Pramiracetam Adverse effects: incidence study

In a retrospective study, the tolerability of the nootrophic pramiracetam was assessed from the results of 14 studies involving 112 healthy volunteers (7 phase I studies), 32 patients with primary degenerative dementia (1 open phase 2 study), 136 patients with Alzheimer's disease (3 controlled double-blind trials) and 168 patients with benign senescent forgetfulness (3 controlled double-blind trials). Volunteers received pramiracetam in single doses up to 1600mg and in multiple doses (~ 1500 mgjday) for 28 days. Patients received 75-750 mgjday for up to 9 weeks.

Phase 1 studies: The most common reaction to a single dose was headache (5 volunteers vs 1 on placebo). There were no clinically significant changes in physical or laboratory measurements.

Open phase 2 study: Reactions were mild and similar to those seen in the controlled studies. No systemic toxic effects were seen in laboratory

Controlled phase 2 studies: No effects on BP, heart rate, brain electrical activity or ECG were seen. Occasional abnormal laboratory results occurred, including elevated glucose values, white blood cell counts and cholesterol. Adverse reactions to pramiracetam were not dose-related and involved the whole body, the digestive, nervous, psychobiological urogenital and cardiovascular systems, skin and appendages, and special senses. 25% of patients on pramiracetam 75mg, 15% on 15Omg, 14% on 300mg and 17% on placebo experienced adverse reactions.

'Although It I. dmlcult to •••••• cognition .ctivator effect. with current methodologl •• , w. have clearly demonstr.ted the .at.ty 01 p'.mlr.c.tam In 336 patient •• '

Dejong R. Current Therapeutic Research 41: 254-257, Feb 1987

14 REACTIONS· 30 May 1987 0157-7271/87/0530-0014/0$01.00/0 © ADIS Press