Side Effects of ganaxolone: A Synthesis of Findings from 21 Studies

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This analysis is based on research papers included in PubMed, but medical research is constantly evolving and may not fully reflect the latest findings. There may also be biases towards certain research areas.

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Original Abstract of the Article

Major Research Findings

Ganaxolone, a synthetic neuroactive steroid, shows promise as a treatment for epilepsy, especially for catamenial epilepsy, a type of epilepsy linked to the menstrual cycle. 18 , 9 , and 15 highlight the potential of ganaxolone in this area. It works by interacting with GABA-A receptors in the brain, which helps to control nerve impulses and reduce seizures. 21 suggests that ganaxolone might even enhance the effects of diazepam, another drug used to treat seizures. 13 even points to ganaxolone's potential effectiveness in treating infantile spasms, a severe form of epilepsy in infants.

Reasons for Side Effects

The side effects of ganaxolone likely stem from its mechanism of action. By interacting with GABA-A receptors, it can suppress nerve activity, which can lead to unwanted effects. 19 suggests this mechanism might be involved in some of the observed side effects. Additionally, the study in 16 indicates that high doses of ganaxolone might negatively impact motor function.

Common Side Effects

Motor Impairment

Research indicates that ganaxolone can have a negative impact on motor function, especially at higher doses. 21 shows that ganaxolone can decrease motor ability in mice when administered in high doses. Similarly, 16 suggests that ganaxolone can affect motor function in rats at high doses.

Sedation

Studies have suggested that ganaxolone can lead to sedation. 21 indicates that ganaxolone has sedative effects in mice. 9 also points out that progesterone and its derivatives show sedative effects in animal models.

Measures for Side Effects

Measures for Motor Impairment

To prevent motor impairment, adjusting the dosage of ganaxolone is crucial. Gradual increases in dosage can help minimize the risk of motor impairment. Furthermore, administering other medications alongside ganaxolone may also help reduce this risk.

Measures for Sedation

Preventing sedation requires careful adjustment of ganaxolone dosage. Adjusting the time of ganaxolone administration can help mitigate sedation. For instance, administering ganaxolone before bedtime is a possible approach.

Comparison between Studies

Commonalities in Studies

Multiple studies indicate that ganaxolone's antiepileptic effects stem from its interaction with GABA-A receptors. The common finding across studies is that ganaxolone has the potential to induce sedation. Additionally, a consistent finding is that ganaxolone may have a negative impact on motor function.

Differences in Studies

Variations in animal species and dosages used in studies investigating ganaxolone's side effects can lead to discrepancies in findings. Furthermore, some studies report varying degrees of ganaxolone's side effects. Therefore, further research is crucial to thoroughly investigate ganaxolone's side effects.

Points to Note for Real-Life Applications

Numerous studies demonstrate that ganaxolone is a promising medication for treating epilepsy. However, as ganaxolone can potentially cause side effects like sedation and motor impairment, it's essential to take it as directed by your doctor. While taking ganaxolone, avoid activities that require alertness, such as driving or operating machinery. If you experience any unusual symptoms while taking ganaxolone, consult your doctor immediately.

Limitations of Current Research

Research on ganaxolone is still in its early stages. Long-term side effects of ganaxolone are not yet fully understood. Clinical trials on ganaxolone are currently limited. Therefore, further research is needed to fully assess the safety of ganaxolone.

Future Research Directions

To investigate ganaxolone's side effects in greater detail, clinical trials involving humans are required. Long-term follow-up studies are needed to investigate the long-term side effects of ganaxolone. Further research is essential to determine the optimal dosage and administration methods for ganaxolone.

Conclusion

Numerous studies show that ganaxolone is a promising medication for the treatment of epilepsy. However, as ganaxolone can potentially cause side effects such as sedation and motor impairment, it's crucial to take it as directed by your doctor. Further research is needed to fully assess the safety of ganaxolone.

Literature analysis of 21 papers
Positive Content
20
Neutral Content
0
Negative Content
1
Article Type
5
0
0
8
21
1.

Treatment of perennial rhinitis with flunisolide corticosteroid spray.

Author: JonesL M, SpectorS L, EnglishG M, Taylor-DawsonK

Reduced eosinophils
Candida infection

Flunisolide nasal spray was not significantly different from placebo in treating perennial rhinitis. Both groups showed a decrease in eosinophils on nasal smears.

Clinical TrialA clinical trial is a planned study conducted on humans to evaluate the efficacy and safety of pharmaceuticals, medical devices, and treatment methods. It aims to explore the possibilities of new treatments and improve the health of patients.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.

Language : English

2.

Flunisolide--a new intranasal steroid for the treatment of allergic rhinitis.

Author: SahayJ N, ChatterjeeS S, EnglerC

Improved everyday life
Improved sleep quality
Relieved nasal obstruction
Relieved sneezing
Minor side effects

A study of 50 patients with perennial allergic rhinitis found that flunisolide nasal spray (200 micrograms daily) was significantly more effective than a placebo in reducing symptoms of sneezing, nasal congestion, post-nasal drip, and improving sleep and daily life. Both patients and doctors preferred the flunisolide spray. Minor side effects were reported during both placebo and flunisolide phases, and no evidence of adrenal suppression was observed.

Clinical TrialA clinical trial is a planned study conducted on humans to evaluate the efficacy and safety of pharmaceuticals, medical devices, and treatment methods. It aims to explore the possibilities of new treatments and improve the health of patients.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.

Language : English

3.

Flunisolide nasal spray for perennial rhinitis in children.

Author: SarsfieldJ K, ThomsonG E

Effective rhinitis treatment
No adrenal axis effect
Safe for children
Nasal stinging

A study of 27 children with perennial rhinitis found that flunisolide nasal spray was significantly more effective than a placebo in relieving symptoms. Patients, doctors, and diary card assessments all favored flunisolide. The most common side effect was temporary nasal stinging. Flunisolide treatment was safe and did not affect the pituitary-adrenal axis. The study concluded that flunisolide is a safe and effective treatment for perennial rhinitis in children.

Clinical TrialA clinical trial is a planned study conducted on humans to evaluate the efficacy and safety of pharmaceuticals, medical devices, and treatment methods. It aims to explore the possibilities of new treatments and improve the health of patients.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.

Language : English

4.

A comparative trial testing budesonide and flunisolide nasal sprays in patients with seasonal allergic rhinitis.

Author: PipkornU, GeterudA

Effective for rhinitis
Nasal irritation

Both budesonide and flunisolide nasal sprays were effective in controlling nasal symptoms in patients with seasonal allergic rhinitis. However, flunisolide was associated with a higher incidence of nasal irritation.

Clinical TrialA clinical trial is a planned study conducted on humans to evaluate the efficacy and safety of pharmaceuticals, medical devices, and treatment methods. It aims to explore the possibilities of new treatments and improve the health of patients.
Comparative StudyResearch that compares multiple groups/interventions to determine differences/similarities in outcomes/characteristics.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

5.

Short-term efficacy trial and twenty-four-month follow-up of flunisolide nasal spray in the treatment of perennial rhinitis.

Author: ClaytonD E, KooistraJ B, GellerM, OuelletteJ, CohenM, ReedC E, BusseW

No adrenal suppression
Safe and effective

Flunisolide nasal spray was found to be safe and effective in treating perennial rhinitis. No serious side effects were observed over a two-year follow-up period.

Clinical TrialA clinical trial is a planned study conducted on humans to evaluate the efficacy and safety of pharmaceuticals, medical devices, and treatment methods. It aims to explore the possibilities of new treatments and improve the health of patients.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.
Research Support, U.S. Gov't, P.H.S.Research funding provided by the Public Health Service (PHS).

Language : English

6.

Isobolographic analysis of adjunct antiseizure activity of the FDA-approved cannabidiol with neurosteroids and benzodiazepines in adult refractory focal onset epilepsy.

Author: GolubVictoria, RamakrishnanSreevidhya, ReddyDoodipala Samba

Epilepsy treatment
Seizure prevention

This study evaluated the adjunct antiseizure activity of a clinical CBD product in an adult 6-Hz model of focal refractory epilepsy. CBD was found to be effective both as a monotherapy and as an adjunct therapy in combination with GABAergic ASMs.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, N.I.H., ExtramuralResearch funding provided by the NIH to external research institutions and researchers.
Research Support, U.S. Gov't, Non-P.H.S.Research funding provided by US government agencies other than the Public Health Service.

Language : English

7.

Novel antidepressant drugs: Beyond monoamine targets.

Author: GondaXenia, DomePeter, NeillJoanna C, TaraziFrank I

Improved efficacy of antidepressants
Reduced side effects

Antidepressants have been largely focused on targeting monoamine neurotransmitters but have limited efficacy and side effects. Novel antidepressants are being developed that target other pathways, including glutamatergic and GABAergic pathways, to improve efficacy, safety, and tolerability. Psychedelic drugs like psilocybin, Ayahuasca, 5-MeO-DMT, and LSD are also being explored as potential treatments for depression.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

8.

[New antiepileptic drugs].

Author: VidaurreJorge, HerbstJames

Epilepsy treatment
Side effects

This study explores the effectiveness and safety profile of third-generation antiepileptic drugs for treating epilepsy. It highlights the benefits of newer drugs like brivaracetam, clobazam, lacosamide, and eslicarbazepine in managing different types of seizures and discusses the potential future role of drugs like cannabidiol, fenfluramine, allopregnenolona, and ganaxolone.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : Spanish

10.

Neurosteroid replacement therapy using the allopregnanolone-analogue ganaxolone following preterm birth in male guinea pigs.

Author: ShawJulia C, DysonRebecca M, PalliserHannah K, GrayClint, BerryMary J, HirstJonathan J

Neurodevelopmental impairment
Preterm birth

Premature babies, especially boys, have a higher chance of developing ADHD and learning problems. Ganaxolone treatment after preterm birth could potentially reduce these developmental issues.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

11.

Effects of antiepileptic drugs on mitochondrial functions, morphology, kinetics, biogenesis, and survival.

Author: FinstererJosef, ScorzaFulvio A

Mitochondrial function
Mitochondrial damage

This review discusses the effects of antiepileptic drugs (AEDs) on mitochondria, focusing on the implications for patients with mitochondrial disorders and epilepsy. The study highlights the complex interactions between AEDs and mitochondrial function, which can both benefit and harm patients with these conditions.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

13.

A potential effect of ganaxolone in an animal model of infantile spasms.

Author: YumMi-Sun, LeeMinyoung, KoTae-Sung, VelíšekLibor

IS treatment

This study used an animal model of infantile spasms (IS) to test the efficacy of ganaxolone, a synthetic neurosteroid, in promoting tonic GABAA inhibition.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

14.

Recent advances in the pharmacotherapy of infantile spasms.

Author: RiikonenRaili

Improved cognitive outcome
Infantile spasms treatment
Side effects

This review examines recent developments in the pharmacotherapy of infantile spasms, focusing on first-line treatments such as ACTH, oral corticosteroids, and vigabatrin, as well as other antiepileptic drugs and novel treatments. The article highlights the importance of early intervention and the potential for preventive treatments.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

15.

Neurosteroids: endogenous role in the human brain and therapeutic potentials.

Author: ReddyDoodipala Samba

Anti-seizure activity
Improve memory
Reduce anxiety
Treat anxiety
Treat depression
Treat epilepsy

Neurosteroids are synthesized in the brain and rapidly modulate neuronal excitability. They have therapeutic potential in anxiety, epilepsy, and other brain disorders.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, N.I.H., ExtramuralResearch funding provided by the NIH to external research institutions and researchers.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

16.

Anticonvulsant doses of ganaxolone do not compromise motor performance in immature rats.

Author: MaresPavel, StehlíkováMariana

Anticonvulsant effect
Motor function compromise

Ganaxolone, a neuroactive steroid, showed anticonvulsant effects in rats, specifically suppressing epileptic afterdischarges (ADs) in 25-day-old rats and delaying their onset in 12-day-old rats.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

17.

Role of neurosteroids in catamenial epilepsy.

Author: ReddyDoodipala S

Increased seizures

Catamenial epilepsy is a seizure disorder that occurs in relation to the menstrual cycle. Current treatments are not specific to this condition. The study discusses the potential of neurosteroids as a novel treatment option.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

19.

Effect of ganaxolone on flurothyl seizures in developing rats.

Author: LiptákováS, VelísekL, VelískováJ, MoshéS L

Anticonvulsant effect
Motor side effects

Ganaxolone (GNX) has anticonvulsant effects against flurothyl-induced seizures in all age groups tested. Its effects are more prominent in the two younger age groups, especially in PN 15 rats, but are associated with motor side effects.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.
Research Support, U.S. Gov't, P.H.S.Research funding provided by the Public Health Service (PHS).

Language : English

20.

Effect of ganaxolone in a rodent model of cerebral hematoma.

Author: LydenP, ShinC, Jackson-FriedmanC, HassidS, ChongA, MacdonaldR L

Treatment of intracerebral hematoma

Ganaxolone, a synthetic neuroactive steroid that positively modulates GABA, may be beneficial in treating intracerebral hematoma.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.
Research Support, U.S. Gov't, Non-P.H.S.Research funding provided by US government agencies other than the Public Health Service.

Language : English

21.

Anticonvulsant and behavioral effects of neuroactive steroids alone and in conjunction with diazepam.

Author: GasiorM, CarterR B, GoldbergS R, WitkinJ M

anticonvulsant effect
epilepsy treatment
motor toxicity

Neuroactive steroids may be a new direction for epilepsy treatment. This study evaluated the protective effects of four neuroactive steroids against seizures in mice. The steroids, along with diazepam and phenobarbital, protected against pentylenetetrazol-induced convulsions. Neuroactive steroids were also effective against cocaine-induced convulsions and some were effective against N-methyl-D-aspartate-induced seizures and lethality.

Comparative StudyResearch that compares multiple groups/interventions to determine differences/similarities in outcomes/characteristics.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, U.S. Gov't, P.H.S.Research funding provided by the Public Health Service (PHS).

Language : English

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