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Perampanel for Sporadic Amyotrophic Lateral Sclerosis (ALS)

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ClinicalTrials.gov Identifier: NCT03019419
Recruitment Status : Recruiting
First Posted : January 12, 2017
Last Update Posted : May 1, 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)

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 2019
Estimated Study Completion Date : December 2019


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 ]


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Ages Eligible for Study:   40 Years to 78 Years   (Adult, Senior)
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


Contacts
Contact: Hitoshi Aizawa, MD,PhD +81-3-3342-6111 haizawa@tokyo-med.ac.jp
Contact: Tomohiro Haga +81-3-5800-9762 tomohirohaga-tky@umin.ac.jp

Locations
Japan
Kitasato University East Hospital Recruiting
Kanagawa, Japan
Contact: Makiko Nagai, MD,PhD         
Kumamoto Saishunso National Hospital Recruiting
Kumamoto, Japan
Contact: Hidetsugu Ueyama, MD,PhD         
Nagoya University Hospital Recruiting
Nagoya, Japan
Contact: Masahisa Katsuno, MD,PhD         
Okayama University Hospital Recruiting
Okayama, Japan
Contact: Koji Abe, MD,PhD         
Hokkaido University Hospital Recruiting
Sapporo, Japan
Contact: Ichiro Yabe, MD,PhD         
Tohoku University Hospital Recruiting
Sendai, Japan
Contact: Hitoshi Warita, MD,PhD         
Shiga University of Medical Science Hospital Recruiting
Shiga, Japan
Contact: Makoto Urushitani, MD,PhD         
Tokyo Medical University Recruiting
Tokyo, Japan, 160-0023
Contact: Haruhisa Kato, MD,PhD         
The University of Tokyo Hospital Recruiting
Tokyo, Japan
Contact: Hiroyuki Ishiura, MD,PhD         
Tokyo Metropolitan Neurological Hospital Recruiting
Tokyo, Japan
Contact: Akihiro Kawata, MD,PhD         
University of Tsukuba Hospital Recruiting
Tsukuba, Japan
Contact: Akira Tamaoka, MD,PhD         
Yamaguchi University Hospital Recruiting
Yamaguchi, Japan
Contact: Takashi Kanda, MD,PhD         
Sponsors and Collaborators
Tokyo Medical University
Investigators
Study Director: Tomohiro Haga The University of Tokyo Hospital

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: May 1, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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:
Sclerosis
Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases