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Trial record 20 of 487 for:    ALS (Amyotrophic Lateral Sclerosis)

Efficacy and Safety Study of MCI-186 for Treatment of Amyotrophic Lateral Sclerosis (ALS) Who Met Severity Classification III

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: NCT00415519
Recruitment Status : Completed
First Posted : December 25, 2006
Results First Posted : December 20, 2017
Last Update Posted : December 20, 2017
Sponsor:
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Corporation

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Amyotrophic Lateral Sclerosis (ALS)
Interventions Drug: MCI-186
Drug: Placebo of MCI-186
Enrollment 25
Recruitment Details  
Pre-assignment Details  
Arm/Group Title MCI-186 Placebo of MCI-186
Hide Arm/Group Description MCI-186 Injection 30 mg, 2 ampoules per treatment, once daily, intravenously infused over 60 min MCI-186 Injection Placebo, 2 ampoules per treatment, once daily, intravenously infused over 60 min
Period Title: Overall Study
Started 13 12
Completed 9 12
Not Completed 4 0
Reason Not Completed
Adverse Event             1             0
Withdrawal by Subject             2             0
Patient’s convenience             1             0
Arm/Group Title MCI-186 Placebo of MCI-186 Total
Hide Arm/Group Description MCI-186 Injection 30 mg, 2 ampoules per treatment, once daily, intravenously infused over 60 min MCI-186 Injection Placebo, 2 ampoules per treatment, once daily, intravenously infused over 60 min Total of all reporting groups
Overall Number of Baseline Participants 13 12 25
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 12 participants 25 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
11
  84.6%
10
  83.3%
21
  84.0%
>=65 years
2
  15.4%
2
  16.7%
4
  16.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 12 participants 25 participants
Female
6
  46.2%
6
  50.0%
12
  48.0%
Male
7
  53.8%
6
  50.0%
13
  52.0%
1.Primary Outcome
Title Change From Baseline in Revised ALS Functional Rating Scale (ALSFRS-R) Score in Full Analysis Set (FAS) Population at 24 Weeks
Hide Description

No primary endpoint was used, because various exploratory analyses were performed.

0=worst; 48=best

Time Frame baseline and 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MCI-186 Placebo of MCI-186
Hide Arm/Group Description:
MCI-186 Injection 30 mg, 2 ampoules per treatment, once daily, intravenously infused over 60 min
MCI-186 Injection Placebo, 2 ampoules per treatment, once daily, intravenously infused over 60 min
Overall Number of Participants Analyzed 13 12
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-6.52  (1.78) -6  (1.83)
2.Primary Outcome
Title Death or a Specified State of Disease Progression
Hide Description

No primary endpoint was used, because various exploratory analyses were performed.

Any of “death, disability of independent ambulation, loss of upper arm function, tracheotomy, use of respirator, and use of tube feeding” was defined as an event.

Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MCI-186 Placebo of MCI-186
Hide Arm/Group Description:
MCI-186 Injection 30 mg, 2 ampoules per treatment, once daily, intravenously infused over 60 min
MCI-186 Injection Placebo, 2 ampoules per treatment, once daily, intravenously infused over 60 min
Overall Number of Participants Analyzed 13 12
Measure Type: Number
Unit of Measure: events
death 1 0
disability of independent ambulation 4 2
loss of upper arm function 1 2
tracheotomy 0 0
use of respirator 0 0
use of tube feeding 1 0
3.Primary Outcome
Title Change From Baseline in % Forced Vital Capacity (%FVC) in Full Analysis Set (FAS) Population at 24 Weeks
Hide Description No primary endpoint was used, because various exploratory analyses were performed.
Time Frame baseline and 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
"1 patient with missing value at baseline" was excluded from the FAS in the MCI-186 group.
Arm/Group Title MCI-186 Placebo of MCI-186
Hide Arm/Group Description:
MCI-186 Injection 30 mg, 2 ampoules per treatment, once daily, intravenously infused over 60 min
MCI-186 Injection Placebo, 2 ampoules per treatment, once daily, intravenously infused over 60 min
Overall Number of Participants Analyzed 12 12
Least Squares Mean (Standard Error)
Unit of Measure: percentage of FVC
-18.75  (4.58) -15.69  (4.58)
4.Primary Outcome
Title Percentage of Participants With Adverse Events
Hide Description No primary endpoint was used, because various exploratory analyses were performed.
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MCI-186 Placebo of MCI-186
Hide Arm/Group Description:
MCI-186 Injection 30 mg, 2 ampoules per treatment, once daily, intravenously infused over 60 min
MCI-186 Injection Placebo, 2 ampoules per treatment, once daily, intravenously infused over 60 min
Overall Number of Participants Analyzed 13 12
Measure Type: Number
Unit of Measure: percentage of participants
92.3 100
5.Primary Outcome
Title Percentage of Participants With Adverse Drug Reactions
Hide Description No primary endpoint was used, because various exploratory analyses were performed.
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MCI-186 Placebo of MCI-186
Hide Arm/Group Description:
MCI-186 Injection 30 mg, 2 ampoules per treatment, once daily, intravenously infused over 60 min
MCI-186 Injection Placebo, 2 ampoules per treatment, once daily, intravenously infused over 60 min
Overall Number of Participants Analyzed 13 12
Measure Type: Number
Unit of Measure: percentage of participants
23.1 8.3
6.Primary Outcome
Title The Percentage of Participants With an Abnormal Change in Laboratory Tests That Occurred in More Than Two Patients
Hide Description No primary endpoint was used, because various exploratory analyses were performed.
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MCI-186 Placebo of MCI-186
Hide Arm/Group Description:
MCI-186 Injection 30 mg, 2 ampoules per treatment, once daily, intravenously infused over 60 min
MCI-186 Injection Placebo, 2 ampoules per treatment, once daily, intravenously infused over 60 min
Overall Number of Participants Analyzed 13 12
Measure Type: Number
Unit of Measure: percentage of participants
White blood cell count (WBC) 23.1 8.3
Other laboratory tests except for WBC 0 0
7.Primary Outcome
Title Percentage of Participants With Abnormal Changes in Sensory Examinations
Hide Description No primary endpoint was used, because various exploratory analyses were performed.
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description

A note:

Each three patients of both groups did not have data to Staggering due to data missing. Therefore, concerning staggering, the number of participants analysed are 10 in the MCI-186 group and 9 in the placebo of MCI-186 group.

Arm/Group Title MCI-186 Placebo of MCI-186
Hide Arm/Group Description:
MCI-186 Injection 30 mg, 2 ampoules per treatment, once daily, intravenously infused over 60 min
MCI-186 Injection Placebo, 2 ampoules per treatment, once daily, intravenously infused over 60 min
Overall Number of Participants Analyzed 13 12
Measure Type: Number
Unit of Measure: percentage of participants
Numbness Number Analyzed 13 participants 12 participants
0 0
Staggering Number Analyzed 10 participants 9 participants
10 0
Vibratory sensation Number Analyzed 13 participants 12 participants
0 0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title MCI-186 Placebo of MCI-186
Hide Arm/Group Description MCI-186 Injection 30 mg, 2 ampoules per treatment, once daily, intravenously infused over 60 min MCI-186 Injection Placebo, 2 ampoules per treatment, once daily, intravenously infused over 60 min
All-Cause Mortality
MCI-186 Placebo of MCI-186
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
MCI-186 Placebo of MCI-186
Affected / at Risk (%) Affected / at Risk (%)
Total   3/13 (23.08%)   2/12 (16.67%) 
Gastrointestinal disorders     
Dysphagia  2/13 (15.38%)  0/12 (0.00%) 
General disorders     
Gait disturbance  1/13 (7.69%)  0/12 (0.00%) 
Musculoskeletal and connective tissue disorders     
Musculoskeletal disorder  1/13 (7.69%)  1/12 (8.33%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnoea  1/13 (7.69%)  0/12 (0.00%) 
Respiratory failure  1/13 (7.69%)  0/12 (0.00%) 
Vascular disorders     
Pelvic venous thrombosis  0/13 (0.00%)  1/12 (8.33%) 
1
Term from vocabulary, MedDRA 11.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
MCI-186 Placebo of MCI-186
Affected / at Risk (%) Affected / at Risk (%)
Total   12/13 (92.31%)   12/12 (100.00%) 
Ear and labyrinth disorders     
Vertigo positional  1/13 (7.69%)  0/12 (0.00%) 
Eye disorders     
Abnormal sensation in eye  0/13 (0.00%)  1/12 (8.33%) 
Gastrointestinal disorders     
Constipation  2/13 (15.38%)  0/12 (0.00%) 
Diarrhoea  3/13 (23.08%)  1/12 (8.33%) 
Dyschezia  0/13 (0.00%)  3/12 (25.00%) 
Gingivitis  1/13 (7.69%)  0/12 (0.00%) 
Proctalgia  0/13 (0.00%)  1/12 (8.33%) 
Stomach discomfort  0/13 (0.00%)  1/12 (8.33%) 
Stomatitis  0/13 (0.00%)  3/12 (25.00%) 
Toothache  0/13 (0.00%)  1/12 (8.33%) 
Vomiting  0/13 (0.00%)  1/12 (8.33%) 
General disorders     
Abasia  0/13 (0.00%)  1/12 (8.33%) 
Feeling cold  1/13 (7.69%)  0/12 (0.00%) 
Gait disturbance  3/13 (23.08%)  1/12 (8.33%) 
Impaired healing  1/13 (7.69%)  0/12 (0.00%) 
Thirst  0/13 (0.00%)  1/12 (8.33%) 
Infections and infestations     
Acarodermatitis  1/13 (7.69%)  0/12 (0.00%) 
Cystitis  0/13 (0.00%)  1/12 (8.33%) 
Nasopharyngitis  2/13 (15.38%)  2/12 (16.67%) 
Oral herpes  1/13 (7.69%)  0/12 (0.00%) 
Pharyngitis  0/13 (0.00%)  1/12 (8.33%) 
Sinusitis  0/13 (0.00%)  1/12 (8.33%) 
Tinea pedis  1/13 (7.69%)  0/12 (0.00%) 
Injury, poisoning and procedural complications     
Ankle fracture  0/13 (0.00%)  1/12 (8.33%) 
Contusion  1/13 (7.69%)  1/12 (8.33%) 
Joint sprain  0/13 (0.00%)  2/12 (16.67%) 
Investigations     
Blood urine present  0/13 (0.00%)  1/12 (8.33%) 
Glucose urine present  1/13 (7.69%)  0/12 (0.00%) 
Musculoskeletal and connective tissue disorders     
Back pain  0/13 (0.00%)  1/12 (8.33%) 
Muscular weakness  1/13 (7.69%)  0/12 (0.00%) 
Musculoskeletal disorder  0/13 (0.00%)  1/12 (8.33%) 
Musculoskeletal pain  0/13 (0.00%)  1/12 (8.33%) 
Myalgia  0/13 (0.00%)  2/12 (16.67%) 
Pain in extremity  0/13 (0.00%)  1/12 (8.33%) 
Nervous system disorders     
Headache  3/13 (23.08%)  2/12 (16.67%) 
Post herpetic neuralgia  0/13 (0.00%)  1/12 (8.33%) 
Tension headache  0/13 (0.00%)  1/12 (8.33%) 
Psychiatric disorders     
Anxiety disorder  0/13 (0.00%)  1/12 (8.33%) 
Depression  1/13 (7.69%)  0/12 (0.00%) 
Insomnia  1/13 (7.69%)  1/12 (8.33%) 
Respiratory, thoracic and mediastinal disorders     
Aspiration  1/13 (7.69%)  0/12 (0.00%) 
Cough  0/13 (0.00%)  1/12 (8.33%) 
Oropharyngeal pain  0/13 (0.00%)  1/12 (8.33%) 
Productive cough  0/13 (0.00%)  1/12 (8.33%) 
Respiratory disorder  1/13 (7.69%)  0/12 (0.00%) 
Sputum retention  1/13 (7.69%)  0/12 (0.00%) 
Upper respiratory tract inflammation  3/13 (23.08%)  1/12 (8.33%) 
Skin and subcutaneous tissue disorders     
Dermatitis contact  0/13 (0.00%)  1/12 (8.33%) 
Erythema  1/13 (7.69%)  0/12 (0.00%) 
Haemorrhage subcutaneous  0/13 (0.00%)  1/12 (8.33%) 
Pruritus  2/13 (15.38%)  1/12 (8.33%) 
Rash  2/13 (15.38%)  0/12 (0.00%) 
Seborrhoeic dermatitis  0/13 (0.00%)  1/12 (8.33%) 
1
Term from vocabulary, MedDRA 11.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
 
Results Point of Contact
Name/Title: Clinical Trials, Information Desk
Organization: Mitsubishi Tanabe Pharma Corporation
Responsible Party: Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier: NCT00415519     History of Changes
Other Study ID Numbers: MCI186-18
First Submitted: December 22, 2006
First Posted: December 25, 2006
Results First Submitted: September 6, 2017
Results First Posted: December 20, 2017
Last Update Posted: December 20, 2017