Clinical trial NCT00445172: A Long-Term Study in Patients With Amyotrophic Lateral Sclerosis (ALS)
Official title: A Long-Term Study in Patients With Amyotrophic Lateral Sclerosis (ALS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Amyotrophic Lateral Sclerosis (ALS)
Keywords: Amyotrophic Lateral Sclerosis
Motor Neurons
Muscular Atrophy
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2007-03-08
Enrollment: 135
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the safety and efficacy of long-term E0302 administration in patients with Amyotrophic Lateral Sclerosis (ALS).


Eligibility criteria: Inclusion Criteria:

1. Patients who have completed Phase II/III study of E0302 (E0302-J081-761, hereafter referred to as Study 761) except for those patients who discontinued the treatment of Study 761. Completed patients are defined as those who completed the treatment period of Study 761, those on 24-hour use of non-invasive positive pressure ventilation (NIPPV), or those who eventually resulted in the use of NIPPV.
2. Patients who are able to submit written informed consent. If patients are duly capable of study consent but are unable to sign (or affix a seal) 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.

Exclusion Criteria:

1. Patients with cognitive impairment.
2. Pregnant women or women who may have a possibility of becoming pregnant.
3. Patients or their partners who are not willing to use reliable contraception.
4. Patients with severe disease in the renal, cardiovascular, hematological, or hepatic system (severe disease will be judged referring to "Ministry of Health, Labor and Welfare (MHLW) Drug Safety Dept. Notification No. 80, Drug Safety Classification Criteria for Severity of Adverse Drug Reaction by Medicinal Products, Grade 3." However, an event due to the primary disease will be precluded).
5. Patients with malignant tumor.
6. Patients who participated in another clinical study after the completion of Study 761.
7. Patients with present illness or history of drug allergy or severe allergic disease (anaphylactic shock).
8. Patients who are judged to be ineligible for study entry by the investigator or subinvestigator.

Primary outcomes:
measure: Number of participants with Adverse Events as a Measure of safety
timeFrame: Every 3 months
Secondary outcomes:
measure: Survival rate
timeFrame: Every 3 months
measure: Functional rating scale
timeFrame: Every 3 months
measure: Percent-predicted forced vital capacity (%FVC.)
timeFrame: Every 3 months
Other outcomes:
Locations:
city: Nagoya-shi
country: Japan
state: Aichi
city: Aomori-shi
country: Japan
state: Aomori
city: Chiba-shi
country: Japan
state: Chiba
city: Touon-shi
country: Japan
state: Ehime
city: Fukuoka-shi
country: Japan
state: Fukuoka
city: Kitakyushi-shi
country: Japan
state: Fukuoka
city: Fukushima-shi
country: Japan
state: Fukushima
city: Maebashi-shi
country: Japan
state: Gunma
city: Higashihiroshima-shi
country: Japan
state: Hiroshima
city: Miyoshi-shi
country: Japan
state: Hiroshima
city: Otake-shi
country: Japan
state: Hiroshima
city: Sapporo-shi
country: Japan
state: Hokkaido
city: Kanazawa-shi
country: Japan
state: Ishikawa
city: Ichinoseki-shi
country: Japan
state: Iwate
city: Sagamihara-shi
country: Japan
state: Kanagawa
city: Yokohama-shi
country: Japan
state: Kanagawa
city: Nangoku-shi
country: Japan
state: Kochi
city: Kyoto-shi
country: Japan
state: Kyoto
city: Tsu-shi
country: Japan
state: Mie
city: Sendai-shi
country: Japan
state: Miyagi
city: Watari-gun
country: Japan
state: Miyagi
city: Nagano-shi
country: Japan
state: Nagano
city: Higashisonogi-gun
country: Japan
state: Nagasaki
city: Kashiwazaki-shi
country: Japan
state: Niigata
city: Niigata-shi
country: Japan
state: Niigata
city: Tsukubo-gun
country: Japan
state: Okayama
city: Ginowan-shi
country: Japan
state: Okinawa
city: Toyonaka-shi
country: Japan
state: Osaka
city: Hasuda-shi
country: Japan
state: Saitama
city: Saitama-shi
country: Japan
state: Saitama
city: Hamamatsu-shi
country: Japan
state: Shizuoka
city: Shizuoka-shi
country: Japan
state: Shizuoka
city: Shimotsuke-shi
country: Japan
state: Tochigi
city: Tokushima-shi
country: Japan
state: Tokushima
city: Yoshinogawa-shi
country: Japan
state: Tokushima
city: Bunkyo-ku
country: Japan
state: Tokyo
city: Kodaira-shi
country: Japan
state: Tokyo
city: Ota-ku
country: Japan
state: Tokyo
city: Wakayama-shi
country: Japan
state: Wakayama
city: Yonezawa-shi
country: Japan
state: Yamagata
city: Shimonoseki-shi
country: Japan
state: Yamaguchi
city: Yanai-shi
country: Japan
state: Yamaguchi
Study officials:
affiliation: Neuroscience Clinical Development Section. JAC PCU. Eisai Co., Ltd.
name: Kazunori Saeki
role: STUDY_DIRECTOR
References: