Phase 3, 28-week, Randomized, Double-blind, Placebo-controlled Safety and Efficacy Study of Nabiximols as an add-on Therapy in Subjects With Spasticity Due to Multiple Sclerosis.

• Register: ClinicalTrials.gov
• Last refreshed on: 22 August 2016
• Main ID: NCT01868048
• Date of registration: 30/05/2013
• Prospective Registration: Yes
• Primary sponsor: GW Research Ltd
• Public title: Phase 3, 28-week, Randomized, Double-blind, Placebo-controlled Safety and Efficacy Study of Nabiximols as an add-on Therapy in Subjects With Spasticity Due to Multiple Sclerosis.
• Scientific title: 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.
• Date of first enrolment: October 2013
• Target sample size: 0
• Recruitment status: Withdrawn
• URL: https://clinicaltrials.gov/show/NCT01868048
• 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
• Phase: Phase 3

Key inclusion & exclusion criteria

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.

- Has significantly impaired renal function as evidenced by a creatinine clearance
lower than 50mL/min at Visit 1.

- Has significantly impaired hepatic function at Visit 1 (Alanine Aminotransferase >5
times upper limit of normal (ULN) or bilirubin (TBL) > 2 times ULN). If the Alanine
Aminotransferase or Aspartate Aminotransferase >3 times ULN and the TBL >2 times ULN
(or International Normalized Ratio >1.5), this subject should not enter the study.

- Female subject of child-bearing potential and male subject whose partner is of
child-bearing potential, unless willing to ensure that they or their partner use
effective contraception or complete abstinence, for example, oral contraception,
double barrier or intra-uterine device, during the study and for three months
thereafter (however, a male condom should not be used in conjunction with a female
condom as this may not prove effective).

- Female subject who is pregnant, lactating or planning pregnancy during the course of
the study and for three months thereafter.

- Subjects who have received a non-approved investigational medicinal product within 30
days of Visit 1.

- Any other significant disease or disorder which, in the opinion of the investigator
or sponsor, may either put the subject at risk because of participation in the study,
or may influence the result of the study, or the subject's ability to participate in
the study.

- Travel outside the country of residence planned during the study.

- Subjects previously enrolled into this study.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Multiple Sclerosis

Spasticity

Intervention(s)

Drug: Placebo

Drug: Sativex

Primary Outcome(s)

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]

Physician Global Impression of Change (PGIC) questionnaire [Time Frame: This is completed by the physician at each visit whilst using the study medication.]

Secondary Outcome(s)

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]

Carer Global Impression of Change Questionnaire [Time Frame: To be completed by the carer at every visit during the treatment period.]

Subject global impression of change (SGIC) questionnaire [Time Frame: To be completed by the patient at every visit during treatment]

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]

Secondary ID(s)

GWMS1315

Source(s) of Monetary Support

Please refer to primary and secondary sponsors