Clinical Trials Register

Summary
EudraCT Number:	2013-005319-28
Sponsor's Protocol Code Number:	CNWL/AL/BACL/01
National Competent Authority:	UK - MHRA
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
Date on which this record was first entered in the EudraCT database:	2015-07-15
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

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A. Protocol Information

A.1

Member State Concerned

UK - MHRA

A.2

EudraCT number

2013-005319-28

A.3

Full title of the trial

Improving GHB withdrawal with baclofen (The GHB Trial)

A.3.1

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

Improving GHB withdrawal with baclofen.

A.3.2

Name or abbreviated title of the trial where available

The GHB Trial

A.4.1

Sponsor's protocol code number

CNWL/AL/BACL/01

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	Central and North West London NHS Foundation Trust
B.1.3.4	Country	United Kingdom
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support
B.4.2	Country
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Central and North West London NHS Foundation Trust
B.5.2	Functional name of contact point	Angela Williams
B.5.3	Address:
B.5.3.1	Street Address	1st Floor, Bloomsbury Building, St Pancras Hospital, 4 St Pancras Way
B.5.3.2	Town/ city	London
B.5.3.3	Post code	NW1 0PE
B.5.3.4	Country	United Kingdom
B.5.4	Telephone number	020 3317 3765
B.5.5	Fax number	020 7685 5788
B.5.6	E-mail	baclofen.noclor@nhs.net

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	Yes
D.2.1.1.1	Trade name	Baclofen - generic product
D.2.1.1.2	Name of the Marketing Authorisation holder	Generics (UK) Limited T/A Mylan
D.2.1.2	Country which granted the Marketing Authorisation	United Kingdom
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	Baclofen
D.3.4	Pharmaceutical form	Tablet
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	Baclofen
D.3.9.1	CAS number	1134-47-0
D.3.9.3	Other descriptive name	(RS)-4-amino-3-(4-chlorophenyl)butanoic acid
D.3.9.4	EV Substance Code	AS1
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	10mg
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	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	No
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	No
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	Capsule
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

GHB/GBL Withdrawal Syndrome

E.1.1.1

Medical condition in easily understood language

Using GHB/GBL repeatedly can cause severe withdrawal symptoms, including insomnia, anxiety, tremors, and increased heart rate and blood pressure

E.1.1.2

Therapeutic area

Psychiatry and Psychology [F] - Mental Disorders [F03]

MedDRA Classification

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Feasibility of a full scale RCT

E.2.2

Secondary objectives of the trial

- Examine withdrawal symptoms and complications such as delirium and requirement for treatment escalation during detoxification in two populations: those presenting to a busy London emergency department requiring immediate acute withdrawal management (unplanned) and those presenting to a specialist outpatient ‘club drug’ clinic requiring planned GHB detoxification. Treatment escalation is defined as admission to ICU for those presenting to emergency department (unplanned) and admission to general hospital for those in club drug clinic (planned).

- Examine as part of a planned detoxification whether starting baclofen 2 days prior to stopping GHB/GBL (preloading) confers additional benefits in our proposed outcome measures.

- Monitor recruitment rate and manage any difficulties.

- Examine impact of GHB/GBL withdrawal on anxiety, depression, sleep, quality of life.

- Examine impact of study participation on GHB/GBL use up to 30 days post-randomisation.

- Explore research pa

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Anyone (>18 years old) who is:
• either in active withdrawal;
• has underlying GHB/GBL dependence and wishes to undergo GHB/GBL detoxification
• is thought to have underlying dependence and is at risk of acute withdrawal

E.4

Principal exclusion criteria

An individual will not be eligible for inclusion in this study if any of the following criteria are known to apply:
• Clinician does not deem that medication is required for management of GHB/GBL withdrawal.
• Lacks capacity to consent
• Unable to take oral medication
• Unable to take baclofen (according to SPC) due to
a. Known hypersensitivity to baclofen or any of the excipients
b. hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption
c. active peptic ulceration
d. porphyria.
• Unable to follow the study protocol due to serious mental health disorder e.g. enduring psychotic illness, suicidal intent
• Could be pregnant and refuses a pregnancy test.
• Taken any investigational drug within 30 days prior to drug administration
• Where there are “Special warnings and precautions for use” according to the SPC and where risk vs benefit ratio for prescribing is not in favour of prescribing baclofen
a. Has epilepsy not well controlled either with or without medication
b. End stage renal failure (CKD stage 5, GFR <15 mL/min)

E.5 End points

E.5.1

Primary end point(s)

The primary focus of this study is to assess the feasibility of undertaking a definitive trial. In particular we will characterize optimal recruitment rate and strategies and characteristics of the proposed primary outcome measure (symptom severity, complications, requirement for treatment escalation).

E.5.1.1

Timepoint(s) of evaluation of this end point

Assessments shall be carried out at:

- Baseline
- Daily from pre-load up to last day of detoxification, maximum 12 days
- Follow-up on Day 30

E.5.2

Secondary end point(s)

Not applicable for this feasibility study.

Data for our proposed secondary outcomes in the definitive trial will include change in anxiety, depression, sleep as well as relapse to GHB/GBL use or change in other illicit drug or alcohol use 30 days after randomisation. We will examine withdrawal symptoms and complications such as delirium and requirement for treatment escalation during detoxification in two populations: those presenting to an emergency department requiring immediate acute withdrawal management (unplanned) and those presenting to a specialist outpatient ‘club drug’ clinic requiring GHB/GBL detoxification (planned). We will also identify appropriate criteria e.g. benzodiazepine requirement or withdrawal score for minimisation or stratification in the full RCT.

E.5.2.1

Timepoint(s) of evaluation of this end point

n/a

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

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

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)

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

Yes

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

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

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

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

The end of the trial is defined as completion of follow-up of or 3 attempts to contact the last participant randomised to study medication. The trial may terminate before 100 participants have been recruited if we have obtained sufficient information about recruitment, engagement and measuring outcome measures.

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 years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1