Trial Outcomes & Findings for Alpha-lipoic Acid/L-acetyl Carnitine for Progressive Supranuclear Palsy (NCT NCT01537549)

NCT ID: NCT01537549

Last Updated: 2017-05-30

Results Overview

Incidence and severity of adverse events

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 11 participants
• Primary outcome timeframe: at 25 weeks
• Results posted on: 2017-05-30

Participant Flow

Participant milestones

Measure	Juvenon alpha-lipoic acid and L-acetyl carnitine: alpha-lipoic acid and L-acetyl carnitine capsules, 600mg/1.5g daily for 6 months
Overall Study STARTED	11
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Measure	Juvenon alpha-lipoic acid and L-acetyl carnitine: alpha-lipoic acid and L-acetyl carnitine capsules, 600mg/1.5g daily for 6 months
Overall Study Lost to Follow-up	1
Overall Study Withdrawal by Subject	2

Baseline Characteristics

Alpha-lipoic Acid/L-acetyl Carnitine for Progressive Supranuclear Palsy

Baseline characteristics by cohort

Measure	Juvenon n=11 Participants alpha-lipoic acid and L-acetyl carnitine: alpha-lipoic acid and L-acetyl carnitine capsules, 600mg/1.5g daily for 6 months
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants
Age, Categorical >=65 years	7 Participants n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Region of Enrollment United States	11 Participants n=5 Participants

PRIMARY outcome

Timeframe: at 25 weeks

Population: ITT

Incidence and severity of adverse events

Outcome measures

Measure	Juvenon n=11 Participants alpha-lipoic acid and L-acetyl carnitine: alpha-lipoic acid and L-acetyl carnitine capsules, 600mg/1.5g daily for 6 months	Juvenon at 1 Month alpha-lipoic acid and L-acetyl carnitine: alpha-lipoic acid and L-acetyl carnitine capsules, 600mg/1.5g daily (1 month)
Adverse Events	23 Number of Adverse Events	—

SECONDARY outcome

Timeframe: at baseline and at week 5

Population: per Protocol

changes of cerebral lactate and glutathione levels as determined by magnetic resonance spectroscopy

Outcome measures

Measure	Juvenon n=7 Participants alpha-lipoic acid and L-acetyl carnitine: alpha-lipoic acid and L-acetyl carnitine capsules, 600mg/1.5g daily for 6 months	Juvenon at 1 Month n=7 Participants alpha-lipoic acid and L-acetyl carnitine: alpha-lipoic acid and L-acetyl carnitine capsules, 600mg/1.5g daily (1 month)
Cerebral Oxidative Stress Markers	4 Ratio Standard Deviation 1.67	4.6 Ratio Standard Deviation 1.41

Adverse Events

Juvenon

Serious events: 1 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Measure	Juvenon n=11 participants at risk alpha-lipoic acid and L-acetyl carnitine: alpha-lipoic acid and L-acetyl carnitine capsules, 600mg/1.5g daily for 6 months
Infections and infestations Leg Cellulitis	9.1% 1/11 • At Baseline, Week 5, and Week 25

Other adverse events

Measure	Juvenon n=11 participants at risk alpha-lipoic acid and L-acetyl carnitine: alpha-lipoic acid and L-acetyl carnitine capsules, 600mg/1.5g daily for 6 months
Gastrointestinal disorders Gastro Disturbances	45.5% 5/11 • Number of events 7 • At Baseline, Week 5, and Week 25
General disorders Odor of Urine, Breath, or Sweat	36.4% 4/11 • Number of events 5 • At Baseline, Week 5, and Week 25
Skin and subcutaneous tissue disorders Skin Rashes, Itching, Swelling	18.2% 2/11 • Number of events 3 • At Baseline, Week 5, and Week 25
Respiratory, thoracic and mediastinal disorders Bronchoconstriction, Cough	9.1% 1/11 • Number of events 1 • At Baseline, Week 5, and Week 25
General disorders Other Possible Effects	54.5% 6/11 • Number of events 9 • At Baseline, Week 5, and Week 25

Additional Information

Dr. Claire Henchcliffe

Weill Cornell Medicine

Phone: 2127462584

Email: clh2007@med.cornell.edu

Results disclosure agreements

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