Study to Compare the Efficacy and Safety of NT 201 (Botulinum Toxin) With Placebo for the Treatment of Lower Limb Spasticity Caused by Stroke or Traumatic Brain Injury (PATTERN)
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| ClinicalTrials.gov Identifier: NCT03992404 |
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Recruitment Status :
Recruiting
First Posted : June 20, 2019
Last Update Posted : May 20, 2024
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The purpose of this study is to determine whether a single treatment with administration of 400 Units NT 201 (botulinum toxin) is superior to placebo (no medicine) for the treatment of lower limb spasticity caused by stroke or traumatic brain injury (Main 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 4 to 5 treatment cycles will investigate the safety and tolerability of treatment with NT 201 (botulinum toxin) when administered in doses between 400 and 800 Units (Open Label Extension Period). All participants will receive the treatment and the dose will depend on whether only lower limb spasticity or combined upper and lower limb spasticity are treated.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Lower Limb or Combined Lower Limb and Upper Limb Spasticity Due to Stroke or Traumatic Brain Injury | Drug: NT 201 Drug: Placebo | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 600 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | Prospective, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Investigate the Efficacy and Safety of NT 201 in the Treatment of Lower Limb Spasticity Caused by Stroke or Traumatic Brain Injury in Adult Subjects, Followed by an Open Label Extension With or Without Combined Upper Limb Treatment |
| Actual Study Start Date : | September 16, 2019 |
| Estimated Primary Completion Date : | August 2025 |
| Estimated Study Completion Date : | April 2027 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: NT 201 (IncobotulinumtoxinA, Xeomin)
Main Period (1 treatment cycle): subjects to receive intramuscular injection of NT 201 (400 units) into muscles of the lower limb. Open Label Extension Period (4-5 treatment cycles): subjects to receive intramuscular injection of NT 201 (up to 800 units) into muscles of the lower limb and upper limb, if indicated. |
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:
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Placebo Comparator: Placebo
Main Period (1 treatment cycle): subjects to receive intramuscular placebo injection into muscles of the lower limb. Open Label Extension Period (4-5 treatment cycles): subjects to receive intramuscular injection of NT 201 (up to 800 units) into muscles of the lower limb and upper limb, if indicated. |
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:
Drug: Placebo Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl). |
- Change from baseline in derived Modified Ashworth Scale-Bohannon (MAS) ankle score (knee extended) at weeks 4 to 6 [ Time Frame: Baseline to week 4-6 ]The MAS is a 6-grade scale
- Co-Primary: Global Impression of Change Scale (GICS) assessed by physician at Week 4 to 6 [ Time Frame: Week 4-6 ]The GICS s a 9-grade scale
- Occurrence of treatment emergent adverse events [TEAEs] in the Main Period [ Time Frame: Baseline to week 12 ]
- Change from Study Baseline in Goal Attainment Scale [GAS] at Week 6 [ Time Frame: Baseline to week 6 ]The GAS is a 6-grade scale
- Global Impression of Change Scale (GICS) assessed by the study subject at Week 4 to 6 [ Time Frame: Week 4-6 ]The GICS s a 9-grade scale
- Global Impression of Change Scale (GICS) assessed by the caregiver at Week 4 to 6 [ Time Frame: Week 4-6 ]The GICS s a 9-grade scale
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| Ages Eligible for Study: | 18 Years to 85 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Female or male subject ≥ 18 years and ≤ 85 years at screening
- Diagnosis of lower limb spasticity with or without upper limb spasticity of the same body side caused by stroke or traumatic brain injury
- Disabling ankle flexor spasticity presenting as pes equinus or pes equinovarus
- Modified Ashworth Scale-Bohannon [MAS] score of 2 or 3 points in the ankle plantar flexor of the target lower limb (supine position, knee extended)
- Minimum passive range of motion in ankle of the target lower limb (supine position, knee extended): 10°dorsiflexion and 20°plantarflexion
- At least 4 months since last botulinum neurotoxin [BoNT] injection for treatment of spasticity or any other condition
- For subjects receiving anticoagulation therapy, the investigator confirms and documents that the subject has an:
- Activated partial thromboplastin time [aPTT] ≤ 80 seconds (subjects on dabigatran or other direct thrombin inhibitors) or
- International normalized ratio [INR] value of ≤ 2.5 (subjects on coumarins or other anticoagulants monitored by INR)
Exclusion Criteria:
- Generalized disorders of muscle activity (e.g. myasthenia gravis, Lambert Eaton syndrome, amyotrophic lateral sclerosis) or any other significant peripheral neuromuscular dysfunction which might interfere with the study
- Bilateral lower limb paresis/paralysis/spasticity or tetraparesis/paralysis/spasticity
- Body weight < 50 kg
- Severe atrophy of the target limb muscles
- Previous, ongoing or planned treatments of spasticity with intrathecal baclofen
- Previous, ongoing, or planned treatments of spasticity in the target lower limb with any of the following procedures: Surgical Intervention; Alcohol or phenol block; Muscle afferent block
- Physiotherapy or use of orthoses or splints at the target limb initiated less than 4 weeks before screening or expected to change during the double blind phase of the study
- Current or planned treatment with parenterally administered drugs that interfere with neuromuscular transmission (e.g. intrathecal baclofen, tubocurarine type muscle relaxants used in anesthesia), or local anesthetics in the treated region within 2 weeks prior to screening
- Infection or inflammation at the injection sites
- Subjects with presence or history of aspiration pneumonia, recurrent lower respiratory tract infections, or compromised respiratory function as per investigator's clinical judgment
- Pregnancy (as verified by a positive pregnancy test) or breast feeding
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): NCT03992404
| Contact: Public Disclosure Manager | +49 69 1503 0 | clinicaltrials@merz.de |
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| Study Director: | Merz Medical Expert | Merz Pharmaceuticals GmbH |
| Responsible Party: | Merz Pharmaceuticals GmbH |
| ClinicalTrials.gov Identifier: | NCT03992404 |
| Other Study ID Numbers: |
M602011014 2018-001639-35 ( EudraCT Number ) |
| First Posted: | June 20, 2019 Key Record Dates |
| Last Update Posted: | May 20, 2024 |
| Last Verified: | May 2024 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
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Muscle Spasticity Stroke Brain Injuries Brain Injuries, Traumatic Wounds and Injuries Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases Craniocerebral Trauma Trauma, Nervous System Muscular Diseases Musculoskeletal Diseases |
Muscle Hypertonia Neuromuscular Manifestations Neurologic Manifestations 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 |