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Idiopathic Parkinson's Disease clinical trials

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NCT ID: NCT00663312 Terminated - Clinical trials for Idiopathic Parkinson's Disease

Impact of Deep Brain Stimulation of Subthalamic Nucleus on the Hepatic Glucose Production in Parkinson's Disease

Start date: April 2008
Phase: N/A
Study type: Interventional

Parkinson' disease is a neurodegenerative disorder characterised by bradykinesia, rigidity, rest tremor and postural instability. Dopaminergic therapy such as L-Dopa and dopamine agonists usually leads to a dramatic improvement of symptoms, but disease progression nevertheless remains inevitable. Bilateral Deep brain stimulation in subthalamic nucleus (STN) leads to a spectacular clinical improvement in patients with motor complications and is now considered as the gold standard surgical treatment. However, this surgery induces a post-operative body weight gain which may limit the benefits of this technique and induce critical metabolic disorders such as profound alterations in the central control of energy metabolism. Previous data seems to show that glucose metabolism is also altered. The aim of this prospective study was to identify if the STN stimulation could modify glucose metabolism regulation especially the endogen glucose production (by liver) Hypothalamus is able to detect glucose concentration variations and to control/adjust glucose levels by modulating the hepatic glucose production. As hypothamus and STN are anatomically closed, we hypothesise that the STN stimulation could modulate the hypothalamus function and consequently modify glucose production.

NCT ID: NCT00643045 Completed - Clinical trials for Idiopathic Parkinson's Disease

Safinamide as Add-On Therapy in Patients With Early Idiopathic Parkinson's Disease Treated With a Stable Dose of a Single Dopamine Agonist

Start date: December 2004
Phase: Phase 3
Study type: Interventional

To evaluate the safety and efficacy of two dose ranges of safinamide (High Dose: 150 to 200 mg/day and Low Dose: 50 to 100 mg/day) orally, as compared to Placebo, as add-on therapy in patients with early idiopathic Parkinson's disease who are currently receiving a stable dose of a single dopamine agonist. It is hypothesized that, over a 24-week period, add-on treatment with safinamide will result in greater improvement of motor symptoms in these patients, compared to treatment with a dopamine agonist alone.

NCT ID: NCT00627640 Completed - Clinical trials for Idiopathic Parkinson's Disease

Safinamide in Idiopathic Parkinson's Disease (IPD) With Motor Fluctuations, as add-on to Levodopa

SETTLE
Start date: February 2009
Phase: Phase 3
Study type: Interventional

Parkinson's Disease is a major neurodegenerative disorder in which there is a progressive loss of dopamine-containing neurons. The understanding that PD is a syndrome of dopamine (DA) deficiency led to the introduction in the clinical practice of L-dopa, a precursor of DA that crosses the blood brain barrier, and also to the use of selective inhibitors of MAO-B, the major DA metabolising enzyme in man. Safinamide is an inhibitor of MAO-B. This is a phase III trial to evaluate the efficacy and safety of safinamide (50 and 100 mg p.o. q.a.m.) compared to placebo as add-on therapy to a stable dose to levodopa in subjects with advance idiopathic Parkinson's Disease. The principal efficacy measure is the increase in mean daily "on" time during the 18-hr diary recording period.

NCT ID: NCT00605683 Completed - Clinical trials for Idiopathic Parkinson's Disease

MOTION, Safinamide in Early IPD, as add-on to Dopamine Agonist

MOTION
Start date: November 2007
Phase: Phase 3
Study type: Interventional

Parkinson's disease is a major neurodegenerative disorder in which there is a progressive loss of nigrostriatal dopaminergic neurons. The understanding that PD is a syndrome of dopamine (DA) deficiency led to the introduction in the clinical practice of L-dopa, a precursor of DA that crosses the blood brain barrier, and also to the use of selective inhibitors of MAO B, the major DA metabolising enzyme in man. This is a double-blind, placebo-controlled, parallel-group, randomised, multi-centre, multi national, Phase III trial, comparing two doses of safinamide (50 and 100 mg p.o. q.a.m.) versus placebo as add-on therapy to a stable dose of a single dopamine agonist in subjects with early idiopathic Parkinson's Disease. The principal efficacy measure, i.e., change in mean value of UPDRS - Section III total score from baseline to endpoint, was chosen based on regulatory guidance and prior use in other trials in similar populations.

NCT ID: NCT00505687 Completed - Clinical trials for Idiopathic Parkinson's Disease

An Open-Label Extension Trial to Assess the Safety and Tolerability of Long Term Treatment of Rotigotine in Subjects With Idiopathic Parkinson's Disease

Start date: February 2005
Phase: Phase 3
Study type: Interventional

The objective of this open-label extension is to assess the safety and tolerability of long-term treatment of rotigotine in subjects with idiopathic PD.

NCT ID: NCT00498758 Not yet recruiting - Clinical trials for Idiopathic Parkinson's Disease

The APOS System: Effects on Gait, Mobility and QOL in Patients With Parkinson's Disease

Start date: August 2007
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the benefits of a biomechanical wedge system - The APOS system, for improving the stability of gait, mobility and quality of life in Parkinson's disease patients.

NCT ID: NCT00400634 Completed - Clinical trials for Idiopathic Parkinson's Disease

Double-Blind, Multicenter, Sham Surgery Controlled Study of CERE-120 in Subjects With Idiopathic Parkinson's Disease

Start date: November 2006
Phase: Phase 2
Study type: Interventional

The purpose of this double blind study is to determine whether CERE-120 (adeno-associated virus serotype 2 [AAV2]-neurturin [NTN]) is effective and safe in the treatment of patients with idiopathic Parkinson's Disease. CERE-120 is administered via bilateral stereotactic injections targeting the putaminal region of the brain. The design of this study involves approximately 34 patients receiving CERE-120 treatment via stereotactic surgery and approximately 17 patients receiving sham stereotactic surgery (no CERE-120 administered).

NCT ID: NCT00279825 Completed - Clinical trials for Idiopathic Parkinson's Disease

Comparison of IPX054, IR Carbidopa-Levodopa, and CR Carbidopa-Levodopa in Subjects With Parkinson's Disease

Start date: January 2006
Phase: Phase 2
Study type: Interventional

The objective of this study is to compare the pharmacokinetics and pharmacodynamics of IPX054, carbidopa-levodopa immediate-release tablets, and carbidopa-levodopa controlled-release tablets in subjects with idiopathic Parkinson's disease.

NCT ID: NCT00261781 Terminated - Clinical trials for Idiopathic Parkinson's Disease

Walking Capacity in Parkinson's Disease (PD-Walk)

Start date: May 2005
Phase: N/A
Study type: Interventional

The major aim of this study is to determine the efficacy of a home-based treadmill walking program in improving walking capacity and quality of life in people with early mid-stage Parkinson's disease(PD).

NCT ID: NCT00243945 Completed - Clinical trials for IDIOPATHIC PARKINSON'S DISEASE

A Trial to Evaluate the Effects of Rotigotine Transdermal Patch on Early Morning Motor Impairment and Sleep Disorders Idiopathic Parkinson's Disease

Start date: December 2004
Phase: Phase 3
Study type: Interventional

The objective of this trial is to assess the effect of rotigotine (SPM 962) on the control of early morning motor impairment and sleep disorders in subjects with idiopathic PD. Subjects who meet eligibility criteria will begin treatment with rotigotine transdermal patches. Trial medication will be titrated to an optimal daily dose, or to the maximal dose. Following a Titration period of up to 8 weeks, subjects will be maintained on the optimal or maximal dose for 4 weeks. After the Maintenance period, subjects will have the option to enter into an open-label extension study. The first subject was enrolled in December 2004. The last subject was enrolled in April 2005 and the last subject visit was conducted in July 2005. This study is now closed