: December 18, 2006Last updated:
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Trial Snapshot

Phase
Phase 1
Status
Active, not recruiting
Enrollment
240
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

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

Investigators

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