Trial Outcomes & Findings for Electromyography in Patients on Chronic Pyridostigmine Therapy (NCT NCT02364180)

Results Overview

Normally when a nerve is rapidly stimulated the successive Compound Muscle Action Potentials (CMAP) are of the same height. We are hoping to investigate if chronic pyridostigmine therapy reduces the margin of safety and hence the successive CMAPs may be smaller than the preceding ones.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

11 participants

Primary outcome timeframe

Baseline measurement only. First and Fifth stimuli delivered 2 seconds apart on the same day. There are no additional days/times.

Results posted on

2017-05-09

Participant Flow

All subjects taking Pyridostigmine for at least 6months, except for the treatment of myasthenia gravis, will be considered. Subjects will be recruited from existing patients treated at the university and will be seen in the outpatient clinics.

Participant milestones

Participant milestones
Measure	Pyridostigmine Bromide Treatment Group pyridostigmine bromide treatment is a single arm. Subjects must be treated with pyridostigmine for at least 6months and must not be treated for myasthenia gravis.
Overall Study STARTED	11
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Pyridostigmine Bromide Treatment Group pyridostigmine bromide treatment is a single arm. Subjects must be treated with pyridostigmine for at least 6months and must not be treated for myasthenia gravis.
Overall Study Screen Fail	1

Baseline Characteristics

Electromyography in Patients on Chronic Pyridostigmine Therapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pyridostigmine Bromide Treatment Group n=11 Participants All subjects investigated were taking pyridostigmine.
Age, Continuous	63 years n=99 Participants
Sex: Female, Male Female	5 Participants n=99 Participants
Sex: Female, Male Male	6 Participants n=99 Participants

PRIMARY outcome

Timeframe: Baseline measurement only. First and Fifth stimuli delivered 2 seconds apart on the same day. There are no additional days/times.

Normally when a nerve is rapidly stimulated the successive Compound Muscle Action Potentials (CMAP) are of the same height. We are hoping to investigate if chronic pyridostigmine therapy reduces the margin of safety and hence the successive CMAPs may be smaller than the preceding ones.

Outcome measures

Outcome measures
Measure	Pyridostigmine Bromide Treatment Group n=10 Participants Subjects taking pyridostigmine bromide for more than 6 months for a condition other than myasthenia gravis
Percent Change in the Amplitude of Evoked Compound Muscle Action Potential by Electromyography Between the First to Fifth Response	0 percent change Interval -4.0 to 13.0

Adverse Events

Pyridostigmine Bromide Treatment Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Shashi Bhatt, MD

The University of Toledo

Phone: 419-383-3556

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place