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Trial record 2 of 3 for:    CAN04

Use of Cannabinoids in Patients With Multiple Sclerosis

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ClinicalTrials.gov Identifier: NCT00202423
Recruitment Status : Unknown
Verified September 2005 by S. Andrea Hospital.
Recruitment status was:  Recruiting
First Posted : September 20, 2005
Last Update Posted : November 29, 2005
Sponsor:
Collaborator:
University of Roma La Sapienza
Information provided by:
S. Andrea Hospital

Brief Summary:
This is a 10-week, randomised, double blind, placebo-controlled, crossover trial to investigate the effect of Cannabis Based Medicine Extract (Sativex) on patterns of brain activation associated with movement in 20 MS patients suffering from lower limb spasticity. Spasticity is a common symptom in Multiple Sclerosis (MS), occurring all over the course of the disease, particularly in the progressive phase.Physiologically, spasticity and hyperreflexia habitually seen in patients with pyramidal syndrome is due to lesions of other descending pathways, such as the cortico reticulospinal pathways, which participate in voluntary movements.It is now known that an endocannabinoid system acts in humans by at least two types of cannabinoids receptors, CB1 and CB2. There is evidence to support the view that the psychoactive ingredient in cannabis, delta 9-tetrahydrocannabinol (delta 9-THC), and cannabinoids in general, can reduce muscle spasticity in people with MS. Aim of the study will be to evaluate the effect of Sativex on: (i) patterns of brain activation associated with movement (fMRI) in MS patients suffering from spasticity; (ii) changes in level of spasticity (H-reflex); (iii) changes in intracortical excitability and on synaptic intracortical network of the motor areas (double shock TMS).

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Drug: Sativex Phase 2

Detailed Description:
Baseline assessment will be followed by randomisation and dose introduction. Patients will be randomly assigned to two counterbalanced groups starting either with Sativex or with placebo as the first drug. They will be dispensed sufficient study medication for two weeks together with a diary. During the two-week treatment period all the patients will have to be reached the optimal, individualised dosage to subjectively relief spasticity.Patient will return after three weeks and they will undergo the fMRI and neurophysiological evaluations.Then patients will perform a two-week washout period and they will be requested to intake the alternative medicine. After two weeks patients will perform a second fMRI/neurophysiological study. Two weeks later, after a second washout period, a last visit will be performed to conclude the study.

Study Type : Interventional  (Clinical Trial)
Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: fMRI and Neurophysiological Study Protocol on Cannabinoids in Multiple Sclerosis
Study Start Date : July 2005

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. To evaluate the effect of Sativex on: a)patterns of brain activation associated with movement(fMRI); b) changes in level of spasticity (H-reflex); c)changes in intracortical excitability and on synaptic intracortical network of the motor areas(TMS).


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female subjects between 18 and 60 years of age (inclusive)
  2. Have definite Multiple Sclerosis as per Poser Criteria
  3. Have either relapsing remitting or secondary progressive course
  4. Baseline EDSS score from 3.0 to 6.5 (inclusive)
  5. Stable disease for at least 30 days prior to study entry
  6. Be right-handed with normal right hand function
  7. Female patients of child bearing potential and male patients whose partner is of child bearing potential who are willing to ensure that they or their partner use effective contraception during the study and for three months thereafter
  8. If female, be neither pregnant nor breast-feeding. Confirmation that the subjects not pregnant must be established by a negative serum hCG pregnancy test at baseline.
  9. No cannabinoids use (cannabis, Marinol, Nabilone) for at least three months prior to entry into the study and willing to abstain from any use of cannabis during the study
  10. Significant spasticity in at least two muscle groups defined as a score of 2 or more on the Ashworth scale for each muscle group
  11. Antispastic/antiepileptic treatments (dosage, frequency and route of administration) stable for at least one month prior the study entry

Exclusion Criteria:

  1. Have a primary progressive MS
  2. Patients under disease modifying therapies prescribed in the 6 months prior the study entry
  3. Patients who have participated in another research study in the past 6 months
  4. Changes in antispastic/antiepileptic treatments (dosage, frequency and route of administration) within one month prior the study entry
  5. Have a psychiatric disorders or cognitive impairment that preclude safe participation in the study
  6. Known history of alcohol or substance abuse
  7. Concurrent clinically important immunologic, pulmonary, renal, liver, active thyroid, and/or other major disease other than MS
  8. Severe cardiovascular, disorders, such as ischaemic heart disease, arrhythmias, poorly controlled hypertension or severe heart failure
  9. Patients suffering from acute or chronic pain
  10. History of epilepsy
  11. Female patient who is pregnant, lactating or planning pregnancy during the course of the study
  12. Scheduled elective surgery or other procedures requiring general anaesthesia during the study
  13. Patient who is terminally ill or is inappropriate for placebo medication
  14. Systemic corticosteroid therapy within 4 weeks of randomization or exacerbation of MS within 30 days
  15. Regular levodopa therapy within 7 days of the study entry
  16. Male patient currently receiving sildenafil (Viagra) and unwilling to stop medication for the duration of the study
  17. Patients who are currently taking antiarrhythmic medications
  18. Known or suspected adverse reaction to cannabinoids
  19. Travel outside the Italy planned during the study
  20. Donation of blood during the study
  21. Contraindications to MRI scans -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00202423


Contacts
Contact: Carlo Pozzilli, MD +390649914716 carlo.pozzilli@uniroma1.it
Contact: Emanuela Onesti, MD +390649914716 emanuela.onesti@uniroma1.it

Locations
Italy
Department of Neurology- University of Rome la Sapienza Recruiting
Rome, Italy, 00185
Principal Investigator: Maurizio Inghilleri, MD         
Sub-Investigator: Carlo Pozzilli, MD         
Sub-Investigator: Valentina Tomassini, MD         
Sub-Investigator: Emanuela Onesti, MD         
Sub-Investigator: Patrizia Pantano, MD         
Sponsors and Collaborators
S. Andrea Hospital
University of Roma La Sapienza
Investigators
Principal Investigator: Maurizio Inghilleri, MD Policlinico Umberto I, University of Rome "La Sapienza"
Study Director: Carlo Pozzilli, MD Policlinico Umberto I, University of Rome "La Sapienza"

Publications:

ClinicalTrials.gov Identifier: NCT00202423     History of Changes
Other Study ID Numbers: NEU-CAN-04
CRI.FS032
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: November 29, 2005
Last Verified: September 2005

Keywords provided by S. Andrea Hospital:
Multiple sclerosis
Cannabinoids
Spasticity
fMRI
TMS

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases