Perampanel for Sporadic Amyotrophic Lateral Sclerosis (ALS)

NCT03019419 | Completed Phase 2 DMC

• 1 other identifier: A2016-J000-001
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 12

Brief Summary

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

Conditions

ALS

Keywords

sporadic ALS; perampanel

Outcome Measures

Primary Outcomes (1)

• Change in ALS Functional rating scale

  48 weeks

Secondary Outcomes (3)

• Change in ALS Functional rating scale

  12, 24, 36, and 48 weeks

• Manual Muscle Test

  12, 24, 36, and 48 weeks

• Percent-predicted forced vital capacity

  12, 24, 36, and 48 weeks

Study Arms (3)

Perampanel 4mg

EXPERIMENTAL

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

Drug: Perampanel

Perampanel 8mg

EXPERIMENTAL

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

Drug: Perampanel

Placebo

PLACEBO COMPARATOR

Once daily placebo for control for 48 weeks

Drug: placebo

Interventions

Perampanel DRUG

4mg/d or 8mg/d

Also known as: non-competitive AMAP antagonist

Perampanel 4mg; Perampanel 8mg

placebo DRUG

placebo

Placebo

Eligibility Criteria

• Age: 40 Years - 78 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tokyo Medical University: lead

Study Sites (12)

Kitasato University East Hospital

Kanagawa, Japan

Location

Kumamoto Saishunso National Hospital

Kumamoto, Japan

Location

Nagoya University Hospital

Nagoya, Japan

Location

Okayama University Hospital

Okayama, Japan

Location

Hokkaido University Hospital

Sapporo, Japan

Location

Tohoku University Hospital

Sendai, Japan

Location

Shiga University of Medical Science Hospital

Shiga, Japan

Location

Tokyo Medical University

Tokyo, 160-0023, Japan

Location

The University of Tokyo Hospital

Tokyo, Japan

Location

Tokyo Metropolitan Neurological Hospital

Tokyo, Japan

Location

University of Tsukuba Hospital

Tsukuba, Japan

Location

Yamaguchi University Hospital

Yamaguchi, Japan

Location

MeSH Terms

Interventions

perampanel

Study Officials

• Tomohiro Haga

  The University of Tokyo Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2017
• First Posted: January 12, 2017
• Study Start: April 24, 2017
• Primary Completion: December 23, 2020
• Study Completion: December 23, 2020
• Last Updated: January 15, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

JP (12)