Clinical Trials Register

Summary
EudraCT Number:	2014-000995-24
Sponsor's Protocol Code Number:	GWEP1332
National Competent Authority:	Poland - Office for Medicinal Products
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2014-10-31
Trial results	View results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

Expand All Collapse All

A. Protocol Information

A.1

Member State Concerned

Poland - Office for Medicinal Products

A.2

EudraCT number

2014-000995-24

A.3

Full title of the trial

A double-blind, placebo-controlled two-part study to investigate the dose-ranging safety and pharmacokinetics, followed by the efficacy and safety of cannabidiol (GWP42003-P) in children and young adults with Dravet syndrome.

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

A study of the safety, pharmacokinetics and efficacy of cannabidiol (GWP42003-P) in children and young adults with Dravet syndrome

A.4.1

Sponsor's protocol code number

GWEP1332

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	GW Research Ltd
B.1.3.4	Country	United Kingdom
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	GW Research Ltd
B.4.2	Country	United Kingdom
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	GW Research Ltd
B.5.2	Functional name of contact point	GW Research Ltd Switchboard
B.5.3	Address:
B.5.3.1	Street Address	Sovereign House, Vision Park, Chivers Way
B.5.3.2	Town/ city	Histon, Cambridge
B.5.3.3	Post code	CB24 9BZ
B.5.3.4	Country	United Kingdom
B.5.4	Telephone number	+441223266800
B.5.5	Fax number	+441223235667
B.5.6	E-mail	info@gwpharm.com

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Cannabidiol (CBD)
D.3.2	Product code	GWP42003-P
D.3.4	Pharmaceutical form	Oral solution
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	N/A
D.3.9.1	CAS number	13956-29-1
D.3.9.2	Current sponsor code	GWP42003-P
D.3.9.3	Other descriptive name	CANNABIDIOL
D.3.9.4	EV Substance Code	SUB26600
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	100
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	Yes
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	Yes
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Cannabidiol (CBD)
D.3.2	Product code	GWP42003-P
D.3.4	Pharmaceutical form	Oral solution
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	N/A
D.3.9.1	CAS number	13956-29-1
D.3.9.2	Current sponsor code	GWP42003-P
D.3.9.3	Other descriptive name	CANNABIDIOL
D.3.9.4	EV Substance Code	SUB26600
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	25
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	Yes
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	Yes
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Oral solution
D.8.4	Route of administration of the placebo	Oral use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Dravet Syndrome

E.1.1.1

Medical condition in easily understood language

Epilepsy

E.1.1.2

Therapeutic area

Diseases [C] - Nervous System Diseases [C10]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	18.1
E.1.2	Level	PT
E.1.2	Classification code	10073677
E.1.2	Term	Severe myoclonic epilepsy of infancy
E.1.2	System Organ Class	10010331 - Congenital, familial and genetic disorders

E.1.3

Condition being studied is a rare disease

Yes

E.2 Objective of the trial

E.2.1

Main objective of the trial

Part A:
To evaluate the safety of multiple doses of GWP42003-P compared with placebo with respect to:
• Incidence, type and severity of adverse events (AEs).
• Effect on vital signs, physical examination parameters including weight.
• Effect on 12-lead electrocardiogram (ECG) findings.
• Effect on laboratory parameters.
• Changes in seizure frequency.
Part B:
• To assess the efficacy of GWP42003-P as an adjunctive antiepileptic treatment compared with placebo, with respect to the percentage change from baseline during the treatment period of the study in convulsive seizure frequency.

E.2.2

Secondary objectives of the trial

Part A:
• To determine the PKs of CBD and its major metabolites following single and multiple doses of GWP42003-P.
• To investigate the effect of GWP42003-P on the plasma concentration of clobazam and its primary metabolite, N- desmethylclobazam, if taken as a concomitant medication.
• Where possible, to investigate the effects of CBD on plasma concentrations of other concomitant antiepileptic drugs, if applicable.
Part B:
• To assess changes from baseline in non-convulsive seizure frequency, duration of seizures, usage of rescue medication, number of inpatient hospitalizations due to epilepsy, sleep disruption, daytime sleepiness, quality of life, growth and development, menstruation cycles and conduct behavioral assessments in patients taking GWP42003-P as an adjunctive treatment, when compared with placebo.
• To determine effects of GWP42003-P on plasma concentrations of concomitant AEDs, where available.
• To assess the safety of GWP42003-P when compared with placebo.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Inclusion Criteria: Part A
For inclusion in Part A of the study, patients must fulfil ALL of the following criteria:
• Patient and/or parent(s)/legal representative must be willing and able to give informed assent/ consent for participation in the study.
• Patient and their caregiver must be willing and able (in the investigator’s opinion) to comply with all study requirements.
• Patient must be male or female aged between 4 and 10 years (inclusive).
• Patient must have a documented history of DS which is not completely controlled by current AEDs.
• Patient must be experiencing fewer than four convulsive seizures (i.e., tonic-clonic, tonic, clonic, atonic seizures) during the 28-day baseline period.
• Patient must be taking one or more AEDs at a dose which has been stable for at least four weeks.
• All medications or interventions for epilepsy (including ketogenic diet and vagus nerve stimulation [VNS]) must have been stable for four weeks prior to screening and patient and caregiver are willing to maintain a stable regimen throughout the study. The ketogenic diet and VNS treatments are not counted as an AED.
• Patient and/or parent(s)/legal representative is willing to allow his or her primary care practitioner and consultant to be notified of participation in the study.
Inclusion Criteria: Part B
For inclusion in Part B of the study, patients must fulfil ALL of the following criteria:
• Patient and/or parent(s)/legal representative must be willing and able to give informed assent/consent for participation in the study.
• Patient and their caregiver must be willing and able (in the investigator’s opinion) to comply with all study requirements.
• Patient must be male or female aged between 2 and 18 years (inclusive).
• Patient must have a documented history of DS which is not completely controlled by current AEDs.
• Patient must be experiencing four or more convulsive seizures (i.e., tonic-clonic, tonic, clonic, atonic seizures) during the first 28-days of the baseline period.
• Patient must be taking one or more AEDs at a dose which has been stable for at least four weeks.
• All medications or interventions for epilepsy (including ketogenic diet and VNS) must have been stable for four weeks prior to screening and patient and caregiver are willing to maintain a stable regimen throughout the study. The ketogenic diet and VNS treatments are not counted as an AED.
• Patient and/or parent(s)/legal representative is willing to allow his or her primary care practitioner and consultant to be notified of participation in the study.
• Patient has completed their Interactive Voice Response System (IVRS) telephone diary on at least 25 days of the baseline period; patients who are non-compliant will be deemed ineligible to continue.

E.4

Principal exclusion criteria

Exclusion Criteria: Parts A and B
The patient may not enter the study (Part A or Part B) if ANY of the following apply:
• Patient has clinically significant unstable medical conditions other than epilepsy.
• Patient has had clinically relevant symptoms or a clinically significant illness in the four weeks prior to screening or randomization, other than epilepsy.
• Patient has clinically significantly abnormal, in the investigator’s opinion, laboratory values at screening or randomization.
• Patient has clinically relevant abnormalities in the 12-lead ECG measured at screening or randomization.
• Patient has any concurrent cardiovascular conditions, which will, in the investigator’s opinion, interfere with the ability to read their ECGs.
• Patient has a history or presence of alcohol or substance abuse within the last two years prior to the study or daily consumption of five or more alcohol-containing beverages.
• Patient is currently using or has in the past used recreational or medicinal cannabis, or synthetic cannabinoid based medications (including Sativex®) within the three months prior to study entry.
• Patient is unwilling to abstain from using recreational or medicinal cannabis, or synthetic cannabinoid based medications (including Sativex) during the study.
• Patient has a history of symptoms (e.g., dizziness, light-headedness, blurred vision, palpitations, weakness, syncope) related to a drop in blood pressure due to postural changes.
• Patient has ingested alcohol in the 24-hour period prior to the first study visit and/or is unwilling to abstain from drinking alcohol throughout the treatment period.
• Patient has consumed grapefruit or grapefruit juice three days prior to screening and/or is unwilling to abstain from consuming these during the study.
• Patient has any known or suspected hypersensitivity to cannabinoids or any of the excipients of the IMP(s), e.g., sesame oil.
• Female patient is of child bearing potential or male patient’s partner is of child bearing potential; unless willing to ensure that they or their partner use highly effective contraception for the duration of the study and for three months thereafter. Highly effective methods of contraception are defined as those, alone or in combination, that result in a low failure rate (i.e., less than 1% per year) when used consistently and correctly. Such methods include hormonal contraceptives, intrauterine devices/hormone-releasing systems, bilateral tubal occlusion, vasectomized partner or sexual abstinence.
• Female patient is pregnant (positive pregnancy test), lactating or planning pregnancy during the course of the study and for three months thereafter.
• Patient has been part of a clinical trial involving an investigational product in the previous six months.
• Patient is taking felbamate and they have been taking it for less than one year prior to screening.
• Any other significant disease or disorder which, in the opinion of the investigator, may either put the patient at risk because of participation in the study, may influence the result of the study, or affect the patient’s ability to participate in the study.
• Patient has significantly impaired hepatic function at screening (Visit A1 or B1) or randomization (Visit A2 or B2) (Alanine aminotransferase [ALT] >5 × upper limit of normal [ULN] and total bilirubin [TBL] >2 × ULN) OR the ALT or Aspartate aminotransferase (AST) >3 × ULN and (TBL >2 × ULN or international normalized ratio [INR] >1.5). This criterion can only be confirmed once the laboratory results are available; patients randomized into the study who are later found to meet this criterion must be withdrawn from the study.
• Following a physical examination, the patient has any abnormalities that, in the opinion of the investigator would prevent the patient from safe participation in the study.
• Patients unwilling to abstain from donation of blood during the study.
• There are plans for the patient to travel outside their country of residence during the study.
• Patient previously randomized into this study. In particular, patients randomized in Part A of the study cannot enter Part B.
• Any history of suicidal behavior or any suicidal ideation of type four or five on the C-SSRS at screening.

E.5 End points

E.5.1

Primary end point(s)

Part A: The primary endpoint is the safety profile of single and multiple doses of GWP42003-P compared with placebo.
The variables for analysis will be the difference in incidence, type and severity of AEs, vital signs, ECG, laboratory safety parameters, physical examination parameters and changes in seizure frequency in patients taking GWP42003-P compared with placebo.
Part B: The primary endpoint is the mean percentage change from baseline in total convulsive seizure frequency during the treatment period of the study (Day B1 to the end of the evaluable period) in patients taking GWP42003-P compared with placebo.

E.5.1.1

Timepoint(s) of evaluation of this end point

Part A
• Incidence, type and severity of adverse events (AEs) - From Visit A1 to Visit A5
• Vital signs, ECG, laboratory safety parameters and physical examination parameters - Visits 1, 2, 3 and 4
Part B
• Total Convulsive seizure frequency - From Visit B1 to Visit B8

E.5.2

Secondary end point(s)

Part A – PK:
• The plasma concentration/time curve of CBD and its major metabolites will be described following single and multiple
doses of GWP42003-P, with the aim being to define:
- Peak Plasma concentration (Cmax).
- Time to peak plasma concentration (tmax).
- Area under the plasma concentration-time curve from time zero to infinity (AUC0-∞) or to the last measurable concentration (AUC0-tz).
- Terminal half-life (t½).
• If taken as a concomitant medication, the plasma concentrations of clobazam and N-CLB will be described pre-treatment and then after 21 days of treatment with GWP42003-P. As far as possible, the plasma concentration/time relationship pre-treatment will be compared with the results following treatment with GWP42003-P. The same analysis will be carried out for other concomitant AEDs, if possible and applicable.
Part B – Efficacy and Safety:
The following will be analyzed:
• Number of patients experiencing a >25% worsening, −25 to +25% no change, 25–50% improvement, 50–75% improvement or >75% improvement in convulsive seizures from baseline.
• Number of patients considered treatment responders, defined as those with a ≥25%, ≥50% or ≥75% reduction in
convulsive seizures from baseline.
• Changes from baseline in number of episodes of status epilepticus.
• Number of patients who are convulsive seizure free.
• Percentage changes from baseline in total non-convulsive seizure frequency.
• Change in types of seizures.
• Changes from baseline in duration of seizure subtypes as assessed by the Caregiver Global Impression of Change in Seizure Duration (CGICSD).
• Changes from baseline in usage of rescue medication.
• Changes from baseline in number of inpatient hospitalizations due to epilepsy.
• Changes from baseline in Sleep Disruption 0-10 Numerical Rating Scale (0-10 NRS) score.
• Changes from baseline in Epworth Daytime Sleepiness Scale (EDSS) score.
• Changes from baseline in the Quality of Life in Childhood Epilepsy (QOLCE) score.
• Changes from baseline in the Vineland Adaptive Behavior Scales, Second Edition (Vineland-II) score.
• Changes from baseline in Caregiver Global Impression of Change (CGIC) score.
• Change from baseline in growth and development for patients less than 18 years of age by measurement of height,
weight, insulin-like growth factor-1 (IGF-1) levels and Tanner Staging (for patients aged 10-17 years [inclusive], or earlier if clinically indicated by onset of menarche or other signs of precocious puberty).
• Plasma concentrations of concomitant AEDs before and after treatment with GWP42003-P, where available.
• The safety profile of GWP42003-P will also be assessed by measuring the differences in incidence, type and severity of AEs, Columbia-Suicide Severity Rating Scale (C-SSRS), vital signs, ECG, laboratory safety parameters, physical examination parameters, and effects on menstruation cycles (in females) of patients taking GWP42003-P compared with placebo.

E.5.2.1

Timepoint(s) of evaluation of this end point

• PK of GWP42003-P and 7-OH-CBD - Visits A2 and A4: pre-dose, 2 to 3h post-dose, 4 to 6h post-dose
• PK of clobazam and N-CLB - A2, A4: 2h post clobazam dose Part B.
• Percentage change non-convulsive seizure freq : B1-B8
• Percentage change convulsive seizure freq: B1- B8
• Treatment responders, Number of status epilepticus episodes
• Sleep disruption, daytime sleepiness, adaptive behavior - B2 to B6, B8
• CGIC, CGICSD: B3, B4, B6, B8
• Change in C-SSRS:B1-B4, B6, B8, B9
• Effect on menstruation:B2, B8
• Developmental changes in patients < 18 yrs: Height, weight, IGF-1 and Tanner Staging (signs of puberty)
• Plasma concentrations of AEDs before/after treatment
• Incidence, type and severity of AEs: B1 to B9
• Vital signs, ECG, lab and physical exam parameters - B1to B4, B6, B8

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

Yes

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

Yes

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

Yes

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

France

Poland

United Kingdom

United States

E.8.7

Trial has a data monitoring committee

Yes

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

Last patient last visit or last contact, whichever occurs last.

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial months

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

Yes

F.1.1

Number of subjects for this age range:

120

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

Yes

F.1.1.5.1

Number of subjects for this age range:

F.1.1.6

Adolescents (12-17 years)

Yes

F.1.1.6.1

Number of subjects for this age range:

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

F.1.3

Elderly (>=65 years)

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

Yes

F.3.3.6.1

Details of subjects incapable of giving consent

Some patients entering this study will be unable to give consent personally due to Mental Disability or Cognitive Impairment.
In these cases consent/assent will be sought from patient and/or parent(s)/legal representative (See 9.1.1 of the Protocol)

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

F.4.2.2

In the whole clinical trial

125

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

None

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2015-03-09

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2014-10-21

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2015-11-26

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