Extension Study of Talampanel for Amyotrophic Lateral Sclerosis (ALS) (ALSTAR OL)

Teva Pharmaceuticals

Status and phase: Terminated; Phase 2

Conditions: Amyotrophic Lateral Sclerosis

Treatments: Drug: Talampanel

Study type: Interventional

Funder types: Industry

Identifiers

NCT00982150

ALS-TAL-201-OL

Details and patient eligibility

About

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.

Enrollment: 446 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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446 participants in 1 patient group

Talampanel

Experimental group

Description:

Talampanel 50mg tid

Treatment:

Drug: Talampanel