Perampanel for Sporadic Amyotrophic Lateral Sclerosis (ALS)

NCT ID: NCT03019419

Last Updated: 2021-01-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-24
• Study Completion Date: 2020-12-23

Brief Summary

To investigate the safety and the efficacy of perampanel in patients with sporadic amyotrophic lateral sclerosis

Detailed Description

To evaluate the effect of peramanel for 48 weeks on progression of disease in subjects with ALS, as measured by ALS Functional Rating Scale-Revised (ALSFRS-R)

Conditions

ALS

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Perampanel 4mg

Once daily 4mg of perampanel with dose-escalation tolerable from 2mg to 4mg for 48 weeks

Group Type: EXPERIMENTAL

Perampanel

Intervention Type: DRUG

4mg/d or 8mg/d

Perampanel 8mg

Once daily 8mg of perampanel with dose-escalation tolerable from 2mg to 8mg for 48 weeks

Group Type: EXPERIMENTAL

Perampanel

Intervention Type: DRUG

4mg/d or 8mg/d

Placebo

Once daily placebo for control for 48 weeks

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

placebo

Interventions

Perampanel

4mg/d or 8mg/d

Intervention Type: DRUG

placebo

placebo

Intervention Type: DRUG

Other Intervention Names

non-competitive AMAP antagonist

Eligibility Criteria

Inclusion Criteria

• The progression on score of ALSFRS-R during 12 weeks of observation period must be between -2 and -5
• Patients who has not initiated newly introduced riluzole therapy after starting the observation period. Or those who has not received dose escalation or resumed administration of riluzole therapy after previous down titration or discontinuation
• Patients who has not initiated newly introduced edaravone therapy after starting the observation period
• Patients who are judged to be eligible for continuation of the study by the investigators

Exclusion Criteria

• Patients who underwent tracheostomy.
• Patients who experienced non-invasive positive pressure ventilation.
• Patients whose percent-predicted forced vital capacity (%FVC) is ≤80%.
• Patients with progressive bulbar palsy type.
• Patients with cognitive impairment, severe disease in the renal, cardiovascular, or hematological system.
• Patients with hepatic disease.
• Patients with malignant tumor.
• Pregnant women or women with a possibility of becoming pregnant.
• Patients who participated in another clinical study within 12 weeks before starting the observation period.
• Patients who has initiated perampanel therapy in the past or at present.
• Patients who are judged to be ineligible for study entry by the investigators.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 78 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tokyo Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tomohiro Haga

Role: STUDY_DIRECTOR

The University of Tokyo Hospital

Locations

Kitasato University East Hospital

Kanagawa, , Japan

Kumamoto Saishunso National Hospital

Kumamoto, , Japan

Nagoya University Hospital

Nagoya, , Japan

Okayama University Hospital

Okayama, , Japan

Hokkaido University Hospital

Sapporo, , Japan

Tohoku University Hospital

Sendai, , Japan

Shiga University of Medical Science Hospital

Shiga, , Japan

Tokyo Medical University

Tokyo, , Japan

The University of Tokyo Hospital

Tokyo, , Japan

Tokyo Metropolitan Neurological Hospital

Tokyo, , Japan

University of Tsukuba Hospital

Tsukuba, , Japan

Yamaguchi University Hospital

Yamaguchi, , Japan

Countries

Japan

Other Identifiers

A2016-J000-001

Identifier Type: -

Identifier Source: org_study_id