levodopa/carbidopa CR / Generic mfg. - LARVOL DELTA

Effect of Long-acting Levodopa on Obstructive Sleep Apnea in Parkinson's Disease (clinicaltrials.gov) - P4 | N=36 | Completed | Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre | Recruiting ➔ Completed

Trial completion • CNS Disorders • Movement Disorders • Obstructive Sleep Apnea • Parkinson's Disease • Respiratory Diseases • Sleep Disorder

"In my experience SInemet CR worsen dyskinesia" (@Marcelo65708093)

Movement Disorders

Pharmaceutical and pharmacokinetic evaluation of a newly formulated multiparticulate matrix of levodopa and carbidopa. (PubMed, ADMET DMPK) - "The AUC for levodopa/carbidopa multiparticulate matrix (Formulation 3: 484.98 ± 18.70 μg.hr/mL); Formulation 4: 535.60 ± 33.04 μg.hr/mL), and C (Formulation 3: 36.28 ± 1.52 μg/mL; Formulation 4: 34.80 ± 2.19 μg/mL) were higher than Sinemet CR (AUC 262.84 ± 16.73 μg.hr/mL and C 30.62 ± 3.37 μg/mL). The t of the new formulation was longer compared to Sinemet CR."

Journal • PK/PD data • CNS Disorders • Movement Disorders • Parkinson's Disease

Effect of Long-acting Levodopa on Obstructive Sleep Apnea in Parkinson's Disease (clinicaltrials.gov) - P4 | N=42 | Recruiting | Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre | Trial completion date: Mar 2022 ➔ Mar 2023 | Trial primary completion date: Feb 2022 ➔ Dec 2022

Trial completion date • Trial primary completion date • CNS Disorders • Movement Disorders • Obstructive Sleep Apnea • Parkinson's Disease • Respiratory Diseases • Sleep Disorder

TESDR: Treating Early Stage Diabetic Retinopathy (clinicaltrials.gov) - P1 | N=244 | Enrolling by invitation | Sponsor: VA Office of Research and Development | Not yet recruiting ➔ Enrolling by invitation

Enrollment open • Diabetic Retinopathy • Retinal Disorders

European Academy of Neurology/Movement Disorder Society-European Section Guideline on the Treatment of Parkinson's Disease: I. Invasive Therapies. (PubMed, Mov Disord) - "Evidence for invasive therapies in PD is heterogeneous. Only some of these therapies have a strong scientific basis. They differ in their profile of effects and have been tested only for specific patient groups."

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

TESDR: Treating Early Stage Diabetic Retinopathy (clinicaltrials.gov) - P1 | N=244 | Not yet recruiting | Sponsor: VA Office of Research and Development | Initiation date: Apr 2022 ➔ Jul 2022

Trial initiation date • Diabetic Retinopathy • Retinal Disorders

"Question: How much time between the last dosage of Sinemet and Sinemet CR ?" (@GerryGennarelli)

TESDR: Treating Early Stage Diabetic Retinopathy (clinicaltrials.gov) - P1; N=244; Not yet recruiting; Sponsor: VA Office of Research and Development

New P1 trial • Diabetic Retinopathy • Retinal Disorders

Parkinson’s Disease On-Demand Morning Therapy - Episode 7: The Relationship Between the Gut and Parkinson’s Disease (NeurologyLive) - "Stuart Isaacson, MD: Initially, the carbidopa levodopa works so consistently, the so-called honeymoon period, and then we get these OFF episodes that disrupt, and the benefit of dose of medications are gone and the symptoms reemerge....Daniel E. Kremens, MD, JD: Bill focused primarily on the central mechanism of motor fluctuation, but he hinted that there's this peripheral mechanism, and that was getting to the gut described as the second brain. In patients with Parkinson, the gut is loaded with Lewy body pathology, as we see in the brain....William G. Ondo, MD: There are a number of things inhibiting oral levodopa and, to some extent, other oral medications. It's quite a journey from the mouth to the brain, down a slowed esophagus, a slowed stomach for levodopa's sake, into the ileum where it has to be absorbed-a very small area, and it competes with other branch chain neutral amino acids."

Video

Parkinson’s Disease On-Demand Morning Therapy - Episode 5: Parkinson’s Disease: Evaluating Patients for OFF Episodes (NeurologyLive) - "Stuart Isaacson, MD: How do you evaluate your patients for OFF, and how do you evaluate patients from morning OFF? Patients don't always come in and say that they have a morning OFF. How do you look for it, and what questions do you ask? Which patients do you ask? William G. Ondo, MD: After asking about how they're doing, typically my next question is, 'Tell me the exact times you're taking your levodopa'-7:11, 3:08, whatever. 'At any point in between these doses, are your symptoms changing? Is anything worse?' I often say, 'Around the time you're taking a pill,' because some patients think that when they take the pill, in 2 seconds the pill is going to have its effect, but it's typically at least 30 minutes'....Khashayar Dashtipour, MD: I start with education because I can get important information from my patient if I educate them about why I'm asking the question."

Video

Effect of Long-acting Levodopa on Obstructive Sleep Apnea in Parkinson's Disease (clinicaltrials.gov) - P4; N=42; Recruiting; Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre; Trial completion date: Dec 2021 ➔ Mar 2022; Trial primary completion date: Jul 2021 ➔ Feb 2022

Trial completion date • Trial primary completion date • CNS Disorders • Movement Disorders • Obstructive Sleep Apnea • Parkinson's Disease • Respiratory Diseases • Sleep Disorder

VCU Parkinson's and Movement Disorders Center - "Levodopa is the most effective medication for managing the motor symptoms of Parkinson's disease; nevertheless, quite a bit of controversy exists about the ideal time to initiate levodopa therapy. Some physicians believe that it should be the drug of first choice for everyone, while others prefer to rely on other medications for as long as possible before starting levodopa. In this webinar, we will discuss the rationale for both treatment paradigms."

Live event

MSD withdraws Parkinson's disease treatment from Korean market (Korea Biomedical Review) - "The Ministry of Food and Drug Safety said MSD withdrew all three of its Sinemet lineup of Parkinson's disease treatment -- Sinemet, Sinemet 25/100, and Sinemet-CR -- from Korea on Tuesday....Experts pointed out that substitute drugs with the same ingredients and content have been available while MSD discontinued their distribution."

Commercial • CNS Disorders • Parkinson's Disease

Per-oral image guided gastrojejunostomy insertion for levodopa-carbidopa intestinal gel in Parkinson's disease is safe and may be advantageous. (PubMed, Parkinsonism Relat Disord) - "In summary, PIG-J insertion is safe with a similar complication rate to traditional PEG-J, well tolerated and effective for use in LCIG administration. This may widen access to LCIG for PD patients who may not be suitable or unable to tolerate PEG-J."

Journal • Anesthesia • CNS Disorders • Infectious Disease • Movement Disorders • Parkinson's Disease

Chitosan-Coated Hydroxypropylmethyl Cellulose Microparticles of Levodopa (and Carbidopa): In Vitro and Rat Model Kinetic Characteristics. (PubMed, Curr Ther Res Clin Exp) - "In evaluating in vivo pharmacokinetics, Sprague Dawley rats were administered either levodopa/carbidopa powder, levodopa/carbidopa microparticles, or Sinemet CR (a controlled release formulation of levodopa/carbidopa)."

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

"Dr Okin,57yr old male y.o.p.d. Do 10/31/2005. Sinemet cr 50/200 1q 3h - Sinemet 25/100 1.5 q3. Amantadine q6 Doing fairly well but eye trouble is problematic. Convergence issues inc double visionHave a prism in my eyeglasses but it’s a struggle. One neuro-opthamologist ,in town" (@chico1640101)

Episode 10: Device-Assisted and Surgical Options for Advanced Motor Fluctuations in Parkinson’s Disease (NeurologyLive) - "Rajeev Kumar, MD: Typically, we've used the term device-aided therapies to refer to both deep-brain stimulation [DBS] and to pump therapies. If we think about surgical options, we could potentially talk about lesioning therapies also....Daniel E. Kremens, MD, JD: Then they'll opt for Duopa [carbidopa-levodopa] therapy. You are right: The size can be challenging. However, I've had a lot of clever patients come up with all sorts of ways to hide their pump in clothing. They design stuff."

Interview • Video

Nondopaminergic therapies should be used before increasing levodopa for OFF episodes: Yes (CONy 2020) - No abstract available.

Effect of Long-acting Levodopa on Obstructive Sleep Apnea in Parkinson's Disease (clinicaltrials.gov) - P4; N=42; Recruiting; Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre; Trial completion date: Sep 2021 ➔ Dec 2021; Trial primary completion date: Jan 2021 ➔ Jul 2021

Trial completion date • Trial primary completion date • CNS Disorders • Movement Disorders • Obstructive Sleep Apnea • Parkinson's Disease • Sleep Disorder

Why Dyskinesias Are A Research Priority In PD - "LID is not just a fascinating topic for scientific investigation. It is a concrete medical problem affecting the lives of many people with PD. It is estimated that approximately 80% of levodopa-treated PD patients develop LID within 10 years, although people with young-onset PD are affected earlier and more severely....LID research will not only benefit people who suffer from this particular complication, but it will also help us understand and eventually treat some related problems in PD, such as motor fluctuations, non-motor fluctuations, impulse control disorders, and graft-induced dyskinesias (which may emerge with future cell therapy interventions)."

Online posting

Carbidopa-levodopa extended-release (CD-LD ER) alone or in combination with carbidopa-levodopa immediate release (IR) to IPX066 followed by extension safety study of IPX066 in subjects with advanced Parkinson's disease (clinicaltrials.gov) - P3, N=40; Recruiting -> Active, not recruiting

Enrollment closed • Parkinson's Disease

Intec Pharma completes enrollment of pivotal phase 3 clinical trial of Accordion Pill carbidopa/levodopa for the treatment of advanced Parkinson's disease patients (PRNewswire) - P3, N=420; ACCORDANCE (NCT02605434); Sponsor: Intec Pharma; "Intec Pharma...today announces the completion of patient enrollment in the Company's pivotal Phase 3 clinical trial (the ACCORDANCE trial) evaluating the safety and efficacy of Accordion Pill™-Carbidopa/Levodopa (AP-CD/LD) compared with immediate release CD/LD (IR-CD/LD; Sinemet®) as a treatment for the symptoms of advanced Parkinson's disease...The study is being conducted at approximately 90 clinical sites throughout the U.S., Europe and Israel...On Track to Report Topline Data in Mid-2019 for Potential New Baseline Levodopa Treatment."

Enrollment status • P3 data: top line • CNS Disorders • Parkinson's Disease

Study to Assess Pharmacokinetics of Accordion Pill Carbidopa-Levodopa Compared to Immediate Release Carbidopa-Levodopa in Parkinson's Disease Patients (clinicaltrials.gov) - P2; N=12; Not yet recruiting; Sponsor: Intec Pharma Ltd.

New P2 trial • Biosimilar • CNS Disorders • Gene Therapies • Genetic Disorders • Parkinson's Disease

Blue and green emission-transformed fluorescent copolymer: Specific detection of levodopa of anti-Parkinson drug in human serum. (PubMed, Talanta) - "Additionally, the proposed method was successfully applied to assess the content of levodopa in three anti-Parkinson drugs (carbidopa and levodopa CR tablets, levodopa and benserazide hydrochloride tablets, and levodopa tablets). More importantly, the levodopa determination of three anti-Parkinson drugs in human serum also exhibit an excellent recovery. Therefore, our strategy provides a promising method for mechanism study and treatment of Parkinson's disease."

Journal • CNS Disorders • Gene Therapies • Genetic Disorders • Movement Disorders • Parkinson's Disease