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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT00605930
• Date of registration: 14/01/2008
• Prospective Registration: No
• Primary sponsor: University of Louisville
• Public title: A Pilot Clinical Trial of Pyruvate, Creatine, and Niacinamide in Progressive Supranuclear Palsy.
• Scientific title: Energy Metabolism in Neurodegenerative Diseases: A Randomized, Double Blind, Placebo-Controlled Clinical Pilot Trial of Pyruvate, Creatine, and Niacinamide in Progressive Supranuclear Palsy.
• Date of first enrolment: April 2004
• Target sample size: 20
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00605930
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: N/A

Countries of recruitment

United States

Contacts

• Name: Irene Litvan, MD
• Affiliation: University of Louisville, Division of Movement Disorders

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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.



Age minimum: N/A
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Progressive Supranuclear Palsy

Intervention(s)

Dietary Supplement: Placebo

Dietary Supplement: Pyruvate, creatine, niacinamide

Primary Outcome(s)

Clinical features of PSP, including motor function, neuropsychological function, and blood chemistry [Time Frame: Baseline, 4 weeks, 24 weeks]

Secondary Outcome(s)

CSF metabolite concentrations [Time Frame: Baseline, 24 weeks]

Secondary ID(s)

083.03

420

Source(s) of Monetary Support

Please refer to primary and secondary sponsors