EUCTR2011-000985-36-ES
Active, not recruiting
Not Applicable
Study on the Use of surface electromyography in the detection of objective differencies in patients with spasticity due to multiple sclerosis identified as responders and not responders under treatment with Sativex
JOSE MANUEL GARCIA DOMINGUEZ0 sitesJanuary 25, 2012
ConditionsSpasticity due to multiple sclerosis identified as responders and not responders under treatment with SativexMedDRA version: 14.1Level: LLTClassification code 10041416Term: SpasticitySystem Organ Class: 100000004852Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
DrugsSATIVEX
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Spasticity due to multiple sclerosis identified as responders and not responders under treatment with Sativex
- Sponsor
- JOSE MANUEL GARCIA DOMINGUEZ
- Status
- Active, not recruiting
- Last Updated
- 11 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Both sex subjects older than 18\.
- •Diagnosis of Multiple Sclerosis according to current McDonald criteria, with moderate to severe spasticity
- •Patients under prescription of Sativex according to the current approved indications by EMA/AEMPS, initiating treatment in the moment of inclusion. Decision of treatment should be previous and independent of study participation.
- •Women in reproductive age must have a negative serum/urine pregnancy test at selection visit, and accept to take contraceptive measures from at least 14 days prior to the first dose of the drug and at least 3 months after the last dose.
- •Patients giving written informed consent.
- •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 29
- •F.1\.3 Elderly (\>\=65 years) no
Exclusion Criteria
- •Relapse 30 days prior to inclusion
- •Methylprednisolone administration (orally or intranvenous) 30 days prior to inclusion.
- •Botullinum toxin administration for spasticity in the 4 months prior to inclusion.
- •Contraindication for Sativex as to current indication uses.
- •Hypersensitivity to Cannabinoids or any excipient.
- •Personal history, known or suspected, or with familiar history of schizophrenia or other psycotic conditions, personal history of serious personality disorder or other important psychiatric conditions, apart from depression due to underlying disease.
- •Breastfeeding
Outcomes
Primary Outcomes
Not specified
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