Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Perampanel for Sporadic Amyotrophic Lateral Sclerosis (ALS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03019419
Recruitment Status : Active, not recruiting
First Posted : January 12, 2017
Last Update Posted : October 23, 2018
Sponsor:
Information provided by (Responsible Party):
Tokyo Medical University

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

Condition or disease Intervention/treatment Phase
ALS Drug: Perampanel Drug: placebo Phase 2

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)

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Perampanel for Sporadic Amyotrophic Lateral Sclerosis (ALS): A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Phase 2 Trials
Actual Study Start Date : April 24, 2017
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022


Arm Intervention/treatment
Experimental: Perampanel 4mg
Once daily 4mg of perampanel with dose-escalation tolerable from 2mg to 4mg for 48 weeks
Drug: Perampanel
4mg/d or 8mg/d
Other Name: non-competitive AMAP antagonist

Experimental: Perampanel 8mg
Once daily 8mg of perampanel with dose-escalation tolerable from 2mg to 8mg for 48 weeks
Drug: Perampanel
4mg/d or 8mg/d
Other Name: non-competitive AMAP antagonist

Placebo Comparator: Placebo
Once daily placebo for control for 48 weeks
Drug: placebo
placebo




Primary Outcome Measures :
  1. Change in ALS Functional rating scale [ Time Frame: 48 weeks ]

Secondary Outcome Measures :
  1. Change in ALS Functional rating scale [ Time Frame: 12, 24, 36, and 48 weeks ]
  2. Manual Muscle Test [ Time Frame: 12, 24, 36, and 48 weeks ]
  3. Percent-predicted forced vital capacity [ Time Frame: 12, 24, 36, and 48 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   40 Years to 78 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

[Eligibility Criteria for Interim Registration]

  • Patients who are able to submit written informed consent. If patients are duly capable of study consent but are unable to sign by themselves due to aggravation of disease condition, written informed consent can be obtained from a legally authorized representative who can sign on behalf of the patients after confirming the patients' agreement to study participation.
  • Patients who are male or female aged 40 years to 78 years at the time of obtaining informed consent
  • Patients who have clinically definite ALS, clinically probable ALS, or clinically probable-laboratory supported ALS as specified in the revised El Escorial Airlie House diagnostic criteria.
  • The sum of the 3 respiratory items of the ALSFRS-R must total 12 points or more
  • Patients within 2-year elapsed time period from disease onset at the time of obtaining informed consent
  • Patients who can visit study site for out-patient treatment

[Eligibility Criteria for Registration]

Subjects who meet the following criteria in addition to the inclusion criteria for the interim registration

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03019419


Locations
Layout table for location information
Japan
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, 160-0023
The University of Tokyo Hospital
Tokyo, Japan
Tokyo Metropolitan Neurological Hospital
Tokyo, Japan
University of Tsukuba Hospital
Tsukuba, Japan
Yamaguchi University Hospital
Yamaguchi, Japan
Sponsors and Collaborators
Tokyo Medical University
Investigators
Layout table for investigator information
Study Director: Tomohiro Haga The University of Tokyo Hospital

Layout table for additonal information
Responsible Party: Tokyo Medical University
ClinicalTrials.gov Identifier: NCT03019419     History of Changes
Other Study ID Numbers: A2016-J000-001
First Posted: January 12, 2017    Key Record Dates
Last Update Posted: October 23, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Tokyo Medical University:
sporadic ALS
perampanel

Additional relevant MeSH terms:
Layout table for MeSH terms
Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases