Efficacy of Pramipexole Extended Release in the Treatment of Essential Tremor
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| ClinicalTrials.gov Identifier: NCT01441284 |
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Recruitment Status :
Withdrawn
(Lack of financial support)
First Posted : September 27, 2011
Last Update Posted : May 8, 2017
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Essential Tremor | Drug: pramipexole Drug: placebo | Phase 3 |
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 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 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Process 1
10 weeks of pramipexole treatment 2 weeks wash-out period (cross-over) 10 weeks placebo treatment
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Drug: pramipexole
pramipexole extended release, 2.1 mg pramipexole base (3.0mg pramipexole salt) once daily
Other Name: Mirapexin retard Drug: placebo placebo |
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Placebo Comparator: Process 2
10 weeks of placebo treatment 2 weeks wash-out period (cross-over) 10 weeks pramipexole treatment
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Drug: pramipexole
pramipexole extended release, 2.1 mg pramipexole base (3.0mg pramipexole salt) once daily
Other Name: Mirapexin retard Drug: placebo placebo |
- Improvement in tremor severity [ Time Frame: 10 weeks of treatment ]Improvement in tremor severity measured by Fahn-Tolosa-Marin Tremor Rating Scale
- Improvement in quality of life [ Time Frame: 10 weeks of treatment ]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 ]
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| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01441284
| Hungary | |
| Department of Neurology, University of Pécs | |
| Pécs, Baranya Megye, Hungary, H-7623 | |
| Kaposi Mór County Hospital | |
| Kaposvár, Somogy Megye, Hungary, H-7400 | |
| Principal Investigator: | Norbert Kovacs, MD, PhD | Associate professor |
Publications:
| 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 Key Record Dates |
| 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:
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pramipexole essential tremor cross-over |
Additional relevant MeSH terms:
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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 |