Lipoic Acid to Treat Chronic Inflammatory Demyelinating Polyneuropathy

NCT00962429 | Completed Phase 2 Results

• 1 other identifier: CMT-Lou
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to examine if alpha lipoic acid is an effective treatment for chronic inflammatory demyelinating polyneuropathy (CIDP).

Conditions

CIDP; Chronic Inflammatory Demyelinating Polyneuropathy

Keywords

neuropathy, lipoic acid

Outcome Measures

Primary Outcomes (1)

• Muscle Strength

  16 weeks

Secondary Outcomes (3)

• Hughes Functional Disability Scale

  16 weeks

• Forced Vital Capacity (FVC)

  16 weeks

• Motor Nerve Conduction Studies (NCS)

  16 weeks

Study Arms (2)

Lipoic acid

ACTIVE COMPARATOR

alpha lipoic acid

Drug: lipoic acid

Placebo

PLACEBO COMPARATOR

sugar pill

Drug: lipoic acid

Interventions

lipoic acid DRUG

Subjects will be started on a single daily dose of 600 mg of alpha lipoic acid or placebo for the first 4 weeks and then increased to 1200 mg for the remainder of the study.

Also known as: LA

Lipoic acid; Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosis of CIDP
• on a stable dose of immunotherapy for at least 3 months before enrolling in the study

You may not qualify if:

• myelopathy or evidence of central demyelination
• persistent neurological deficits from stroke, CNS trauma, or peripheral neuropathy from other causes (eg, diabetes mellitus, IgM, paraproteinaemia, or uraemic, toxic, or familial neuropathy)
• evidence of systemic disease that might cause neuropathy
• heart diseases (congestive heart failure or arrhythmia)
• pulmonary conditions (asthma or CIPD)
• rheumatoid conditions (such as rheumatoid arthritis)
• renal failure

Sponsors & Collaborators

• Oregon Health and Science University: lead
• Collins Medical Trust: collaborator

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

Interventions

Thioctic Acid

Condition Hierarchy (Ancestors)

Polyradiculoneuropathy; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Polyneuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Autoimmune Diseases; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Carboxylic Acids; Organic Chemicals; Thiophenes; Sulfur Compounds; Coenzymes; Enzymes and Coenzymes; Fatty Acids; Lipids

Limitations and Caveats

The Responsible Party has left the institution and has indicated that they do not have the raw data. They've confirmed that, despite all efforts to locate the data by contacting study team members, efforts were unsuccessful and no data are available.

Results Point of Contact

• Title: Diana Dimitrova
• Organization: Oregon Health and Science University

dimitrov@ohsu.edu

503-494-7269

Study Officials

• Jau-Shin Lou, MD, PhD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2009
• First Posted: August 20, 2009
• Study Start: February 1, 2009
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: August 19, 2020
• Results First Posted: August 19, 2020

Record last verified: 2020-08

Locations

US (1)