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AzTrials

Multiple SclerosisPhase 2NCT00202423

Use of Cannabinoids in Patients With Multiple Sclerosis

A Phase 2 study testing Sativex in people with Multiple Sclerosis, run by S. Andrea Hospital at 1 site in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Multiple Sclerosis
What is being tested?
Sativex
How many people
20 participants
Where
1 siteItaly
Study dates
Jul 2005to not given
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Male or female subjects between 18 and 60 years of age (inclusive)
  • Have definite Multiple Sclerosis as per Poser Criteria
  • Have either relapsing remitting or secondary progressive course
  • Baseline EDSS score from 3.0 to 6.5 (inclusive)
  • Stable disease for at least 30 days prior to study entry
  • Be right-handed with normal right hand function
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  • 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
  • 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.
  • 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
  • Significant spasticity in at least two muscle groups defined as a score of 2 or more on the Ashworth scale for each muscle group
  • Antispastic/antiepileptic treatments (dosage, frequency and route of administration) stable for at least one month prior the study entry
  • -

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Carlo Pozzilli, MD contact

+390649914716

carlo.pozzilli@uniroma1.it

Emanuela Onesti, MD contact

+390649914716

emanuela.onesti@uniroma1.it

Italy1 site, 1 recruiting

  • Department of Neurology- University of Rome la Sapienza

    Rome, 00185

    Maurizio Inghilleri, MD

    Carlo Pozzilli, MD

    Recruiting

Other trials in Italy

About this study

Official title: fMRI and Neurophysiological Study Protocol on Cannabinoids in Multiple Sclerosis

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).

Read the 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.

Being tested
Sativex
Keywords
Multiple sclerosis, Cannabinoids, Spasticity, fMRI, TMS
Medical subject headings
Multiple Sclerosis, Muscle Spasticity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SativexDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Sep 2005 (estimated)
  2. Study startJul 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Enrolment
20 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00202423
Sponsor's protocol ID
NEU-CAN-04
Other IDs
CRI.FS032
Status last verified
Sep 2005
First submitted
12 Sep 2005
Last updated
29 Nov 2005
Results posted
No

Publications

  • Pertwee RG. Cannabinoid receptor ligands: clinical and neuropharmacological considerations, relevant to future drug discovery and development. Expert Opin Investig Drugs. 2000 Jul;9(7):1553-71. doi: 10.1517/13543784.9.7.1553.

    PubMed 11060760

  • Smith PF. Cannabinoids in the treatment of pain and spasticity in multiple sclerosis. Curr Opin Investig Drugs. 2002 Jun;3(6):859-64.

    PubMed 12137404

  • Zajicek J, Fox P, Sanders H, Wright D, Vickery J, Nunn A, Thompson A; UK MS Research Group. Cannabinoids for treatment of spasticity and other symptoms related to multiple sclerosis (CAMS study): multicentre randomised placebo-controlled trial. Lancet. 2003 Nov 8;362(9395):1517-26. doi: 10.1016/S0140-6736(03)14738-1.

    PubMed 14615106

  • Baker D, Pryce G, Croxford JL, Brown P, Pertwee RG, Huffman JW, Layward L. Cannabinoids control spasticity and tremor in a multiple sclerosis model. Nature. 2000 Mar 2;404(6773):84-7. doi: 10.1038/35003583.

    PubMed 10716447

  • Wade DT, Robson P, House H, Makela P, Aram J. A preliminary controlled study to determine whether whole-plant cannabis extracts can improve intractable neurogenic symptoms. Clin Rehabil. 2003 Feb;17(1):21-9. doi: 10.1191/0269215503cr581oa.

    PubMed 12617376

  • Wade DT, Makela P, Robson P, House H, Bateman C. Do cannabis-based medicinal extracts have general or specific effects on symptoms in multiple sclerosis? A double-blind, randomized, placebo-controlled study on 160 patients. Mult Scler. 2004 Aug;10(4):434-41. doi: 10.1191/1352458504ms1082oa.

    PubMed 15327042

  • Vaney C, Heinzel-Gutenbrunner M, Jobin P, Tschopp F, Gattlen B, Hagen U, Schnelle M, Reif M. Efficacy, safety and tolerability of an orally administered cannabis extract in the treatment of spasticity in patients with multiple sclerosis: a randomized, double-blind, placebo-controlled, crossover study. Mult Scler. 2004 Aug;10(4):417-24. doi: 10.1191/1352458504ms1048oa.

    PubMed 15327040

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sativex in people with Multiple Sclerosis, run by S. Andrea Hospital at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 29 Nov 2005. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Carlo Pozzilli, MD (+390649914716, carlo.pozzilli@uniroma1.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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).. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00202423, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2005.

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