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)

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2008-002062-62-NL
• Date of registration: 02/06/2008
• Prospective Registration: Yes
• Primary sponsor: Teva Pharmaceutical Industries, Ltd
• Public title: 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)
• Scientific title: 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)
• Date of first enrolment: 14/10/2008
• Target sample size: 540
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-002062-62
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no

Countries of recruitment

Belgium, France, Germany, Hungary, Italy, Netherlands, Spain

Key inclusion & exclusion criteria

Inclusion criteria:
Inclusion Criteria:
Subjects must meet all the inclusion criteria to be eligible:
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.

Are the trial subjects under 18? no
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) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
Exclusion Criteria:
Any of the following will exclude the subject from entering the study:
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 medicinal products (as specified in the protocol).
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.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Amyotrophic lateral sclerosis (ALS).
MedDRA version: 9.1 Level: PT Classification code 10052653 Term: Amyotrophic lateral sclerosis gene carrier

Intervention(s)

Product Name: talampanel
Product Code: TV-7110
Pharmaceutical Form: Capsule*
INN or Proposed INN: Not available yet
CAS Number: 161832-65-1
Current Sponsor code: TV-7110
Other descriptive name: talampanel
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 12.5 and 25-
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use

Product Name: talampanel
Product Code: TV-7110
Pharmaceutical Form: Capsule*
INN or Proposed INN: Not available yet
CAS Number: 161832-65-1
Current Sponsor code: TV-7110
Other descriptive name: talampanel
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 12.5 and 25-
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use

Primary Outcome(s)

Main Objective: Comparison of the primary endpoint between the 50 mg tid talampanel group and the placebo group.

Primary end point(s): Primary Endpoint:
Slope of the changes from baseline to each visit in ALSFRS-R score

Secondary Objective: Secondary study objectives are in line with the hierarchy principal according the following order:
1. Comparison of the secondary endpoint between the 50 mg tid talampanel group and the placebo group
2. Comparison of the primary endpoint between the 25 mg tid talampanel group and the placebo group
3. Comparison of the secondary endpoint between the 25 mg tid talampanel group and the placebo group

Secondary ID(s)

ALS-TAL-201