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Dyskinesia clinical trials

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NCT ID: NCT02274766 Completed - Clinical trials for Parkinson's Disease (PD)

Efficacy and Safety Study of ADS-5102 in PD Patients With Levodopa-Induced Dyskinesia

EASE LID 3
Start date: October 2014
Phase: Phase 3
Study type: Interventional

This is a multi-center, randomized, double-blind, placebo-controlled, 2-arm, parallel group study to evaluate the efficacy and safety of ADS-5102 extended release (ER) capsules, an investigational formulation of amantadine, dosed once nightly at bedtime for the treatment of levodopa-induced dyskinesia (LID) in subjects with Parkinson's disease (PD). The novel pharmacokinetic profile of ADS-5102 is expected to achieve i) maximal concentrations in the early morning through mid-day, when LID can be troublesome, and ii) lower concentrations in the evening, potentially reducing the negative impact of amantadine on sleep. This pharmacokinetic profile could enable higher doses to be tolerated with a once-nightly ER formulation than can be tolerated with an immediate-release formulation. The once-nightly dosing regimen may also provide enhanced convenience and compliance. In a previous clinical study, ADS-5102 met its primary endpoint; LID was significantly reduced as measured by the change in UDysRS score over 8 weeks vs. placebo.

NCT ID: NCT02202551 Completed - Clinical trials for Parkinson's Disease (PD)

Open-Label Safety Study of ADS-5102 in PD Patients With LID

Start date: July 2014
Phase: Phase 3
Study type: Interventional

This is a 105-week open-label study to evaluate the safety and tolerability of ADS-5102 oral capsules, an extended release formulation of amantadine, in Parkinson's Disease (PD) patients with Levodopa Induced Dyskinesia (LID).

NCT ID: NCT02136914 Completed - Parkinson's Disease Clinical Trials

ADS-5102 for the Treatment of Levodopa Induced Dyskinesia (EASE LID Study)

EASE LID
Start date: May 2014
Phase: Phase 3
Study type: Interventional

This is a multi-center, randomized, double-blind, placebo-controlled, 2-arm, parallel group study to evaluate the efficacy and safety of ADS-5102 extended release (ER) capsules, an investigational formulation of amantadine, dosed once nightly at bedtime for the treatment of levodopa induced dyskinesia (LID) in subjects with Parkinson's disease (PD). The novel pharmacokinetic profile of ADS-5102 is expected to achieve i) maximal concentrations in the early morning through mid-day, when LID can be troublesome, and ii) lower concentrations in the evening, potentially reducing the negative impact of amantadine on sleep. This pharmacokinetic profile could enable higher doses to be tolerated with a once-nightly ER formulation than can be tolerated with an immediate-release formulation. The once-nightly dosing regimen may also provide enhanced convenience and compliance. In a previous clinical study, ADS-5102 met its primary endpoint; LID was significantly reduced as measured by the change in UDysRS score over 8 weeks vs. placebo.

NCT ID: NCT01937078 Completed - Dyskinesia Clinical Trials

Famotidine for Levodopa-induced Dyskinesia in PD

Start date: April 2011
Phase: Phase 2
Study type: Interventional

Levodopa-induced dyskinesia is a common problem in Parkinson's disease (PD). In particular, targeting non-dopaminergic systems may be an option for reducing dyskinesia without worsening motor symptoms. One such target may be histamine. The central histaminergic system is involved in diverse biological functions including thermoregulation, eating, and sleep; a role in motor activity is suggested by strong histaminergic innervation of the basal ganglia. Histamine H2 receptors are highly expressed in the striatum, particularly on the GABAergic striatal-pallidal and striatal-nigral pathways Histamine H2 stimulation modulates acetylcholine release. Previous studies have demonstrated that blocking acetylcholine with anticholinergic agents can induce chorea. The investigators propose that histamine H2 receptor stimulation decreases acetylcholine in the striatum and increases activity of the direct striatal output pathway, a key component of the neural mechanisms underlying dyskinesia. The investigators hypothesise that H2 antagonists would reduce activity of the direct striatopallidal pathway and so potentially reduce levodopa-induced chorea Famotidine has also been assessed in schizophrenia in a small cases series to treat schizophrenia, with tolerability. Clinical experience thus suggests the suitability of using this agent as a histamine H2 antagonist in clinical studies for PD.

NCT ID: NCT01767129 Completed - Parkinson's Disease Clinical Trials

Safety and Efficacy of AVP-923 in the Treatment of Levodopa-induced Dyskinesia in Parkinson's Disease Patients

LID in PD
Start date: October 16, 2013
Phase: Phase 2
Study type: Interventional

To evaluate the efficacy, safety, and tolerability of AVP-923 capsules containing 45 mg dextromethorphan and 10 mg quinidine (AVP-923-45) compared to placebo for the treatment of levodopa-induced dyskinesia (LID) in patients with Parkinson's disease (PD).

NCT ID: NCT01429207 Completed - Parkinson's Disease Clinical Trials

Capturing Parkinson's Disease Medication Side Effects During Daily Activities

Start date: August 2011
Phase: N/A
Study type: Observational

The purpose of the study is to test whether body-worn wireless motion sensors can measure dyskinesias (involuntary movements caused by medications) in individuals with Parkinson disease (PD) independent of voluntary activity being performed and other PD motor symptoms (e.g. tremor).

NCT ID: NCT01397422 Completed - Parkinson's Disease Clinical Trials

Extended Release Amantadine Safety and Efficacy Study in Levodopa-Induced Dyskinesia (EASED Study)

EASED
Start date: July 2011
Phase: Phase 2/Phase 3
Study type: Interventional

This is a multi-center, randomized, double-blind, placebo-controlled, 4-arm parallel group study to evaluate the tolerability and efficacy of each of three dose levels of ADS-5102 oral capsules, an extended release formulation of amantadine, dosed once daily for the treatment of levodopa-induced dyskinesia (LID) in subjects with Parkinson's disease (PD). The novel pharmacokinetic profile of ADS-5102 is expected to achieve i) higher amantadine plasma concentrations during daytime hours when dyskinesia as well as motor and non-motor symptoms of PD are most problematic, ii) low amantadine plasma concentrations overnight, which may reduce the sleep disturbances and vivid dreams occasionally associated with amantadine, and iii) a reduced initial rate of rise in plasma concentration, which is expected to improve overall tolerability of amantadine.

NCT ID: NCT00314288 Completed - Parkinson's Disease Clinical Trials

Sarizotan in Parkinson Patients With L-dopa-induced Dyskinesia

Start date: July 2002
Phase: Phase 2
Study type: Interventional

The primary purpose of the study is to investigate the anti-dyskinetic effect of several doses of sarizotan in Parkinson patients in order to generate information on the dose-response relationship (dose-finding).

NCT ID: NCT00114595 Completed - Schizophrenia Clinical Trials

Ethyl-Eicosapentaenoic Acid and Tardive Dyskinesia

Start date: April 2003
Phase: Phase 4
Study type: Interventional

Tardive dyskinesia is a common complication of conventional antipsychotic treatment in subjects with schizophrenia. This study investigates whether the addition of the omega-3 fatty acid, ethyl-eicosapentaenoic acid (EPA) to usual treatment improves movement disorder in 84 schizophrenia subjects with established tardive dyskinesia. The initial double-blinded, randomised trial duration is 12 weeks, followed by further 46 weeks of open-label treatment.

NCT ID: NCT00105521 Completed - Parkinson's Disease Clinical Trials

Sarizotan in Participants With Parkinson's Disease Suffering From Treatment Associated Dyskinesia

Start date: September 30, 2004
Phase: Phase 3
Study type: Interventional

The purpose of this study is to test multiple doses of sarizotan to establish a dose with maximal safety and efficacy for treating treatment associated dyskinesia in Parkinson's disease participants.