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Befejeződött2. fázis

Study to Evaluate SAGE-324 in Participants With Essential Tremor

A legfontosabb adatok

Ki végzi
Sage Therapeutics
Hol
Asheville, Atlanta, Austin, Boca Raton, Boston, Boynton Beach, Bradenton, Chicago, Cincinnati, Coral Springs, Dayton, Decatur, Englewood, Farmington Hills, Fort Worth, Fountain Valley, Fullerton, Gainesville, Hollywood, Hoover, Houston, Kansas City, Katy, Kendall, Kirkland, Lansing, Las Vegas, Lexington, Los Angeles, McLean, Memphis, Miami, Naples, New York, Orlando, Pensacola, Phoenix, Port Charlotte, Round Rock, San Antonio, Scottsdale, Shreveport, Spokane, Springfield, Sun City, Tampa, Tulsa és West Falls Church (Egyesült Államok)Mind a 48 helyszín megnézése
Azonosító
Állapot
Befejeződött
Fázis
2. fázis
Résztvevők
146 fő vett részt
Kezdés
2022. jan. 5.
Befejezés
2024. máj. 16.
A vizsgálat típusa
Beavatkozással járó, 4 csoportAz egyik csoport placebót (hatóanyag nélküli szert) kap, összehasonlításként.
A vizsgált kezelések
  • SAGE-324
  • SAGE-324 Matched Placebo
A regiszteradat frissítve
2025. május 16.

Ki vehet részt

Életkor
18 év – 80 év
Nem
Nők és férfiak
Egészséges önkéntesek
Nem vehetnek részt

A regiszter feltételei, szó szerint

Mind a 15 feltétel megnézéseKevesebb

Ki vehet részt

  • Diagnosis of ET, as defined by all of the following criteria:; Isolated tremor syndrome consisting of bilateral upper limb action tremor; At least 3 years duration; With or without tremor in other locations (eg, head, voice, or lower limbs)
  • Absence of other neurological signs, such as dystonia, ataxia, or parkinsonism, isolated focal tremors (eg, voice, head), task- and position-specific tremors, sudden tremor onset, or evidence of stepwise deterioration of tremor
  • Participant has the following:; Scores of at least 12 in the combined TETRAS Performance Subscale Item 4 (upper limb tremor) at both Screening and pre-dose on Day 1; Scores of at least 6 in the total TETRAS Performance Subscale Item 4 score for the dominant upper limb (the sum of the three items for either the right or left upper limb, whichever is dominant) at both Screening and pre-dose on Day 1
  • Participant has a baseline TETRAS ADL Subscale score of at least 20 at Screening
  • Willing to discontinue medications taken for the treatment of ET except propranolol at least 14 days or 5 half-lives (whichever is longer) prior to receiving the investigational product (IP). Medications taken for the treatment of ET that were discontinued prior to receiving IP may be resumed following Day 97. Participants in the adjunct therapy cohort must be on a stable dose of propranolol (maximum total daily propranolol dose up to 320 mg allowed) for the treatment of ET from 3 months prior to Screening through Day 97 of the study
  • Participant is willing to limit use of alcohol to 2 units per day for males and 1 unit per day for females starting at least 1 week prior to Day 1 and through Day 97 of the study
  • Participant is willing to maintain prestudy consumption of products that contain nicotine starting at least 1 week prior to Day 1 and through Day 97 of the study

Ki nem vehet részt

  • Participant has had newly administered tremorgenic drugs (14 days or 5 half-lives [whichever is longer] prior to Day 1) or presence of alcohol withdrawal state
  • Direct or indirect injury or trauma to the nervous system within 3 months before the onset of tremor
  • Previous procedure for the treatment of ET, deep brain stimulation, brain lesioning, or magnetic resonance (MR) guided procedure, eg, MR-guided focused ultrasound. Use of Cala Trio bracelet for the treatment of ET from two weeks prior to Day 1 through Day 97 is prohibited
  • Participant has history of substance abuse or dependence prior to Screening, has a positive screen for drugs of abuse at Screening or predose on Day 1. Participants with nicotine use disorder that impacts their tremor are excluded
  • Historical or clinical evidence of tremor with functional neurological syndrome origin
  • Participant currently requires propranolol treatment for a medical condition other than ET
  • Presence of known causes of enhanced physiological tremor
  • Participant has had botulinum toxin for treatment of ET within 6 months of Screening

Helyszínek itt: Egyesült Államok

  • Asheville, North CarolinaHospital not named in the registry
  • Atlanta, GeorgiaHospital not named in the registry
  • Austin, TexasHospital not named in the registry
  • Boca Raton, FloridaHospital not named in the registry
  • Boston, MassachusettsHospital not named in the registry
  • Boynton Beach, FloridaHospital not named in the registry
  • Bradenton, FloridaHospital not named in the registry
  • Chicago, IllinoisHospital not named in the registry
  • Cincinnati, OhioHospital not named in the registry
  • Coral Springs, FloridaHospital not named in the registry
  • Dayton, OhioHospital not named in the registry
  • Decatur, GeorgiaHospital not named in the registry
  • Englewood, ColoradoHospital not named in the registry
  • Farmington Hills, MichiganHospital not named in the registry
  • Fort Worth, TexasHospital not named in the registry
  • Fountain Valley, CaliforniaHospital not named in the registry
  • Fullerton, CaliforniaHospital not named in the registry
  • Gainesville, FloridaHospital not named in the registry
  • Hollywood, FloridaHospital not named in the registry
  • Hoover, AlabamaHospital not named in the registry
  • Houston, TexasHospital not named in the registry
  • Kansas City, KansasHospital not named in the registry
  • Katy, TexasHospital not named in the registry
  • Kendall, FloridaHospital not named in the registry
  • Kirkland, WashingtonHospital not named in the registry
  • Lansing, MichiganHospital not named in the registry
  • Las Vegas, NevadaHospital not named in the registry
  • Lexington, KentuckyHospital not named in the registry
  • Los Angeles, CaliforniaHospital not named in the registry
  • McLean, VirginiaHospital not named in the registry
  • Memphis, TennesseeHospital not named in the registry
  • Miami, FloridaHospital not named in the registry
  • Naples, FloridaHospital not named in the registry
  • New YorkHospital not named in the registry
  • Orlando, FloridaHospital not named in the registry
  • Pensacola, FloridaHospital not named in the registry
  • Phoenix, ArizonaHospital not named in the registry
  • Port Charlotte, FloridaHospital not named in the registry
  • Round Rock, TexasHospital not named in the registry
  • San Antonio, TexasHospital not named in the registry
  • Scottsdale, ArizonaHospital not named in the registry
  • Shreveport, LouisianaHospital not named in the registry
  • Spokane, WashingtonHospital not named in the registry
  • Springfield, IllinoisHospital not named in the registry
  • Sun City, ArizonaHospital not named in the registry
  • Tampa, FloridaHospital not named in the registry
  • Tulsa, OklahomaHospital not named in the registry
  • West Falls Church, VirginiaHospital not named in the registry

A vizsgálatról

Mit akar kideríteni a vizsgálat

The primary purpose of this study is to evaluate the dose-response relationship of different doses of SAGE-324 on upper extremity tremor in participants with essential tremor (ET) in the monotherapy cohort.

A vizsgálat 4 csoportja

  • SAGE-324 Matched PlaceboPlacebo, összehasonlításként

    Participants will receive SAGE-324 matched placebo, stratified by baseline propranolol use. Monotherapy: Participants will receive SAGE-324 matched placebo, oral tablets, once daily (QD), in the evening, from Day 1 to Day 90 in a double-blind treatment period. Adjunct therapy: Participants will receive SAGE-324 matched placebo, oral tablets, QD, in the evening, from Day 1 to Day 90 along with a stable dose of up to 320 milligrams (mg) of propranolol from 3 months prior to Screening up to Day 90 in a double-blind treatment period.

  • SAGE-324 15 mgA vizsgált kezelés

    Participants will receive SAGE-324, 15 mg, stratified by baseline propranolol use. Monotherapy: Participants will receive SAGE-324, 15 mg, oral tablets, QD, in the evening, from Day 1 to Day 90 in a double-blind treatment period. Adjunct therapy: Participants will receive SAGE-324, 15 mg, oral tablets, QD, in the evening, from Day 1 to Day 90 along with a stable dose of up to 320 mg of propranolol from 3 months prior to Screening up to Day 90 in a double-blind treatment period.

    Kezelés: SAGE-324

  • SAGE-324 30 mgA vizsgált kezelés

    Participants will receive SAGE-324, 30 mg, stratified by baseline propranolol use. Monotherapy: Participants will receive SAGE-324, 30 mg, oral tablets, QD, in the evening, from Day 1 to Day 90 in a double-blind treatment period. Adjunct therapy: Participants will receive SAGE-324, 30 mg, oral tablets, QD, in the evening, from Day 1 to Day 90 along with a stable dose of up to 320 mg of propranolol from 3 months prior to Screening up to Day 90 in a double-blind treatment period.

    Kezelés: SAGE-324

  • SAGE-324 60 mgA vizsgált kezelés

    Participants will receive SAGE-324: 15 mg, 30 mg, 45 mg, and 60 mg, stratified by baseline propranolol use. Monotherapy: Participants will receive SAGE-324, 15 mg from Day 1 to 14, followed by up-titration to 30 mg from Day 15 to 28, then to 45 mg from Day 29 to 42, and then to 60 mg from Day 43 to 90, oral tablets, QD, in the evening, from Day 1 to Day 90 in a double-blind treatment period. Adjunct therapy: Participants will receive SAGE-324, 15 mg from Day 1 to 14, followed by up-titration to 30 mg from Day 15 to 28, then to 45 mg from Day 29 to 42, and then to 60 mg from Day 43 to 90, oral tablets, QD, in the evening, from Day 1 to Day 90 along with a stable dose of up to 320 mg of propranolol from 3 months prior to Screening up to Day 90 in a double-blind treatment period.

    Kezelés: SAGE-324

Adatok és források

Regiszteradat
Szerepel a ClinicalTrials.gov-on.
Hivatalos cím
A Phase 2, Double-Blind, Randomized, Placebo-Controlled, Dose-Response Study of SAGE-324 for the Treatment of Essential Tremor
A regiszteradat frissítve
2025. május 16.