Efficacy of Pramipexole Extended Release in the Treatment of Essential Tremor - Full Text View

Purpose

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

Condition	Intervention	Phase
Essential Tremor	Drug: pramipexole Drug: placebo	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

Genetics Home Reference related topics: essential tremor

MedlinePlus related topics: Tremor

Drug Information available for: Pramipexole dihydrochloride Pramipexole

U.S. FDA Resources

Further study details as provided by University of Pecs:

Primary Outcome Measures:

Improvement in tremor severity [ Time Frame: 10 weeks of treatment ] [ Designated as safety issue: No ]
Improvement in tremor severity measured by Fahn-Tolosa-Marin Tremor Rating Scale

Secondary Outcome Measures:

Improvement in quality of life [ Time Frame: 10 weeks of treatment ] [ Designated as safety issue: No ]
Improvement in quality of life assessed by EQ-5D score
Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 10 weeks of treatment ] [ Designated as safety issue: Yes ]


Estimated Enrollment:	60
Study Start Date:	March 2016
Estimated Study Completion Date:	December 2017
Estimated Primary Completion Date:	December 2017 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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.

Eligibility


Ages Eligible for Study:	18 Years to 80 Years (Adult, Senior)
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01441284

Contacts


Contact: Norbert Kovacs, MD, PhD	+3672536001 ext 7642	kovacsnorbert06@gmail.com

Locations


Hungary
Department of Neurology, University of Pécs	Not yet recruiting
Pécs, Baranya Megye, Hungary, H-7623
Contact: Norbert Kovacs, MD, PhD +3672536001 ext 37642 kovacsnorbert06@gmail.com
Principal Investigator: Norbert Kovacs, MD, PhD
Kaposi Mór County Hospital	Not yet recruiting
Kaposvár, Somogy Megye, Hungary, H-7400
Contact: Ferenc Nagy, MD, PhD fnagy8@yahoo.com
Principal Investigator: Ferenc Nagy, MD, PhD

Sponsors and Collaborators

University of Pecs

Investigators


Principal Investigator:	Norbert Kovacs, MD, PhD	Associate professor

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
Study First Received:	September 21, 2011
Last Updated:	January 14, 2016
Health Authority:	Hungary: Institutional Ethics Committee

Keywords provided by 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

ClinicalTrials.gov processed this record on September 29, 2016