Talampanel for Amyotrophic Lateral Sclerosis (ALS)

• Sponsor: Teva Branded Pharmaceutical Products R&D, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00696332
• Collaborator: (none)
• Enrollment: 559
• Locations: 24
• Arms: 3
• Duration (Months): 19.9
• Patients Per Site: 23.3
• Patients Per Site Per Month: 1.2

Study Details

Study Description

Brief Summary

The purpose of this study is to assess the efficacy, tolerability and safety of oral administration of talampanel compared to a placebo in subjects with ALS.

Condition or Disease	Intervention/Treatment	Phase
ALS	Drug: Talampanel; Drug: Talampanel; Other: placebo	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 559 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official 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)
• Study Start Date: Sep 1, 2008
• Actual Primary Completion Date: Apr 1, 2010
• Actual Study Completion Date: May 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Talampanel 50mg 50mg Talampanel 3 times per day	Drug: Talampanel; capsules Talampanel, 3 times per day, 52 weeks; Other Names: AMPA antagonist
Experimental: Talampanel 25mg 25mg Talampanel 3 times per day	Drug: Talampanel; capsules Talampanel, 3 times per day, 52 weeks; Other Names: AMPA antagonist
Placebo Comparator: Placebo placebo 3 times per day	Other: placebo; capsules, placebo, 3 times a day, for 52 weeks

Outcome Measures

Primary Outcome Measures

1. Change in ALS Functional Rating Score (ALSFRS-R slope) [52 weeks]

Secondary Outcome Measures

1. Time from baseline to the first occurrence of either death, tracheostomy or permanent assisted ventilation. [52 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Subjects with sporadic or familial ALS classified as definite, probable, or laboratory-supported probable ALS according to the revised El Escorial criteria.

Inclusion Criteria:

1. Diagnosis of definite or probable ALS in accordance with the El-Escorial criteria.

2. Subject has experienced his/her first ALS symptoms within 3 years prior to the screening visit.

3. Slow VC test equal to or greater than 70% of the predicted value.

4. The sum of the 3 respiratory items on the ALSFRS-R must total at least 10 points.

5. Subjects taking riluzole must be on a stable dose for at least 8 weeks prior to screening visit.

6. Ages 18-80 (inclusive)

Exclusion Criteria:

1. The use of invasive or non-invasive ventilation.

2. Subject having undergone gastrostomy.

3. Subject with any clinically significant or unstable medical condition.

4. Subject participating in any other investigational drug trial or using investigational drug (within 12 weeks prior to screening and thereafter).

5. Females who are pregnant or nursing.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CA Medical Center for Movement Disorders-Forbes Norris MDA/ALS Research Center	San Francisco	California	United States	94115
2	University of Kansas Medical Center - Dept of Neurology	Kansas City	Kansas	United States	66160
3	Johns Hopkins OPC - Meyer Bldg	Baltimore	Maryland	United States	21287
4	Massachusetts General Hospital-Neurology Clinical Trials Unit	Charlestown	Massachusetts	United States	02129
5	Mayo Clinic	Rochester	Minnesota	United States	55905
6	Columbia University - Neurology Institute	New York	New York	United States	10032
7	SUNY Upstate Medical University	Syracuse	New York	United States	13210
8	Academic Hospital University of Leuven - ALS dept	Leuven		Belgium	B-3000
9	ALS Centre	Vancouver	British Columbia	Canada	V5Z 2G9
10	London Health Sciences Centre Motor Neuro Diseases Clinic	London	Ontario	Canada	N6A 5A5
11	Montreal Neurological Institute	Montreal	Quebec	Canada	H3A 2B4
12	C.H.U. La Timone - Service de Neurologie	Marseille Cedex 5		France	13385
13	C.H.U. de Montpellier - Hopital Gui de Chauliac - Service des Explorations Neurologiques	Montpellier Cedex 5		France	34295
14	Hopital La Pitie Salpetriere - Federation de Neurologie	Paris		France	75013
15	Universitaetsklinik Berlin-Charite, Campus Virchow Klinikum, Neurologische Klinik	Berlin		Germany	13353
16	Berufsgenossenschaftliche Klinik Bergmannsheil, Neurologische Klinik	Bochum		Germany	44789
17	Universitaet Ulm	Ulm		Germany	89081
18	Semmelweis University, Department of Neurology	Budapest		Hungary	1083
19	Sourasky MC -EMG Unit	Tel Aviv		Israel	64239
20	Fondazione "S.Maugeri" Clinica della Riabilitazione IRCCS-Istituto Scientifico di Lissone	Lissone (MI)		Italy	20035
21	Centro Clinico NEMO	Milano		Italy	20162
22	Azienda Ospedaliero Universitaria San Giovanni Battista di Torino - Dipartimento di Neuroscienze	Torino		Italy	10126
23	Universitair Medisch Centrum Utrecht	Utrecht		Netherlands	3584 CX
24	Hospital Carlos III	Madrid		Spain	28029

Sponsors and Collaborators

• Teva Branded Pharmaceutical Products R&D, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Teva Branded Pharmaceutical Products R&D, Inc.
• ClinicalTrials.gov Identifier: NCT00696332
• Other Study ID Numbers: ALS-TAL-201 (ALSTAR); ALSTAR
• First Posted: Jun 12, 2008
• Last Update Posted: Oct 21, 2011
• Last Verified: Oct 1, 2011

• Keywords provided by Teva Branded Pharmaceutical Products R&D, Inc.: ALS
• Additional relevant MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis; alpha-Amino-3-hydroxy-5-methyl-4-isoxazolepropionic Acid

Study Results

No Results Posted as of Oct 21, 2011