Efficacy of Pramipexole Extended Release in the Treatment of Essential Tremor

NCT ID: NCT01441284

Last Updated: 2017-05-08

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-31
• Study Completion Date: 2018-12-31

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.

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.

Conditions

Essential Tremor

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Process 1

10 weeks of pramipexole treatment 2 weeks wash-out period (cross-over) 10 weeks placebo treatment

Group Type: ACTIVE_COMPARATOR

pramipexole

Intervention Type: DRUG

pramipexole extended release, 2.1 mg pramipexole base (3.0mg pramipexole salt) once daily

placebo

Intervention Type: DRUG

placebo

Process 2

10 weeks of placebo treatment 2 weeks wash-out period (cross-over) 10 weeks pramipexole treatment

Group Type: PLACEBO_COMPARATOR

pramipexole

Intervention Type: DRUG

pramipexole extended release, 2.1 mg pramipexole base (3.0mg pramipexole salt) once daily

placebo

Intervention Type: DRUG

placebo

Interventions

pramipexole

pramipexole extended release, 2.1 mg pramipexole base (3.0mg pramipexole salt) once daily

Intervention Type: DRUG

placebo

placebo

Intervention Type: DRUG

Other Intervention Names

Mirapexin retard

Eligibility 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

• 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.)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Pecs

OTHER

Sponsor Role: lead

Responsible Party

Dr. Norbert Kovacs

Associate professor, specialist in neurology and movement disorders, Department of Neurology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Norbert Kovacs, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Associate professor

Locations

Department of Neurology, University of Pécs

Pécs, Baranya, Hungary

Kaposi Mór County Hospital

Kaposvár, Somogy County, Hungary

Countries

Hungary

References

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.

Reference Type: BACKGROUND

Other Identifiers

34039/KA-OTKA/11-10

Identifier Type: OTHER

Identifier Source: secondary_id

AOK_KA_2011_pramipexole

Identifier Type: -

Identifier Source: org_study_id