Efficacy of donepezil in patients with chronic tinnitus

Researchers in Brazil are studying the effects of donepezil in patients with chronic tinnitus.

Some quick details on donepezil and the new phase 2 trial:

Donepezil is a drug that is similar to memantine, rivastigmine, and galantamine.

From Wikipedia:

Donepezil was approved for medical use in the United States in 1996. It is available as a generic medication. In 2018, it was the 128th most commonly prescribed medication in the United States, with more than 5 million prescriptions.

It is a cholinesterase inhibitor that “inhibits voltage-activated sodium currents reversibly and delays rectifier potassium currents and fast transient potassium currents.” More detailed information available here: https://www.ncbi.nlm.nih.gov/books/NBK513257/

It is already approved and used to treat other conditions (such as Alzheimer’s disease) – though its effects are apparently small and its mechanism still not fully understood.

And now it is being investigated as part of a phase 2 trial to determine whether or not it can help people with chronic tinnitus caused by sensorineural hearing loss.

The study was registered about 6 months ago on November 3, 2020.

It will enroll up to 50 participants.

According to the study record, the date of first enrollment = January 29, 2021.

But according to that same study record, the study status = Not yet recruiting.

Which means there was probably either a delay in starting the trial or a delay in updating parts of the study record. (Probably the latter.)

This information is current as of May 17, 2021. However, it is based on records that are only current as of February 23, 2021. So, the current status might actually be recruiting. We just can’t tell from the current study record.

But it does tell us about outcomes and the hypothesis:

Primary Outcome(s)
Improvement is expected from patients with tinnitus who will use the medication comparing to placebo group. The methods Student’s t test and ANOVA analysis will be used, before and after placebo and active drug therapy, for quantitative variables. Statistical significance level of 0.05 or 5% will be adopted for two-tailed samples and study power of 95%. The qualitative variables will be described by their frequency of presentation.

Secondary Outcome(s)
The memory improvement is expected from patients who will use the medication comparing to placebo group. The methods Student’s t test and ANOVA analysis will be used, before and after placebo and active drug therapy, for quantitative variables. Statistical significance level of 0.05 or 5% will be adopted for two-tailed samples and study power of 95%. The qualitative variables will be described by their frequency of presentation.

That’s all for now.

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References

Further reading


Important Reminder

  • nothing on this website qualifies as medical advice and is not intended to guide treatment decisions
  • everything you read or see here is for entertainment or informational purposes only
  • do not attempt to “copy” this trial’s intervention or try a “do-it-yourself” regimen
  • donepezil can have extremely serious side effects for some people (including withdrawal effects)
  • always talk to a doctor or qualified professional when making treatment decisions
  • have a nice day

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