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

Completed · Not applicable · Has a placebo group

Conditions studied: Progressive Supranuclear Palsy

In brief

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

Key facts

Study ID

NCT00605930

Run by

University of Louisville

People needed

20

Starts

2004-04-01

Expected to finish

2009-12-01

Last updated by the study team

2017-04-10

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Frazier Rehab — Louisville, Kentucky, United States

Full record on ClinicalTrials.gov

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