Phase 4 N=33 Randomized Treatment

Alpha Lipoic Acid for Treatment of Diabetic Neuropathy

Diabetic Neuropathy

Bottom Line

View on ClinicalTrials.gov: NCT02439879 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2016

Primary outcome: Primary: Total Symptoms Score — 2.5; 3.1 units on a scale — p=< 0.05

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Alpha lipoic acid (Drug)
Age: Pediatric, Adult, Older Adult
Sex: All
Sponsor: Universidad Popular Autónoma del Estado de Puebla
Primary completion: Dec 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Total Symptoms Score	2.5; 3.1	< 0.05 sig

Summary

Patients with diabetic neuropathy and total symptoms score(TSS) >7 points were invited to this open multicenter study. Patients were free of pain medications and severe diabetic complications .Patients started alpha lipoic acid (ALA)1800 mg for 4 weeks. Patients with a decrease >3 points in the TSS were randomly allocated to 600 mg of ALA (ALA group) or no medications (ALA withdrawal) for 16 weeks. In each visit investigators evaluated any change in the TSS and the necessity of rescue medication to control symptoms (mainly pain). At the end of the study investigators compared between ALA and ALA withdrawal groups TSS levels and the frequency of use of rescue medications. Physicians were free to manage glucose to maintain Hba1c close to the ADA target (HbA1c <7%).

Eligibility Criteria

Inclusion Criteria

Type 2 diabetic patients (according to American Diabetes Association (ADA) criteria)
Symptomatic diabetic polyneuropathy
Total Symptom Score (TSS) >7 points,
HbA1c<10%,
Serum creatinine <2 mg/dl.

Exclusion Criteria

Active cardiovascular disease
Malignancy
Any other conditions causing neuropathic pain
Use of analgesic, antidepressant, or antiepileptic drugs, or any other medication aimed to relief neuropathic pain.
Child-bearing female patients not using any effective birth control method and under surveillance of a board-certified gynecologist

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Data sourced from ClinicalTrials.gov (NCT02439879). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.