INTERVENTIONALWITHDRAWNNCT01868048

A Phase 3 Dose Response Study to Assess the Safety and Efficacy of Nabiximols Oromucosal Spray (Sativex) in the Symptomatic Relief of Spasticity in Subjects With Spasticity Due to Multiple Sclerosis.

The purpose of this study is to determine the effective dose range and to demonstrate a non-effective dose range of Sativex compared with placebo in relieving symptoms of spasticity due to multiple sclerosis.

Locally preserved from ClinicalTrials.govOpen ClinicalTrials.govlast source update 2016-08-11

What this record can show

Protocol only - no registry results posted

This locally preserved record separates the registered protocol from source-reported registry results. Neither is a treatment recommendation.

Registry facts

Study at a glance

Phase: PHASE3
Enrollment: 0 (ACTUAL)
Start date: Not reported
Sponsor: GW Research Ltd
Design: RANDOMIZED · PARALLEL · SUPPORTIVE CARE
Locations: 0
Results record: Not present in registry snapshot

Linked local records

Related local records

Local links use governed condition terms or exact source-reported intervention names. They are navigation candidates, not efficacy claims.

Interventions

What was registered

DRUG

Sativex

Contains delta -9 tetrahydrocannabinol (THC), 27 mg/mL:cannabidiol (CBD), 25 mg/mL, in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavoring. Subjects receive study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose is 10 actuations per day. Each actuation delivers THC 2.7 mg and CBD 2.5 mg.

GW-1000-02 · Nabiximols · THC/CBD spray

DRUG

Placebo

Oromucosal spray, containing no active drug but ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavoring and colorants. Maximum permitted dose is 10 actuations per day.

GA0034

Eligibility

Population and criteria

Sex: ALL
Minimum age: 18 Years
Maximum age: Not reported
Healthy volunteers: Not accepted

Inclusion criteria

Willing and able to give written informed consent.
The subject is at least 18 years of age or older.
Diagnosed with any disease sub-type of multiple sclerosis of at least six months duration.
Spasticity due to multiple sclerosis of at least six months duration, which is not wholly relieved with current anti-spasticity therapy, and which is expected to remain stable for the duration of the study.
Subject must be receiving at least one of the following anti-spasticity therapies to be eligible: Baclofen, Tizanidine, Clonazepam, Diazepam, Dantrolene.
Subject is willing to maintain anti-spasticity medication at a stable dose for the duration of the study and should be stable for 30 days prior to screening.
If the subject is currently taking disease-modifying medication, this must be at a stable dose for at least three months prior to the screening visit; the dose must also remain stable for the duration of the study.

Exclusion criteria

Has previously used Nabiximols or Sativex.
The subject is currently using or has used cannabis or cannabinoid based medications within 30 days of study entry and is unwilling to abstain for the duration of the study.
Any history or immediate family history of schizophrenia, other psychotic illness, severe personality disorder or other significant psychiatric disorder other than depression associated with their underlying condition.
In the opinion of the Investigator, any known or suspected history of a substance abuse disorder (including opiate abuse), current heavy alcohol consumption (more than 60g of pure alcohol per day for men, and more than 40g of pure alcohol per day for women), current use of an illicit drug or current non prescribed use of any prescription drug that should exclude the subject from participation.
Has poorly controlled epilepsy or recurrent seizures (i.e. one or more seizure during the last year).
Any known or suspected hypersensitivity to cannabinoids or any of the excipients of the study medication.
Has experienced myocardial infarction or clinically significant cardiac dysfunction within the last 12 months or has a cardiac disorder that, in the opinion of the investigator would put the subject at risk of a clinically significant arrhythmia or myocardial infarction.

primary outcomes

primary measures

Physician Global Impression of Change (PGIC) questionnaire

Time frame: This is completed by the physician at each visit whilst using the study medication.

Change in mean Modified Ashworth Scale score from baseline to the end of treatment period.

Time frame: The Modified Ashworth Scale will be performed at each visit of the study

All 20 muscle groups were assessed for spasticity (using a 0-4 scale): 0= no increase in muscle tone to 4=considerable increase in muscle tone, passive movement is difficult. The score for all 20 muscle groups were added to give a total score out of 80. A decrease in score indicates an improvement in condition.

secondary outcomes

secondary measures

Change in mean sleep disruption (0-10 NRS) score from baseline to the end of treatment (Part B)

Time frame: Recorded using IVRS daily diary every day

Change in mean spasm frequency (number of spasms per day) from baseline to the end of treatment (Part B).

Time frame: Recorded using the IVRS daily day every day

Subject global impression of change (SGIC) questionnaire

Time frame: To be completed by the patient at every visit during treatment

At Visit 2 (i.e. prior to commencing any treatment) subjects were asked to write a brief description of their spasticity caused by multiple sclerosis and how it affected them emotionally, physically and their ability to function with day to day activities. If subjects were unable to write due to disability then the investigator staff could assist as necessary. Prior to answering the Subject global impression of change, subjects were given the description of their spasticity to aid their memory regarding their symptoms at the start of the study. They were then be asked to complete the global impression of change by answering the following question to be rated on a seven-point scale, "Please assess the change in your spasticity due to multiple sclerosis since immediately before receiving the first course of study treatment (Visit 2) using the scale below" with this anchors: Very much worse, Much worse, Minimally worse, No change, Minimally better, Much better, Very much better.

Carer Global Impression of Change Questionnaire

Time frame: To be completed by the carer at every visit during the treatment period.

Publications

Locally readable linked articles

No exact PMID-linked public article is currently readable locally.

Snapshot provenance

Snapshot: e26c0bb4-ccf7-4bb3-a93d-db2bfa361ca0
Retrieved: 11/09/2026, 14:15:52
SHA-256: f681d5d2d75903f1b2359077230142a436dffa9ccc2a983f4313a710d9aa9fd8