Study 4 of 108 for search of: Spasticity
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Evaluate the Maintenance of Effect After Long-Term Treatment With Sativex® in Subjects With Symptoms of Spasticity Due to Multiple Sclerosis
This study is ongoing, but not recruiting participants.
Sponsored by: GW Pharmaceuticals Ltd.
Information provided by: GW Pharmaceuticals Ltd.
ClinicalTrials.gov Identifier: NCT00702468
  Purpose

The purpose of this study is to evaluate the maintenance of effect after long-term treatment with Sativex® in subjects with symptoms of spasticity due to MS who have been receiving long-term benefit from treatment with Sativex®.


Condition Intervention Phase
Spasticity
Multiple Sclerosis
Drug: Sativex
Drug: Placebo
Phase III

MedlinePlus related topics: Multiple Sclerosis
Drug Information available for: Propylene glycol Cannabis GW-1000 Ethanol
U.S. FDA Resources
Study Type: Interventional
Study Design: Supportive Care, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title: A Placebo Controlled, Parallel Group, Randomised Withdrawal Study of Subjects With Symptoms of Spasticity Due to Multiple Sclerosis Who Are Receiving Long-Term GW-1000-02 (Sativex®).

Further study details as provided by GW Pharmaceuticals Ltd.:

Primary Outcome Measures:
  • The time to treatment failure in the randomised-withdrawal period. [ Time Frame: Week 1- Week 5 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Average daily spasticity severity as measured on a spasticity severity 0-10 Numerical rating scale (NRS). [ Time Frame: Week 1- Week 5 ] [ Designated as safety issue: No ]
  • Modified Ashworth Scale. [ Time Frame: Day 7 and Day 28 ] [ Designated as safety issue: No ]
  • Motricity Index [ Time Frame: Week 2 and Week 5 ] [ Designated as safety issue: No ]
  • Timed 10-metre walk. [ Time Frame: Week 2 and Week 5 ] [ Designated as safety issue: No ]
  • Daily sleep disruption NRS [ Time Frame: Week 1- Week 5 ] [ Designated as safety issue: No ]
  • Carer, Physician and Subject global impressions of change. [ Time Frame: Day 35 ] [ Designated as safety issue: No ]
  • Carer global impressions of change for ease of transfer. [ Time Frame: Day 35 ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: Day 1 - Day 35 ] [ Designated as safety issue: Yes ]
  • Clinical laboratory tests [ Time Frame: Day 1 - Day 35 ] [ Designated as safety issue: Yes ]
  • Vital signs [ Time Frame: Weeks 1,2 and 5 ] [ Designated as safety issue: Yes ]
  • Oral Examination [ Time Frame: Day 1 - Day 35 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: November 2007
Estimated Study Completion Date: February 2009
Estimated Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A: Experimental
Sativex
Drug: Sativex
containing THC (27 mg/ml):CBD (25 mg/ml), in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavouring. Dose: 100 µl oromucosal spray, as required for symptom relief
B: Placebo Comparator
Placebo
Drug: Placebo
containing ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavouring and colourings FD&C Yellow No.5 (E102 tartrazine) (0.0260%), FD&C Yellow No.6 (E110 sunset yellow) (0.0038%), FD&C Red No. 40 (E129 Allura red AC) (0.00330%) and FD&C Blue No.1 (E133 Brilliant blue FCF) (0.00058%)

Detailed Description:

This five week (one week baseline and four weeks randomised treatment period), multi-centre, placebo controlled, parallel group, randomized withdrawal study will evaluate the maintenance of effect after long-term treatment with Sativex® in subjects with symptoms of spasticity due to MS who have been receiving long-term benefit from treatment with Sativex®. Subjects will be selected from the Supply of Unlicensed Sativex® (SUS) or named patient supply programmes and must have been receiving Sativex® for at least 12 weeks prior to study entry. Following informed consent and screening, eligible subjects will enter the study (Visit 1, Day 1) and commence a seven day open label baseline period, before returning for a randomisation visit (Visit 2, Day 7), at which point they are randomised to receive either Sativex® or placebo (randomised withdrawal period). Subjects will return to the centre for an end of study visit at week five (Visit 3, Day 35) or earlier if they withdraw from treatment. Spasticity and sleep disruption review and dosing diaries will be completed each day from the start of the baseline period until completion or withdrawal.

  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 written informed consent for participation in the study.
  • Male or female, aged 18 years or above.
  • Subject is able (in the investigator's opinion) and willing to comply with all study requirements.
  • Diagnosed with MS.
  • Received Sativex for the relief of spasticity for at least 12 weeks prior to screening and willing to stop dosing with their own supply for the duration of the study.
  • Judged to have been receiving benefit from and shown tolerability to Sativex, in the investigators' and subjects' opinion.
  • Takes a minimum dose of Sativex of two sprays per day.
  • If receiving disease-modifying medications, these must have been at a stable dose for at least three months prior to screening, and willing to maintain this for the duration of the study.
  • Has had a stable regimen for at least 30 days prior to study entry, for all medications and non-pharmacological therapies that may have an affect on spasticity; and willing to maintain this for the duration of the study (N.B. This should be three months prior to study entry, in the case of Interferon therapy).
  • Willing to allow his or her general practitioner and consultant, if appropriate, to be notified of participation in the study.
  • Willing for his or her name to be notified to the responsible authorities for participation in this study

Exclusion Criteria:

  • Has any concomitant disease or disorder that has symptoms of spasticity or that may influence the subject's level of spasticity.
  • Unable to rate their level of spasticity or distinguish it from other MS symptoms.
  • Currently receiving a prohibited medication (Botulinum Toxin, or Acomplia (Rimonabant), and unwilling to stop or comply for the duration of the study or had received said medication/ therapy within three months prior to the screening visit.
  • Unwilling to stop their own Sativex treatment for the duration of the study.
  • Any known or suspected immediate family history of schizophrenia, other psychotic illness, severe personality disorder or other significant psychiatric disorder other than depression associated with their underlying condition.
  • Has evidence of cardiomyopathy.
  • Has experienced myocardial infarction or clinically relevant 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 relevant arrhythmia or myocardial infarction.
  • Has a QT interval of > 450 ms (males) or > 470 ms (females) at Visit 1.
  • Has a secondary or tertiary atrioventricular (AV) block or sinus bradycardia (HR <50bpm unless physiological) or sinus tachycardia (HR>110bpm) at Visit 1.
  • Has a diastolic blood pressure of <50 mmHg or >105 mmHg (when measured in a sitting position at rest for five minutes) prior to randomisation
  • Has impaired renal function e.g. creatinine clearance is lower than 50ml/min at Visit 1 and is indicative of renal impairment.
  • Has significantly impaired hepatic function, at Visit 1, in the investigator's opinion.
  • Female subjects of child bearing potential and male subjects whose partner is of child bearing potential, unless willing to ensure that they or their partner use effective contraception during the study and for three months thereafter.
  • Female subject who is pregnant, lactating or planning pregnancy during the course of the study and for three months thereafter.
  • Subjects who have received any IMP within the 12 weeks before Visit 1.
  • 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, may influence the result of the study, or the subject's ability to participate in the study.
  • Following a physical examination, the subject has any abnormalities that, in the opinion of the investigator, would prevent them from safely participating in the study.
  • Travel outside the UK planned during the study.
  • Unwilling to abstain from donation of blood during the study.
  • Subjects previously randomised into this study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00702468

Locations
United Kingdom, Norfolk
James Paget University Hospital NHS Foundation Trust
Gorleston on Sea, Norfolk, United Kingdom, NR31 6LA
Sponsors and Collaborators
GW Pharmaceuticals Ltd.
Investigators
Principal Investigator: William Notcutt, MB ChB, FRCA James Paget University Hospital NHS Foundation Trust
  More Information

Responsible Party: GW Pharmaceuticals Ltd. ( Sophie Axford / Senior Clinical Research Associate )
Study ID Numbers: GWSP0702
Study First Received: June 19, 2008
Last Updated: January 8, 2009
ClinicalTrials.gov Identifier: NCT00702468  
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by GW Pharmaceuticals Ltd.:
Spasticity
Multiple Sclerosis

Study placed in the following topic categories:
Autoimmune Diseases
Demyelinating Diseases
Sclerosis
Demyelinating diseases
Signs and Symptoms
Muscle Spasticity
Multiple Sclerosis
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Demyelinating Autoimmune Diseases, CNS
Neurologic Manifestations
Autoimmune Diseases of the Nervous System
Ethanol

Additional relevant MeSH terms:
Neuromuscular Manifestations
Pathologic Processes
Immune System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on January 30, 2009