Arimoclomol in Sporadic Inclusion Body Myositis - Full Text View

Sponsors and Collaborators:	University of Kansas Food and Drug Administration (FDA)
Information provided by:	University of Kansas
ClinicalTrials.gov Identifier:	NCT00769860

Purpose

Inclusion body myositis (IBM) is the most common progressive and debilitating muscle disease beginning in persons over 50 years of age. This study will assess the safety and tolerability of Arimoclomol in IBM as compared to placebo over 4 months of treatment.

Condition	Intervention	Phase
Inclusion Body Myositis	Drug: Arimoclomol Other: Placebo	Phase II Phase III

MedlinePlus related topics: Myositis

Drug Information available for: Arimoclomol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Safety and Tolerability Trial of Arimoclomol for Sporadic Inclusion Body Myositis

Further study details as provided by University of Kansas:

Primary Outcome Measures:

Adverse event reporting [ Time Frame: Every 2 weeks for 4 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Muscle Strength Testing [ Time Frame: Monthly for 4 months ] [ Designated as safety issue: No ]
IBM functional rating scale [ Time Frame: Monthly for 4 months ] [ Designated as safety issue: No ]
Muscle biopsy [ Time Frame: pre and post treatment ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	12
Study Start Date:	September 2008
Estimated Study Completion Date:	September 2010
Estimated Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Arimoclomol	Drug: Arimoclomol Arimoclomol 100 mg TID for 4 months
2: Placebo Comparator	Other: Placebo Placebo for 4 months

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Meet the diagnostic criteria for definite or probable IBM (Griggs 1995)
Muscle function adequate for quantitative muscle testing
Age > 50 years
Women must be postmenopausal or status post hysterectomy
For any patient currently taking medication for IBM, they must remain on current dosage for the extent of the study and last dosage change must be > 30 days previous to enrollment

Exclusion Criteria:

Presence of any one of the following medical conditions: diabetes mellitus or patients taking anti-diabetic medications, chronic infection, chronic renal insufficiency, cancer other than skin cancer less than 5 years previously, multiple sclerosis or prior episode or central nervous system demyelination, or other chronic serious medical illnesses
Presence of any of the following on routine blood screening: WBC < 3000, platelets < 100,000, hematocrit < 30%, BUN > 30 mg%, creatine > 1.5 mg%, symptomatic liver disease with serum albumin < 3 g/dl, PT or PTT > upper range of control values
Women who are pregnant or lactating
History of non-compliance with other therapies
Coexistence of other neuromuscular disease
Drug or alcohol abuse within the last 3 months
Inability to give informed consent
Known bleeding disorder
Use of potentially renal toxic drugs
Prior difficulties with local anesthetic

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00769860

Contacts

Contact: Richard Barohn, MD

913-588-6094

rbarohn@kumc.edu

Locations

United States, Kansas
University of Kansas Medical Center	Recruiting
Kansas City, Kansas, United States, 66160
Contact: Richard Barohn, MD 913-588-6094 rbarohn@kumc.edu

Sponsors and Collaborators

University of Kansas

Food and Drug Administration (FDA)

More Information

Responsible Party:	University of Kansas Medical Center ( Richard Barohn MD )
Study ID Numbers:	10656
Study First Received:	October 8, 2008
Last Updated:	October 8, 2008
ClinicalTrials.gov Identifier:	NCT00769860
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of Kansas:

myositis
IBM
inclusion body myositis

Study placed in the following topic categories:

Myositis
Muscular Diseases
Neuromuscular Diseases
Musculoskeletal Diseases

Myositis, inclusion body
Idiopathic myopathy
Myositis, Inclusion Body

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009