Lipoic Acid to Treat Chronic Inflammatory Demyelinating Polyneuropathy

• Sponsor: Oregon Health and Science University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00962429
• Collaborator: Collins Medical Trust (Other)
• Enrollment: 7
• Location: 1
• Arms: 2
• Duration (Months): 47
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
CIDP; Chronic Inflammatory Demyelinating Polyneuropathy	Drug: lipoic acid	Phase 2

Detailed Description

Chronic inflammatory demyelinating polyneuropathy (CIDP) is a progressive disease leading to paralysis. CIDP is an immune-mediated disorder resulting from a synergistic interaction of T cell-mediated and B cell-mediated immune responses directed against peripheral nerve antigens. These immune mediated responses in turn increase the production of reactive oxygen intermediate and cause oxidative damage of the peripheral nerve system. Although corticosteroids, plasma exchange, and intravenous immunoglobulin (IVIg) reduce impairment caused by CIDP at least temporarily and can be used as a first-line treatments, they are not ideal for long-term treatment because of serious side effects and cost. Alpha lipoic acid (LA) is an antioxidant that also possesses anti-immune activity. It is effective in treating diabetic neuropathy. It is also promising in treating patients with multiple sclerosis.

Study Design

• Study Type: Interventional
• Actual Enrollment: 7 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Lipoic Acid for Chronic Inflammatory Demyelinating Polyneuropathy-A Randomized, Double-Blind, Placebo Controlled Pilot Study
• Study Start Date: Feb 1, 2009
• Actual Primary Completion Date: Jan 1, 2013
• Actual Study Completion Date: Jan 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Lipoic acid alpha lipoic acid	Drug: lipoic acid; 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.; Other Names: LA
Placebo Comparator: Placebo sugar pill	Drug: lipoic acid; 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.; Other Names: LA

Outcome Measures

Primary Outcome Measures

1. Muscle Strength [16 weeks]

Secondary Outcome Measures

1. Hughes Functional Disability Scale [16 weeks]

2. Forced Vital Capacity (FVC) [16 weeks]

3. Motor Nerve Conduction Studies (NCS) [16 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• diagnosis of CIDP

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

Exclusion Criteria:

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Oregon Health & Science University	Portland	Oregon	United States	97239

Sponsors and Collaborators

• Oregon Health and Science University
• Collins Medical Trust

Investigators

• Principal Investigator: Jau-Shin Lou, MD, PhD, Oregon Health and Science University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Oregon Health and Science University
• ClinicalTrials.gov Identifier: NCT00962429
• Other Study ID Numbers: CMT-Lou
• First Posted: Aug 20, 2009
• Last Update Posted: Aug 19, 2020
• Last Verified: Aug 1, 2020

• Keywords provided by Oregon Health and Science University: neuropathy, lipoic acid
• Additional relevant MeSH terms: Polyneuropathies; Polyradiculoneuropathy, Chronic Inflammatory Demyelinating; Thioctic Acid

Study Results

Participant Flow

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

Arm/Group Title	Lipoic Acid	Placebo
Arm/Group Description	alpha lipoic acid lipoic acid: 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.	sugar pill lipoic acid: 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.
Period Title: Overall Study
STARTED	0	0
COMPLETED	0	0
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Lipoic Acid	Placebo	Total
Arm/Group Description	alpha lipoic acid lipoic acid: 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.	sugar pill lipoic acid: 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.	Total of all reporting groups
Overall Participants	0	0	0
Age () []
<=18 years
Between 18 and 65 years
>=65 years
Age () []
Sex: Female, Male () []
Female
Male
Race and Ethnicity Not Collected () []
Region of Enrollment (participants) []

Outcome Measures

1. Primary Outcome

Title	Muscle Strength
Time Frame	16 weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Lipoic Acid	Placebo
Arm/Group Description	alpha lipoic acid lipoic acid: 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.	sugar pill lipoic acid: 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.
Measure Participants	0	0

2. Secondary Outcome

Title	Hughes Functional Disability Scale
Time Frame	16 weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Lipoic Acid	Placebo
Arm/Group Description	alpha lipoic acid lipoic acid: 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.	sugar pill lipoic acid: 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.
Measure Participants	0	0

3. Secondary Outcome

Title	Forced Vital Capacity (FVC)
Time Frame	16 weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Lipoic Acid	Placebo
Arm/Group Description	alpha lipoic acid lipoic acid: 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.	sugar pill lipoic acid: 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.
Measure Participants	0	0

4. Secondary Outcome

Title	Motor Nerve Conduction Studies (NCS)
Time Frame	16 weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Lipoic Acid	Placebo
Arm/Group Description	alpha lipoic acid lipoic acid: 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.	sugar pill lipoic acid: 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.
Measure Participants	0	0

Adverse Events

Adverse Event Reporting Description	The Responsible Party has left the institution and has indicated that they do not have the raw data. They have confirmed that, despite all efforts to locate the data by contacting study team members, efforts were unsuccessful and no data are available.
Arm/Group Title	Lipoic Acid		Placebo
Arm/Group Description	alpha lipoic acid lipoic acid: 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.		sugar pill lipoic acid: 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.
All Cause Mortality
	Lipoic Acid		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)
Serious Adverse Events
	Lipoic Acid		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Lipoic Acid		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)

Limitations/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.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT 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.