Talampanel for Amyotrophic Lateral Sclerosis (ALS)

Teva Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: ALS

Treatments: Other: placebo; Drug: Talampanel

Study type: Interventional

Funder types: Industry

Identifiers

NCT00696332

ALS-TAL-201 (ALSTAR)

ALSTAR

Details and patient eligibility

About

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.

Enrollment: 559 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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559 participants in 3 patient groups, including a placebo group

Talampanel 50mg

Experimental group

Description:

50mg Talampanel 3 times per day

Treatment:

Drug: Talampanel

Drug: Talampanel

Talampanel 25mg

Experimental group

Description:

25mg Talampanel 3 times per day

Treatment:

Drug: Talampanel

Drug: Talampanel

Placebo

Placebo Comparator group

Description:

placebo 3 times per day

Treatment:

Other: placebo