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    Clinical Trial Results:
    A double blind, randomized, placebo-controlled, two-part study to investigate the pharmacokinetics, followed by efficacy and safety of GWP42006 as add-on therapy in patients with inadequately controlled focal seizures.

    Summary
    EudraCT number
    2014-002594-11
    Trial protocol
    GB   CZ   ES   HU  
    Global end of trial date
    01 Sep 2017

    Results information
    Results version number
    v1(current)
    This version publication date
    15 Feb 2019
    First version publication date
    15 Feb 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    GWEP1330
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Other trial identifiers
    NCT Number (Part A): NCT02369471, NCT Number (Part B): NCT02365610
    Sponsors
    Sponsor organisation name
    GW Research Ltd.
    Sponsor organisation address
    Sovereign House, Vision Park, Chivers Way, Histon, Cambridge, United Kingdom, CB24 9BZ
    Public contact
    GW Research Ltd. Switchboard, GW Research Ltd., +44 1223266800, info@gwpharm.com
    Scientific contact
    GW Research Ltd. Switchboard, GW Research Ltd., +44 1223266800, info@gwpharm.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    01 Sep 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 Sep 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Sep 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Part A: To determine the pharmacokinetics of GWP42006 and human metabolites, 7-hydroxy-cannabidivarin (7-OH-CBDV) and 6-hydroxy-cannabidivarin (6-OH-CBDV), in the presence of other antiepileptic drugs (AEDs). To evaluate the safety and tolerability of GWP42006 compared with placebo, in the presence of other AEDs. To evaluate the effects of GWP42006 on plasma concentrations of concomitant AEDs. Part B: To evaluate the efficacy of GWP42006, compared with placebo, as add-on therapy to treat inadequately controlled focal seizures.
    Protection of trial subjects
    This trial was conducted in accordance with International Council on Harmonisation (ICH) Good Clinical Practice, and the principles of the Declaration of Helsinki, in addition to following the laws and regulations of the country or countries in which a trial is conducted.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    28 Apr 2015
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Poland: 98
    Country: Number of subjects enrolled
    Spain: 19
    Country: Number of subjects enrolled
    United Kingdom: 21
    Country: Number of subjects enrolled
    Czech Republic: 32
    Country: Number of subjects enrolled
    Hungary: 24
    Worldwide total number of subjects
    194
    EEA total number of subjects
    194
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    194
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    This trial consisted of 2 parts. Part A included participants who had focal seizures despite prior treatment with at least 2 AEDs and who were currently taking 1 to 3 AEDs. Part B included participants who had well-documented histories of focal seizures despite prior treatment with at least 2 AEDs and who were currently taking 1 to 3 AEDs.

    Period 1
    Period 1 title
    Parts A and B Combined (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Monitor
    Blinding implementation details
    The study drug was provided in a packed and labelled state. Following randomization, participants were allocated a prepacked, numbered study drug. The identity of the study drug assigned to participants was held by an interactive voice response system.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Part A: GWP42006, 400 mg twice daily
    Arm description
    Part A consisted of a 2-week baseline period and a 2-week treatment period. Participants were required to attend 6 trial visits, with a follow-up call 4 weeks after the last dose of study drug. GWP42006 was taken orally, 400 milligrams (mg) twice daily for 2 weeks, by participants who were categorized into 1 of 3 groups according to their concomitant AED regimen at trial entry. Group 1 included participants who took inducer AEDs (carbamazepine, phenobarbital, primidone, or phenytoin), but did not take inhibitor AEDs (valproic acid). Group 2 included participants who took inhibitor AEDs (valproic acid), but who did not take inducer AEDs (carbamazepine, phenobarbital, primidone, or phenytoin). Group 3 included participants on AEDs that were neither inducers nor inhibitors.
    Arm type
    Experimental

    Investigational medicinal product name
    GWP42006
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    GWP42006 was taken orally as an oral solution containing 50 mg/milliliter (mL) CBDV dissolved in the excipients sesame oil and anhydrous ethanol (79 mg/mL) with added sweetener (sucralose 0.5 mg/mL) and strawberry flavoring (0.2 mg/mL).

    Arm title
    Part A: Placebo, 400 mg twice daily
    Arm description
    Part A consisted of a 2-week baseline period and a 2-week treatment period. Participants were required to attend 6 trial visits, with a follow-up call 4 weeks after the last dose of study drug. Placebo was taken orally, 400 mg twice daily for 2 weeks, by participants who were categorized into 1 of 3 groups according to their concomitant AED regimen at trial entry. Group 1 included participants who took inducer AEDs (carbamazepine, phenobarbital, primidone, or phenytoin), but did not take inhibitor AEDs (valproic acid). Group 2 included participants who took inhibitor AEDs (valproic acid), but who did not take inducer AEDs (carbamazepine, phenobarbital, primidone, or phenytoin). Group 3 included participants on AEDs that were neither inducers nor inhibitors.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo oral solution contained the excipients sesame oil (0 mg/mL CBDV) and anhydrous ethanol (79 mg/mL) with added sweetener (sucralose, 0.5 mg/mL) and strawberry flavoring (0.2 mg/mL).

    Arm title
    Part B: GWP42006, 800 mg twice daily
    Arm description
    Part B consisted of a 4-week baseline period, a 2-week dose-escalation period, a 6-week stable treatment period, and a 12-day taper period. GWP42006 was taken orally, 800 mg twice daily, for approximately 10 weeks. Participants were required to attend 8 trial visits, with a follow-up call 4 weeks after the last dose.
    Arm type
    Experimental

    Investigational medicinal product name
    GWP42006
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    GWP42006 was taken orally as an oral solution containing 50 mg/mL CBDV dissolved in the excipients sesame oil and anhydrous ethanol (79 mg/mL) with added sweetener (sucralose 0.5 mg/mL) and strawberry flavoring (0.2 mg/mL).

    Arm title
    Part B: Placebo, 800 mg twice daily
    Arm description
    Part B consisted of a 4-week baseline period, a 2-week dose-escalation period, a 6-week stable treatment period, and a 12-day taper period. Placebo was taken orally, 800 mg twice daily, for approximately 10 weeks. Participants were required to attend 8 trial visits, with a follow-up call 4 weeks after the last dose.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo oral solution contained the excipients sesame oil (0 mg/mL CBDV) and anhydrous ethanol (79 mg/mL) with added sweetener (sucralose, 0.5 mg/mL) and strawberry flavoring (0.2 mg/mL).

    Number of subjects in period 1
    Part A: GWP42006, 400 mg twice daily Part A: Placebo, 400 mg twice daily Part B: GWP42006, 800 mg twice daily Part B: Placebo, 800 mg twice daily
    Started
    26
    6
    81
    81
    Received At Least 1 Dose Of Study Drug
    26
    6
    81
    81
    Completed
    26
    6
    65
    77
    Not completed
    0
    0
    16
    4
         Protocol deviation
    -
    -
    1
    1
         Adverse event, non-fatal
    -
    -
    9
    1
         Met Withdrawal Criteria
    -
    -
    1
    -
         Consent withdrawn by subject
    -
    -
    5
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Part A: GWP42006, 400 mg twice daily
    Reporting group description
    Part A consisted of a 2-week baseline period and a 2-week treatment period. Participants were required to attend 6 trial visits, with a follow-up call 4 weeks after the last dose of study drug. GWP42006 was taken orally, 400 milligrams (mg) twice daily for 2 weeks, by participants who were categorized into 1 of 3 groups according to their concomitant AED regimen at trial entry. Group 1 included participants who took inducer AEDs (carbamazepine, phenobarbital, primidone, or phenytoin), but did not take inhibitor AEDs (valproic acid). Group 2 included participants who took inhibitor AEDs (valproic acid), but who did not take inducer AEDs (carbamazepine, phenobarbital, primidone, or phenytoin). Group 3 included participants on AEDs that were neither inducers nor inhibitors.

    Reporting group title
    Part A: Placebo, 400 mg twice daily
    Reporting group description
    Part A consisted of a 2-week baseline period and a 2-week treatment period. Participants were required to attend 6 trial visits, with a follow-up call 4 weeks after the last dose of study drug. Placebo was taken orally, 400 mg twice daily for 2 weeks, by participants who were categorized into 1 of 3 groups according to their concomitant AED regimen at trial entry. Group 1 included participants who took inducer AEDs (carbamazepine, phenobarbital, primidone, or phenytoin), but did not take inhibitor AEDs (valproic acid). Group 2 included participants who took inhibitor AEDs (valproic acid), but who did not take inducer AEDs (carbamazepine, phenobarbital, primidone, or phenytoin). Group 3 included participants on AEDs that were neither inducers nor inhibitors.

    Reporting group title
    Part B: GWP42006, 800 mg twice daily
    Reporting group description
    Part B consisted of a 4-week baseline period, a 2-week dose-escalation period, a 6-week stable treatment period, and a 12-day taper period. GWP42006 was taken orally, 800 mg twice daily, for approximately 10 weeks. Participants were required to attend 8 trial visits, with a follow-up call 4 weeks after the last dose.

    Reporting group title
    Part B: Placebo, 800 mg twice daily
    Reporting group description
    Part B consisted of a 4-week baseline period, a 2-week dose-escalation period, a 6-week stable treatment period, and a 12-day taper period. Placebo was taken orally, 800 mg twice daily, for approximately 10 weeks. Participants were required to attend 8 trial visits, with a follow-up call 4 weeks after the last dose.

    Reporting group values
    Part A: GWP42006, 400 mg twice daily Part A: Placebo, 400 mg twice daily Part B: GWP42006, 800 mg twice daily Part B: Placebo, 800 mg twice daily Total
    Number of subjects
    26 6 81 81 194
    Age categorical
    Units: Subjects
        In utero
    0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0 0 0 0
        Newborns (0-27 days)
    0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    0 0 0 0 0
        Children (2-11 years)
    0 0 0 0 0
        Adolescents (12-17 years)
    0 0 0 0 0
        Adults (18-64 years)
    26 6 81 81 194
        85 years and over
    0 0 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    45.1 ± 12.59 41.6 ± 13.84 36.0 ± 10.61 36.1 ± 12.84 -
    Gender categorical
    Units: Subjects
        Female
    16 4 47 43 110
        Male
    10 2 34 38 84

    End points

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    End points reporting groups
    Reporting group title
    Part A: GWP42006, 400 mg twice daily
    Reporting group description
    Part A consisted of a 2-week baseline period and a 2-week treatment period. Participants were required to attend 6 trial visits, with a follow-up call 4 weeks after the last dose of study drug. GWP42006 was taken orally, 400 milligrams (mg) twice daily for 2 weeks, by participants who were categorized into 1 of 3 groups according to their concomitant AED regimen at trial entry. Group 1 included participants who took inducer AEDs (carbamazepine, phenobarbital, primidone, or phenytoin), but did not take inhibitor AEDs (valproic acid). Group 2 included participants who took inhibitor AEDs (valproic acid), but who did not take inducer AEDs (carbamazepine, phenobarbital, primidone, or phenytoin). Group 3 included participants on AEDs that were neither inducers nor inhibitors.

    Reporting group title
    Part A: Placebo, 400 mg twice daily
    Reporting group description
    Part A consisted of a 2-week baseline period and a 2-week treatment period. Participants were required to attend 6 trial visits, with a follow-up call 4 weeks after the last dose of study drug. Placebo was taken orally, 400 mg twice daily for 2 weeks, by participants who were categorized into 1 of 3 groups according to their concomitant AED regimen at trial entry. Group 1 included participants who took inducer AEDs (carbamazepine, phenobarbital, primidone, or phenytoin), but did not take inhibitor AEDs (valproic acid). Group 2 included participants who took inhibitor AEDs (valproic acid), but who did not take inducer AEDs (carbamazepine, phenobarbital, primidone, or phenytoin). Group 3 included participants on AEDs that were neither inducers nor inhibitors.

    Reporting group title
    Part B: GWP42006, 800 mg twice daily
    Reporting group description
    Part B consisted of a 4-week baseline period, a 2-week dose-escalation period, a 6-week stable treatment period, and a 12-day taper period. GWP42006 was taken orally, 800 mg twice daily, for approximately 10 weeks. Participants were required to attend 8 trial visits, with a follow-up call 4 weeks after the last dose.

    Reporting group title
    Part B: Placebo, 800 mg twice daily
    Reporting group description
    Part B consisted of a 4-week baseline period, a 2-week dose-escalation period, a 6-week stable treatment period, and a 12-day taper period. Placebo was taken orally, 800 mg twice daily, for approximately 10 weeks. Participants were required to attend 8 trial visits, with a follow-up call 4 weeks after the last dose.

    Primary: Percent Reduction From Baseline In Focal Seizure Frequency In Participants Taking GWP42006 Compared With Placebo During The Treatment Period

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    End point title
    Percent Reduction From Baseline In Focal Seizure Frequency In Participants Taking GWP42006 Compared With Placebo During The Treatment Period [1]
    End point description
    This end point reports the evaluation of the efficacy of GWP42006, compared with placebo, as add-on therapy to treat inadequately controlled focal seizures (defined as: focal motor seizures without impairment of consciousness or awareness; focal seizures with impairment of consciousness or awareness, and focal seizures evolving to bilateral convulsive seizures). The reported outcome variable was the change from baseline in focal seizure frequency during the treatment period of the trial. Due to non-normality of the seizure data, negative binomial regression analyses were conducted on the sum of the seizure counts during the treatment period; treatment ratios <1 indicate a difference in favor of GWP42006. The intention-to-treat (ITT) analysis set, all participants who were randomized in Part B, was used in the analysis of this end point.
    End point type
    Primary
    End point timeframe
    Baseline, Day 57 (±3)
    Notes
    [1] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: End point not applicable to Part A as changes in focal seizure frequency were not reported for this part of the trial. This end point provides data for Part B of the trial only.
    End point values
    Part B: GWP42006, 800 mg twice daily Part B: Placebo, 800 mg twice daily
    Number of subjects analysed
    81 [2]
    81 [3]
    Units: Percent Reduction
        number (confidence interval 95%)
    40.5 (31.4 to 48.4)
    37.7 (28.2 to 45.9)
    Notes
    [2] - ITT
    [3] - ITT
    Statistical analysis title
    Percent Reduction (GWP42006 versus Placebo)
    Comparison groups
    Part B: GWP42006, 800 mg twice daily v Part B: Placebo, 800 mg twice daily
    Number of subjects included in analysis
    162
    Analysis specification
    Pre-specified
    Analysis type
    other [4]
    P-value
    = 0.648
    Method
    Negative Binomial Regression
    Parameter type
    Percent Reduction
    Point estimate
    4.6
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -16.7
         upper limit
    21.9
    Notes
    [4] - Treatment Difference

    Secondary: Participants Who Experienced Treatment-Related, Treatment-Emergent Adverse Events (TEAEs)

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    End point title
    Participants Who Experienced Treatment-Related, Treatment-Emergent Adverse Events (TEAEs)
    End point description
    For both Parts A and B, an AE was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which was present following baseline screening and the post-treatment, safety follow-up visit, which may or may not have been considered to be related to the study drug. Any event that was the result of a trial procedure was to be recorded as an AE. A TEAE was defined as an AE with a start date on or after the first dose of study drug. If an AE had a partial start date and it was unclear from the partial date (or the stop date) whether the AE started prior to or post first dose of the study drug, then the AE was considered treatment emergent. An AE was considered treatment-related if the plausibility relationship to the study drug was recorded on the case report form as ‘yes’. A summary of serious and other non-serious AEs, regardless of causality, is located in the Adverse Events module.
    End point type
    Secondary
    End point timeframe
    Baseline through Safety Follow-up Visit
    End point values
    Part A: GWP42006, 400 mg twice daily Part A: Placebo, 400 mg twice daily Part B: GWP42006, 800 mg twice daily Part B: Placebo, 800 mg twice daily
    Number of subjects analysed
    26 [5]
    6 [6]
    81 [7]
    81 [8]
    Units: Participants
    5
    2
    46
    28
    Notes
    [5] - Safety Set: All participants who received at least 1 dose of GWP42006.
    [6] - Safety Set: All participants who received at least 1 dose of placebo.
    [7] - Safety Set: All participants who received at least 1 dose of GWP42006.
    [8] - Safety Set: All participants who received at least 1 dose of placebo.
    No statistical analyses for this end point

    Secondary: Participants Considered Treatment Responders

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    End point title
    Participants Considered Treatment Responders [9]
    End point description
    The number of participants considered treatment responders in Part B is summarized and reported. Treatment responders were defined as those participants meeting the 4 following response thresholds for percent reduction (compared to baseline) in focal seizure frequency: ≥25%; ≥50%; ≥75%; 100%.
    End point type
    Secondary
    End point timeframe
    Baseline, Day 57 (±3)
    Notes
    [9] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: End point not applicable to Part A as treatment responders were not reported for this part of the trial. This end point provides data for Part B of the trial only.
    End point values
    Part B: GWP42006, 800 mg twice daily Part B: Placebo, 800 mg twice daily
    Number of subjects analysed
    81
    81
    Units: Participants
        ≥25%
    52
    53
        ≥50%
    29
    27
        ≥75%
    11
    10
        100%
    2
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Part A: Baseline (up to 2 weeks prior to administration of first dose) to the post-treatment, safety follow-up visit (Week 6). Part B: Baseline (up to 4 weeks prior to administration of first dose) to the post-treatment, safety follow-up visit (Week 14).
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    Part A: GWP42006, 400 mg twice daily
    Reporting group description
    Part A consisted of a 2-week baseline period and a 2-week treatment period. Participants were required to attend 6 trial visits, with a follow-up call 4 weeks after the last dose of study drug. GWP42006 was taken orally, 400 mg twice daily for 2 weeks, by participants who were categorized into 1 of 3 groups according to their concomitant AED regimen at trial entry. Group 1 included participants who took inducer AEDs (carbamazepine, phenobarbital, primidone, or phenytoin), but did not take inhibitor AEDs (valproic acid). Group 2 included participants who took inhibitor AEDs (valproic acid), but who did not take inducer AEDs (carbamazepine, phenobarbital, primidone, or phenytoin). Group 3 included participants on AEDs that were neither inducers nor inhibitors.

    Reporting group title
    Part A: Placebo, 400 mg twice daily
    Reporting group description
    Part A consisted of a 2-week baseline period and a 2-week treatment period. Participants were required to attend 6 trial visits, with a follow-up call 4 weeks after the last dose of study drug. Placebo was taken orally, 400 mg twice daily for 2 weeks, by participants who were categorized into 1 of 3 groups according to their concomitant AED regimen at trial entry. Group 1 included participants who took inducer AEDs (carbamazepine, phenobarbital, primidone, or phenytoin), but did not take inhibitor AEDs (valproic acid). Group 2 included participants who took inhibitor AEDs (valproic acid), but who did not take inducer AEDs (carbamazepine, phenobarbital, primidone, or phenytoin). Group 3 included participants on AEDs that were neither inducers nor inhibitors.

    Reporting group title
    Part B: GWP42006, 800 mg twice daily
    Reporting group description
    Part B consisted of a 4-week baseline period, a 2-week dose-escalation period, a 6-week stable treatment period, and a 12-day taper period. GWP42006 was taken orally, 800 mg twice daily, for approximately 10 weeks. Participants were required to attend 8 trial visits, with a follow-up call 4 weeks after the last dose.

    Reporting group title
    Part B: Placebo, 800 mg twice daily
    Reporting group description
    Part B consisted of a 4-week baseline period, a 2-week dose-escalation period, a 6-week stable treatment period, and a 12-day taper period. Placebo was taken orally, 800 mg twice daily, for approximately 10 weeks. Participants were required to attend 8 trial visits, with a follow-up call 4 weeks after the last dose.

    Serious adverse events
    Part A: GWP42006, 400 mg twice daily Part A: Placebo, 400 mg twice daily Part B: GWP42006, 800 mg twice daily Part B: Placebo, 800 mg twice daily
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 6 (0.00%)
    3 / 81 (3.70%)
    1 / 81 (1.23%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    Toxicity to various agents
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 6 (0.00%)
    1 / 81 (1.23%)
    0 / 81 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Status epilepticus
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 6 (0.00%)
    0 / 81 (0.00%)
    1 / 81 (1.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 6 (0.00%)
    1 / 81 (1.23%)
    0 / 81 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Azotaemia
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 6 (0.00%)
    1 / 81 (1.23%)
    0 / 81 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal failure acute
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 6 (0.00%)
    1 / 81 (1.23%)
    0 / 81 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholelithiasis
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 6 (0.00%)
    1 / 81 (1.23%)
    0 / 81 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Part A: GWP42006, 400 mg twice daily Part A: Placebo, 400 mg twice daily Part B: GWP42006, 800 mg twice daily Part B: Placebo, 800 mg twice daily
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 26 (11.54%)
    4 / 6 (66.67%)
    39 / 81 (48.15%)
    23 / 81 (28.40%)
    Nervous system disorders
    Balance disorder
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 6 (16.67%)
    2 / 81 (2.47%)
    0 / 81 (0.00%)
         occurrences all number
    0
    1
    2
    0
    Dizziness
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 6 (0.00%)
    5 / 81 (6.17%)
    3 / 81 (3.70%)
         occurrences all number
    1
    0
    5
    4
    Headache
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 6 (16.67%)
    7 / 81 (8.64%)
    6 / 81 (7.41%)
         occurrences all number
    0
    1
    9
    25
    Memory impairment
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 6 (16.67%)
    0 / 81 (0.00%)
    0 / 81 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Neuralgia
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 6 (16.67%)
    0 / 81 (0.00%)
    0 / 81 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Somnolence
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 6 (0.00%)
    12 / 81 (14.81%)
    2 / 81 (2.47%)
         occurrences all number
    0
    0
    14
    2
    Tremor
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 6 (16.67%)
    0 / 81 (0.00%)
    1 / 81 (1.23%)
         occurrences all number
    0
    1
    0
    1
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 6 (16.67%)
    2 / 81 (2.47%)
    1 / 81 (1.23%)
         occurrences all number
    0
    1
    2
    1
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 6 (16.67%)
    1 / 81 (1.23%)
    3 / 81 (3.70%)
         occurrences all number
    0
    1
    1
    3
    Affect lability
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 6 (16.67%)
    0 / 81 (0.00%)
    0 / 81 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Mood altered
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 6 (16.67%)
    0 / 81 (0.00%)
    0 / 81 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 6 (0.00%)
    5 / 81 (6.17%)
    1 / 81 (1.23%)
         occurrences all number
    0
    0
    5
    2
    Diarrhoea
         subjects affected / exposed
    2 / 26 (7.69%)
    0 / 6 (0.00%)
    20 / 81 (24.69%)
    6 / 81 (7.41%)
         occurrences all number
    2
    0
    23
    7
    Nausea
         subjects affected / exposed
    1 / 26 (3.85%)
    1 / 6 (16.67%)
    8 / 81 (9.88%)
    8 / 81 (9.88%)
         occurrences all number
    2
    1
    8
    9
    Musculoskeletal and connective tissue disorders
    Muscle contracture
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 6 (16.67%)
    0 / 81 (0.00%)
    0 / 81 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 6 (0.00%)
    2 / 81 (2.47%)
    6 / 81 (7.41%)
         occurrences all number
    0
    0
    2
    6

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    04 May 2016
    Amendment 13: Additional pharmacokinetics sample and metabolite analysis.
    11 May 2016
    Amendment 14 and Amendment 15: Additional pharmacokinetics sample and metabolite analysis.
    25 Oct 2016
    Amendment 16, Amendment 17, and Amendment 18: Increase power to 90% and Part B sample size to 140.

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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