Acamprosate and Methazolamide for Essential Tremor

NCT06312800 | Withdrawn Phase 2

• 1 other identifier: LeWitt02
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This is an investigator initiated study is designed to evaluate the anti-tremor benefits of two marketed medications, methazolamide and acamprosate in subjects with a diagnosis of essential tremor (ET).

Conditions

Essential Tremor

Keywords

Essential Tremor

Outcome Measures

Primary Outcomes (1)

• Fahn-Talosa-Marin rating scale (FTMRS) Part A

  Comparison of placebo to each of the two medications for the sum of upper extremity postural and action tremor scores from the Fahn-Talosa-Marin rating scale (FTMRS). The Fahn-Tolosa-Marin Clinical Rating Scale for Tremor (FTM) has been used for essential tremor (ET), but its anchors for ratings from 0 to 4 of upper limb tremor are probably too low for patients with severe tremor (tremor amplitude \>4 cm; grade 4).

  11 weeks

Study Arms (3)

Acamprosate

EXPERIMENTAL

Commercially available Acamprosate 333 mg tablets will be administered three times daily. Subjects will be started with one tablet with breakfast for 3 days, then one tablet with breakfast and dinner for 3 days, then one tablet 3 times a day for the next 15 days. Intervention order of medication trials will be determined by biostatistician.

Drug: Acamprosate

Placebo

ACTIVE COMPARATOR

Placebo tablets are not available from the manufacturer for either of these drugs which are marketed as white tablets about the size of an aspirin tablet. Custom made placebo tablets will be purchased that are about that size. While not ideal , the extent of disguising the drug identity should be adequate with this. The placebo tablets will be administered three times daily. Subjects will be started with one tablet with breakfast for 3 days, then one tablet with breakfast and dinner for 3 days, then one tablet 3 times a day for the next 15 days. Intervention order of medication trials will be determined by biostatistician

Drug: Placebo

Methazolamide

EXPERIMENTAL

Commercially available methazolamide 50 mg tablets will be administered three times daily. Subjects will be started with one tablet with breakfast for 3 days, then one tablet with breakfast and dinner for 3 days, then one tablet 3 times a day for the next 15 days. Intervention order of medication trials will be determined by biostatistician

Drug: Methazolamide

Interventions

Acamprosate DRUG

Randomized allocation of treatments will guide the dispensation of treatments in one of 6 possible sequences--ex, M (methazolamide)- P(placebo)-A (Acamprosate); or PAM or MAP or PMA or AMP or APM. Biostatistician will devise medication randomization strategies and investigators and staff will be blinded.

Acamprosate

Placebo DRUG

Randomized allocation of treatments will guide the dispensation of treatments in one of 6 possible sequences--ex, M (methazolamide)- P(placebo)-A (Acamprosate); or PAM or MAP or PMA or AMP or APM. Biostatistician will devise medication randomization strategies and investigators and staff will be blinded.

Placebo

Methazolamide DRUG

Randomized allocation of treatments will guide the dispensation of treatments in one of 6 possible sequences--ex, M (methazolamide)- P(placebo)-A (Acamprosate); or PAM or MAP or PMA or AMP or APM. Biostatistician will devise medication randomization strategies and investigators and staff will be blinded.

Methazolamide

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• bilateral, largely symmetric postural or kinetic tremor involving hands and forearms that is visible and persistent. Subjects need to meet a FTMRS. Part A motor score of at least 2 ("Moderate amplitude, 0.5-1 cm, may be intermittent") in the dominant upper limb for action or postural tremor (or both).
• additional tremor (head, voice, or lower extremity) may also be present but in the absence of abnormal posturing so as to suggest the diagnosis of dystonia.

You may not qualify if:

• other abnormal neurologic signs
• the presence of known causes of enhanced physiologic tremor, including current or recent exposure to drugs known to cause or exacerbate tremor, or the presence of a drug -withdrawal state
• historical or clinical evidence of psychogenic tremor
• convincing evidence of sudden onset or other evidence of stepwise deterioration
• primary orthostatic tremor
• isolated position-specific or task-specific tremors, including occupational tremors and primary writing tremor
• tremor possibly or probably due to other neurological disorders (such as Parkinson's disease, cerebellar degeneration, and hyperthyroidism)
• prior brain surgery (including deep brain stimulation of Gamma Knife treatment) for thalamotomy
• known allergy to the study medications
• clinically significant liver, kidney, or cardiac abnormalities

Sponsors & Collaborators

• Henry Ford Health System: lead

Study Sites (1)

Henry Ford West Bloomfield Hospital

West Bloomfield, Michigan, 48322, United States

Location

MeSH Terms

Conditions

Essential Tremor

Interventions

Acamprosate; Methazolamide

Condition Hierarchy (Ancestors)

Movement Disorders; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Taurine; Alkanesulfonic Acids; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Thiadiazoles; Thiazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Peter LeWitt, M.D.

  Henry Ford Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Movement Disorder Principal Investigator

Study Record Dates

• First Submitted: July 13, 2015
• First Posted: March 15, 2024
• Study Start: March 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: December 1, 2017
• Last Updated: September 25, 2024

Record last verified: 2024-09

Locations

US (1)