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Trial record 62 of 677 for:    amyotrophic lateral sclerosis

A Study to Explore the Safety and Tolerability of Acthar in Patients With Amyotrophic Lateral Sclerosis

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: NCT01906658
Recruitment Status : Completed
First Posted : July 24, 2013
Results First Posted : January 6, 2017
Last Update Posted : January 6, 2017
Sponsor:
Information provided by (Responsible Party):
Mallinckrodt

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Amyotrophic Lateral Sclerosis
Intervention Drug: Repository corticotropin injection
Enrollment 43
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Acthar 80 U (1.0 mL) Subcutaneous (SC) Twice Weekly Acthar 24 U (0.3 mL) SC Daily Acthar 56 U (0.7 mL) SC Twice Weekly Acthar 16 U (0.2 mL) SC Daily
Hide Arm/Group Description

Acthar (Repository Corticotropin Injection) 80 U (1.0 mL) SC twice weekly

Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks

Acthar (Repository Corticotropin Injection) 24 U (0.3 mL) SC daily

Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks

Acthar (Repository Corticotropin Injection) 56 U (0.7 mL) SC twice weekly

Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks

Acthar (Repository Corticotropin Injection) 16 U (0.2 mL) SC daily

Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks

Period Title: Overall Study
Started 11 11 10 11
Completed 9 10 7 11
Not Completed 2 1 3 0
Arm/Group Title Acthar 80 U (1.0 mL) SC Twice Weekly Acthar 24 U (0.3 mL) SC Daily Acthar 56 U (0.7 mL) SC Twice Weekly Acthar 16 U (0.2 mL) SC Daily Total
Hide Arm/Group Description

Acthar (Repository Corticotropin Injection) 80 U (1.0 mL) SC twice weekly

Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks

Acthar (Repository Corticotropin Injection) 24 U (0.3 mL) SC daily

Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks

Acthar (Repository Corticotropin Injection) 56 U (0.7 mL) SC twice weekly

Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks

Acthar (Repository Corticotropin Injection) 16 U (0.2 mL) SC daily

Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks

Total of all reporting groups
Overall Number of Baseline Participants 11 11 10 11 43
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 11 participants 10 participants 11 participants 43 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
4
  36.4%
7
  63.6%
6
  60.0%
9
  81.8%
26
  60.5%
>=65 years
7
  63.6%
4
  36.4%
4
  40.0%
2
  18.2%
17
  39.5%
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 11 participants 10 participants 11 participants 43 participants
Female
4
  36.4%
5
  45.5%
4
  40.0%
4
  36.4%
17
  39.5%
Male
7
  63.6%
6
  54.5%
6
  60.0%
7
  63.6%
26
  60.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 11 participants 11 participants 10 participants 11 participants 43 participants
11 11 10 11 43
1.Primary Outcome
Title Proportion of Subjects With Adverse Events (AEs) That Required Study Drug Discontinuation or Could Not be Controlled With Concomitant Medication
Hide Description [Not Specified]
Time Frame Baseline to Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Acthar 80 U (1.0 mL) SC Twice Weekly Acthar 24 U (0.3 mL) SC Daily Acthar 56 U (0.7 mL) SC Twice Weekly Acthar 16 U (0.2 mL) SC Daily
Hide Arm/Group Description:

Acthar (Repository Corticotropin Injection) 80 U (1.0 mL) SC twice weekly

Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks

Acthar (Repository Corticotropin Injection) 24 U (0.3 mL) SC daily

Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks

Acthar (Repository Corticotropin Injection) 56 U (0.7 mL) SC twice weekly

Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks

Acthar (Repository Corticotropin Injection) 16 U (0.2 mL) SC daily

Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks

Overall Number of Participants Analyzed 11 11 10 11
Measure Type: Count of Participants
Unit of Measure: Participants
2
  18.2%
0
   0.0%
2
  20.0%
0
   0.0%
2.Secondary Outcome
Title Proportion of Subjects With Adverse Events That Required Study Drug Discontinuation
Hide Description [Not Specified]
Time Frame Baseline to Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Acthar 80 U (1.0 mL) SC Twice Weekly Acthar 24 U (0.3 mL) SC Daily Acthar 56 U (0.7 mL) SC Twice Weekly Acthar 16 U (0.2 mL) SC Daily
Hide Arm/Group Description:

Acthar (Repository Corticotropin Injection) 80 U (1.0 mL) SC twice weekly

Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks

Acthar (Repository Corticotropin Injection) 24 U (0.3 mL) SC daily

Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks

Acthar (Repository Corticotropin Injection) 56 U (0.7 mL) SC twice weekly

Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks

Acthar (Repository Corticotropin Injection) 16 U (0.2 mL) SC daily

Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks

Overall Number of Participants Analyzed 11 11 10 11
Measure Type: Count of Participants
Unit of Measure: Participants
2
  18.2%
0
   0.0%
2
  20.0%
0
   0.0%
3.Secondary Outcome
Title Proportion of Subjects With Adverse Events That Could Not be Controlled by Concomitant Medication
Hide Description [Not Specified]
Time Frame Baseline to Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Acthar 80 U (1.0 mL) SC Twice Weekly Acthar 24 U (0.3 mL) SC Daily Acthar 56 U (0.7 mL) SC Twice Weekly Acthar 16 U (0.2 mL) SC Daily
Hide Arm/Group Description:

Acthar (Repository Corticotropin Injection) 80 U (1.0 mL) SC twice weekly

Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks

Acthar (Repository Corticotropin Injection) 24 U (0.3 mL) SC daily

Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks

Acthar (Repository Corticotropin Injection) 56 U (0.7 mL) SC twice weekly

Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks

Acthar (Repository Corticotropin Injection) 16 U (0.2 mL) SC daily

Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks

Overall Number of Participants Analyzed 11 11 10 11
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
4.Secondary Outcome
Title Proportion of Subjects With Treatment Emergent Suicidality
Hide Description [Not Specified]
Time Frame Baseline to Week 36
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Acthar 80 U (1.0 mL) SC Twice Weekly Acthar 24 U (0.3 mL) SC Daily Acthar 56 U (0.7 mL) SC Twice Weekly Acthar 16 U (0.2 mL) SC Daily
Hide Arm/Group Description:

Acthar (Repository Corticotropin Injection) 80 U (1.0 mL) SC twice weekly

Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks

Acthar (Repository Corticotropin Injection) 24 U (0.3 mL) SC daily

Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks

Acthar (Repository Corticotropin Injection) 56 U (0.7 mL) SC twice weekly

Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks

Acthar (Repository Corticotropin Injection) 16 U (0.2 mL) SC daily

Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks

Overall Number of Participants Analyzed 11 11 10 11
Measure Type: Count of Participants
Unit of Measure: Participants
1
   9.1%
3
  27.3%
0
   0.0%
0
   0.0%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Acthar 80 U (1.0 mL) SC Twice Weekly Acthar 24 U (0.3 mL) SC Daily Acthar 56 U (0.7 mL) SC Twice Weekly Acthar 16 U (0.2 mL) SC Daily
Hide Arm/Group Description

Acthar (Repository Corticotropin Injection) 80 U (1.0 mL) SC twice weekly

Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks

Acthar (Repository Corticotropin Injection) 24 U (0.3 mL) SC daily

Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks

Acthar (Repository Corticotropin Injection) 56 U (0.7 mL) SC twice weekly

Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks

Acthar (Repository Corticotropin Injection) 16 U (0.2 mL) SC daily

Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks

All-Cause Mortality
Acthar 80 U (1.0 mL) SC Twice Weekly Acthar 24 U (0.3 mL) SC Daily Acthar 56 U (0.7 mL) SC Twice Weekly Acthar 16 U (0.2 mL) SC Daily
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Acthar 80 U (1.0 mL) SC Twice Weekly Acthar 24 U (0.3 mL) SC Daily Acthar 56 U (0.7 mL) SC Twice Weekly Acthar 16 U (0.2 mL) SC Daily
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/11 (18.18%)      3/11 (27.27%)      1/10 (10.00%)      1/11 (9.09%)    
Cardiac disorders         
Supraventricular tachycardia  0/11 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0 1/11 (9.09%)  1
Gastrointestinal disorders         
Gastrointestinal haemorrhage  0/11 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0 1/11 (9.09%)  1
Infections and infestations         
Pneumonia  1/11 (9.09%)  1 0/11 (0.00%)  0 0/10 (0.00%)  0 0/11 (0.00%)  0
Injury, poisoning and procedural complications         
Feeding tube complication  0/11 (0.00%)  0 0/11 (0.00%)  0 1/10 (10.00%)  1 0/11 (0.00%)  0
Metabolism and nutrition disorders         
Hypokalaemia  0/11 (0.00%)  0 1/11 (9.09%)  1 0/10 (0.00%)  0 0/11 (0.00%)  0
Nervous system disorders         
Seizures  1/11 (9.09%)  1 0/11 (0.00%)  0 0/10 (0.00%)  0 0/11 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Respiratory arrest  1/11 (9.09%)  1 0/11 (0.00%)  0 0/10 (0.00%)  0 0/11 (0.00%)  0
Atelectasis  1/11 (9.09%)  1 0/11 (0.00%)  0 0/10 (0.00%)  0 0/11 (0.00%)  0
Respiratory failure  0/11 (0.00%)  0 2/11 (18.18%)  2 1/10 (10.00%)  1 0/11 (0.00%)  0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Acthar 80 U (1.0 mL) SC Twice Weekly Acthar 24 U (0.3 mL) SC Daily Acthar 56 U (0.7 mL) SC Twice Weekly Acthar 16 U (0.2 mL) SC Daily
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   11/11 (100.00%)      11/11 (100.00%)      9/10 (90.00%)      11/11 (100.00%)    
Eye disorders         
Vision blurred  1/11 (9.09%)  2/11 (18.18%)  0/10 (0.00%)  3/11 (27.27%) 
Gastrointestinal disorders         
Salivary hypersecretion  3/11 (27.27%)  1/11 (9.09%)  3/10 (30.00%)  2/11 (18.18%) 
Diarrhea  0/11 (0.00%)  0 1/11 (9.09%)  1 3/10 (30.00%)  3 1/11 (9.09%)  1
General disorders         
Edema, peripheral  4/11 (36.36%)  2/11 (18.18%)  2/10 (20.00%)  6/11 (54.55%) 
Asthenia  4/11 (36.36%)  1/11 (9.09%)  1/10 (10.00%)  2/11 (18.18%) 
Edema  2/11 (18.18%)  3/11 (27.27%)  1/10 (10.00%)  0/11 (0.00%) 
Injury, poisoning and procedural complications         
Fall  4/11 (36.36%)  1/11 (9.09%)  2/10 (20.00%)  2/11 (18.18%) 
Musculoskeletal and connective tissue disorders         
Muscular weakness  4/11 (36.36%)  3/11 (27.27%)  5/10 (50.00%)  4/11 (36.36%) 
Muscle spasms  2/11 (18.18%)  1/11 (9.09%)  2/10 (20.00%)  5/11 (45.45%) 
Back pain  1/11 (9.09%)  0/11 (0.00%)  4/10 (40.00%)  3/11 (27.27%) 
Muscle atrophy  0/11 (0.00%)  0/11 (0.00%)  3/10 (30.00%)  2/11 (18.18%) 
Nervous system disorders         
Headache  0/11 (0.00%)  3/11 (27.27%)  5/10 (50.00%)  4/11 (36.36%) 
Dizziness  0/11 (0.00%)  1/11 (9.09%)  2/10 (20.00%)  3/11 (27.27%) 
Psychiatric disorders         
Anxiety  3/11 (27.27%)  0/11 (0.00%)  2/10 (20.00%)  1/11 (9.09%) 
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.
Institution/Investigator shall not, without Sponsor’s prior written consent, independently publish or otherwise disclose any results of the study until a Multi-Center Publication is published. If a Multi-Center Publication is not submitted for publication within the specified timeframe, Institution and Principal Investigator shall have the right to publish and present the results of Institution’s and Principal Investigator’s activities solely in accordance with the Sponsor’s written provisions.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Lawrence Hill
Organization: Mallinckrodt Pharmaceuticals
Phone: 908-238-6370
EMail: lawrence.hill@mallinckrodt.com
Layout table for additonal information
Responsible Party: Mallinckrodt
ClinicalTrials.gov Identifier: NCT01906658     History of Changes
Other Study ID Numbers: QSC01-ALS-01
First Submitted: July 15, 2013
First Posted: July 24, 2013
Results First Submitted: November 8, 2016
Results First Posted: January 6, 2017
Last Update Posted: January 6, 2017