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Dysport in Post-Surgical Neuralgia (PMOD03)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03663101
Recruitment Status : Completed
First Posted : September 10, 2018
Last Update Posted : November 29, 2019
Sponsor:
Information provided by (Responsible Party):
Ipsen

Brief Summary:
The study is designed to determine whether a currently licensed version of botulinum toxin (Dysport®) is effective for the treatment of pain that has developed and/or persisted for months or years around the scar of a previous surgical site, and whether this condition could be suitable for the testing of similar new medicines. The study will compare three different doses of Dysport® to see if there is benefit and/or a best dose for treating persistent post-surgery scar pain.

Condition or disease Intervention/treatment Phase
Chronic Scar Pain Drug: Lidocaine Biological: Botulinum toxin type A Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Double-blind, Randomised, Placebo Controlled, Proof-of-concept Study in Subjects With Abdominal or Thoracic Chronic Scar Pain to Assess the Analgesic Properties of Intradermal Doses of Dysport®
Actual Study Start Date : October 30, 2018
Actual Primary Completion Date : November 8, 2019
Actual Study Completion Date : November 8, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox Scars

Arm Intervention/treatment
Experimental: Pre-Randomization, Run-In period (part A)
Crossover run-in part A - Subjects will be injected (Test 1) with either saline or local anaesthetic (lidocaine). One week later, they will be crossed over, injected with the other agent (Test 2).
Drug: Lidocaine
0.5 mL (2.5 mg) of lidocaine per injection point will be injected subcutaneously (maximum 10 injection points).

Drug: Placebo
Part A - 0.5 mL of sodium chloride solution 0.9% (saline solution) per injection point will be injected subcutaneously (maximum 10 injection points).
Other Name: Saline solution

Experimental: Dysport dose 1 (part B)
Dysport dose 1 as a single-dose, intradermal injection.
Biological: Botulinum toxin type A
0.2 mL of one of three different doses of Dysport per injection point will be injected intradermally (maximum 10 injection points).
Other Name: AbobotulinumtoxinA (Dysport®)

Experimental: Dysport dose 2 (part B)
Dysport dose 2 as a single-dose, intradermal injection.
Biological: Botulinum toxin type A
0.2 mL of one of three different doses of Dysport per injection point will be injected intradermally (maximum 10 injection points).
Other Name: AbobotulinumtoxinA (Dysport®)

Experimental: Dysport dose 3 (part B)
Dysport dose 3 as a single-dose, intradermal injection.
Biological: Botulinum toxin type A
0.2 mL of one of three different doses of Dysport per injection point will be injected intradermally (maximum 10 injection points).
Other Name: AbobotulinumtoxinA (Dysport®)

Placebo Comparator: Placebo (saline solution) (part B)
Placebo single-dose, intradermal injection.
Drug: Placebo
Part B - 0.2 mL of sodium chloride solution 0.9% (saline solution) per injection point will be injected intradermally (maximum 10 injection points, 2,0 mL maximum).




Primary Outcome Measures :
  1. Time to onset [ Time Frame: From baseline to first time when decrease pain of two points as per spontaneous NRS score data. Up to 24 hours. ]
    Time to decrease points in the spontaneous Pain Numerical Rating Scale (NRS) score in each treatment group.

  2. Peak-effect [ Time Frame: From baseline to time of maximal decrease of pain as per spontaneous NRS score data. Up to 48 hours ]
    The mean peak of maximal decrease in NRC score in each treatment group.

  3. Time to peak-effect [ Time Frame: From baseline to time of maximal .decrease of pain as per spontaneous NRS score data in the treatment group. Up to 48 hours ]
    The time to reach the peak effect in each treatment group.

  4. Duration of effect [ Time Frame: From onset time point till last timepoint with change of NRS score is ≥2 points from baseline. Up to 16 weeks. ]
    The mean duration of effect in each treatment group (for the subjects who reach the time to onset).


Secondary Outcome Measures :
  1. Change in the spontaneous NRS score [ Time Frame: Change from baseline to end of study (up to 16 weeks) - Part B ]
  2. Change in the stimulus-evoked NRS score [ Time Frame: Change from baseline to end of study (up to 16 weeks) - Part B ]
  3. Safety assessment will include monitoring of Adverse events (AEs) [ Time Frame: Baseline to end of study (up to 16 weeks) - Part B ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female subjects aged between 18 and 75 years inclusive at the time of giving informed consent.
  • Subjects suffering from an area of chronic pain post-abdominal or thoracic surgery, chronic abdominal or thoracic scar pain.
  • Longitudinal axis of the pain area of 10 cm long maximum (as mapped upon screening).
  • Subjects with moderate to severe pain, i.e. spontaneous NRS score of 4-8 which has been stable for the previous month before screening.
  • Stable use of analgesics (or any medication impacting pain perception) during the month before screening and expected to be stable for the study duration.
  • Under stable medication regimen for other medication, i.e. during the month before screening.
  • Time from surgery which caused the painful scar more than six months and less than ten years at screening.
  • No other distracting pain either chronic or acute.
  • Female subjects of childbearing potential must have a negative urine pregnancy test result and be willing to use reliable contraceptive measures throughout study participation.
  • The subject's primary care physician has provided evidence which can be used to confirm that within the last 12 months of dosing that there is nothing in their medical history that would preclude their enrolment into a clinical study.

Exclusion Criteria:

  • Previous treatment with Botulinum neurotoxin (BTX) (any serotype) during the past six months before screening.
  • History of hypersensitivity to any of the components of the Dysport formulation (which includes human serum albumin and lactose) or allergy to cow's milk protein.
  • Known hypersensitivity to lidocaine or other anaesthetics of the amide type, known hypersensitivity to hydroxybenzoates, complete heart block, hypovolaemia.
  • Any medical condition that may put the subject at risk with exposure to BTX, including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other disease that might interfere with neuromuscular function.
  • Opioid analgesic use at a Morphine Equivalent Dosage (MED) of >75mg per day.
  • Neuroma in the scar pain area, diagnosed per ultrasound.
  • Use of agents that could interfere with neuromuscular transmission, including calcium channel blockers, penicillamine, aminoglycosides, lincosamides, polymixins, magnesium sulphate, anticholinesterases, succinylcholine and quinidine.
  • Need of any prohibited medication.
  • Any abnormal laboratory value, physical examination, vital signs, or electrocardiogram (ECG) that, in the opinion of the investigator, is clinically significant and that would compromise the safety of the subject in the study.
  • Positive for hepatitis B antigen or hepatitis C virus ribonucleic acid, positive results for human immunodeficiency virus, or who receives diagnosis for acquired immunodeficiency syndrome.
  • Positive urine screen for drugs of abuse (except for cotinine and unless explained by the investigator for therapeutic use of medication) or any history of drug or alcohol abuse, misuse, physical or psychological dependence, mood changes, sleep disturbance and functional capacity which have an impact on pain perception.
  • Significant neurological or psychiatric disorders including mental instability (unrelated to the pain) that could interfere with pain assessments; other pre-existing pain syndromes, acute or chronic, that might impair the assessment of the scar pain.
  • Any medical history of significance and/or inadequately controlled such as cardiovascular (e.g. uncontrolled high blood pressure, high risk of cardiovascular events, severe heart failure), pulmonary (e.g. uncontrolled asthma or emphysema), haematologic, (e.g. coagulopathy/bleeding disorders), neurological (e.g. swallowing problems, blurred or double vision, trouble saying words clearly (dysarthria), hoarseness or change or loss of voice (dysphonia)), liver disease (e.g. severe hepatic impairment), kidney disease (e.g. impaired renal function in subjects taking diuretics, angiotensin converting enzyme (ACE)-inhibitors, or angiotensin II antagonists), endocrine, immunologic, dermatologic painful conditions or any other conditions that may compromise in the opinion of the investigator the ability of the subject to participate in the study.
  • Subjects who participated in a clinical research study involving a new chemical entity or an experimental drug within 30 days before screening.

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): NCT03663101


Locations
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United Kingdom
St Pancras Clinical Research
London, United Kingdom, WC1X8QD
Sponsors and Collaborators
Ipsen
Investigators
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Study Director: Ipsen Medical Director Ipsen
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Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT03663101    
Other Study ID Numbers: D-FR-52120-244
2018-001703-37 ( EudraCT Number )
First Posted: September 10, 2018    Key Record Dates
Last Update Posted: November 29, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lidocaine
Botulinum Toxins
Botulinum Toxins, Type A
abobotulinumtoxinA
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Acetylcholine Release Inhibitors
Cholinergic Agents
Neurotransmitter Agents
Neuromuscular Agents