Mazindol in long-term treatment of narcolepsy

Álvarez, Beatriz Suárez; Dahlitz, M.; Grimshaw, Jeremy; Parkes, J. D.

doi:10.1016/0140-6736(91)92966-6

Cited by 30 publications

(6 citation statements)

References 2 publications

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“… 45 In our study, although AEs occurred in most patients, they were mild or moderate, and none of them required treatment discontinuation. Decreased appetite, already reported with mazindol, 39 is consistent with a pharmacological effect of psychostimulants. 11 Similarly, cardiac function and ECG measurements remained unchanged.…”

Section: Discussionsupporting

confidence: 69%

“… 17 Mazindol has previously been marketed under the brand names Teronac ® (Europe) and Sanorex ® (Canada), and used in short-term treatment of exogenous obesity, in combination with a regimen of weight reduction in patients with such risk factors as hypertension, diabetes, or hyperlipidemia. 31 – 34 Mazindol (1–6 mg/day) has also been studied in the treatment of excessive daytime sleepiness (eg, narcolepsy), 35 – 39 and in the present study, the low dose of 1 mg per day for 7 days was selected based on these previous data.…”

Section: Discussionmentioning

confidence: 99%

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Pilot Phase II study of mazindol in children with attention deficit/hyperactivity disorder

Konofal

Zhao

Laouénan

et al. 2014

DDDT

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ObjectiveMazindol has been proposed as a potential treatment of children with attention deficit/hyperactivity disorder (ADHD). The purpose of this pilot study was to assess its pharmacokinetics, short-term efficacy, and safety.Subjects and methodsA total of 24 children (aged 9–12 years) with ADHD (according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, text-revision criteria) received a daily dose of 1 mg for 7 days and were followed for 3 additional weeks. Pharmacokinetic samples were collected after the first administration. ADHD symptoms were assessed using the ADHD Rating Scale (RS)-IV, Conners’ Parent Rating Scale – Revised: Long (CPRS-R:L) at screening, baseline, and the end of the study. The Clinical Global Impression – Severity (CGI-S) scale was assessed at baseline, and the CGI – Improvement (CGI-I) scale was assessed at subsequent visits.ResultsTwenty-one subjects (aged 10±1 years) were analyzed. Pharmacokinetic data were described by a one-compartment model with first-order absorption, elimination, and lag time. The typical apparent clearance and apparent volume of distribution were 27.9 L/h and 234 L, and increased with fat-free mass and age, respectively. The mean change in score in ADHD RS-IV after 1 week of mazindol was −24.1 (P<0.0001), greater than a 90% improvement from baseline. Reduction of CPRS-R:L and CGI-S scores were −52.1 (P<0.0001) and −2.5 (P<0.01), respectively. Adverse events were mild to moderate, decreased appetite and upper abdominal pain being the most common.ConclusionThis preliminary study shows that mazindol might be an effective, well-tolerated, and long-acting (more than 8 hours) agent for the treatment of ADHD in children.

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Section: Discussionsupporting

confidence: 69%

Section: Discussionmentioning

confidence: 99%

Pilot Phase II study of mazindol in children with attention deficit/hyperactivity disorder

Konofal

Zhao

Laouénan

et al. 2014

DDDT

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“…According to a class II evidence study [22] mazindol was effective on reducing sleepiness at a dose of 2 + 2 mg/day (during 4 weeks) in 53–60% of subjects. In addition several class IV evidence studies [42–45] have shown significant improvement of sleepiness in 50–75% of patients. Clinical experience suggests to start treatment at a low dosage of 1 mg/day which may be effective in individual patients.…”

Section: Resultsmentioning

confidence: 99%

EFNS guidelines on management of narcolepsy

Billiard

Bassetti

Dauvilliers

et al. 2006

Euro J of Neurology

229

131

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Management of narcolepsy with or without cataplexy relies on several classes of drugs, namely stimulants for excessive daytime sleepiness and irresistible episodes of sleep, antidepressants for cataplexy and hypnosedative drugs for disturbed nocturnal sleep. In addition, behavioral measures can be of notable value. Guidelines on the management of narcolepsy have already been published. However contemporary guidelines are necessary given the growing use of modafinil to treat excessive daytime sleepiness in Europe within the last 5-10 years, and the decreasing need for amphetamines and amphetamine-like stimulants; the extensive use of new antidepressants in the treatment of cataplexy, apart from consistent randomized placebo-controlled clinical trials; and the present re-emergence of gamma-hydroxybutyrate under the name sodium oxybate, as a treatment of all major symptoms of narcolepsy. A task force composed of the leading specialists of narcolepsy in Europe has been appointed. This task force conducted an extensive review of pharmacological and behavioral trials available in the literature. All trials were analyzed according to their class evidence. Recommendations concerning the treatment of each single symptom of narcolepsy as well as general recommendations were made. Modafinil is the first-line pharmacological treatment of excessive daytime sleepiness and irresistible episodes of sleep in association with behavioral measures. However, based on several large randomized controlled trials showing the activity of sodium oxybate, not only on cataplexy but also on excessive daytime sleepiness and irresistible episodes of sleep, there is a growing practice in the USA to use it for the later indications. Given the availability of modafinil and methylphenidate, and the forseen registration of sodium oxybate for narcolepsy (including excessive daytime sleepiness, cataplexy, disturbed nocturnal sleep) in Europe, the place of other compounds will become fairly limited. Since its recent registration cataplexy sodium oxybate has now become the first-line treatment of cataplexy. Second-line treatments are antidepressants, either tricyclics or newer antidepressants, the later being increasingly used these past years despite few or no randomized placebo-controlled clinical trials. As for disturbed nocturnal sleep the best option is still hypnotics until sodium oxybate is registered for narcolepsy. The treatments used for narcolepsy, either pharmacological or behavioral, are diverse. However the quality of the published clinical evidences supporting them varies widely and studies comparing the efficacy of different substances are lacking. Several treatments are used on an empirical basis, specially antidepressants for cataplexy, due to the fact that these medications are already used widely in depressed patients, leaving little motivation from the manufacturers to investigate efficacy in relatively rare indications. Others, in particular the more recently developed substances, such as modafinil or sodium oxybate, are evaluated...

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“…In France, mazindol was available for the treatment of EDS in narcolepsy until 2016, with a therapeutic dosage that varied from 1 to 4 mg per day. Hepatotoxicity has been described for this drug [52,53], and new results on the risk-benefit ratio are needed in narcolepsy.…”

Section: Third-line Treatmentsmentioning

confidence: 99%

Narcolepsy treatment: pharmacological and behavioral strategies in adults and children

et al. 2019

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Narcolepsy is a disabling, rare, and chronic sleep disorder, currently classified as distinct central nervous system hypersomnia in narcolepsy type 1 (NT1) and narcolepsy type 2 (NT2). Although today a reliable pathogenic hypothesis identifies the cause of NT1 as an autoimmune process destroying hypocretin-producing cells, there is no cure for narcolepsy, and the symptomatic pharmacological available treatments are not entirely effective for all symptoms. Behavioral therapies play a synergistic role in the disease treatment. We here review the available therapeutic options for narcolepsy, including symptomatic pharmacological treatments as well as behavioral and psychosocial interventions that could help clinicians improve the quality of life of patients with narcolepsy in adulthood and childhood.

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Mazindol in long-term treatment of narcolepsy

Cited by 30 publications

References 2 publications

Pilot Phase II study of mazindol in children with attention deficit/hyperactivity disorder

Pilot Phase II study of mazindol in children with attention deficit/hyperactivity disorder

EFNS guidelines on management of narcolepsy

Narcolepsy treatment: pharmacological and behavioral strategies in adults and children

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