Clinical Trials Register

Summary
EudraCT Number:	2008-002062-62
Sponsor's Protocol Code Number:	ALS-TAL-201
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2008-06-27
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

Italy - Italian Medicines Agency

A.2

EudraCT number

2008-002062-62

A.3

Full title of the trial

A Multinational, Multicenter, Randomized, Double-Blind, Placebo- Controlled, Parallel-Group Study to Assess the Efficacy, Tolerability and Safety of talampanel in Subjects with Amyotrophic Lateral Sclerosis (ALS)

A.3.2

Name or abbreviated title of the trial where available

ALSTAR

A.4.1

Sponsor's protocol code number

ALS-TAL-201

A.5.1

ISRCTN (International Standard Randomised Controlled Trial) Number

A.7

Trial is part of a Paediatric Investigation Plan

Information not present in EudraCT

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Teva Pharmaceutical Industries,Ltd
B.1.3.4	Country	Israel
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
B.4.2	Country
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation
B.5.2	Functional name of contact point

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	tallampanel
D.3.2	Product code	TV-7110
D.3.4	Pharmaceutical form	Capsule, hard
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.1	CAS number	161832-65-1
D.3.9.2	Current sponsor code	TV-7110
D.3.10	Strength
D.3.10.1	Concentration unit	mg/g milligram(s)/gram
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	12.5
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)	Information not present in EudraCT
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	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Information not present in EudraCT
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	Information not present in EudraCT
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.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	talampanel
D.3.4	Pharmaceutical form	Capsule, hard
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.1	CAS number	161832-65-1
D.3.9.2	Current sponsor code	TV-7110
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	25
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)	Information not present in EudraCT
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	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Information not present in EudraCT
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	Information not present in EudraCT
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, hard
D.8.4	Route of administration of the placebo	Oral use
D.8 Placebo: 2
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Capsule, hard
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

Amyotrophic Lateral Sclerosis

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	9.1
E.1.2	Level	LLT
E.1.2	Classification code	10052653
E.1.2	Term	Amyotrophic lateral sclerosis gene carrier

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

To assess the efficacy, tolerability and safety of oral administration of talampanel compared to placebo in subjects with ALS.

E.2.2

Secondary objectives of the trial

Time from baseline to the first occurrence of either death, tracheostomy or permanent assisted ventilation; Additional Endpoints; Change from baseline to Last Observed Values (LOV) in ALSFRS-R; Time to death; Slope of the changes from baseline to each visit in pulmonary function as assessed by Slow VC; Change from baseline to LOV in Slow VC; Slope of the changes from baseline to each visit in Manual Muscle Testing (MMT); Change from baseline to LOV in MMT; Change from baseline to LOV in Quality of Life ALS-Specific Quality of life (ALSSQOL) scale to assess drug effect on health status. Change from baseline to LOV in Quality of Life EuroQol-5 Dimensions (EQ-5D) health outcomes scales to assess drug effect on health status. Change from baseline to LOV in Health Care Resource Utilization Questionnaire for ALS to assess drug effect on health care resource use. Change from baseline to LOV in Zarit Burden Interview (ZBI) to assess drug effect on Caregiver Burde

E.2.3

Trial contains a sub-study

Yes

E.2.3.1

Full title, date and version of each sub-study and their related objectives

FARMACOGENETICA: Versione:finale Data:2008/05/05 Titolo:Incluso nel protocollo principale Obiettivi:Relazione tra risposta del farmaco e polimorfismo del gene NAT2

FARMACOCINETICA/FARMACODINAMICA: Versione:finale Data:2008/05/05 Titolo:Incluso nel protocollo principale Obiettivi:Profilo cinetico in relazione a profilo di sicurezza e tollerabilita'

E.3

Principal inclusion criteria

1) Males and females with definite, probable or probable laboratory-supported ALS according to the World Federation of Neurology revised El Escorial criteria. ALS may be familial or sporadic (Appendix 1). 2) Subjects must be between 18 and 80 years of age (inclusive). 3) Subjects must have experienced their first ALS symptoms within 3 years inclusive prior to the screening visit. 4) Subjects must have a Slow VC score equal to or greater than 70% of the predicted value for gender, height and age at the screening and baseline visits. 5) The sum of the 3 respiratory items from the ALSFRS-R must total at least 10 points at the screening and baseline visits. 6) Subjects taking riluzole must be on a stable dose for at least 8 weeks prior to the screening visit. 7) Participants must be able to take oral medication at time of screening and baseline visits. 8) Subjects must be willing and able to give written informed consent prior to performing any study procedures. If the subject is unable to write, he/she may give oral consent or if not possible visual consent (such as head nodding) in the presence of at least one witness as provided in local country legislation.

E.4

Principal exclusion criteria

1) The use of mechanical ventilation (invasive or non-invasive, including Continuous Positive Airway Pressure (CPAP) for any part of the day or night or Bilevel Positive Airway Pressure (BiPap) for any part of the day prior to the screening visit or baseline. 2) Feeding tube present at time of screening or baseline. 3) Any clinically significant or unstable medical or surgical condition including cardiovascular, hepatic, pulmonary, renal, autoimmune, endocrine, metabolic, malignancy or psychiatric or any other condition that, in the investigator's opinion, places the subject at undue risk by participating in the study. 4) Patients whose mean QTc value calculated from 3 baseline measurements is above 450msec 5) Patients with clinical signs and symptoms of dementia 6) Known HIV positive. 7) History of known sensitivity or intolerability to benzodiazepines. 8) Subjects having used within the specified time prior to screening any of the following:  Talampanel (any previous use)  Mecasermin (rhIGF-1) (within 4 weeks prior to screening)  Chronic use of minocycline (14 consecutive days or more within 4 weeks prior to screening)  Chronic use of lithium carbonate use within 4 weeks prior to screening  Use of more than 600mg/day coenzyme Q10 (within 4 weeks prior to screening)  Any marketed drug, (within 12 weeks prior to screening) if its use was not clearly indicated for any underlying medical condition other than ALS (symptomatic drugs for ALS and supplements allowed)  Subjects participating in any other investigational drug trial and use of any other investigational drug within 12 weeks prior to screening  Taking any drugs which induce or inhibit talampanel metabolism within 2 weeks prior to screening (Appendix 2)  Taking substrates of CYP2C8 within 2 weeks prior to screening, with the exception of amiodarone and chloroquine that should not be taken within 4 months prior to screening (Appendix 2) 9) Females who are pregnant or nursing. 10) Females of child-bearing potential who do not practice medically acceptable methods of contraception [surgical sterilization, intrauterine device (IUD), hormonal preparations, or double barrier method (e.g. condom or diaphragm, and spermicide)]. 11) Addiction to a drug or substance within the past year prior to screening. 12) Any condition which the investigator feels may interfere with participation in the study. 13) Subjects unable at time of the screening and baseline visits to comply with the planned schedule of study visits and study procedures.

E.5 End points

E.5.1

Primary end point(s)

Safety and Tolerability Outcome Efficacy Endpoints:  Primary Endpoint  Slope of the changes from baseline to each visit in ALSFRS-R score

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

Yes

E.6.8

Bioequivalence

E.6.9

Dose response

Yes

E.6.10

Pharmacogenetic

Yes

E.6.11

Pharmacogenomic

Yes

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)

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

Yes

E.8.2.3.1

Comparator description

- same IMP used at different dosage

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

Information not present in EudraCT

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

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

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

F. Population of Trial Subjects
F.1 Age Range
F.1.1	Trial has subjects under 18	No
F.1.1.1	In Utero	No
F.1.1.2	Preterm newborn infants (up to gestational age < 37 weeks)	No
F.1.1.3	Newborns (0-27 days)	No
F.1.1.4	Infants and toddlers (28 days-23 months)	No
F.1.1.5	Children (2-11years)	No
F.1.1.6	Adolescents (12-17 years)	No
F.1.2	Adults (18-64 years)	Yes
F.1.3	Elderly (>=65 years)	Yes
F.2 Gender
F.2.1	Female	Yes
F.2.2	Male	Yes
F.3 Group of trial subjects
F.3.1	Healthy volunteers	No
F.3.2	Patients	Yes
F.3.3	Specific vulnerable populations	Yes
F.3.3.1	Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2008-06-27.	Yes
F.3.3.2	Women of child-bearing potential using contraception	Yes
F.3.3.3	Pregnant women	No
F.3.3.4	Nursing women	No
F.3.3.5	Emergency situation	No
F.3.3.6	Subjects incapable of giving consent personally	No
F.3.3.7	Others	No
F.4 Planned number of subjects to be included
F.4.1	In the member state	80
F.4.2	For a multinational trial
F.4.2.1	In the EEA	360
F.4.2.2	In the whole clinical trial	540

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

2008-06-16

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2008-06-16

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2010-07-19

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