Talampanel for Amyotrophic Lateral Sclerosis (ALS)

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)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00696332

Acronym

ALS

Enrollment

559

Registered

2008-06-12

Start date

2008-09-30

Completion date

2010-05-31

Last updated

2011-10-21

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

Conditions

ALS

Keywords

ALS

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.

Interventions

DRUGTalampanel

capsules Talampanel, 3 times per day, 52 weeks

OTHERplacebo

capsules, placebo, 3 times a day, for 52 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Change in ALS Functional Rating Score (ALSFRS-R slope)	52 weeks

Secondary

Measure	Time frame
Time from baseline to the first occurrence of either death, tracheostomy or permanent assisted ventilation.	52 weeks

Countries

Belgium, Canada, France, Germany, Hungary, Israel, Italy, Netherlands, Spain, United States

Outcome results

None listed

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