Extension Study of Talampanel for Amyotrophic Lateral Sclerosis (ALS)

NCT00982150 | Terminated Phase 2 DMC

• 1 other identifier: ALS-TAL-201-OL
• Study Type: interventional
• Target: 446
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Amyotrophic Lateral Sclerosis

Keywords

Talampanel; Open-Label Study; Amyotrophic Lateral Sclerosis

Outcome Measures

Primary Outcomes (1)

• ALSFRS-R

  every 4 weeks

Secondary Outcomes (1)

• Vital Signs, ECG, Adverse Event Reports

  every 26 weeks

Study Arms (1)

Talampanel

EXPERIMENTAL

Talampanel 50mg tid

Drug: Talampanel

Interventions

Talampanel DRUG

50mg capsules tid

Talampanel

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Teva Branded Pharmaceutical Products R&D, Inc.: lead

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Interventions

talampanel

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2009
• First Posted: September 23, 2009
• Study Start: September 1, 2009
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: August 26, 2013

Record last verified: 2013-08