What is the mechanism of action of this treatment?

The most common treatments for Parkinson's Disease include levodopa, dopamine agonists, MAO-B inhibitors, and anticholinergics. Levodopa is converted to dopamine in the brain, replenishing the diminished neurotransmitter and improving motor symptoms. Dopamine agonists mimic dopamine by stimulating dopamine receptors directly. MAO-B inhibitors prevent the breakdown of dopamine, increasing its availability. Anticholinergics reduce the activity of acetylcholine, helping to balance neurotransmitter levels. Suvecaltamide, a calcium channel modulator, is being studied for its potential to reduce tremors by stabilizing neuronal activity. These mechanisms are crucial for PD patients as they aim to restore the balance of neurotransmitters, alleviate motor symptoms, and improve quality of life.

What side effects are associated with this type of intervention?

Common treatments for Parkinson's Disease, including those similar to suvecaltamide (calcium channel modulation), often have side effects. Levodopa, a primary treatment, can cause nausea, dizziness, headache, and more serious effects like confusion, hallucinations, and orthostatic hypotension. Dopamine agonists may lead to compulsive behaviors, somnolence, and hallucinations. Cholinesterase inhibitors, used for cognitive symptoms, can worsen tremors and cause nausea and vomiting. Calcium channel modulators like suvecaltamide are being studied for their efficacy and safety, but specific side effects are not yet well-documented.

What prior FDA approvals exist?

FDA-approved treatments for Parkinson's Disease primarily include dopaminergic therapies such as levodopa/carbidopa, dopamine agonists (e.g., pramipexole, ropinirole), and MAO-B inhibitors (e.g., selegiline, rasagiline). Other treatments include amantadine for dyskinesia and anticholinergics for tremor. While specific calcium channel modulators like suvecaltamide are not mentioned, the focus on motor symptom management remains central to these therapies.

What other types of research exist?

Promising novel alternatives to Suvecaltamide for Parkinson's Disease patients include: 1) Rasagiline, which is a valuable therapeutic alternative to entacapone for motor fluctuations. 2) mGlu2 positive allosteric modulators like CBiPES, which may be effective for treating dyskinesia, psychosis, and motor fluctuations. 3) Perampanel, an AMPA-receptor antagonist, which has shown efficacy in reducing motor symptoms and 'wearing off' motor fluctuations.

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Suvecaltamide for Tremors in Parkinson's Disease

Phase 2

Recruiting

Research Sponsored by Jazz Pharmaceuticals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants have moderate to severe impairment associated with tremor at both the screening and baseline visits, as determined by all the following: A score of > 21 on The Essential Tremor Assessment Rating Scale, Activities of Daily Living (TETRAS-ADL) subscale; and Clinician Global Impression of Severity (CGI-S) rating of tremor severity of > 2 (at least moderate for participant's ability to function)

Diagnosis of clinically probable or clinically established Parkinson's disease (PD) meeting the Movement Disorder Society (MDS) 2015 criteria

Must not have

Prior or planned surgical intervention to treat PD, including but not limited to magnetic resonance-guided focused ultrasound thalamotomy, deep brain stimulation, ablative thalamotomy, and gamma knife thalamotomy

Botulinum toxin injection in the 6 months before screening or planned use at any time during the study. Note: Use of botulinum toxin for other reasons (eg, cosmetic, excessive salivation, dystonia) is permitted as long as the location of use is anatomically distinct from the region with tremor

Timeline

Screening 28 days

Treatment 17 weeks

Follow Up 2 weeks

Summary

This trial tests suvecaltamide, a medication aimed at reducing severe tremors in adults with Parkinson's disease whose current treatments are not effective. The medication likely helps by calming the overactive nerves or muscles responsible for the tremors.

Who is the study for?

Adults with Parkinson's Disease who've had it for less than 5 years and experience moderate to severe tremor not controlled by current medications. They must be stable on their Parkinson's or tremor meds for at least 6 weeks, have a specific score on the TETRAS-ADL scale, and can't be bedridden or have unpredictable 'ON'/'OFF' periods.

What is being tested?

The trial is testing Suvecaltamide against a placebo over 17 weeks to see if it helps adults with Parkinson's reduce their persistent tremors. Participants will receive either the actual drug or a dummy pill without knowing which one they're getting.

What are the potential side effects?

While specific side effects of Suvecaltamide are not listed here, common ones in trials may include nausea, dizziness, sleep issues, digestive changes, and potential interactions with other drugs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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You have significant tremors that affect your daily activities and have been assessed by a doctor to be moderate or severe.

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I have been diagnosed with Parkinson's disease according to the MDS 2015 criteria.

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I've been on a steady dose of my Parkinson's or tremor medication for at least 6 weeks.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had or am planning to have surgery for Parkinson's disease.

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I have not had botulinum toxin injections in areas affected by tremor in the last 6 months.

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I can stop using proton pump inhibitors 2 weeks before and during the study.

Timeline

Screening ~ 28 days1 visit

Treatment ~ 17 weeks6 visits

Follow Up ~ 2 weeks1 visit

Screening ~ 28 days

Treatment ~ 17 weeks

Follow Up ~2 weeks

This trial's timeline: 28 days for screening, 17 weeks for treatment, and 2 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change from Baseline to Week 17 on the Essential Tremor Rating Scale (TETRAS) Composite Outcome Score

Secondary study objectives

Change from Baseline to Week 17 on TETRAS total score (TETRAS-ADL + TETRAS-PS)

Change from Baseline to Week 17 on The Essential Tremor Rating Scale, Activities of Daily Living Subscale (TETRAS-ADL)

Change from Baseline to Week 17 on The Essential Tremor Rating Scale, Performance Subscale (TETRAS-PS)

+5 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: SulvecaltamideExperimental Treatment1 Intervention

Participants who will receive an optimal dose of suvecaltamide during the Dose Titration, Optimization Period, and Maintenance Period.

Group II: PlaceboPlacebo Group1 Intervention

Participants who will receive a matching placebo during the Dose Titration, Optimization Period, and Maintenance Period.

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Parkinson's Disease include levodopa, dopamine agonists, MAO-B inhibitors, and anticholinergics. Levodopa is converted to dopamine in the brain, replenishing the diminished neurotransmitter and improving motor symptoms. Dopamine agonists mimic dopamine by stimulating dopamine receptors directly. MAO-B inhibitors prevent the breakdown of dopamine, increasing its availability. Anticholinergics reduce the activity of acetylcholine, helping to balance neurotransmitter levels. Suvecaltamide, a calcium channel modulator, is being studied for its potential to reduce tremors by stabilizing neuronal activity. These mechanisms are crucial for PD patients as they aim to restore the balance of neurotransmitters, alleviate motor symptoms, and improve quality of life.

A quantitative study of levodopa-induced dyskinesia in Parkinson's disease.New pharmacological options for treating advanced Parkinson's disease.