Trial Outcomes & Findings for Alpha Lipoic Acid for Treatment of Diabetic Neuropathy (NCT NCT02439879)

NCT ID: NCT02439879

Last Updated: 2016-03-02

Results Overview

Total symptoms score is a summation of presence, severity, and duration of the four main positive neuropathic sensory symptoms: lancinating/stabbing pain, burning pain, paresthesia, and asleep numbness

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 45 participants
• Primary outcome timeframe: 20 weeks
• Results posted on: 2016-03-02

Participant Flow

Type 2 diabetic patients with symptomatic neuropathic symptoms from 3 medical clinics in Puebla city, Mexico (one private, 2 public) were invited direct by investigator to participate if they fulfill inclusion criteria and no exclusion criteria. First patient was included on January 8th 2010 and the last visit of one patient was on December 2010

All patients meeting inclusion criteria received 600 mg of alfa-lipoic acid orally tid for 4 weeks. Patients with a TSS reduction >3 points by the end of phase 1 were selected to proceed with phase 2 of the study. Patients with a decrease <3 points in TSS or who used other neuropathic pain drugs were excluded from study phase 2.

Participant milestones

Measure	Alpha Lipoic Acid Treatment After a decrease in the total symptoms score \>3 points with 600 mg orally tid of alpha lipoic acid for 4 weeks patients were randomized to recieve for 16 weeks 600 mg orally once a day of alpha lipoic acid	Alpha Lipoic Acid Withdrawal After a decrease in the total symptoms Score \>3 points with 600 mg orally tid of alpha lipoic acid for 4 weeks patients were randomized to recieve for 16 weeks no treatment
Overall Study STARTED	16	17
Overall Study COMPLETED	16	17
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Alpha Lipoic Acid for Treatment of Diabetic Neuropathy

Baseline characteristics by cohort

Measure	Alpha Lipoic Acid Treatment n=16 Participants After a decrease in the total symptoms score \>3 points with 600 mg orally tid of alpha lipoic acid for 4 weeks patients were randomized to recieve for 16 weeks 600 mg orally once a day of alpha lipoic acid Alpha lipoic acid: Alpha lipoic acid 1800 mg PO divided in 3 doses for 4 weeks . If total symptoms score decreased \>3 points patients received alpha lipoic acid 600 mg PO each day or no treatment for 16 weeks.	Alpha Lipoic Acid Withdrawal n=17 Participants After a decrease in the total symptoms Score \>3 points with 600 mg orally tid of alpha lipoic acid for 4 weeks patients were randomized to recieve for 16 weeks no treatment	Total n=33 Participants Total of all reporting groups
Age, Continuous	57.5 years STANDARD_DEVIATION 10 • n=5 Participants	59 years STANDARD_DEVIATION 11 • n=7 Participants	58.4 years STANDARD_DEVIATION 10.5 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	11 Participants n=7 Participants	22 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	6 Participants n=7 Participants	11 Participants n=5 Participants
TSS	3.7 units on a scale STANDARD_DEVIATION 1.97 • n=5 Participants	3.23 units on a scale STANDARD_DEVIATION 2.07 • n=7 Participants	3.45 units on a scale STANDARD_DEVIATION 2 • n=5 Participants

PRIMARY outcome

Timeframe: 20 weeks

Total symptoms score is a summation of presence, severity, and duration of the four main positive neuropathic sensory symptoms: lancinating/stabbing pain, burning pain, paresthesia, and asleep numbness

Outcome measures

Measure	Alpha Lipoic Acid Treatment n=16 Participants After a decrease in the total symptoms score \>3 points with 600 mg orally tid of alpha lipoic acid for 4 weeks patients were randomized to recieve for 16 weeks 600 mg orally once a day of alpha lipoic acid	Alpha Lipoic Acid Withdrawal n=17 Participants After a decrease in the total symptoms Score \>3 points with 600 mg orally tid of alpha lipoic acid for 4 weeks patients were randomized to recieve for 16 weeks no treatment
Total Symptoms Score	2.5 units on a scale Standard Error 0.6	3.1 units on a scale Standard Error 0.8

Adverse Events

Alpha Lipoic Acid Treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Alpha Lipoic Acid Withdrawal

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Hector Garcia Alcala

Universidad Popular Autonoma del Estado de Puebla

Phone: +522222299400

Email: hector.garcia@upaep.mx

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place