pramipexole IR / Generic mfg. - LARVOL DELTA

Case Report: Neuropsychiatric and cognitive phenomena in a highly complex patient affected by psychiatric and oncological diseases. (PubMed, Front Psychiatry) - "This case report describes the management of a complex psycho-organic syndrome occurring in a patient treated with the combination of pembrolizumab and lenvatinib...Flumazenil was administered with diagnostic-therapeutic success to correct GABAergic redundancy, and pramipexole was introduced to treat extrapyramidal manifestations and akathisia. This case highlights how overlapping immunological, vascular, and neuropharmacological effects can generate reversible encephalopathic patterns in complex oncological patients. Symptom resolution through psychopharmacological modulation and suspension of targeted treatment alone underscores the critical importance of active neuropsychiatric surveillance and close interdisciplinary collaboration between oncologists and psychopharmacologists."

Journal • CNS Disorders • Cognitive Disorders • Depression • Endometrial Cancer • Mood Disorders • Movement Disorders • Oncology • Psychiatry • Solid Tumor

Pramipexole to Enhance Social Connections (clinicaltrials.gov) - P2 | N=108 | Active, not recruiting | Sponsor: University of California, San Diego | Recruiting ➔ Active, not recruiting | Trial completion date: Mar 2026 ➔ Mar 2027 | Trial primary completion date: Mar 2026 ➔ Nov 2026

Enrollment closed • Trial completion date • Trial primary completion date • CNS Disorders • Depression • Mood Disorders • Psychiatry

Pramipexole enhances levodopa's therapeutic efficacy in Parkinson's disease: Role of glutaredoxin-1 (GRX1), peroxiredoxin3 (PRX3), thioredoxin (TRX), 8-hydroxy-2 -deoxyguanosine (8-OHDG), and neurosteroid dehydroepiandrosterone sulfate (DHEA-S). (PubMed, J Med Biochem) - "The inclusion of novel biomarkers such asGrx1, Prx3, Trx, 8-OHdG, and DHEA-S provides deeperinsight into the molecular mechanisms underlying thesetherapeutic effects. This combination therapy represents avaluable strategy for improving PD management and warrants wider clinical application."

Journal • CNS Disorders • Movement Disorders • Parkinson's Disease • GLRX

A Study in Healthy People to Compare Two Tablet Formulations of Pramipexole (clinicaltrials.gov) - P1 | N=25 | Active, not recruiting | Sponsor: Boehringer Ingelheim | Recruiting ➔ Active, not recruiting

Enrollment closed

Adaptive Topology-Semantic Fusion Contrastive Learning for Drug Repositioning. (PubMed, J Chem Inf Model) - "Furthermore, by predicting previously unknown drug-disease associations on the Gdata set and validating them against authoritative databases, ATSFCL-DR identifies pramipexole as a promising candidate drug for Alzheimer's disease. In summary, ATSFCL-DR provides an effective approach for drug-disease association prediction and candidate drug screening by adaptively integrating topological and semantic information within a contrastive learning framework."

Journal • Alzheimer's Disease • CNS Disorders

Pramipexole and the Risk of Serious Adverse Events (clinicaltrials.gov) - P=N/A | N=1100 | Active, not recruiting | Sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's | Trial completion date: Dec 2024 ➔ Dec 2028 | Completed ➔ Active, not recruiting

Adverse events • Enrollment closed • Serious adverse event • Trial completion date • Chronic Kidney Disease • Nephrology • Renal Disease

Ekbom's Delusional Parasitosis Related to Pramipexole and Amantadine Use: A Case Report. (PubMed, J Pharm Pract) - "Delusional parasitosis can occur in patients receiving concomitant treatment with pramipexole and amantadine. Patients receiving high doses of these agents in combination with other risk factors such as advanced age and impaired renal function should be monitored for symptoms of delusional parasitosis."

Journal • CNS Disorders • Movement Disorders • Multiple Sclerosis • Parkinson's Disease • Psychiatry • Restless Legs Syndrome • Sleep Disorder

Identification of a Novel SLC18A2 Splicing Variant in a Case of Infantile Parkinsonism-Dystonia Type 2. (PubMed, Case Rep Neurol Med) - "Levodopa-benserazide failed to provide sustained benefit and caused irritability and insomnia, whereas pramipexole produced modest improvement in bradykinesia, ptosis, and sweating with persistence of dystonia and oculogyric crises. Comparison with reported international cases shows a consistent phenotype and limited therapeutic response. This case expands the mutational spectrum of SLC18A2-related disease and highlights the importance of early genetic diagnosis."

Journal • CNS Disorders • Developmental Disorders • Dystonia • Insomnia • Movement Disorders • Parkinson's Disease • Sleep Disorder

Pramipexole treatment and substance use disorder risk in unipolar and bipolar depression: a Swedish nationwide register study. (PubMed, Front Psychiatry) - "High cumulative exposure to pramipexole was associated with increased risk of incident substance use disorder in individuals with mood disorders, with the strongest associations observed in bipolar disorder. Although no causal inference can be made due to the observational design, these findings raise the possibility that prolonged pramipexole exposure may be associated with increased risk of substance use disorder in some psychiatric populations, particularly among individuals with bipolar disorder."

Journal • Bipolar Disorder • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

Pharmacological treatments of REM sleep behaviour disorder in synucleinopathies: a systematic review of effectiveness and safety. (PubMed, Sleep Med) - "pharmacological treatment of synucleinopathy-associated RBD remains supported by limited and heterogeneous evidence. Larger randomised trials using standardised clinical and vPSG outcomes are needed to clarify efficacy and safety."

Journal • Review • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Dementia • Lewy Body Disease • Movement Disorders • Multiple System Atrophy • Parkinson's Disease • Psychiatry • Sleep Disorder

A Study in Healthy People to Compare Two Tablet Formulations of Pramipexole (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: Boehringer Ingelheim | Not yet recruiting ➔ Recruiting

Enrollment open

Reproducible Generalized Thermal Sensation Triggered by Levodopa in a Patient With Parkinson's Disease. (PubMed, J Med Cases) - "The phenomenon was subsequently reproduced during supervised medication rechallenge, but did not occur during monotherapy or combination therapy with dopamine agonists (pramipexole, rotigotine, and bromocriptine) and selegiline. The described phenomenon may represent a rare or underrecognized adverse effect of levodopa. As a part of comprehensive follow-up on patient's health and wellbeing after treatment for PD, careful attention to emergent unusual thermal phenomena can constitute good clinical practice."

Journal • CNS Disorders • Movement Disorders • Pain • Parkinson's Disease

Pramipexole alleviates non-motor symptoms and autophagy-related protein abnormalities in a dual neurotoxin Parkinson's disease model. (PubMed, Brain Res Bull) - "In our molecular detection, PPX treatment was accompanied by enhanced key components of autophagy (Beclin-1/P62) and rectified deficient mitophagy (BNIP3L/PINK1/Parkin). This study identifies PPX as a dual-action therapeutic that concurrently alleviates motor/NMS in PD model mice, and this therapeutic effect may be associated with altered expression of autophagy-related proteins."

Journal • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Depression • Mood Disorders • Movement Disorders • Parkinson's Disease • Psychiatry • BECN1 • BNIP3L

Comparative pharmacovigilance of Levodopa and Pramipexole: a disproportionality analysis of the FAERS database. (PubMed, Neurol Sci) - "This large-scale study confirms the well-established risks of both drugs and identifies potential new safety signals for Levodopa, particularly concerning respiratory manifestations. The fundamentally distinct risk profiles underscore the necessity for drug-specific monitoring strategies and caution in combination therapy. These findings provide critical real-world evidence for optimizing risk-benefit management in PD."

Adverse events • Clinical • Journal • CNS Disorders • Mental Retardation • Movement Disorders • Parkinson's Disease • Psychiatry • Restless Legs Syndrome • Sleep Disorder

Pramipexole ameliorates cognitive deficits in aged mice after sevoflurane anesthesia by upregulating dopamine D2 receptors in parvalbumin interneuron of the hippocampus. (PubMed, Exp Neurol) - "PPX attenuated glial cell activation, reversed the downregulation of parvalbumin (PV) expression, rescued the reduction in the activity of PV interneuron and the imbalance of local neuronal excitatory/inhibitory, reversed the reduction in gamma oscillations, and ameliorated the downregulation of dopamine D2 receptors in the hippocampus after repeated sevoflurane exposure in aged mice. Our findings suggest that PPX confers neuroprotection, at least in part, by attenuating neuroinflammation and PV interneuron dysfunction via upregulation of hippocampal dopamine D2 receptors, thereby ameliorating memory and cognitive deficits."

Journal • Preclinical • Alzheimer's Disease • Anesthesia • CNS Disorders • Cognitive Disorders • Inflammation • Movement Disorders • Parkinson's Disease • Restless Legs Syndrome • Sleep Disorder • DRD2

When Psychosis Conceals a Motor Crisis: A Misleading Case of Catatonia Unveiling Parkinson's Disease off Phenomenon. (PubMed, Acta Neurol Taiwan) - "A Bush-Francis Catatonia Rating Scale score of 16 was documented, but a lorazepam challenge failed to elicit improvement. These symptoms coincided with the tapering of dopaminergic therapy, particularly pramipexole...This case highlights the importance of distinguishing catatonia from PD off states in patients with overlapping motor and psychiatric symptoms. Careful medication history, response to benzodiazepines, and interdisciplinary collaboration are critical to diagnostic accuracy and treatment success."

Journal • CNS Disorders • Depression • Movement Disorders • Parkinson's Disease • Psychiatry

A Study in Healthy People to Compare Two Tablet Formulations of Pramipexole (clinicaltrials.gov) - P1 | N=24 | Not yet recruiting | Sponsor: Boehringer Ingelheim

New P1 trial

Response to the commentary by Tundo et al. on "Pramipexole exposure and risk of incident gambling disorder in individuals with psychiatric disorders: A nationwide register-based cohort study". (PubMed, J Affect Disord) - No abstract available

Journal • CNS Disorders • Mental Retardation • Psychiatry

Intranasal 6-OHDA Induces TRPM3-mediated Neuroinflammation in the pVTA: A Preclinical Early-stage Parkinson's Disease Model. (PubMed, Mol Neurobiol) - "Intraperitoneal (i.p.) treatment of TRPM3 inhibitor primidone (2.5, 5, and 10 mg/kg) significantly reversed these alterations, and standard pramipexole (3 mg/kg, i.p.) also reduced behavioral deficits. Overall, the intranasal 6-OHDA model reproduces key features of early-stage PD, including non-motor deficits, dopaminergic dysfunction, TRPM3-associated neuroinflammation, and impaired neuroplasticity, providing a simple and clinically relevant platform for therapeutic evaluation."

Journal • Preclinical • CNS Disorders • Cognitive Disorders • Depression • Inflammation • Mood Disorders • Movement Disorders • Parkinson's Disease • Psychiatry • IL1B • TRPM3

Generic vs. brand-name pramipexole: effectiveness, safety, and cost comparison in a multicenter retrospective cohort study. (PubMed, Front Aging Neurosci) - "With comparable efficacy and safety, our results indicate the generic pramipexole should be considered a valuable alternative to the brand-name drug. Future prospective research is needed to confirm these findings in clinical practice."

HEOR • Journal • Reimbursement • Retrospective data • US reimbursement • CNS Disorders • Movement Disorders • Parkinson's Disease

Pramipexole Versus Escitalopram to Treat Major Depressive Disorder (MDD) and Comorbid MDD With Mild Neurocognitive Disorder (MND) in Persons With HIV (clinicaltrials.gov) - P2 | N=186 | Suspended | Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) | Recruiting ➔ Suspended

Trial suspension • CNS Disorders • Cognitive Disorders • Depression • Developmental Disorders • Human Immunodeficiency Virus • Infectious Disease • Major Depressive Disorder • Mood Disorders • Psychiatry

Comment on "Pramipexole exposure and risk of incident gambling disorder in individuals with psychiatric disorders: A nationwide register-based cohort study". (PubMed, J Affect Disord) - No abstract available

Journal • CNS Disorders • Mental Retardation • Psychiatry

Pharmacological treatment of anhedonic depression: the role of dopaminergic and anti-inflammatory mechanisms. (PubMed, Expert Opin Pharmacother) - No abstract available

Journal • CNS Disorders • Depression • Inflammation • Mood Disorders • Psychiatry

Gait Analysis in Neurological Disease (clinicaltrials.gov) - P=N/A | N=120 | Active, not recruiting | Sponsor: Beth Israel Deaconess Medical Center | Recruiting ➔ Active, not recruiting | Trial completion date: Jun 2026 ➔ Jul 2027 | Trial primary completion date: Jun 2026 ➔ Jul 2027

Enrollment closed • Trial completion date • Trial primary completion date • Ataxia • CNS Disorders • Genetic Disorders • Huntington's Disease • Movement Disorders • Multiple System Atrophy • Parkinson's Disease • Progressive Supranuclear Palsy

Long-term survival in glioblastoma patients treated with dopamine agonists: A report of two cases and implications for drug repurposing. (PubMed, Surg Neurol Int) - "The first patient, treated with the ergot derivative bromocriptine for a prolactinoma, presented with multifocal disease and underwent subtotal resection...The second patient, a 70-year-old male with Parkinson's disease treated with the non-ergot dopamine agonist pramipexole and with Sinemet, which increases the amount of available dopamine...These observational cases suggest a hypothetical association between dopamine agonist therapy and improved survival outcomes in GBM, challenging the current paradigm that favors receptor antagonism. Given the safety, low cost, and blood-brain barrier penetrance of these Food and Drug Administration-approved drugs, we propose that dopamine agonists warrant further investigation as repurposed adjuvant agents in GBM treatment."

Journal • Brain Cancer • CNS Disorders • Glioblastoma • Movement Disorders • Oncology • Parkinson's Disease • Solid Tumor • DRD2