A Pilot Clinical Trial of Pyruvate, Creatine, and Niacinamide in Progressive Supranuclear Palsy.

NCT00605930 | Completed

• 2 other identifiers: 083.03420
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This study intends to study the safety and tolerance of the combination of pyruvate, creatine, and niacinamide over 6 months in patients with PSP.

Conditions

Progressive Supranuclear Palsy

Keywords

Progressive Supranuclear Palsy; PSP; Nutriceutical; Pyruvate; Creatine; Niacinamide

Outcome Measures

Primary Outcomes (1)

• Clinical features of PSP, including motor function, neuropsychological function, and blood chemistry

  Baseline, 4 weeks, 24 weeks

Secondary Outcomes (1)

• CSF metabolite concentrations

  Baseline, 24 weeks

Study Arms (2)

Pyruvate, creatine, niacinamide

ACTIVE COMPARATOR

Pyruvate, creatine, niacinamide administered

Dietary Supplement: Pyruvate, creatine, niacinamide

Placebo

PLACEBO COMPARATOR

placebo

Dietary Supplement: Placebo

Interventions

Pyruvate, creatine, niacinamide DIETARY_SUPPLEMENT

A bar of 2 gm of pyruvate and 1 gm of creatine, and a pill of 1 gm of niacinamide once a day for 24 weeks.

Pyruvate, creatine, niacinamide

Placebo DIETARY_SUPPLEMENT

25% of subjects will receive a placebo bar and a placebo pill once a day for 24 weeks.

Placebo

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• All subjects must meet the clinically definite or probable NINDS-SPSP PSP diagnostic research criteria that includes the presence of postural instability at disease onset, as well as supranuclear vertical ophthalmoparesis.
• All subjects must be able to tolerate oral feedings and be ambulatory
• All subjects or their caregivers must be able to read and understand the consent

You may not qualify if:

• Any contraindications to the use of pyruvate, creatine, and niacinamide
• the presence of a medical condition that can reasonably be expected to subject the patient to unwarranted risk or require frequent changes in medication.
• Pregnancy, nursing, or lack of effective contraception, if still at child-bearing age.
• History of prior sever traumatic brain injury or other severe neurologic or psychiatric condition, such as psychosis, stroke, multiple sclerosis, or spinal cord injury, which will interfere with outcome evaluation, in the opinion of the local principal investigator
• Subject unable to discontinue prohibited medication, which includes antiparkinsonian medications with potential neuroprotective effects such as amantadine, deprenyl, and vitamin E supplements \> 400 IU per day.

Sponsors & Collaborators

• University of Louisville: lead

Study Sites (1)

Frazier Rehab

Louisville, Kentucky, 40202, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Supranuclear Palsy, Progressive

Interventions

Pyruvic Acid; Creatine; Niacinamide

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Ophthalmoplegia; Ocular Motility Disorders; Cranial Nerve Diseases; Tauopathies; Neurodegenerative Diseases; Paralysis; Neurologic Manifestations; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pyruvates; Keto Acids; Carboxylic Acids; Organic Chemicals; Guanidines; Amidines; Amino Acids; Amino Acids, Peptides, and Proteins; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Irene Litvan, MD

  University of Louisville, Division of Movement Disorders

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2008
• First Posted: January 31, 2008
• Study Start: April 1, 2004
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: April 10, 2017

Record last verified: 2017-04

Locations

US (1)