Extension Study of Talampanel for Amyotrophic Lateral Sclerosis (ALS)

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

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00982150

Acronym

ALSTAR OL

Enrollment

446

Registered

2009-09-23

Start date

2009-09-30

Completion date

2010-06-30

Last updated

2013-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amyotrophic Lateral Sclerosis

Keywords

Talampanel, Open-Label Study, Amyotrophic Lateral Sclerosis

Brief 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.

Interventions

DRUGTalampanel

50mg capsules tid

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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.

Design outcomes

Primary

Measure	Time frame
ALSFRS-R	every 4 weeks

Secondary

Measure	Time frame
Vital Signs, ECG, Adverse Event Reports	every 26 weeks

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026