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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
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

Collapse all Expand all

Trial information

Top of page

Sponsor protocol code

GWEP1330

ISRCTN number

-

US NCT number

-

WHO universal trial number (UTN)

-

Other trial identifiers

NCT Number (Part A): NCT02369471, NCT Number (Part B): NCT02365610

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

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

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

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

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

Top of page

Recruitment details

-

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 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.

Are arms mutually exclusive

Yes

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).

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).

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).

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
Consent withdrawn by subject	-	-	5	2
Adverse event, non-fatal	-	-	9	1
Protocol deviation	-	-	1	1
Met Withdrawal Criteria	-	-	1	-

Baseline characteristics

Top of page

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

Top of page

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

Top of page

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

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)

Top of page

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

Top of page

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

Top of page

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 name

MedDRA

Dictionary version

17.1

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
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
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

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
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
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
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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Were there any global substantial amendments to the protocol? Yes

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.

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

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