Trial · NCT00769860

Arimoclomol in Sporadic Inclusion Body Myositis

NCT00769860, Phase 2, Phase 3, Completed, Richard Barohn, MD; results first posted 2017-01-19

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Arimoclomol in Sporadic Inclusion Body Myositis. Trials, record NCT00769860. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00769860

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Trial

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

Title: Arimoclomol in Sporadic Inclusion Body Myositis
NCT number: NCT00769860
Status: Completed
Phases: Phase 2, Phase 3
Enrollment: 24 participants, actual
Lead sponsor: Richard Barohn, MD
Conditions: Inclusion Body Myositis
Interventions: Arimoclomol, Placebo
First posted: 2008-10-09
Last updated: 2017-01-19
Results first posted: 2017-01-19

Source ClinicalTrials.gov

Registered outcomes11

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

List	Outcome	Time frame	Description
Primary	Count of Adverse Events Reported	Month 12	Measure reflects the total number of adverse events reported during course of the study.
Secondary	Heat Shock Protein 70 (HSP70) Levels in the Tissue	Change from Baseline to Month 4	Biopsy taken from participants at baseline and month 4 visits. Measured change in HSP70 levels in the tissue.
Secondary	Muscle Strength Testing	Change from Baseline to Month 4	Change in MMT score for the period. The MMT score range is 0-5. A score of 0 is the lowest and represents no visible or palpable contraction. A score of 5 is the highest and represents full range of motion against gravity, maximal resistance.
Secondary	Muscle Strength Testing	Change from Baseline to Month 8	Change in MMT score for the period. The MMT score range is 0-5. A score of 0 is the lowest and represents no visible or palpable contraction. A score of 5 is the highest and represents full range of motion against gravity, maximal resistance.
Secondary	Muscle Strength Testing	Change from Baseline to Month 12	Change in MMT score for the period. The MMT score range is 0-5. A score of 0 is the lowest and represents no visible or palpable contraction. A score of 5 is the highest and represents full range of motion against gravity, maximal resistance.
Secondary	Inclusion Body Myositis-Functional Rating Scale (IBMFRS) Score	Change from Baseline to Month 4	Measured change for the period. The questionnaire has 10 questions. The maximum score is 40. The higher the score the better the functional status of the patient.
Secondary	Inclusion Body Myositis-Functional Rating Scale (IBMFRS) Score	Change from Baseline to Month 8	Measured change for the period. The questionnaire has 10 questions. The maximum score is 40. The higher the score the better the functional status of the patient.
Secondary	Inclusion Body Myositis-Functional Rating Scale (IBMFRS) Score	Change from Baseline to Month 12	Measured change for the period. The questionnaire has 10 questions. The maximum score is 40. The higher the score the better the functional status of the patient.
Secondary	Maximum Isometric Voluntary Contraction Testing (MVICT) Score	Change from Baseline to Month 4	Measured MVICT using the Quantitative Muscle Assessment (QMA) system designed by Computer Source, Atlanta, GA. The system uses an adjustable cuff to attach the patient's arm or leg to an inelastic strap that is connected to force transducer with a load of 0.5 to 1,000 Newtons. Maximum force is recorded.
Secondary	Maximum Isometric Voluntary Contraction Testing (MVICT) Score	Change from Baseline to Month 8	Measured MVICT using the Quantitative Muscle Assessment (QMA) system designed by Computer Source, Atlanta, GA. The system uses an adjustable cuff to attach the patient's arm or leg to an inelastic strap that is connected to force transducer with a load of 0.5 to 1,000 Newtons. Maximum force is recorded.

1 to 10 of 11Source ClinicalTrials.gov

See all 11 registered outcomes

Outcomes11

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Count of Adverse Events Reported	Month 12		adverse events reported	NUMBER
SECONDARY	Heat Shock Protein 70 (HSP70) Levels in the Tissue	Change from Baseline to Month 4		ng/100ng myosin	MEAN
SECONDARY	Muscle Strength Testing	Change from Baseline to Month 4		units on a scale	MEAN
SECONDARY	Muscle Strength Testing	Change from Baseline to Month 8		units on a scale	MEAN
SECONDARY	Muscle Strength Testing	Change from Baseline to Month 12		units on a scale	MEAN
SECONDARY	Inclusion Body Myositis-Functional Rating Scale (IBMFRS) Score	Change from Baseline to Month 4		units on a scale	MEAN
SECONDARY	Inclusion Body Myositis-Functional Rating Scale (IBMFRS) Score	Change from Baseline to Month 8		units on a scale	MEAN
SECONDARY	Inclusion Body Myositis-Functional Rating Scale (IBMFRS) Score	Change from Baseline to Month 12	One of the subjects that dropped from the study in the Arimoclomol arm, returned for the 12 month visit.	units on a scale	MEAN
SECONDARY	Maximum Isometric Voluntary Contraction Testing (MVICT) Score	Change from Baseline to Month 4		newtons	MEAN
SECONDARY	Maximum Isometric Voluntary Contraction Testing (MVICT) Score	Change from Baseline to Month 8		newtons	MEAN

1 to 10 of 11Source ClinicalTrials.gov

See all 11 outcomes

Results by group22

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

Outcome	Group	Value	Spread	Units
Count of Adverse Events Reported	Arimoclomol	109		adverse events reported
Count of Adverse Events Reported	Placebo	52		adverse events reported
Heat Shock Protein 70 (HSP70) Levels in the Tissue	Arimoclomol	-110.72	Standard Deviation 757.40	ng/100ng myosin
Heat Shock Protein 70 (HSP70) Levels in the Tissue	Placebo	-34.70	Standard Deviation 336.35	ng/100ng myosin
Muscle Strength Testing	Arimoclomol	-0.04	Standard Deviation 0.19	units on a scale
Muscle Strength Testing	Placebo	-0.12	Standard Deviation 0.20	units on a scale
Muscle Strength Testing	Arimoclomol	-0.12	Standard Deviation 0.22	units on a scale
Muscle Strength Testing	Placebo	-0.26	Standard Deviation 0.27	units on a scale
Muscle Strength Testing	Arimoclomol	-0.21	Standard Deviation 0.21	units on a scale
Muscle Strength Testing	Placebo	-0.35	Standard Deviation 0.20	units on a scale

1 to 10 of 22Source ClinicalTrials.gov

See all 22 results by group

Participant flow10

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Arimoclomol	16
Overall Study	STARTED	Placebo	8
Overall Study	Month 4	Arimoclomol	16
Overall Study	Month 4	Placebo	8
Overall Study	Month 8	Arimoclomol	14
Overall Study	Month 8	Placebo	8
Overall Study	COMPLETED	Arimoclomol	14
Overall Study	COMPLETED	Placebo	8
Overall Study	NOT COMPLETED	Arimoclomol	2
Overall Study	NOT COMPLETED	Placebo	0

Source ClinicalTrials.gov

Adverse events116

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	Events
other	Palpitations	Cardiac disorders	Arimoclomol	1	16	1
other	Palpitations	Cardiac disorders	Placebo	0	8	0
other	Dizziness/tinnitus	Ear and labyrinth disorders	Arimoclomol	2	16	2
other	Dizziness/tinnitus	Ear and labyrinth disorders	Placebo	0	8	0
other	Conjunctivitis	Eye disorders	Arimoclomol	1	16	1
other	Conjunctivitis	Eye disorders	Placebo	0	8	0
other	Eye pain	Eye disorders	Arimoclomol	1	16	1
other	Eye pain	Eye disorders	Placebo	0	8	0
other	Dry eyes	Eye disorders	Arimoclomol	0	16	0
other	Dry eyes	Eye disorders	Placebo	1	8	1

1 to 10 of 116Source ClinicalTrials.gov

See all 116 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Arimoclomol
Total, all-cause mortality	Placebo
Total, other adverse events	Arimoclomol	16	16
Total, other adverse events	Placebo	8	8
Total, serious adverse events	Arimoclomol	0	16
Total, serious adverse events	Placebo	1	8

Source ClinicalTrials.gov

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 comparisons1

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

Comparison
Arimoclomol vs Placebo: serious adverse events

Source Trial comparisons

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.

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