An international clinical trial programme was undertaken to evaluate the clinical safety and tolerability of remoxipride during a 12 month long‐term study and to evaluate safety, tolerability and efficacy of remoxipride for up to 6 months in a double‐blind comparison with haloperidol. A total of 145 patients were treated with remoxipride for at least 12 months. In the double‐blind evaluation 106 patients on remoxipride and 50 on haloperidol were included. The doses of remoxipride ranged between 90–600 mg daily and of haloperidol between 5–45 mg daily. The therapeutic efficacy of remoxipride obtained in short‐term studies was maintained during long‐term treatment in most patients and was similar to that of haloperidol. Remoxipride had a clear cut advantage concerning extrapyramidal symptoms and anticholinergic drugs were needed less frequently with remoxipride than with haloperidol. The tolerability and safety showed no clinically significant differences compared to the data from short‐term studies. This indicates that remoxipride can be used safely and with maintained efficacy for long‐term treatment.
Ninety‐two patients with schizophrenia were included in a double‐blind multicentre parallel‐group trial comparing remoxipride and haloperidol. The mean daily dose during the last week of treatment was 316 mg (range, 150–600 mg) in the remoxipride group and 8.7 mg (range, 5–20 mg) in the haloperidol group. The study period was six weeks with at least one day of washout. Both Clinical Global Impression (CGI) rating, and Brief Psychiatric Rating Scale (BPRS) total scores declined at the end of the trial compared with pretreatment values in both groups. No significant differences were found between the remoxipride and haloperidol groups with regard to the treatment outcome. Treatment‐emergent extrapyramidal symptoms were statistically more frequent and more severe during haloperidol than during remoxipride treatment. Haloperidol‐treated patients reported also significantly more concentration difficulties. Severe extrapyramidal side effects in the haloperidol group and clinical ineffectiveness in the remoxipride group were the most frequent reasons for premature discontinuation of treatment.
A double‐blind, randomized, multicentre study comparing the efficacy and safety of intramuscular (i.m.) remoxipride to that of i.m. haloperidol was undertaken in 119 psychotic patients (mean age: 37 ± 13.4 years). The study period was 1 week i.m., followed by 3 weeks of oral treatment. Dosage was 200–600 mg/day for remoxipride and 10–30 mg/day for haloperidol during i.m. and 150–600 mg/day for remoxipride and 10–40 mg/day for haloperidol during oral treatment. Both drugs produced marked clinical improvements during i.m. and oral treatment. During the i.m. week, the median Brief Psychiatric Rating Scale (BPRS) total score decreased from 51 to 34 in the remoxipride group and from 53 to 38 in the haloperidol group. Over the 4‐week treatment period, there was a significantly greater reduction in ‘some factors’ for remoxipride‐treated patients when compared to haloperidol‐treated patients. Somnolence was reported by 14% of haloperidol‐treated patients during i.m. treatment. Akathisia and tremor occurred significantly less in remoxipride‐treated patients as compared to haloperidol‐treated patients. Intramuscularly administered remoxipride is as effective as haloperidol in reducing acute phase psychotic symptoms, and is associated with fewer extrapyramidal symptoms.
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