Extension Study of Talampanel for Amyotrophic Lateral Sclerosis (ALS)

Amyotrophic Lateral Sclerosis Clinical Trial

— ALSTAR OL  

Official title:

A Multinational, Multicenter, Open Label Phase to Assess Tolerability and Safety of Talampanel 50mg Tid in Subjects With Amyotrophic Lateral Sclerosis (ALS)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00982150
• Other study ID #: ALS-TAL-201-OL
• Status: Terminated
• Phase: Phase 2
• First received: September 22, 2009
• Last updated: August 16, 2013
• Start date: September 2009
• Est. completion date: June 2010

Study information

• Verified date: August 2013
• Source: Teva Pharmaceutical Industries
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationBelgium: Federal Agency for Medicinal Products and Health ProductsCanada: Health CanadaFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Federal Ministry of Food, Agriculture and Consumer ProtectionHungary: National Institute of PharmacyIsrael: Ministry of HealthItaly: National Monitoring Centre for Clinical Trials - Ministry of HealthNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)Spain: Agencia Española de Medicamentos y Productos Sanitarios
• Study type: Interventional

Clinical Trial Summary

This will be an open label treatment extension phase in patients with ALS who have previously participated in the double blind, placebo-controlled ALS-TAL-201 study. This study will make talampanel treatment available to all subjects who completed the double blind placebo-controlled phase of ALS-TAL-201 study and where the investigator and patient consider it to be in the patient's interest to receive talampanel 50mg three times daily (tid). It will also enable the exploration of long-term safety and tolerability of talampanel 50mg tid.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 446
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients must have completed 52 weeks of treatment of the double blind placebo-controlled phase of ALS-TAL-201.

• Women must be postmenopausal, surgically sterile, or using adequate birth control methods.

• Patients must be willing and able to give written informed consent prior to performing any open-label study procedures.

Exclusion Criteria:

• Patients with ECG signs of Brugada syndrome and/ or complete or incomplete Right Bundle Branch Block

• Patients using any of the following:

• Chronic use of lithium carbonate

• Chronic use of mecasermin (rhIGF-1)

• Chronic use of minocycline

• Chronic use of more than 600mg/day coenzyme Q10

• Chronic use of any marketed drug, if its use was not clearly indicated for any underlying medical condition other than ALS (symptomatic drugs for ALS and supplements allowed)

• Patients participating in any other investigational drug study and use of any other investigational drug

• Patients taking drugs that may interact with Talampanel

• Females who are pregnant or nursing.

• Females of child-bearing potential who do not practice medically acceptable methods of contraception.

• Any condition of the patient which the investigator feels may interfere with participation in the study.

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Motor Neuron Disease
• Sclerosis

Intervention

Drug:
• Talampanel
50mg capsules tid

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Teva Pharmaceutical Industries

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ALSFRS-R		every 4 weeks	No
Secondary	Vital Signs, ECG, Adverse Event Reports		every 26 weeks	Yes