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A Study to Investigate the Efficacy and Safety of NT 201 (Botulinum Toxin) Compared With Placebo for the Treatment of Adult Participants With Essential Tremor in the Arm

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ClinicalTrials.gov Identifier: NCT04766723
Recruitment Status : Recruiting
First Posted : February 23, 2021
Last Update Posted : May 4, 2021
Sponsor:
Information provided by (Responsible Party):
Merz Pharmaceuticals GmbH

Brief Summary:

The purpose of this study is to determine whether a single treatment with administration of NT 201 (botulinum toxin) is superior to placebo (no medicine) for one-sided treatment of essential tremor in the arm (Unilateral Period). Participants will be assigned to the treatment groups by chance and neither the participants nor the research staff who interact with them will know the allocation.

The following treatment cycle will investigate the safety and tolerability of two-sided treatment with NT 201 (botulinum toxin) (Open Label Bliaterial Period). All participants will receive NT 201 treatment.


Condition or disease Intervention/treatment Phase
Essential Tremor Drug: NT 201 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Prospective, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial With an Open-label Period to Investigate the Efficacy and Safety of NT 201 in the Unilateral and Bilateral Treatment of Essential Tremor of the Upper Limb
Actual Study Start Date : February 24, 2021
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : November 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tremor

Arm Intervention/treatment
Experimental: NT 201 (IncobotulinumtoxinA, Xeomin)

Unilateral Treatment Period (1 treatment cycle): subjects to receive unilateral intramuscular injection of NT 201 (130-165 units) into muscles of the upper limb.

Open Label Bilateral Treatment Period (1 treatment cycle): subjects to receive bilateral intramuscular injection of NT 201 (130-165 units) into muscles of the upper limbs.

Drug: NT 201
Active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins. Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl).
Other Names:
  • Incobotulinumtoxin A
  • IncobotulinumtoxinA
  • Xeomin
  • Botulinum toxin type A (150 kiloDalton), free from complexing proteins

Placebo Comparator: Placebo

Unilateral Treatment Period (1 treatment cycle): subjects to receive unilateral intramuscular placebo injection into muscles of the upper limb.

Open Label Bilateral Treatment Period (1 treatment cycle): subjects to receive bilateral intramuscular injection of NT 201 (130-165 units per arm) into muscles of the upper limbs.

Drug: NT 201
Active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins. Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl).
Other Names:
  • Incobotulinumtoxin A
  • IncobotulinumtoxinA
  • Xeomin
  • Botulinum toxin type A (150 kiloDalton), free from complexing proteins

Drug: Placebo
Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl).




Primary Outcome Measures :
  1. Change from study baseline to Week 6 in maximum tremor amplitude measurement at wrist level during the unilateral treatment period [ Time Frame: From baseline to week 6 ]

Secondary Outcome Measures :
  1. Change from study baseline to Week 6 in the Essential Tremor Rating Assessment Scale [TETRAS] Performance dominant upper limb [UL] score [ Time Frame: From baseline to week 6 ]
  2. Change from study baseline to Week 6 in TETRAS Activities of Daily Living [ADL] UL score [ Time Frame: From baseline to week 6 ]
  3. Change from study baseline to Week 6 in TETRAS ADL Functional Impact score [ Time Frame: From baseline to week 6 ]
  4. Subject´s Global Impression of Change Scale [GICS] score of motor dominant UL at Week 6 [ Time Frame: Week 6 ]
  5. Investigator´s Global Impression of Change Scale [GICS] score of motor dominant UL at Week 6 [ Time Frame: Week 6 ]
  6. Change from Cycle 2 baseline to Week 6 in TETRAS Performance dominant UL score [ Time Frame: Week 24 to week 36 ]
  7. Change from Cycle 2 baseline to Week 6 in TETRAS Performance subscale score [ Time Frame: Week 24 to week 36 ]
  8. Change from Cycle 2 baseline to Week 6 in TETRAS ADL UL score [ Time Frame: Week 24 to week 36 ]
  9. Change from Cycle 2 baseline to Week 6 in TETRAS ADL Functional Impact score [ Time Frame: Week 24 to week 36 ]
  10. Incidence of treatment-emergent AEs [TEAEs] related to treatment [ Time Frame: From baseline to week 36 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

- Score of ≥ 2 (at least 1 cm tremor amplitude) in at least two out of three maneuvers of test item 4 (upper limb tremor) confirmed by an independent TETRAS expert by means of video assessment.

Exclusion Criteria:

  • History or presence of day-to-day fluctuations in ET which would jeopardize meaningful tremor assessment over time, e.g. severe tremor on one day and minimal or no tremor on another day.
  • Other neurological signs, such as dystonia, ataxia, or parkinsonism, which in the judgment of the investigator could interfere with the ET diagnosis and/or assessment of ET in ULs.
  • Tremor types other than ET

Information from the National Library of Medicine

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): NCT04766723


Contacts
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Contact: Public Disclosure Manager +49 69 1503 0 clinicaltrials@merz.com

Locations
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United States, Florida
USF, Department of Neurology, Merz Investigational Site #0010020 Recruiting
Tampa, Florida, United States, 33612
United States, Washington
Selkirk Neurology, Merz Investigational Site #0010456 Recruiting
Spokane, Washington, United States, 99202
Sponsors and Collaborators
Merz Pharmaceuticals GmbH
Investigators
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Study Director: Merz Medical Expert Merz Pharmaceuticals GmbH
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Responsible Party: Merz Pharmaceuticals GmbH
ClinicalTrials.gov Identifier: NCT04766723    
Other Study ID Numbers: M602011069
First Posted: February 23, 2021    Key Record Dates
Last Update Posted: May 4, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Tremor
Essential Tremor
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Movement Disorders
Central Nervous System Diseases
Botulinum Toxins
Botulinum Toxins, Type A
abobotulinumtoxinA
incobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents