Efficacy of Pramipexole Extended Release in the Treatment of Essential Tremor

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

Aim of the study is to perform a double-blind, crossover, placebo-controlled multicenter study evaluating the efficacy of pramipexole on essential tremor.

Condition or disease	Intervention/treatment	Phase
Essential Tremor	Drug: pramipexole; Drug: placebo	Phase 3

Detailed Description:

Essential tremor is one of the most common movement disorders with the prevalence of 3-5% among the elderly population. Although its main clinical feature is the bilateral, predominantly postural-kinetic tremor, newer studies suggest that ET is a spectrum of clinical features with both motor and nonmotor elements not homogeneously distributed.

Despite its high occurrence, the pharmacological treatment of ET is limited. Although the mainline drugs, propranolol and primidone, can provide good clinical benefit in a portion of cases, >50% of the patients stop the medication due to inefficacy or side-effects. Hypotension, dizziness, bradycardia, cognitive impairment, fatigue and erectile dysfunction are the most common side-effects contributing to medication discontinuation.

In an open-label pilot study, the investigators previously demonstrated that 2.1 mg/day pramipexole extended-release improved both the severity of tremor (by 52%) and health-related quality of life.

The present study aims to confirm this hypothesis in a double-blind, crossover, placebo-controlled multicenter study.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	0 participants
Allocation:	Randomized
Intervention Model:	Crossover Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	Efficacy of Pramipexole Extended Release in the Treatment of Essential Tremor: a Double-blind, Cross-over, Placebo-controlled Multicenter Study
Estimated Study Start Date :	December 2017
Estimated Primary Completion Date :	December 2018
Estimated Study Completion Date :	December 2018

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Active Comparator: Process 1; 10 weeks of pramipexole treatment 2 weeks wash-out period (cross-over) 10 weeks placebo treatment	Drug: pramipexole; pramipexole extended release, 2.1 mg pramipexole base (3.0mg pramipexole salt) once daily; Other Name: Mirapexin retard Drug: placebo; placebo
Placebo Comparator: Process 2; 10 weeks of placebo treatment 2 weeks wash-out period (cross-over) 10 weeks pramipexole treatment	Drug: pramipexole; pramipexole extended release, 2.1 mg pramipexole base (3.0mg pramipexole salt) once daily; Other Name: Mirapexin retard Drug: placebo; placebo

Outcome Measures

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Primary Outcome Measures :

1. Improvement in tremor severity [ Time Frame: 10 weeks of treatment ]
   Improvement in tremor severity measured by Fahn-Tolosa-Marin Tremor Rating Scale

Secondary Outcome Measures :

1. Improvement in quality of life [ Time Frame: 10 weeks of treatment ]
   Improvement in quality of life assessed by EQ-5D score
2. Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 10 weeks of treatment ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 80 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• Diagnosis of ET has to be unambiguous based on the clinical diagnostic criteria.
• Tremor has to be severe enough to produce disability.
• Patients must sign a written informed consent according with the approval of the Regional Ethical Board of University of Pécs

Exclusion Criteria:

• Exclusion criteria are established in accordance to the guidelines of Elble et al3.
• Presence of any medical conditions capable of producing tremor (e.g. hyperthyroidism, drug withdrawal, neuropathy, etc.).
• Except for cogwheel phenomenon, the presence of any abnormal neurological signs (e.g. dystonia, myoclonus, ataxia, parkinsonism, cerebellar or pyramidal signs, etc.)
• Atypical tremor appearance for ET (e.g. isolated vocal-cord tremor, orthostatic tremor, task-specific tremor, etc.)
• Presence or suspicion of psychogenic tremor
• Usage of medication capable of producing tremor (e.g. sympathomimetics, valproate, etc.)
• Concomitant administration of any drugs potentially capable of improving ET (e.g. antiepileptics, beta-receptor blockers).
• Previous neurosurgical treatment (e.g. deep brain stimulation or thalamotomy).
• Presence of serious concomitant disorders capable of interfering with the study (e.g. heart failure, tumorous disorders, etc.)
• Presence of any contraindication for pramipexole treatment (e.g. impulsive control disorder, known hypersensitivity to any components of the tablets, etc.)

Contacts and Locations

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Locations

Hungary
Department of Neurology, University of Pécs
Pécs, Baranya Megye, Hungary, H-7623
Kaposi Mór County Hospital
Kaposvár, Somogy Megye, Hungary, H-7400

Sponsors and Collaborators

University of Pecs

Investigators

Principal Investigator:	Norbert Kovacs, MD, PhD	Associate professor

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:

Kovács N, Pál E, Késmárky I, Komoly S, Nagy F, Herceg M. Pramipexole for treating essential tremor. Eur J Neurol 2011;18(Suppl 2):482.

Responsible Party:	Dr. Norbert Kovacs, Associate professor, specialist in neurology and movement disorders, Department of Neurology, University of Pecs
ClinicalTrials.gov Identifier:	NCT01441284 History of Changes
Other Study ID Numbers:	AOK_KA_2011_pramipexole; 34039/KA-OTKA/11-10 ( Other Identifier: University of Pécs, Faculty of Medicine )
First Posted:	September 27, 2011
Last Update Posted:	May 8, 2017
Last Verified:	May 2017

Studies a U.S. FDA-regulated Drug Product:		No
Studies a U.S. FDA-regulated Device Product:		No

Keywords provided by Dr. Norbert Kovacs, University of Pecs:

pramipexole; essential tremor; cross-over

Additional relevant MeSH terms:

Tremor; Essential Tremor; Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Movement Disorders; Central Nervous System Diseases; Pramipexole	Antioxidants; Molecular Mechanisms of Pharmacological Action; Protective Agents; Physiological Effects of Drugs; Antiparkinson Agents; Anti-Dyskinesia Agents; Dopamine Agonists; Dopamine Agents; Neurotransmitter Agents