Trial · NCT01906658

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

NCT01906658, Phase 2, Completed, Mallinckrodt; results first posted 2017-01-06

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Study to Explore the Safety and Tolerability of Acthar in Patients With Amyotrophic Lateral Sclerosis. Trials, record NCT01906658. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01906658

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Study to Explore the Safety and Tolerability of Acthar in Patients With Amyotrophic Lateral Sclerosis
NCT number: NCT01906658
Status: Completed
Phases: Phase 2
Enrollment: 43 participants, actual
Lead sponsor: Mallinckrodt
Conditions: Amyotrophic Lateral Sclerosis
Interventions: Repository corticotropin injection
First posted: 2013-07-24
Last updated: 2017-01-06
Results first posted: 2017-01-06

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame
Primary	Proportion of Subjects With Adverse Events (AEs) That Required Study Drug Discontinuation or Could Not be Controlled With Concomitant Medication	Baseline to Week 8
Secondary	Proportion of Subjects With Adverse Events That Required Study Drug Discontinuation	Baseline to Week 8
Secondary	Proportion of Subjects With Adverse Events That Could Not be Controlled by Concomitant Medication	Baseline to Week 8
Secondary	Proportion of Subjects With Treatment Emergent Suicidality	Baseline to Week 36

Source ClinicalTrials.gov

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Proportion of Subjects With Adverse Events (AEs) That Required Study Drug Discontinuation or Could Not be Controlled With Concomitant Medication	Baseline to Week 8	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Proportion of Subjects With Adverse Events That Required Study Drug Discontinuation	Baseline to Week 8	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Proportion of Subjects With Adverse Events That Could Not be Controlled by Concomitant Medication	Baseline to Week 8	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Proportion of Subjects With Treatment Emergent Suicidality	Baseline to Week 36	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group16

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Units
Proportion of Subjects With Adverse Events (AEs) That Required Study Drug Discontinuation or Could Not be Controlled With Concomitant Medication	Acthar 80 U (1.0 mL) SC Twice Weekly	2	Participants
Proportion of Subjects With Adverse Events (AEs) That Required Study Drug Discontinuation or Could Not be Controlled With Concomitant Medication	Acthar 24 U (0.3 mL) SC Daily	0	Participants
Proportion of Subjects With Adverse Events (AEs) That Required Study Drug Discontinuation or Could Not be Controlled With Concomitant Medication	Acthar 56 U (0.7 mL) SC Twice Weekly	2	Participants
Proportion of Subjects With Adverse Events (AEs) That Required Study Drug Discontinuation or Could Not be Controlled With Concomitant Medication	Acthar 16 U (0.2 mL) SC Daily	0	Participants
Proportion of Subjects With Adverse Events That Required Study Drug Discontinuation	Acthar 80 U (1.0 mL) SC Twice Weekly	2	Participants
Proportion of Subjects With Adverse Events That Required Study Drug Discontinuation	Acthar 24 U (0.3 mL) SC Daily	0	Participants
Proportion of Subjects With Adverse Events That Required Study Drug Discontinuation	Acthar 56 U (0.7 mL) SC Twice Weekly	2	Participants
Proportion of Subjects With Adverse Events That Required Study Drug Discontinuation	Acthar 16 U (0.2 mL) SC Daily	0	Participants
Proportion of Subjects With Adverse Events That Could Not be Controlled by Concomitant Medication	Acthar 80 U (1.0 mL) SC Twice Weekly	0	Participants
Proportion of Subjects With Adverse Events That Could Not be Controlled by Concomitant Medication	Acthar 24 U (0.3 mL) SC Daily	0	Participants

1 to 10 of 16Source ClinicalTrials.gov

See all 16 results by group

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Acthar 80 U (1.0 mL) Subcutaneous (SC) Twice Weekly	11
Overall Study	STARTED	Acthar 24 U (0.3 mL) SC Daily	11
Overall Study	STARTED	Acthar 56 U (0.7 mL) SC Twice Weekly	10
Overall Study	STARTED	Acthar 16 U (0.2 mL) SC Daily	11
Overall Study	COMPLETED	Acthar 80 U (1.0 mL) Subcutaneous (SC) Twice Weekly	9
Overall Study	COMPLETED	Acthar 24 U (0.3 mL) SC Daily	10
Overall Study	COMPLETED	Acthar 56 U (0.7 mL) SC Twice Weekly	7
Overall Study	COMPLETED	Acthar 16 U (0.2 mL) SC Daily	11
Overall Study	NOT COMPLETED	Acthar 80 U (1.0 mL) Subcutaneous (SC) Twice Weekly	2
Overall Study	NOT COMPLETED	Acthar 24 U (0.3 mL) SC Daily	1

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events92

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Edema, peripheral	General disorders	Acthar 80 U (1.0 mL) SC Twice Weekly	4	11
other	Edema, peripheral	General disorders	Acthar 24 U (0.3 mL) SC Daily	2	11
other	Edema, peripheral	General disorders	Acthar 56 U (0.7 mL) SC Twice Weekly	2	10
other	Edema, peripheral	General disorders	Acthar 16 U (0.2 mL) SC Daily	6	11
other	Muscular weakness	Musculoskeletal and connective tissue disorders	Acthar 80 U (1.0 mL) SC Twice Weekly	4	11
other	Muscular weakness	Musculoskeletal and connective tissue disorders	Acthar 24 U (0.3 mL) SC Daily	3	11
other	Muscular weakness	Musculoskeletal and connective tissue disorders	Acthar 56 U (0.7 mL) SC Twice Weekly	5	10
other	Muscular weakness	Musculoskeletal and connective tissue disorders	Acthar 16 U (0.2 mL) SC Daily	4	11
other	Headache	Nervous system disorders	Acthar 80 U (1.0 mL) SC Twice Weekly	0	11
other	Headache	Nervous system disorders	Acthar 24 U (0.3 mL) SC Daily	3	11

1 to 10 of 92Source ClinicalTrials.gov

See all 92 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Acthar 80 U (1.0 mL) SC Twice Weekly
Total, all-cause mortality	Acthar 24 U (0.3 mL) SC Daily
Total, all-cause mortality	Acthar 56 U (0.7 mL) SC Twice Weekly
Total, all-cause mortality	Acthar 16 U (0.2 mL) SC Daily
Total, other adverse events	Acthar 80 U (1.0 mL) SC Twice Weekly	11	11
Total, other adverse events	Acthar 24 U (0.3 mL) SC Daily	11	11
Total, other adverse events	Acthar 56 U (0.7 mL) SC Twice Weekly	9	10
Total, other adverse events	Acthar 16 U (0.2 mL) SC Daily	11	11
Total, serious adverse events	Acthar 80 U (1.0 mL) SC Twice Weekly	2	11
Total, serious adverse events	Acthar 24 U (0.3 mL) SC Daily	3	11

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01906658

GET https://conductscience.org/api/trials/v1/NCT01906658/events?page=2

API reference For AI assistants