A Study To Assess the Safety and Efficacy of JZP385 in the Treatment of Adults With Moderate to Severe Essential Tremor (ET)

• Status: Not yet recruiting
• Trial end date: 2023-12-11
• Target enrollment: 0
• Participant gender: All

Summary

This is a 12-week, double-blind, placebo-controlled, randomized, parallel-group, multicenter study of the safety and efficacy of JZP385 in the treatment of adult participants with moderate to severe ET.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jazz Pharmaceuticals

Criteria

Inclusion Criteria:

1. Participant must be 18 to 80 years of age inclusive, at the time of signing the informed consent.

2. Participants who are diagnosed with ET (including ET plus) according to the MDS Consensus Statement on the Classification of Tremors from the Task Force on Tremor of the International Parkinson's and Movement Disorder Society.

3. Participants have moderate to severe disability associated with tremor as determined by a score of ≥ 22 on the TETRAS-ADL subscale; and a score of > 5 on the sum of items 6 and 7 of the TETRAS-PS; and a CGI-S rating of at least moderate for participants' ability to function.

4. Sex and Contraceptive/Barrier Requirements

During the study intervention and for at least 30 days after the last dose of study intervention male participants must refrain from donating sperm. Non-abstinent males must agree to use a male condom in combination with female partner use of a highly effective contraceptive method with a failure rate of < 1% per year. All male participants must agree to use a male condom when engaging in any activity that allows for passage of ejaculate to another person.

Female participants must not be pregnant or breastfeeding, are either women of non-childbearing potential (WONCBP), or are women of childbearing potential (WOCBP) using a highly effective contraceptive method with a failure rate of < 1% during the study intervention period and for at least 30 days after the last dose of study intervention. Male partners of WOCBP are required to use barrier protection, eg, condoms, over the same 30 day period.

Exclusion Criteria:

1. Known history or current evidence of other medical or neurological conditions that may cause or explain the participant's tremor.

2. Severe cognitive impairment as defined by a Montreal Cognitive Assessment (MoCA; score <23), or has cognitive impairment that in the opinion of the investigator would prevent completion of study procedures or the ability to provide informed consent.

3. Current suicidal risk as determined from history, by presence of active suicidal ideation as indicated by positive response to item 4 or 5 on the C-SSRS (within the past 24 months), or any history of suicide attempt; current or past (within 1 year) major depressive episode according to DSM-5 criteria.

4. History (within past 2 years at screening) or presence of substance use disorder (including alcohol) according to DSM-5 criteria, known drug dependence, or seeking treatment for alcohol or substance abuse related disorder. Nicotine use disorder is excluded if it impacts tremor.

5. Prior magnetic resonance (MR)-guided focused ultrasound, surgical intervention (eg, deep brain stimulation, ablative thalamotomy, gamma knife thalamotomy), or inability to refrain from using a device for treatment of tremor for the duration of the treatment period.

6. Botulinum toxin injection in the 6 months before screening or planned use at any time during the study.

7. Treatment with any medication that could affect the evaluation of tremor within 2 weeks or 5 half-lives (whichever is longer) before screening or planned use at any time during the study.

8. Use of prescription or nonprescription drugs or other products known to be inducers of CYP3A4or CYP2C9, which cannot be discontinued at least 4 weeks before Baseline, or planned use at any time during the study.

9. Use of prescription or nonprescription drugs, or other products (eg, grapefruit, grapefruit juice, or Seville oranges) known to be strong or moderate inhibitors of CYP3A4or CYP2C9, that cannot be discontinued 2 weeks or 5 half-lives, whichever is longer, before Baseline or planned use at any time during the study.

10. Use of proton pump inhibitors and histamine-2 receptor antagonists, which cannot be discontinued at least 2 weeks before Baseline, or planned use at any time during the study (occasional use of antacids will be permitted, but antacids should be taken at least 4 hours apart from study intervention).

11. Inability to refrain from use of medication/substance(s) that might produce tremor or interfere with the evaluation of tremor on study visit days, such as, but not limited to, stimulant decongestants, beta-agonist bronchodilators, and alcohol.

12. Regular use of more than 3 units of alcohol per day.

13. Regular consumption of caffeine > 400 mg/day or > 4 cups of coffee per day.