Study to Assess the Safety, Tolerability and Preliminary Efficacy of NLX-112 Versus Placebo in L-dopa-induced Dyskinesia
Condition: Medication-Induced Dyskinesia
MeSH terms: Dyskinesias; Dyskinesia, Drug-Induced
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a double-blind, randomized, placebo-controlled Phase 2a study evaluating the safety,
      tolerability, and preliminary efficacy of up to 2 mg/day (1 mg BID) of NLX-112 versus placebo
      in patients with moderate to severe L-DOPA induced dyskinesia (LID) in Parkinson's disease
      (PD). NLX-112 will be up-titrated to either 2 mg/day or to the highest well-tolerated dose
      less than 2 mg/day over 4 weeks, maintained at the well-tolerated dose for an additional 2
      weeks, and then down-titrated over 2 weeks.
    

Detailed description: 
      This is a two-arm, double-blind, randomized, placebo-controlled Phase 2a study evaluating the
      safety, tolerability, and preliminary efficacy of up to 2 mg/day of NLX 112 versus placebo in
      patients with moderate to severe L-DOPA induced dyskinesia (LID) in Parkinson's disease (PD).
      NLX-112 will be up-titrated to either 2 mg/day (1 mg BID) or to the highest well-tolerated
      dose less than 2 mg/day over 4 weeks, maintained at the well-tolerated dose for an additional
      2 weeks, and then down-titrated over 2 weeks.

      Patients will report to the study clinic for a screening visit (Visit 1), followed by a
      baseline visit on Day 1 (Visit 2) where patients will be randomized and begin treatment. Two
      remote safety visits over telephone (Days 7 and 49 [Visit 3 and Visit 8]) will be conducted.
      Once treatment has commenced, there will be 2 in-person safety visits to the clinic (Days 14
      and 21 [Visit 4 and Visit 5]), 2 in-person efficacy visits to the clinic (Days 28 and 42
      [Visit 6 and Visit 7]) and one follow-up in person final safety visit (Day 70 [Visit 9]). In
      total, patients will report to the clinic for 7 in-person visits. Patients entering the study
      will be randomized in a 2:1 ratio (16:8 patients) to receive either NLX 112 or placebo.

      At Visits 2, 6 and 7, efficacy assessments will start 30 minutes after the patient has taken
      150% of his or her regular L-DOPA dose, when the patient is ON and experiencing typical
      dyskinesia.

      A PD Home Dyskinesia Diary (electronic) will be completed by the patients and/or caregiver
      with concordance in ON time with dyskinesia between study staff and patient. Four consecutive
      24-hour diaries will be completed prior to randomization (baseline, Visit 2) and prior to the
      clinic visits on Days 28 and 42 (Visits 6 and 7).

      A wearable dyskinesia assessment device will be used to monitor dyskinesias during a 4-day
      period prior to the baseline visit (Day 1, Visit 2) and a 4-day period prior to the clinic
      visits on Days 28 and 42 (Visits 6 and 7, respectively).

      Blood will be collected for possible NLX-112 plasma concentration measurements on Days 14,
      21, 28, 42 and 70 (Visits 4, 5, 6, 7 and 9).
    

Intervention name(s): NLX-112; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): NLX-112 will be supplied as tablets containing 0.25 mg NLX-112. NLX-112 is a structurally novel centrally acting, high-efficacy selective 5-HT1A receptor agonist with nanomolar affinity for 5-HT1A receptors. Proposed as a treatment for L-DOPA-induced-dyskinesia in Parkinson's disease.; Placebo will be matching tablets (identical weight, shape and color) without NLX-112.
Other intervention name(s): F13640; befiradol; 4-piperidinemethanamine; 1-(3-chloro-4-fluorobenzoyl)-4-fluoro-N-[(5-methyl-2-pyridinyl)-methyl]; (2E)-2-butenedioate
Intervention MeSH terms: Befiradol
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Double-blind, randomized, placebo-controlled Phase 2a study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Levodopa; Dyskinesia; Parkinson´s disease; L-dopa; NLX-112; Befiradol; LID