A Parallel Group Study to Compare Sativex® With Placebo in the Treatment of Detrusor Overactivity in Patients With MS - Full Text View

Sponsor:	GW Pharmaceuticals Ltd.
Information provided by:	GW Pharmaceuticals Ltd.
ClinicalTrials.gov Identifier:	NCT00678795

Purpose

The purpose of this study is to evaluate the efficacy of Sativex® compared with placebo in reducing the daily number of episodes on incontinence.

Condition	Intervention	Phase
Detrusor Overactivity Multiple Sclerosis	Drug: Sativex® Drug: Placebo	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Supportive Care
Official Title:	A Double Blind, Randomised, Placebo Controlled, Parallel Group Study of Cannabis Based Medicine (CBM) Extract, in Patients Suffering Detrusor Overactivity Associated With Multiple Sclerosis.

Resource links provided by NLM:

MedlinePlus related topics: Multiple Sclerosis Urinary Incontinence

Drug Information available for: GW-1000 Cannabis

U.S. FDA Resources

Further study details as provided by GW Pharmaceuticals Ltd.:

Primary Outcome Measures:

Assessment of change from baseline in the mean number of incontinence episodes per day [ Time Frame: Daily diary entries throughout 10 week study period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Episodes of urgency recorded in daily diary [ Time Frame: Daily diary entries throughout 10 week study period ] [ Designated as safety issue: No ]
Instances of nocturia recorded in daily diary [ Time Frame: Daily diary entries throughout 10 week study period ] [ Designated as safety issue: No ]
Daily number of incontinence pads used recorded in daily diary [ Time Frame: Daily diary entries throughout 10 week study period ] [ Designated as safety issue: No ]
Incontinence quality of life (I-QOL) questionnaire [ Time Frame: Performed at baseline and end of study (Week 10) ] [ Designated as safety issue: No ]
Subjective symptom 0-10 NRS [ Time Frame: Performed at baseline and end of study (Week 10) ] [ Designated as safety issue: No ]
Patient's Global Impression of Change [ Time Frame: End of Study (Week 10) ] [ Designated as safety issue: No ]

Enrollment:	135
Study Start Date:	August 2002
Study Completion Date:	October 2005
Primary Completion Date:	October 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: A	Drug: Sativex® Containing ∆9 tetrahydrocannabinol (THC), 27 mg/ml and cannabidiol (CBD), 25 mg/ml as extract of Cannabis sativa L. Subjects received study medication delivered in 100 µl actuations by a pump action oromucosal spray. Maximum permitted dose was eight actuations in any three-hour period and 48 actuations (THC 130 mg:CBD 120 mg) in 24 hours Other Name: GW-10000-02
Placebo Comparator: B	Drug: Placebo containing excipients only. Subjects received study medication delivered in 100 µl actuations from a pump action oromucosal spray. Maximum permitted dose was eight actuations in any three-hour period and 48 actuations in 24 hours. Other Name: GW-4001-01

Detailed Description:

This is a ten week, multicentre, double blind, randomised, placebo controlled parallel group study to evaluate the efficacy of Sativex® on urge incontinence associated with neurogenic unstable bladder. Multiple sclerosis patients with incontinence symptoms are screened to determine eligibility and complete a two-week baseline period. They then return for a further eligibility check, randomisation and initial dosing. Subjects titrate and self-medicate with study medication between study visits at weeks two and five. They will also complete efficacy assessments in their diary-books and at visits.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Willing and able to give informed consent.
Male or female, aged 18 years or over.
Diagnosed with MS and with detrusor overactivity not wholly relieved by current therapy.
At least three incontinence episodes within five consecutive days during the baseline period
Stable dose of anticholinergic medication for at least 14 days leading to study entry.
Agreement, if female and of child bearing potential or if male with a partner of child bearing potential, to ensure that effective contraception is used during the study and for three months thereafter.
Has not used cannabinoids (including cannabis, Marinol® or nabilone) for at least seven days before Visit 1 and willing to abstain from any use of cannabinoids during the study.
Agreement for the UK Home Office, their general practitioner, and their consultant if appropriate, to be notified of their participation in the study.

Exclusion Criteria:

A symptomatic UTI or any cause of detrusor overactivity other than neurogenic causes due to MS.
Using ISC.
A history of schizophrenia, other psychotic illness, severe personality disorder or other significant psychiatric disorder other than depression associated with their underlying condition.
A history of alcohol or substance abuse.
A severe cardiovascular disorder, such as ischaemic heart disease, arrhythmias (other than well controlled atrial fibrillation), poorly controlled hypertension or severe heart failure.
A history of epilepsy.
If female, are pregnant of lactating, or are planning a pregnancy to occur during the course of the study.
Significant renal or hepatic impairment.
Elective surgery or other procedures requiring general anesthesia scheduled to occur during the study.
Terminal illness or any other significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study or influence the result of the study, or the subjects ability to participate in the study.
Regular levodopa (Sinement®, Sinement Plus®, Levodopa, L-dopa, Madopar®, Benserazide) within the seven days leading up to study entry.
Receiving and unwilling to stop fentanyl for the duration of the study.
Known or suspected hypersensitivity to cannabinoids or any of the excipients of the study medications.
Intention to travel internationally or to donate blood during the study.
Participation in another research study in the 12 weeks leading up to study entry.
Previous randomization in to this study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00678795

Locations

United Kingdom
Division of Clinical Neurology, Queen's Medical Centre
Nottingham, Notts, United Kingdom, NG7 2UH

Sponsors and Collaborators

GW Pharmaceuticals Ltd.

Investigators

Principal Investigator:

Cris Constantinescu, MD PhD

Division of Clinical Neurology, Queen's Medical Centre

More Information

No publications provided

Responsible Party:	Richard Potts Clinical Operation Director, GW Pharmaceuticals Ltd.
ClinicalTrials.gov Identifier:	NCT00678795 History of Changes
Other Study ID Numbers:	GWMS0208
Study First Received:	May 14, 2008
Last Updated:	July 10, 2008
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency; Romania: National Medicines Agency; Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment

Keywords provided by GW Pharmaceuticals Ltd.:

Detrusor overactivity
Multiple Sclerosis

Additional relevant MeSH terms:

Multiple Sclerosis
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases

Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on February 09, 2012