A Parallel Group Study to Compare Sativex® With Placebo in the Treatment of Detrusor Overactivity in Patients With Multiple Sclerosis

NCT ID: NCT00678795

Last Updated: 2023-05-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 135 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-08-31
• Study Completion Date: 2005-10-31

Brief Summary

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

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.

Conditions

Detrusor Overactivity; Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

Sativex

Each 100 ul actuation contains 27 mg delta-9-tetrahydrocannabinol (THC) and 25 mg cannabidiol (CBD). A maximum of 48 actuations (130 mg of THC and 120 mg of CBD) was permitted in any 24 hour period.

Group Type: EXPERIMENTAL

Sativex®

Intervention Type: DRUG

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

Placebo

Each 100 ul actuation contains the colorants plus excipients. A maximum of 48 actuations was permitted in any 24 hour period.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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.

Interventions

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

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

GW-10000-02; GW-4001-01

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jazz Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cris Constantinescu, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Division of Clinical Neurology, Queen's Medical Centre

Locations

Division of Clinical Neurology, Queen's Medical Centre

Nottingham, Notts, United Kingdom

Countries

United Kingdom

References

Kavia RB, De Ridder D, Constantinescu CS, Stott CG, Fowler CJ. Randomized controlled trial of Sativex to treat detrusor overactivity in multiple sclerosis. Mult Scler. 2010 Nov;16(11):1349-59. doi: 10.1177/1352458510378020. Epub 2010 Sep 9.

Reference Type: RESULT

PMID: 20829244 (View on PubMed)

Other Identifiers

GWMS0208

Identifier Type: -

Identifier Source: org_study_id